ISO 15223-1:2016
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
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Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users
06-07-2021
French, English
02-11-2016
ISO 15223-1:2016 identifies requirements for symbols used in medical device labelling that convey information on the safe and effective use of medical devices. It also lists symbols that satisfy the requirements of this document.
ISO 15223-1:2016 is applicable to symbols used in a broad spectrum of medical devices, which are marketed globally and therefore need to meet different regulatory requirements.
These symbols may be used on the medical device itself, on its packaging or in the associated documentation. The requirements of this document are not intended to apply to symbols specified in other standards.
DevelopmentNote |
Together with ISO 15223-2 supersedes ISO 15223. (01/2010) Supersedes ISO/DIS 15223-1. (11/2016)
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DocumentType |
Standard
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Pages |
25
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ProductNote |
THIS STANDARD HAVE CORRECT VERSION FOR EN AND FR FOR 2017
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PublisherName |
International Organization for Standardization
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Status |
Withdrawn
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SupersededBy | |
Supersedes |
Standards | Relationship |
UNE-EN ISO 15223-1:2017 | Identical |
I.S. EN ISO 15223-1:2016&LC:2016 | Identical |
NF EN ISO 15223-1 : 2017 | Identical |
NEN EN ISO 15223-1 : 2016 + COR 2017 | Identical |
NS EN ISO 15223-1 : 2016 | Identical |
I.S. EN ISO 15223-1:2016 | Identical |
PN EN ISO 15223-1 : 2017 | Identical |
SN EN ISO 15223-1 : 2017 | Identical |
UNI CEI EN ISO 15223-1 : 2012 | Identical |
CEI UNI EN ISO 15223-1 : 2018 | Identical |
SS-EN ISO 15223-1:2016 | Identical |
NEN-EN-ISO 15223-1:2016 | Identical |
UNI CEI EN ISO 15223-1:2017 | Identical |
EN ISO 15223-1:2016 | Identical |
JIS T 3211-11:2019 | Identical |
IS/ISO 15223 : Part 1 : 2016 | Identical |
ANSI/AAMI/ISO 15223-1:2016 | Identical |
BS EN ISO 15223-1:2016 | Identical |
CEI UNI EN ISO 15223-1 : 2013 | Identical |
DIN EN ISO 15223-1:2015-08 (Draft) | Identical |
NEN ISO 15223-1 : 2007 AMD 1 2008 | Identical |
NBN EN ISO 15223-1 : 2012 | Identical |
GOST R ISO 15223-1 : 2014 | Identical |
CSA C22.2 No. 80601-2-56 : 2012 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-56: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CLINICAL THERMOMETERS FOR BODY TEMPERATURE MEASUREMENT |
BS EN ISO 18113-2:2011 | In vitro diagnostic medical Devices. Information supplied by the manufacturer (labelling) In vitro diagnostic reagents for professional use |
DIN EN ISO 18113-4:2013-01 | In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2009) |
CEI EN 60601-1-11 : 2016 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-11: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS USED IN THE HOME HEALTHCARE ENVIRONMENT |
I.S. EN ISO 5364:2016 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - OROPHARYNGEAL AIRWAYS (ISO 5364:2016) |
NF ISO 28620 : 2010 | MEDICAL DEVICES - NON-ELECTRICALLY DRIVEN PORTABLE INFUSION DEVICES |
PD IEC/TR 60878:2015 | Graphical symbols for electrical equipment in medical practice |
10/30212297 DC : 0 | BS ISO 11040-6 - PREFILLED SYRINGES - PART 6: PLASTIC BARRELS FOR INJECTABLES |
11/30227250 DC : 0 | BS EN ISO 21563 - DENTISTRY - HYDROCOLLOID IMPRESSION MATERIALS |
BS EN ISO 14155:2011 | Clinical investigation of medical devices for human subjects. Good clinical practice |
13/30273308 DC : 0 | BS EN ISO 3826-4 - PLASTICS COLLAPSIBLE CONTAINERS FOR HUMAN BLOOD AND BLOOD COMPONENTS - PART 4: APHAERESIS BLOOD BAG SYSTEMS WITH INTEGRATED FEATURES |
UNI EN ISO 80601-2-61 : 2011 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-61: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF PULSE OXIMETER EQUIPMENT |
DIN EN ISO 80601-2-69:2014-12 | Medical electrical equipment - Part 2-69: Particular requirements for basic safety and essential performance of oxygen concentrator equipment (ISO 80601-2-69:2014) |
DIN EN ISO 3630-4:2009-10 | Dentistry - Root canal instruments - Part 4: Auxiliary instruments (ISO 3630-4:2009) |
BS EN ISO 80601-2-61:2011 | Medical electrical equipment Particular requirements for basic safety and essential performance of pulse oximeter equipment |
BS EN ISO 1135-5:2015 | Transfusion equipment for medical use Transfusion sets for single use with pressure infusion apparatus |
17/30357887 DC : 0 | BS ISO 20493 - TRADITIONAL CHINESE MEDICINE - INFRARED MOXIBUSTION-LIKE INSTRUMENT |
14/30289772 DC : 0 | BS EN 1789:2007+A1:2010/A2 - MEDICAL VEHICLES AND THEIR EQUIPMENT - ROAD AMBULANCES |
13/30276989 DC : 0 | BS EN ISO 11070 - STERILE, SINGLE-USE INTRAVASCULAR CATHETER INTRODUCERS |
CEI EN 60601-2-49 : 2016 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-49: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF MULTIFUNCTION PATIENT MONITORING EQUIPMENT |
11/30242579 DC : 0 | BS EN ISO 6873:2000 - DENTAL GYPSUM PRODUCTS |
UNI EN ISO 23908 : 2013 | SHARPS INJURY PROTECTION - REQUIREMENTS AND TEST METHODS - SHARPS PROTECTION FEATURES FOR SINGLE-USE HYPODERMIC NEEDLES, INTRODUCERS FOR CATHETERS AND NEEDLES USED FOR BLOOD SAMPLING |
ANSI/AAMI CI86:2017 | COCHLEAR IMPLANT SYSTEMS: REQUIREMENTS FOR SAFETY, FUNCTIONAL VERIFICATION, LABELING AND RELIABILITY REPORTING |
BS EN ISO 80601-2-56:2017 | Medical electrical equipment Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement |
PREN ISO 80601-2-61 : DRAFT 2009 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-61: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF PULSE OXIMETER EQUIPMENT FOR MEDICAL USE |
16/30331650 DC : 0 | BS EN ISO 8637-1 - EXTRACORPOREAL SYSTEMS FOR BLOOD PURIFICATION - PART 1: HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS AND HAEMOCONCENTRATORS |
I.S. EN ISO 1135-5:2015 | TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 5: TRANSFUSION SETS FOR SINGLE USE WITH PRESSURE INFUSION APPARATUS (ISO 1135-5:2015) |
DIN EN ISO 13017:2016-05 | DENTISTRY - MAGNETIC ATTACHMENTS (ISO 13017:2012 + AMD.1:2015) |
BS EN ISO 80601-2-69:2014 | Medical electrical equipment Particular requirements for basic safety and essential performance of oxygen concentrator equipment |
14/30295067 DC : 0 | BS EN ISO 16671 - OPHTHALMIC IMPLANTS - IRRIGATING SOLUTIONS FOR OPHTHALMIC SURGERY |
PD ISO/TS 17518:2015 | Medical laboratories. Reagents for staining biological material. Guidance for users |
13/30268585 DC : 0 | BS EN ISO 10079-1 - MEDICAL SUCTION EQUIPMENT - PART 1: ELECTRICALLY POWERED SUCTION EQUIPMENT |
UNI EN ISO 18113-5 : 2012 | IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 5: IN VITRO DIAGNOSTIC INSTRUMENTS FOR SELF- TESTING |
09/30203808 DC : 0 | BS EN ISO 80601-2-12 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-12: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CRITICAL CARE VENTILATORS |
BS EN ISO 18113-3:2011 | In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) In vitro diagnostic instruments for professional use |
16/30346073 DC : 0 | BS ISO 16142-2 - MEDICAL DEVICES - RECOGNIZED ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE OF MEDICAL DEVICES - PART 2: GENERAL ESSENTIAL PRINCIPLES AND ADDITIONAL SPECIFIC ESSENTIAL PRINCIPLES FOR ALL IVD MEDICAL DEVICES AND GUIDANCE ON THE SELECTION OF STANDARDS |
17/30336573 DC : 0 | BS EN ISO 20696 - STERILE URETHAL CATHETERS FOR SINGLE USE |
DIN EN ISO 13079:2011-10 | Laboratory glass and plastics ware - Tubes for the measurement of the erythrocyte sedimentation rate by the Westergren method (ISO 13079:2011) |
DIN EN ISO 8638:2014-03 | CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - EXTRACORPOREAL BLOOD CIRCUIT FOR HAEMODIALYSERS, HAEMODIAFILTERS AND HAEMOFILTERS (ISO 8638:2010) |
DIN EN ISO 18113-3:2013-01 | In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO 18113-3:2009) |
BS EN ISO 26782:2009 | Anaesthetic and respiratory equipment. Spirometers intended for the measurement of time forced expired volumes in humans |
BS EN 60601-1-12:2015 | Medical electrical equipment General requirements for basic safety and essential performance. Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment |
14/30263409 DC : 0 | BS EN ISO 3630-3 - DENTISTRY - ENDODONTIC INSTRUMENTS - PART 3: COMPACTORS: PLUGGERS AND SPREADERS |
BS EN ISO 18113-4:2011 | In vitro diagnostic medical Devices. Information supplied by the manufacturer (labelling) In vitro diagnostic reagents for self-testing |
ANSI/AAMI/ISO 11138-1:2017 | STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 1: GENERAL REQUIREMENTS |
BS ISO 18666:2015 | Traditional Chinese medicine. General requirements of moxibustion devices |
BS EN ISO 16671 : 2015 | OPHTHALMIC IMPLANTS - IRRIGATING SOLUTIONS FOR OPHTHALMIC SURGERY |
13/30284721 DC : 0 | BS EN ISO 8536-8 - INFUSION EQUIPMENT FOR MEDICAL USE - PART 8: INFUSION EQUIPMENT FOR USE WITH PRESSURE INFUSION APPARATUS |
BS EN ISO 8638:2014 | Cardiovascular implants and extracorporeal systems. Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters |
PREN ISO 24234 : DRAFT 2013 | DENTISTRY - DENTAL AMALGAM (ISO/DIS 24234:2013) |
15/30312454 DC : 0 | BS EN ISO 80601-2-56 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-56: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CLINICAL THERMOMETERS FOR BODY TEMPERATURE MEASUREMENT |
PREN 285 : DRAFT 2013 | STERILIZATION - STEAM STERILIZERS - LARGE STERILIZERS |
I.S. EN ISO 23908:2013 | SHARPS INJURY PROTECTION - REQUIREMENTS AND TEST METHODS - SHARPS PROTECTION FEATURES FOR SINGLE-USE HYPODERMIC NEEDLES, INTRODUCERS FOR CATHETERS AND NEEDLES USED FOR BLOOD SAMPLING (ISO 23908:2011) |
BS EN ISO 6710:2017 | Single-use containers for human venous blood specimen collection |
UNE-EN ISO 18113-3:2012 | In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO 18113-3:2009) |
CAN/CSA-C22.2 NO. 80601-2-72:17 | Medical electrical equipment — Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients (Adopted ISO 80601-2-72:2015, first edition, 2015-09-01, with Canadian deviations) |
I.S. EN ISO 10555-1:2013 | INTRAVASCULAR CATHETERS - STERILE AND SINGLE-USE CATHETERS - PART 1: GENERAL REQUIREMENTS (ISO 10555-1:2013/AMD 1:2017) |
BS EN 1865-2 : 2010 | PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 2: POWER ASSISTED STRETCHER |
UNE-EN ISO 18113-2:2012 | In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO 18113-2:2009) |
BS EN ISO 10079-1:2015 | Medical suction equipment Electrically powered suction equipment |
CAN/CSA-Z10524-4:12 (R2017) | Pressure regulators for use with medical gases - Part 4: Low-pressure regulators (Adopted ISO 10524-4:2008, first edition, 2008-06-01, with Canadian deviations) |
EN ISO 3630-3:2015 | Dentistry - Endodontic instruments - Part 3: Compactors: pluggers and spreaders (ISO 3630-3:2015) |
CSA ISO 8637 : 2012 | CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS AND HAEMOCONCENTRATORS |
CSA Z17510.1 : 2010 | SLEEP APNOEA BREATHING THERAPY - PART 1: SLEEP APNOEA BREATHING THERAPY EQUIPMENT |
EN ISO 22413:2013 | Transfer sets for pharmaceutical preparations - Requirements and test methods (ISO 22413:2010) |
CSA ISO 8637 : 2012 : R2017 | CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS AND HAEMOCONCENTRATORS |
DIN EN ISO 21563:2013-12 | Dentistry - Hydrocolloid impression materials (ISO 21563:2013) |
DIN EN ISO 3630-5:2012-01 | DENTISTRY - ENDODONTIC INSTRUMENTS - PART 5: SHAPING AND CLEANING INSTRUMENTS (ISO 3630-5:2011) |
UNE-EN ISO 80601-2-69:2015 | Medical electrical equipment - Part 2-69: Particular requirements for basic safety and essential performance of oxygen concentrator equipment (ISO 80601-2-69:2014) |
ISO 10650:2015 | Dentistry Powered polymerization activators |
I.S. EN 16844:2017+A2:2019 | Aesthetic medicine services - Non-surgical medical treatments |
ISO 5910:2018 | Cardiovascular implants and extracorporeal systems — Cardiac valve repair devices |
I.S. EN ISO 21531:2009 | DENTISTRY - GRAPHICAL SYMBOLS FOR DENTAL INSTRUMENTS |
I.S. EN ISO 11978:2017 | OPHTHALMIC OPTICS - CONTACT LENSES AND CONTACT LENS CARE PRODUCTS - LABELLING (ISO 11978:2017) |
ISO 18397:2016 | Dentistry Powered scaler |
I.S. EN ISO 26782:2009 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - SPIROMETERS INTENDED FOR THE MEASUREMENT OF TIME FORCED EXPIRED VOLUMES IN HUMANS |
I.S. EN ISO 22413:2013 | TRANSFER SETS FOR PHARMACEUTICAL PREPARATIONS - REQUIREMENTS AND TEST METHODS (ISO 22413:2010) |
I.S. EN ISO 10524-4:2008 | PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 4: LOWPRESSURE REGULATORS |
BS EN ISO 80601-2-12:2011 | Medical electrical equipment Particular requirements for basic safety and essential performance of critical care ventilators |
ISO/TS 17518:2015 | Medical laboratories — Reagents for staining biological material — Guidance for users |
ISO 16142-1:2016 | Medical devices — Recognized essential principles of safety and performance of medical devices — Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards |
ISO 16142-2:2017 | Medical devices — Recognized essential principles of safety and performance of medical devices — Part 2: General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards |
UNI EN ISO 18113-4 : 2012 | IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 4: IN VITRO DIAGNOSTIC REAGENTS FOR SELF-TESTING |
ISO 80601-2-70:2015 | Medical electrical equipment Part 2-70: Particular requirements for basic safety and essential performance of sleep apnoea breathing therapy equipment |
ISO 80601-2-74:2017 | Medical electrical equipment Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment |
UNE-EN ISO 1135-3:2017 | Transfusion equipment for medical use - Part 3: Blood-taking sets for single use (ISO 1135-3:2016) |
I.S. EN ISO 3665:2013 | PHOTOGRAPHY - INTRA-ORAL DENTAL RADIOGRAPHIC FILM AND FILM PACKETS - MANUFACTURER SPECIFICATIONS (ISO 3665:2011) |
17/30358661 DC : 0 | BS EN 13795-2 - SURGICAL CLOTHING AND DRAPES - REQUIREMENTS AND TEST METHODS - PART 2: CLEAN AIR SUITS |
UNI EN 14683 : 2014 | MEDICAL FACE MASKS - REQUIREMENTS AND TEST METHODS |
NF EN ISO 26782 : 2009 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - SPIROMETERS INTENDED FOR THE MEASUREMENT OF TIME FORCED EXPIRED VOLUMES IN HUMANS |
UNE-EN ISO 18113-5:2012 | In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009) |
UNI CEI EN 980 : 2009 | SYMBOLS FOR USE IN THE LABELLING OF MEDICAL DEVICES |
DIN EN ISO 11070:2015-03 | STERILE SINGLE-USE INTRAVASCULAR INTRODUCERS, DILATORS AND GUIDEWIRES (ISO 11070:2014) |
I.S. EN 1865-2:2010 | PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 2: POWER ASSISTED STRETCHER |
ISO 11070:2014 | Sterile single-use intravascular introducers, dilators and guidewires |
PD ISO/TS 17137:2014 | Cardiovascular implants and extracorporeal systems. Cardiovascular absorbable implants |
AAMI ES60601-1 : 2005 : INC : AMD 1 : 2012 : R201200 | MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE (IEC 60601-1:2005, MOD) |
AAMI ES60601-1 : 2005 : INC : AMD 2 : 2012 : R201200 | MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE (IEC 60601-1:2005, MOD) |
I.S. EN ISO 3826-1:2013 | PLASTICS COLLAPSIBLE CONTAINERS FOR HUMAN BLOOD AND BLOOD COMPONENTS - PART 1: CONVENTIONAL CONTAINERS (ISO 3826-1:2013) |
AAMI ES60601-1 : 2005 : R2012 | MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE (IEC 60601-1:2005, MOD) |
EN 285:2015 | Sterilization - Steam sterilizers - Large sterilizers |
I.S. EN ISO 3630-1:2008 | DENTISTRY - ROOT-CANAL INSTRUMENTS - PART 1: GENERAL REQUIREMENTS AND TEST METHODS |
UNI EN ISO 3630-1 : 2008 | DENTISTRY - ROOT-CANAL INSTRUMENTS - PART 1: GENERAL REQUIREMENTS AND TEST METHODS |
BS EN ISO 80601-2-13:2012+A2:2019 | Medical electrical equipment Particular requirements for basic safety and essential performance of an anaesthetic workstation |
DIN EN ISO 11499:2014-09 | DENTISTRY - SINGLE-USE CARTRIDGES FOR LOCAL ANAESTHETICS (ISO 11499:2014) |
UNE-EN ISO 24234:2015 | Dentistry - Dental amalgam (ISO 24234:2015) |
ONORM EN ISO 22413 : SEP 2013 | TRANSFER SETS FOR PHARMACEUTICAL PREPARATIONS - REQUIREMENTS AND TEST METHODS (ISO 22413:2010) |
BS EN 13718-1:2014 | Medical vehicles and their equipment. Air ambulances Requirements for medical devices used in air ambulances |
BS EN ISO 11979-4 : 2008 | OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 4: LABELLING AND INFORMATION (ISO 11979-4:2008) |
ONORM EN ISO 3630-1 : 2008 | DENTISTRY - ROOT-CANAL INSTRUMENTS - PART 1: GENERAL REQUIREMENTS AND TEST METHODS |
ISO 10524-4:2008 | Pressure regulators for use with medical gases — Part 4: Low-pressure regulators |
BS EN ISO 8536-9:2015 | Infusion equipment for medical use Fluid lines for single use with pressure infusion equipment |
UNE-EN ISO 3630-3:2016 | Dentistry - Endodontic instruments - Part 3: Compactors: pluggers and spreaders (ISO 3630-3:2015) |
BS EN ISO 11499:2014 | Dentistry. Single-use cartridges for local anaesthetics |
ISO 81060-1:2007 | Non-invasive sphygmomanometers — Part 1: Requirements and test methods for non-automated measurement type |
ISO 8637:2010 | Cardiovascular implants and extracorporeal systems Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators |
ISO 13958:2014 | Concentrates for haemodialysis and related therapies |
UNE-EN 868-2:2017 | Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods |
BS EN ISO 7885:2010 | Dentistry. Sterile injection needles for single use |
BS EN 455-3:2015 | Medical gloves for single use Requirements and testing for biological evaluation |
UNE-EN ISO 14408:2016 | Tracheal tubes designed for laser surgery - Requirements for marking and accompanying information (ISO 14408:2016) |
ISO 8638:2010 | Cardiovascular implants and extracorporeal systems Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters |
BS EN ISO 14534:2015 | Ophthalmic optics. Contact lenses and contact lens care products. Fundamental requirements |
BS EN ISO 3630-3:2015 | Dentistry. Endodontic instruments Compactors: pluggers and spreaders |
UNE-EN ISO 16672:2016 | Ophthalmic implants - Ocular endotamponades (ISO 16672:2015) |
BS EN ISO 3630-2:2013 | Dentistry. Endodontic instruments Enlargers |
I.S. EN ISO 8536-9:2015 | INFUSION EQUIPMENT FOR MEDICAL USE - PART 9: FLUID LINES FOR SINGLE USE WITH PRESSURE INFUSION EQUIPMENT (ISO 8536-9:2015) |
DIN EN 868-2:2017-05 | PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 2: STERILIZATION WRAP - REQUIREMENTS AND TEST METHODS |
EN ISO 5364:2016 | Anaesthetic and respiratory equipment - Oropharyngeal airways (ISO 5364:2016) |
EN ISO 8638:2014 | Cardiovascular implants and extracorporeal systems - Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters (ISO 8638:2010) |
EN ISO 80601-2-13:2012 | Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation (ISO 80601-2-13:2011) |
EN 60601-2-34:2014 | Medical electrical equipment - Part 2-34: Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment |
EN ISO 9680:2014 | Dentistry - Operating lights (ISO 9680:2014) |
DIN EN 868-4:2017-05 | PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 4: PAPER BAGS - REQUIREMENTS AND TEST METHODS |
ONORM EN ISO 3630-2 : 2013 | DENTISTRY - ENDODONTIC INSTRUMENTS - PART 2: ENLARGERS (ISO 3630-2:2013) |
ONORM EN ISO 7439 : 2015 | COPPER-BEARING CONTRACEPTIVE INTRAUTERINE DEVICES - REQUIREMENTS AND TESTS (ISO 7439:2015) |
BS ISO 19611:2017 | Traditional Chinese medicine. Air extraction cupping device |
NF EN ISO 80601-2-61 : 2011 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-61: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF PULSE OXIMETER EQUIPMENT |
BS EN 60601-1-11:2015 | Medical electrical equipment General requirements for basic safety and essential performance. Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment |
DIN EN ISO 3826-4:2015-12 | PLASTICS COLLAPSIBLE CONTAINERS FOR HUMAN BLOOD AND BLOOD COMPONENTS - PART 4: APHAERESIS BLOOD BAG SYSTEMS WITH INTEGRATED FEATURES (ISO 3826-4:2015) |
BS EN ISO 80601-2-13:2012 | Medical electrical equipment Particular requirements for basic safety and essential performance of an anaesthetic workstation |
UNI EN ISO 26782 : 2009 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - SPIROMETERS INTENDED FOR THE MEASUREMENT OF TIME FORCED EXPIRED VOLUMES IN HUMANS |
ISO 13960:2010 | Cardiovascular implants and extracorporeal systems Plasmafilters |
BS ISO 17966:2016 | Assistive products for personal hygiene that support users. Requirements and test methods |
17/30338753 DC : 0 | BS ISO 80601-2-79 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-79: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF VENTILATORY SUPPORT EQUIPMENT FOR VENTILATORY IMPAIRMENT |
BS EN ISO 20072:2013 | Aerosol drug delivery device design verification. Requirements and test methods |
17/30359001 DC : 0 | BS ISO/IEC GUIDE 63 - GUIDE TO THE DEVELOPMENT AND INCLUSION OF ASPECTS OF SAFETY IN INTERNATIONAL STANDARDS FOR MEDICAL DEVICES |
BS EN ISO 80601-2-72:2015 | Medical electrical equipment Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients |
07/30157348 DC : 0 | BS ISO 26782 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - SPIROMETERS INTENDED FOR THE ASSESSMENT OF PULMONARY FUNCTION IN HUMANS |
13/30283691 DC : 0 | BS EN ISO 1135-4 - TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 4: TRANSFUSION SETS FOR SINGLE USE, GRAVITY FEED |
AAMI ISO 81060-1 : 2007 | NON INVASIVE SPHYGMOMANOMETERS - PART 1: REQUIREMENTS AND TEST METHODS FOR NON-AUTOMATED MEASUREMENT TYPE |
I.S. EN ISO 21563:2013 | DENTISTRY - HYDROCOLLOID IMPRESSION MATERIALS (ISO 21563:2013) |
UNE-EN ISO 16061:2015 | Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2015) |
BS EN ISO 8836:2014 | Suction catheters for use in the respiratory tract |
08/30154605 DC : DRAFT APR 2008 | BS ISO 15223-2 - MEDICAL DEVICES - SYMBOLS TO BE USED WITH MEDICAL DEVICE LABELS, LABELLING AND INFORMATION TO BE SUPPLIED - PART 2: SYMBOL DEVELOPMENT, SELECTION AND VALIDATION |
BS EN 61010-2-101:2017 | Safety requirements for electrical equipment for measurement, control and laboratory use Particular requirements for in vitro diagnostic (IVD) medical equipment |
UNE-EN ISO 13504:2013 | Dentistry - General requirements for instruments and related accessories used in dental implant placement and treatment (ISO 13504:2012) |
I.S. EN ISO 6710:2017 | SINGLE-USE CONTAINERS FOR HUMAN VENOUS BLOOD SPECIMEN COLLECTION (ISO 6710:2017) |
I.S. EN 1865-3:2012 | PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 3: HEAVY DUTY STRETCHER |
PREN 14683 : DRAFT 2017 | MEDICAL FACE MASKS - REQUIREMENTS AND TEST METHODS |
PREN 13795-1 : DRAFT 2017 | SURGICAL CLOTHING AND DRAPES - REQUIREMENTS AND TEST METHODS - PART 1: SURGICAL DRAPES AND GOWNS |
BS EN ISO 12836:2015 | Dentistry. Digitizing devices for CAD/CAM systems for indirect dental restorations. Test methods for assessing accuracy |
14/30284310 DC : 0 | BS ISO 10650 - DENTISTRY - POWERED POLYMERIZATION ACTIVATORS |
ANSI/AAMI/ISO 15675:2016 | CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - CARDIOPULMONARY BYPASS SYSTEMS - ARTERIAL BLOOD LINE FILTERS |
17/30358658 DC : 0 | BS EN 13795-1 - SURGICAL CLOTHING AND DRAPES - REQUIREMENTS AND TEST METHODS - PART 1: SURGICAL DRAPES AND GOWNS |
16/30329598 DC : 0 | BS ISO 11195 - GAS MIXERS FOR MEDICAL USE - STAND-ALONE GAS MIXERS |
AAMI ISO 5361 : 2012 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - TRACHEAL TUBES AND CONNECTORS |
DIN EN ISO 1135-5:2016-06 | TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 5: TRANSFUSION SETS FOR SINGLE USE WITH PRESSURE INFUSION APPARATUS (ISO 1135-5:2015) |
DIN EN ISO 80601-2-72:2016-04 | Medical electrical equipment - Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients (ISO 80601-2-72:2015) |
UNE-EN ISO 11978:2018 | Ophthalmic optics - Contact lenses and contact lens care products - Labelling (ISO 11978:2017) |
ISO 20696:2018 | Sterile urethral catheters for single use |
BS EN ISO 21563:2013 | Dentistry. Hydrocolloid impression materials |
13/30240399 DC : 0 | ISO/IEC GUIDE 51 - SAFETY ASPECTS - GUIDELINES FOR THEIR INCLUSION IN STANDARDS |
BS EN ISO 3665:2013 | Photography. Intra-oral dental radiographic film and film packets. Manufacturer specifications |
15/30321502 DC : 0 | BS EN ISO 11138-1 - STERILIZATION OF HEALTH PRODUCTS - BIOLOGICAL INDICATORS - PART 1: GENERAL REQUIREMENTS |
BS ISO 12891-1:2015 | Retrieval and analysis of surgical implants Retrieval and handling |
13/30284776 DC : 0 | BS EN ISO 8536-11 - INFUSION EQUIPMENT FOR MEDICAL USE - PART 11: INFUSION FILTERS FOR SINGLE USE WITH PRESSURE INFUSION EQUIPMENT |
14/30303657 DC : 0 | BS EN ISO 1135-3 - TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 3: BLOOD-TAKING SET FOR SINGLE USE |
13/30278952 DC : 0 | BS EN 16372 - AESTHETIC SURGERY AND AESTHETIC NON-SURGICAL MEDICAL SERVICES |
UNE-EN ISO 18113-4:2012 | In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2009) |
DIN EN 14683:2014-07 | MEDICAL FACE MASKS - REQUIREMENTS AND TEST METHODS |
14/30292011 DC : 0 | BS EN ISO 23747 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - PEAK EXPIRATORY FLOW METERS FOR THE ASSESSMENT OF PULMONARY FUNCTION IN SPONTANEOUSLY BREATHING HUMANS |
UNE-EN ISO 13079:2011 | Laboratory glass and plastics ware. Tubes and support for the measurement of erythrocytic sedimentation rate by the Westergren method (ISO 13079:2011) |
09/30181956 DC : DRAFT MAY 2009 | BS ISO 80601-2-61 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-61: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF PULSE OXIMETER EQUIPMENT FOR MEDICAL USE |
13/30281504 DC : 0 | BS EN 455-3 - MEDICAL GLOVES FOR SINGLE USE - PART 3: REQUIREMENTS AND TESTING FOR BIOLOGICAL EVALUATION |
11/30212235 DC : 0 | BS EN ISO 13504 - DENTISTRY - GENERAL REQUIREMENTS FOR INSTRUMENTS AND RELATED ACCESSORIES USED IN DENTAL IMPLANT PLACEMENT AND TREATMENT |
UNI EN ISO 80601-2-12 : 2011 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-12: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CRITICAL CARE VENTILATORS |
15/30280904 DC : 0 | BS ISO 18190 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - GENERAL REQUIREMENTS FOR AIRWAYS AND RELATED EQUIPMENT |
DIN EN ISO 13958:2016-03 | CONCENTRATES FOR HAEMODIALYSIS AND RELATED THERAPIES (ISO 13958:2014) |
10/30195946 DC : DRAFT DEC 2010 | BS ISO 27185 - CARDIAC RHYTHM MANAGEMENT DEVICES - SYMBOLS TO BE USED WITH CARDIAC RHYTHM MANAGEMENT DEVICE LABELS, AND INFORMATION TO BE SUPPLIED - GENERAL REQUIREMENTS |
DIN EN ISO 12836:2015-11 | DENTISTRY - DIGITIZING DEVICES FOR CAD/CAM SYSTEMS FOR INDIRECT DENTAL RESTORATIONS - TEST METHODS FOR ASSESSING ACCURACY (ISO 12836:2015) |
14/30294895 DC : 0 | BS EN ISO 8537 - STERILE SINGLE-USE SYRINGES, WITH OR WITHOUT NEEDLE, FOR INSULIN |
14/30281863 DC : 0 | BS EN ISO 5364 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - OROPHARYNGEAL AIRWAYS |
13/30270468 DC : 0 | BS ISO 13958 - CONCENTRATES FOR HAEMODIALYSIS AND RELATED THERAPIES |
I.S. EN 16844:2017 | AESTHETIC MEDICINE SERVICES - NON-SURGICAL MEDICAL PROCEDURES |
ANSI/AAMI/ISO 16142-2:2017 | MEDICAL DEVICES - RECOGNIZED ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE OF MEDICAL DEVICES - PART 2: GENERAL ESSENTIAL PRINCIPLES AND ADDITIONAL SPECIFIC ESSENTIAL PRINCIPLES FOR ALL IVD MEDICAL DEVICES AND GUIDANCE ON THE SELECTION OF STANDARDS |
UNI EN ISO 3630-5 : 2012 | DENTISTRY - ENDODONTIC INSTRUMENTS - PART 5: SHAPING AND CLEANING INSTRUMENTS |
BS EN ISO 21531:2009 | Dentistry. Graphical symbols for dental instruments |
BS ISO 81060-1 : 2007 COR 2012 | NON-INVASIVE SPHYGMOMANOMETERS - PART 1: REQUIREMENTS AND TEST METHODS FOR NON-AUTOMATED MEASUREMENT TYPE |
DIN EN ISO 14155:2012-01 | CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - GOOD CLINICAL PRACTICE (ISO 14155:2011 + COR. 1:2011) |
16/30302520 DC : 0 | BS ISO 19611 - TRADITIONAL CHINESE MEDICINE - AIR EXHAUST CUPPING APPARATUS FOR MEDICAL USE |
CSA C22.2 No. 80601-2-56 : 2012 : R2016 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-56: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CLINICAL THERMOMETERS FOR BODY TEMPERATURE MEASUREMENT |
CSA ISO 16628 : 2014 | TRACHEOBRONCHIAL TUBES - SIZING AND MARKING |
ISO 14708-2:2012 | Implants for surgery Active implantable medical devices Part 2: Cardiac pacemakers |
CSA Z8836 :2011 | SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT |
DIN EN ISO 18113-2:2013-01 | In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO 18113-2:2009) |
CSA Z8836 : 2011 : R2015 | SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT |
CAN/CSA-ISO 11138-1:17 | Sterilization of health care products — Biological indicators — Part 1: General requirements (Adopted ISO 11138-1:2017, third edition, 2017-03) |
PREN ISO 11978 : DRAFT 2013 | OPHTHALMIC OPTICS - CONTACT LENSES AND CONTACT LENS CARE PRODUCTS - LABELLING (ISO/DIS 11978:2013) |
AAMI ISO 13958 : 2009 | CONCENTRATES FOR HEMODIALYSIS AND RELATED THERAPIES |
BS EN ISO 10555-1 : 2013 | INTRAVASCULAR CATHETERS - STERILE AND SINGLE-USE CATHETERS - PART 1: GENERAL REQUIREMENTS |
I.S. EN ISO 5361:2016 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - TRACHEAL TUBES AND CONNECTORS (ISO/DIS 5361:2014) |
I.S. EN 61010-2-101:2017 | SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL AND LABORATORY USE - PART 2-101: PARTICULAR REQUIREMENTS FOR IN VITRO DIAGNOSTIC (IVD) MEDICAL EQUIPMENT |
UNE-EN ISO 20072:2013 | Aerosol drug delivery device design verification - Requirements and test methods (ISO 20072:2009) |
BS EN ISO 11070 : 2014 | STERILE SINGLE-USE INTRAVASCULAR INTRODUCERS, DILATORS AND GUIDEWIRES |
CSA C22.2 No. 60601-1-12 : 2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-12: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS INTENDED FOR USE IN THE EMERGENCY MEDICAL SERVICES ENVIRONMENT |
ISO/IEC Guide 51:2014 | Safety aspects Guidelines for their inclusion in standards |
AAMI ISO 5367 : 2015 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - BREATHING SETS AND CONNECTORS |
UNE-EN ISO 14155:2012 | Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011) |
I.S. EN ISO 14457:2017 | DENTISTRY - HANDPIECES AND MOTORS (ISO 14457:2017) |
UNI EN ISO 3826-2 : 2009 | PLASTICS COLLAPSIBLE CONTAINERS FOR HUMAN BLOOD AND BLOOD COMPONENTS - PART 2: GRAPHICAL SYMBOLS FOR USE ON LABELS AND INSTRUCTION LEAFLETS |
BS EN ISO 13017 : 2012 | DENTISTRY - MAGNETIC ATTACHMENTS |
AAMI ISO 8638 : 2010 | CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - EXTRACORPOREAL BLOOD CIRCUIT FOR HEMODIALYZERS, HEMODIAFILTERS AND HEMOFILTERS |
I.S. EN ISO 12417-1:2015 | CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR DEVICE-DRUG COMBINATION PRODUCTS - PART 1: GENERAL REQUIREMENTS (ISO 12417-1:2015) |
AAMI ISO TIR 17137 : 2014 | CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - CARDIOVASCULAR ABSORBABLE IMPLANTS |
UNI EN ISO 80601-2-55 : 2012 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-55: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY GAS MONITORS |
AAMI ISO 8836 : 2015 | SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT |
AAMI ISO 8638 : 2010 : R2015 | CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - EXTRACORPOREAL BLOOD CIRCUIT FOR HEMODIALYZERS, HEMODIAFILTERS AND HEMOFILTERS |
UNE-EN ISO 1135-5:2016 | Transfusion equipment for medical use - Part 5: Transfusion sets for single use with pressure infusion apparatus (ISO 1135-5:2015) |
UNI EN ISO 5367 : 2015 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - BREATHING SETS AND CONNECTORS |
CSA C22.2 No. 60601.2.49 : 2011 : R2016 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-49: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF MULTIFUNCTION PATIENT MONITORING EQUIPMENT |
AAMI ISO 14155 : 2011 | CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - GOOD CLINICAL PRACTICE |
UNI EN ISO 14155 : 2012 | CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - GOOD CLINICAL PRACTICE |
CSA ISO 10079-2 : 2014 | MEDICAL SUCTION EQUIPMENT - PART 2: MANUALLY POWERED SUCTION EQUIPMENT |
CSA Z17510.2 : 2009 | SLEEP APNOEA BREATHING THERAPY - PART 2: MASKS AND APPLICATION ACCESSORIES |
BS EN ISO 5367:2014 | Anaesthetic and respiratory equipment. Breathing sets and connectors |
UNE-EN ISO 14457:2013 | Dentistry - Handpieces and motors (ISO 14457:2012) |
UNE-EN ISO 5367:2015 | Anaesthetic and respiratory equipment - Breathing sets and connectors (ISO 5367:2014) |
UNE-EN ISO 18113-1:2012 | In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009) |
AAMI ISO 15223-2 : 2010 | MEDICAL DEVICES - SYMBOLS TO BE USED WITH MEDICAL DEVICE LABELS, LABELING AND INFORMATION TO BE SUPPLIED - PART 2: SYMBOL DEVELOPMENT, SELECTION AND VALIDATION |
CSA C22.2 No. 80601-2-12 : 2012 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-12: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CRITICAL CARE VENTILATORS |
EN ISO 6710:2017 | Single-use containers for human venous blood specimen collection (ISO 6710:2017) |
ISO 18666:2015 | Traditional Chinese medicine General requirements of moxibustion devices |
EN ISO 11978:2017 | Ophthalmic optics - Contact lenses and contact lens care products - Labelling (ISO 11978:2017) |
UNE-EN ISO 13958:2016 | Concentrates for haemodialysis and related therapies (ISO 13958:2014) |
EN ISO 21563:2013 | Dentistry - Hydrocolloid impression materials (ISO 21563:2013) |
DIN EN ISO 3826-1:2013-09 | PLASTICS COLLAPSIBLE CONTAINERS FOR HUMAN BLOOD AND BLOOD COMPONENTS - PART 1: CONVENTIONAL CONTAINERS (ISO 3826-1:2013) |
ISO 8836:2014 | Suction catheters for use in the respiratory tract |
ISO 5367:2014 | Anaesthetic and respiratory equipment — Breathing sets and connectors |
AAMI ES60601-1 : 2005 | MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE (IEC 60601-1:2005, MOD) |
UNI EN ISO 3826-1 : 2013 | PLASTICS COLLAPSIBLE CONTAINERS FOR HUMAN BLOOD AND BLOOD COMPONENTS - PART 1: CONVENTIONAL CONTAINERS |
DIN EN ISO 23747:2015-12 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - PEAK EXPIRATORY FLOW METERS FOR THE ASSESSMENT OF PULMONARY FUNCTION IN SPONTANEOUSLY BREATHING HUMANS (ISO 23747:2015) |
DIN EN ISO 1135-4:2016-06 | TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 4: TRANSFUSION SETS FOR SINGLE USE, GRAVITY FEED (ISO 1135-4:2015) |
DIN EN 556-2:2015-11 | STERILIZATION OF MEDICAL DEVICES - REQUIREMENTS FOR MEDICAL DEVICES TO BE DESIGNATED 'STERILE' - PART 2: REQUIREMENTS FOR ASEPTICALLY PROCESSED MEDICAL DEVICES |
DIN EN ISO 17510-2:2009-07 | SLEEP APNOEA BREATHING THERAPY - PART 2: MASKS AND APPLICATION ACCESSORIES |
DIN EN ISO 22674:2016-09 | Dentistry - Metallic materials for fixed and removable restorations and appliances (ISO 22674:2016) |
DIN EN ISO 17510-1:2009-07 | Sleep apnoea breathing therapy - Part 1: Sleep apnoea breathing therapy equipment (ISO 17510-1:2007) |
DIN EN ISO 4074:2016-05 | NATURAL RUBBER LATEX MALE CONDOMS - REQUIREMENTS AND TEST METHODS (ISO 4074:2015) |
DIN EN ISO 3630-2:2013-08 | Dentistry - Endodontic instruments - Part 2: Enlargers (ISO 3630-2:2013) |
DIN EN ISO 14408:2016-07 | TRACHEAL TUBES DESIGNED FOR LASER SURGERY - REQUIREMENTS FOR MARKING AND ACCOMPANYING INFORMATION (ISO 14408:2016) |
DIN EN ISO 16672:2015-12 | Ophthalmic implants - Ocular endotamponades (ISO 16672:2015) |
BS EN ISO 7864:2016 | Sterile hypodermic needles for single use. Requirements and test methods |
BS EN 556-2:2015 | Sterilization of medical devices. Requirements for medical devices to be designated \'STERILE\' Requirements for aseptically processed medical devices |
UNE-EN ISO 80601-2-13:2013 | Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation (ISO 80601-2-13:2011) |
BS EN ISO 11138-1:2017 | Sterilization of health care products. Biological indicators General requirements |
BS EN ISO 7439:2015 | Copper-bearing contraceptive intrauterine devices. Requirements and tests |
BS EN ISO 10079-2:2014 | Medical suction equipment Manually powered suction equipment |
BS EN 45502-1:2015 | Implants for surgery. Active implantable medical devices General requirements for safety, marking and for information to be provided by the manufacturer |
UNE-EN ISO 8536-4:2013 | Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed (ISO 8536-4:2010) |
UNE-EN ISO 23747:2016 | Anaesthetic and respiratory equipment - Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans (ISO 23747:2015) |
BS EN ISO 8536-8:2015 | Infusion equipment for medical use Infusion sets for single use with pressure infusion apparatus |
DIN EN ISO 9680:2015-02 | Dentistry - Operating lights (ISO 9680:2014) |
UNE-EN 868-4:2017 | Packaging for terminally sterilized medical devices - Part 4: Paper bags - Requirements and test methods |
ONORM EN 13718-1 : 2014 | MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 1: REQUIREMENTS FOR MEDICAL DEVICES USED IN AIR AMBULANCES |
I.S. EN ISO 14534:2015 | OPHTHALMIC OPTICS - CONTACT LENSES AND CONTACT LENS CARE PRODUCTS - FUNDAMENTAL REQUIREMENTS (ISO 14534:2011) |
I.S. EN ISO 8536-10:2015 | INFUSION EQUIPMENT FOR MEDICAL USE - PART 10: ACCESSORIES FOR FLUID LINES FOR SINGLE USE WITH PRESSURE INFUSION EQUIPMENT (ISO 8536-10:2015) |
I.S. EN 868-4:2017 | PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 4: PAPER BAGS - REQUIREMENTS AND TEST METHODS |
I.S. EN ISO 8536-11:2015 | INFUSION EQUIPMENT FOR MEDICAL USE - PART 11: INFUSION FILTERS FOR SINGLE USE WITH PRESSURE INFUSION EQUIPMENT (ISO 8536-11:2015) |
I.S. EN ISO 23747:2015 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - PEAK EXPIRATORY FLOW METERS FOR THE ASSESSMENT OF PULMONARY FUNCTION IN SPONTANEOUSLY BREATHING HUMANS (ISO 23747:2015) |
I.S. EN ISO 1135-4:2015 | TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 4: TRANSFUSION SETS FOR SINGLE USE, GRAVITY FEED (ISO 1135-4:2015) |
EN ISO 17510-1:2009 | Sleep apnoea breathing therapy - Part 1: Sleep apnoea breathing therapy equipment (ISO 17510-1:2007) |
ONORM EN ISO 8836 : 2015 | SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT (ISO 8836:2014) |
I.S. EN ISO 10079-2:2014 | MEDICAL SUCTION EQUIPMENT - PART 2: MANUALLY POWERED SUCTION EQUIPMENT (ISO 10079-2:2014) |
I.S. EN ISO 17510-1:2009 | SLEEP APNOEA BREATHING THERAPY - PART 1: SLEEP APNOEA BREATHING THERAPY EQUIPMENT |
I.S. EN ISO 17510-2:2009 | SLEEP APNOEA BREATHING THERAPY - PART 2: MASKS AND APPLICATION ACCESSORIES |
I.S. EN 868-2:2017 | PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 2: STERILIZATION WRAP - REQUIREMENTS AND TEST METHODS |
DIN EN ISO 7885:2010-06 | Dentistry - Sterile injection needles for single use (ISO 7885:2010) |
I.S. EN ISO 6873:2013 | DENTISTRY - GYPSUM PRODUCTS (ISO 6873:2013) |
I.S. EN ISO 7439:2015 | COPPER-BEARING CONTRACEPTIVE INTRAUTERINE DEVICES - REQUIREMENTS AND TESTS (ISO 7439:2015) |
I.S. EN ISO 3630-3:2015 | DENTISTRY - ENDODONTIC INSTRUMENTS - PART 3: COMPACTORS: PLUGGERS AND SPREADERS (ISO 3630-3:2015) |
I.S. EN ISO 8537:2016 | STERILE SINGLE-USE SYRINGES, WITH OR WITHOUT NEEDLE, FOR INSULIN (ISO 8537:2016) |
I.S. EN ISO 11499:2014 | DENTISTRY - SINGLE-USE CARTRIDGES FOR LOCAL ANAESTHETICS (ISO 11499:2014) |
I.S. EN ISO 9680:2014 | DENTISTRY - OPERATING LIGHTS (ISO 9680:2014) |
I.S. EN ISO 11138-1:2017 | STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 1: GENERAL REQUIREMENTS (ISO 11138-1:2017) |
I.S. EN ISO 4074:2015 | NATURAL RUBBER LATEX MALE CONDOMS - REQUIREMENTS AND TEST METHODS (ISO 4074:2015) |
I.S. EN ISO 3630-2:2013 | DENTISTRY - ENDODONTIC INSTRUMENTS - PART 2: ENLARGERS (ISO 3630-2:2013) |
ONORM EN 1789 : 2014 | MEDICAL VEHICLES AND THEIR EQUIPMENT - ROAD AMBULANCES |
I.S. EN ISO 7885:2010 | DENTISTRY - STERILE INJECTION NEEDLES FOR SINGLE USE |
DIN EN ISO 11499:1999-08 | DENTISTRY - SINGLE-USE CARTRIDGES FOR LOCAL ANAESTHETICS (ISO 11499:2014) |
I.S. EN ISO 24234:2015 | DENTISTRY - DENTAL AMALGAM (ISO 24234:2015) |
UNI EN 13718-1 : 2014 | MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 1: REQUIREMENTS FOR MEDICAL DEVICES USED IN AIR AMBULANCES |
DIN EN 14180:2003-10 | STERILIZERS FOR MEDICAL PURPOSES - LOW TEMPERATURE STEAM AND FORMALDEHYDE STERILIZERS - REQUIREMENTS AND TESTING |
I.S. EN ISO 14408:2016 | TRACHEAL TUBES DESIGNED FOR LASER SURGERY - REQUIREMENTS FOR MARKING AND ACCOMPANYING INFORMATION (ISO 14408:2016) |
I.S. EN 14180:2014 | STERILIZERS FOR MEDICAL PURPOSES - LOW TEMPERATURE STEAM AND FORMALDEHYDE STERILIZERS - REQUIREMENTS AND TESTING |
DIN EN ISO 24234:2015-08 | DENTISTRY - DENTAL AMALGAM (ISO 24234:2015) |
DIN EN 1789:2014-12 | MEDICAL VEHICLES AND THEIR EQUIPMENT - ROAD AMBULANCES |
I.S. EN 45502-1:2015 | IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL REQUIREMENTS FOR SAFETY, MARKING AND FOR INFORMATION TO BE PROVIDED BY THE MANUFACTURER |
I.S. EN ISO 8536-8:2015 | INFUSION EQUIPMENT FOR MEDICAL USE - PART 8: INFUSION SETS FOR SINGLE USE WITH PRESSURE INFUSION APPARATUS (ISO 8536-8:2015) |
I.S. EN ISO 7864:2016 | STERILE HYPODERMIC NEEDLES FOR SINGLE USE - REQUIREMENTS AND TEST METHODS (ISO/DIS 7864:2014) |
I.S. EN ISO 22674:2016 | DENTISTRY - METALLIC MATERIALS FOR FIXED AND REMOVABLE RESTORATIONS AND APPLIANCES (ISO 22674:2016) |
I.S. EN ISO 16672:2015 | OPHTHALMIC IMPLANTS - OCULAR ENDOTAMPONADES (ISO 16672:2015) |
I.S. EN ISO 10079-3:2014 | MEDICAL SUCTION EQUIPMENT - PART 3: SUCTION EQUIPMENT POWERED FROM A VACUUM OR POSITIVE PRESSURE GAS SOURCE (ISO 10079-3:2014) |
DIN 820-12:2014-06 | STANDARDIZATION - PART 12: GUIDELINES FOR THE INCLUSION OF SAFETY ASPECTS IN STANDARDS (ISO/IEC GUIDE 51:2014) |
OVE/ONORM EN 60601-1 : 2014 | MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE (IEC 60601-1:2005 + COR.:2006 + COR.:2007 + A1:2012) |
DIN EN ISO 1135-3:2017-05 | TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 3: BLOOD-TAKING SETS FOR SINGLE USE (ISO 1135-3:2016) |
UNI EN ISO 11070 : 2015 | STERILE SINGLE-USE INTRAVASCULAR INTRODUCERS, DILATORS AND GUIDEWIRES |
BS ISO 11040-6:2012 | Prefilled syringes Plastic barrels for injectables |
ISO 20697:2018 | Sterile drainage catheters and accessory devices for single use |
CSA C22.2 No. 60601-1-11 : 2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-11: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS USED IN THE HOME HEALTHCARE ENVIRONMENT |
BS EN 1865-3 : 2012 | PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 3: HEAVY DUTY STRETCHER |
BS EN 60601-2-34:2014 | Medical electrical equipment Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment |
DIN EN ISO 8637:2014-03 | CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS AND HAEMOCONCENTRATORS (ISO 8637:2010, INCLUDING AMENDMENT 1:2013-04-01) |
UNI EN ISO 81060-1 : 2012 | NON-INVASIVE SPHYGMOMANOMETERS - PART 1: REQUIREMENTS AND TEST METHODS FOR NON-AUTOMATED MEASUREMENT TYPE |
BS EN ISO 10650:2015 | Dentistry. Powered polymerization activators |
16/30339831 DC : 0 | PD ISO/TR 14283 - IMPLANTS FOR SURGERY - ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE |
BS ISO 17218:2014 | Sterile acupuncture needles for single use |
I.S. EN ISO 81060-1:2012 | NON-INVASIVE SPHYGMOMANOMETERS - PART 1: REQUIREMENTS AND TEST METHODS FOR NON-AUTOMATED MEASUREMENT TYPE (ISO 81060-1:2007) |
13/30260084 DC : 0 | BS ISO 17256 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - RESPIRATORY THERAPY TUBING AND CONNECTORS |
15/30281262 DC : 0 | BS ISO 18666 - TRADITIONAL CHINESE MEDICINE - GENERAL REQUIREMENTS OF MOXIBUSTION DEVICES |
10/30216098 DC : 0 | BS ISO 3665 - PHOTOGRAPHY - INTRA-ORAL DENTAL RADIOGRAPHIC FILM AND FILM PACKETS - MANUFACTURER SPECIFICATIONS |
UNI EN ISO 21531 : 2009 | DENTISTRY - GRAPHICAL SYMBOLS FOR DENTAL INSTRUMENTS |
UNI EN ISO 3665 : 2013 | PHOTOGRAPHY - INTRA-ORAL DENTAL RADIOGRAPHIC FILM AND FILM PACKETS - MANUFACTURER SPECIFICATIONS |
ANSI/AAMI/IEC 60601-2-4:2010/A1:2018 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-4: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CARDIAC DEFIBRILLATORS |
I.S. EN 285:2015 | STERILIZATION - STEAM STERILIZERS - LARGE STERILIZERS |
16/30348158 DC : 0 | BS EN ISO 6710 - SINGLE-USE CONTAINERS FOR VENOUS BLOOD SPECIMEN COLLECTION |
09/30197590 DC : 0 | BS EN ISO 80601-2-55 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-55: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY GAS MONITORS |
16/30337378 DC : 0 | BS EN ISO 28319 - DENTISTRY - LASER WELDING |
13/30285624 DC : 0 | BS EN ISO 16061 - INSTRUMENTATION FOR USE IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS |
11/30255602 DC : 0 | BS ISO 8536-12:2007/AMD 1 - INFUSION EQUIPMENT FOR MEDICAL USE - PART 12: CHECK VALVES |
16/30312315 DC : 0 | BS EN ISO 80601-2-55 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-55: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY GAS MONITORS |
11/30215841 DC : 0 | BS EN ISO 14457 - DENTISTRY - HAND PIECES AND MOTORS |
DIN EN 1865-2:2015-05 | Patient handling equipment used in road ambulances - Part 2: Power assisted stretcher (includes Amendment A1:2015) |
EN ISO 10650:2015 | Dentistry - Powered polymerization activators (ISO 10650:2015) |
BS ISO 15223-2:2010 | Medical devices. Symbols to be used with medical device labels, labelling, and information to be supplied Symbol development, selection and validation |
15/30300279 DC : 0 | BS ISO 80601-2-74 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-74: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY HUMIDIFYING EQUIPMENT |
15/30317874 DC : 0 | BS EN 16844 - AESTHETIC MEDICINE SERVICES - NON-SURGICAL MEDICAL PROCEDURES |
DD ISO/TS 12417:2011 | Cardiovascular implants and extracorporeal systems. Vascular device-drug combination products |
ISO 8637-1:2017 | Extracorporeal systems for blood purification — Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators |
17/30321202 DC : DRAFT MAY 2017 | BS EN ISO 23500-4 - GUIDANCE FOR THE PREPARATION AND QUALITY MANAGEMENT OF FLUIDS FOR HAEMODIALYSIS AND RELATED THERAPIES - PART 4: CONCENTRATES FOR HAEMODIALYSIS AND RELATED THERAPIES |
13/30254718 DC : 0 | BS ISO 11040-7 - PREFILLED SYRINGES - PART 7: PACKAGING SYSTEMS FOR STERILIZED SUBASSEMBLED SYRINGES READY FOR FILLING |
UNE-EN 1865-1:2011 | Patient handling equipment used in road ambulances - Part 1: General stretcher systems and patient handling equipment |
DIN EN ISO 25539-1:2015-07 (Draft) | CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES (ISO 25539-1:2017) |
BS ISO 18190:2016 | Anaesthetic and respiratory equipment. General requirements for airways and related equipment |
ISO 19611:2017 | Traditional Chinese medicine — Air extraction cupping device |
BS EN ISO 81060-1:2012 | Non-invasive sphygmomanometers Requirements and test methods for non-automated measurement type |
DIN EN ISO 26782:2010-02 | Anaesthetic and respiratory equipment - Spirometers intended for the measurement of time forced expired volumes in humans (ISO 26782:2009 + Cor. 1:2009) (includes Corrigendum AC:2009) |
BS EN ISO 5364:2016 | Anaesthetic and respiratory equipment. Oropharyngeal airways |
BS EN ISO 3630-4:2009 | Dentistry. Root canal instruments Auxiliary instruments |
BS EN ISO 12417-1:2015 | Cardiovascular implants and extracorporeal systems. Vascular device-drug combination products General requirements |
13/30284773 DC : 0 | BS EN ISO 8536-10 - INFUSION EQUIPMENT FOR MEDICAL USE - PART 10: ACCESSORIES FOR FLUID LINES FOR USE WITH PRESSURE INFUSION EQUIPMENT |
13/30257549 DC : 0 | BS EN ISO 11499 - DENTISTRY - SINGLE-USE CARTRIDGES FOR LOCAL ANAESTHETICS |
NF EN ISO 80601-2-56 : 2017 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-56: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CLINICAL THERMOMETERS FOR BODY TEMPERATURE MEASUREMENT |
I.S. EN ISO 3630-5:2011 | DENTISTRY - ENDODONTIC INSTRUMENTS - PART 5: SHAPING AND CLEANING INSTRUMENTS (ISO 3630-5:2011) |
CAN/CSA-ISO 5364:16 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - OROPHARYNGEAL AIRWAYS |
UNI EN ISO 80601-2-69 : 2014 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-69: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF OXYGEN CONCENTRATOR EQUIPMENT |
UNE-EN ISO 5364:2017 | Anaesthetic and respiratory equipment - Oropharyngeal airways (ISO 5364:2016) |
13/30245306 DC : 0 | BS EN ISO 9680 - DENTISTRY - OPERATING LIGHTS |
13/30263416 DC : 0 | BS EN ISO 9687 - DENTISTRY - GRAPHICAL SYMBOLS FOR DENTAL EQUIPMENT |
UNE-EN ISO 16671:2016 | Ophthalmic implants - Irrigating solutions for ophthalmic surgery (ISO 16671:2015) |
BS EN ISO 3826-2:2008 | Plastics collapsible containers for human blood and blood components Graphical symbols for use on labels and instruction leaflets |
10/30168898 DC : 0 | BS EN ISO 24234/A1 - REQUIREMENTS FOR MARKING AND MANUFACTURER'S INSTRUCTIONS CONCERNING MERCURY |
14/30263397 DC : 0 | BS EN ISO 22674 - DENTISTRY - METALLIC MATERIALS FOR FIXED AND REMOVABLE RESTORATIONS AND APPLIANCES |
UNE-EN ISO 10079-1:2016 | Medical suction equipment - Part 1: Electrically powered suction equipment (ISO 10079-1:2015) |
13/30284770 DC : 0 | BS EN ISO 8536-9 - INFUSION EQUIPMENT FOR MEDICAL USE - PART 9: FLUID LINES FOR USE WITH PRESSURE INFUSION EQUIPMENT |
BS ISO 8536-12 : 2007 | INFUSION EQUIPMENT FOR MEDICAL USE - PART 12: CHECK VALVES |
BS ISO 3665 : 2011 | PHOTOGRAPHY - INTRA-ORAL DENTAL RADIOGRAPHIC FILM AND FILM PACKETS - MANUFACTURER SPECIFICATIONS |
ANSI/AAMI/ISO 25539-1:2017 | CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES |
NF ISO 15223-2 : 2010 | MEDICAL DEVICES - SYMBOLS TO BE USED WITH MEDICAL DEVICE LABELS, LABELLING AND INFORMATION TO BE SUPPLIED - PART 2: SYMBOL DEVELOPMENT, SELECTION AND VALIDATION |
BS ISO 16142-1:2016 | Medical devices. Recognized essential principles of safety and performance of medical devices General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards |
14/30290166 DC : 0 | BS ISO 16142-1 - MEDICAL DEVICES - RECOGNIZED ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE OF MEDICAL DEVICES - PART 1: GENERAL ESSENTIAL PRINCIPLES AND ADDITIONAL SPECIFIC ESSENTIAL PRINCIPLES FOR ALL NON-IVD MEDICAL DEVICES AND GUIDANCE ON THE SELECTION OF STANDARDS |
13/30278676 DC : 0 | BS EN 285 - STERILIZATION - STEAM STERILIZERS - LARGE STERILIZERS |
09/30207531 DC : 0 | BS EN ISO 14534 - OPHTHALMIC OPTICS - CONTACT LENSES AND CONTACT LENS CARE PRODUCTS - FUNDAMENTAL REQUIREMENTS |
BS ISO 28620:2010 | Medical devices. Non-electrically driven portable infusion devices |
11/30193150 DC : 0 | BS EN 60601-1:2006 AMD.1 - MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE |
BS EN ISO 11978:2017 | Ophthalmic optics. Contact lenses and contact lens care products. Labelling |
BS EN ISO 13079:2011 | Laboratory glass and plastics ware. Tubes for the measurement of the erythrocyte sedimentation rate by the Westergren method |
AAMI ISO 81060-1:2007(R2013) | NON INVASIVE SPHYGMOMANOMETERS - PART 1: REQUIREMENTS AND TEST METHODS FOR NON-AUTOMATED MEASUREMENT TYPE |
UNE-EN 16372:2015 | Aesthetic surgery services |
ISO 11195:2018 | Gas mixers for medical use — Stand-alone gas mixers |
16/30346835 DC : 0 | BS ISO 20789 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - PASSIVE HUMIDIFIERS |
16/30340242 DC : 0 | BS IEC 60601-2-4 ED3.0 AMD 1 - EQUIPMENT - PART 2-4: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CARDIAC DEFIBRILLATORS |
CSA Z8836 : 2011 : FR | SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT |
UNI EN ISO 20072 : 2013 | AEROSOL DRUG DELIVERY DEVICE DESIGN VERIFICATION - REQUIREMENTS AND TEST METHODS |
UNI EN ISO 21563 : 2013 | DENTISTRY - HYDROCOLLOID IMPRESSION MATERIALS |
UNI EN ISO 8836 : 2015 | A SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT |
UNE-EN ISO 8836:2015 | Suction catheters for use in the respiratory tract (ISO 8836:2014) |
CSA ISO 8638 : 2012 : R2017 | CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - EXTRACORPOREAL BLOOD CIRCUIT FOR HAEMODIALYSERS, HAEMODIAFILTERS AND HAEMOFILTERS |
BS EN ISO 8637:2014 | Cardiovascular implants and extracorporeal systems. Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators |
DIN EN ISO 22413:2013-10 | Transfer sets for pharmaceutical preparations - Requirements and test methods (ISO 22413:2010) |
CSA ISO 8637 : 2012 : INC : AMD 1 : 2015 | CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS AND HAEMOCONCENTRATORS |
I.S. EN ISO 80601-2-12:2011 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-12: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CRITICAL CARE VENTILATORS (ISO 80601-2-12:2011/COR 1:2011) |
I.S. EN ISO 28319:2010 | DENTISTRY - LASER WELDING AND FILLER MATERIALS (ISO 28319:2018) |
UNE-EN ISO 80601-2-56:2013 | Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement (ISO 80601-2-56:2009) |
ISO 12891-1:2015 | Retrieval and analysis of surgical implants Part 1: Retrieval and handling |
CEI UNI EN 15986 : 2011 | SYMBOL FOR USE IN THE LABELLING OF MEDICAL DEVICES - REQUIREMENTS FOR LABELLING OF MEDICAL DEVICES CONTAINING PHTHALATES |
BS EN 60601-2-49:2015 | Medical electrical equipment Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment |
I.S. EN 15986:2011 | SYMBOL FOR USE IN THE LABELLING OF MEDICAL DEVICES - REQUIREMENTS FOR LABELLING OF MEDICAL DEVICES CONTAINING PHTHALATES |
ANSI/AAMI/ISO 17664:2017 | PROCESSING OF HEALTH CARE PRODUCTS - INFORMATION TO BE PROVIDED BY THE MEDICAL DEVICE MANUFACTURER FOR THE PROCESSING OF MEDICAL DEVICES |
I.S. EN 16372:2014 | AESTHETIC SURGERY SERVICES |
I.S. EN 60601-1-12:2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-12: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS INTENDED FOR USE IN THE EMERGENCY MEDICAL SERVICES ENVIRONMENT |
CSA ISO 10079-3:14 (R2019) | Medical suction equipment - Part 3: Suction equipment powered from a vacuum or positive pressure gas source (Adopted ISO 10079-3:2014, third edition, 2014-05-01) |
I.S. EN ISO 8637:2014 | CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS AND HAEMOCONCENTRATORS (ISO 8637:2010, INCLUDING AMENDMENT 1 2013-04-01) |
UNI EN ISO 5361 : 2013 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - TRACHEAL TUBES AND CONNECTORS |
ISO 15675:2016 | Cardiovascular implants and artificial organs — Cardiopulmonary bypass systems — Arterial blood line filters |
UNE-EN ISO 3665:2013 | Photography - Intra-oral dental radiographic film and film packets - Manufacturer specifications (ISO 3665:2011) |
ISO 14708-6:2010 | Implants for surgery Active implantable medical devices Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators) |
I.S. EN ISO 8638:2014 | CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - EXTRACORPOREAL BLOOD CIRCUIT FOR HAEMODIALYSERS, HAEMODIAFILTERS AND HAEMOFILTERS (ISO 8638:2010) |
CSA ISO 10079-3 : 2014 | MEDICAL SUCTION EQUIPMENT - PART 3: SUCTION EQUIPMENT POWERED FROM A VACUUM OR POSITIVE PRESSURE GAS SOURCE |
I.S. EN ISO 11070:2014 | STERILE SINGLE-USE INTRAVASCULAR INTRODUCERS, DILATORS AND GUIDEWIRES (ISO 11070:2014) |
IEC TR 60878:2015 | Graphical symbols for electrical equipment in medical practice |
OVE/ONORM EN ISO 80601-2-55 : 2012 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-55: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY GAS MONITORS (ISO 80601-2-55:2011) |
ISO 15798:2013 | Ophthalmic implants Ophthalmic viscosurgical devices |
UNE-EN ISO 9687:2015 | Dentistry - Graphical symbols for dental equipment (ISO 9687:2015) |
ISO 27185:2012 | Cardiac rhythm management devices — Symbols to be used with cardiac rhythm management device labels, and information to be supplied — General requirements |
BIS IS/ISO 11979-4 : 2008 | OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 4: LABELING INFORMATION |
ASTM F 2943 : 2014 : REDLINE | Standard Guide for Presentation of End User Labeling Information for Musculoskeletal Implants |
UNI EN ISO 8637 : 2014 | CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS AND HAEMOCONCENTRATORS |
EN ISO 80601-2-61:2011 | Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment (ISO 80601-2-61:2011) |
EN 16844:2017 | Aesthetic medicine services - Non-surgical medical treatments |
EN ISO 80601-2-55:2018 | Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors (ISO 80601-2-55:2018) |
I.S. EN ISO 16671:2015 | OPHTHALMIC IMPLANTS - IRRIGATING SOLUTIONS FOR OPHTHALMIC SURGERY (ISO 16671:2015) |
I.S. EN ISO 17664:2017 | PROCESSING OF HEALTH CARE PRODUCTS - INFORMATION TO BE PROVIDED BY THE MEDICAL DEVICE MANUFACTURER FOR THE PROCESSING OF MEDICAL DEVICES (ISO 17664:2017) |
ISO 6710:2017 | Single-use containers for human venous blood specimen collection |
I.S. EN ISO 8836:2014 | SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT (ISO 8836:2014) |
ISO 17664:2017 | Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical devices |
DIN EN ISO 3630-3:2015-12 | Dentistry - Endodontic instruments - Part 3: Compactors: pluggers and spreaders (ISO 3630-3:2015) |
DIN EN ISO 6873:2013-07 | DENTISTRY - GYPSUM PRODUCTS (ISO 6873:2013) |
DIN EN ISO 7439:2015-08 | Copper-bearing contraceptive intrauterine devices - Requirements and tests (ISO 7439:2015) |
DIN EN 455-3:2015-07 | Medical gloves for single use - Part 3: Requirements and testing for biological evaluation |
DIN EN 13718-1:2014-12 | MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 1: REQUIREMENTS FOR MEDICAL DEVICES USED IN AIR AMBULANCES |
DIN EN ISO 10079-3:2014-09 | Medical suction equipment - Part 3: Suction equipment powered from a vacuum or positive pressure gas source (ISO 10079-3:2014) |
DIN EN 455-2:2015-07 | Medical gloves for single use - Part 2: Requirements and testing for physical properties |
DIN EN ISO 8536-10:2015-11 | INFUSION EQUIPMENT FOR MEDICAL USE - PART 10: ACCESSORIES FOR FLUID LINES FOR SINGLE USE WITH PRESSURE INFUSION EQUIPMENT (ISO 8536-10:2015) |
DIN EN 285:2016-05 | Sterilization - Steam sterilizers - Large sterilizers |
DIN EN ISO 8536-9:2015-11 | INFUSION EQUIPMENT FOR MEDICAL USE - PART 9: FLUID LINES FOR SINGLE USE WITH PRESSURE INFUSION EQUIPMENT (ISO 8536-9:2015) |
BS EN ISO 8536-10:2015 | Infusion equipment for medical use Accessories for fluid lines for single use with pressure infusion equipment |
ISO 1135-5:2015 | Transfusion equipment for medical use — Part 5: Transfusion sets for single use with pressure infusion apparatus |
UNI EN ISO 8536-4 : 2013 | INFUSION EQUIPMENT FOR MEDICAL USE - PART 4: INFUSION SETS FOR SINGLE USE, GRAVITY FEED |
ISO 3630-5:2011 | Dentistry Endodontic instruments Part 5: Shaping and cleaning instruments |
BS EN ISO 23747:2015 | Anaesthetic and respiratory equipment. Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans |
ISO 3630-2:2013 | Dentistry — Endodontic instruments — Part 2: Enlargers |
BS EN ISO 1135-4:2015 | Transfusion equipment for medical use Transfusion sets for single use, gravity feed |
ISO 5364:2016 | Anaesthetic and respiratory equipment — Oropharyngeal airways |
ISO 80601-2-69:2014 | Medical electrical equipment Part 2-69: Particular requirements for basic safety and essential performance of oxygen concentrator equipment |
ISO 13079:2011 | Laboratory glass and plastics ware — Tubes for the measurement of the erythrocyte sedimentation rate by the Westergren method |
UNE-EN ISO 8536-8:2015 | Infusion equipment for medical use - Part 8: Infusion sets for single use with pressure infusion apparatus (ISO 8536-8:2015) |
UNE-EN ISO 7439:2015 | Copper-bearing contraceptive intrauterine devices - Requirements and tests (ISO 7439:2015) |
UNE-EN ISO 26782:2010 | Anaesthetic and respiratory equipment - Spirometers intended for the measurement of time forced expired volumes in humans (ISO 26782:2009) |
ISO 14155:2011 | Clinical investigation of medical devices for human subjects Good clinical practice |
BS EN 30-1-2:2012 | Domestic cooking appliances burning gas. Safety Appliances having forced-convection ovens and/or grills |
UNE-EN ISO 11499:2014 | Dentistry - Single-use cartridges for local anaesthetics (ISO 11499:2014) |
I.S. EN 1789:2007 | MEDICAL VEHICLES AND THEIR EQUIPMENT - ROAD AMBULANCES |
EN 1789:2007+A2:2014 | Medical vehicles and their equipment - Road ambulances |
EN ISO 80601-2-69:2014 | Medical electrical equipment - Part 2-69: Particular requirements for basic safety and essential performance of oxygen concentrator equipment (ISO 80601-2-69:2014) |
I.S. EN ISO 11979-4:2008 | OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 4: LABELLING AND INFORMATION (ISO 11979-4:2008) |
EN ISO 8836:2014 | Suction catheters for use in the respiratory tract (ISO 8836:2014) |
EN 60601-1-12:2015 | Medical electrical equipment - Part 1-12: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment |
UNE-EN ISO 7885:2010 | Dentistry - Sterile injection needles for single use (ISO 7885:2010) |
EN ISO 3630-5:2011 | Dentistry - Endodontic instruments - Part 5: Shaping and cleaning instruments (ISO 3630-5:2011) |
EN 60601-2-4:2011 | Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators |
CSA C22.2 No. 80601-2-12 : 2012(R2017) | MEDICAL ELECTRICAL EQUIPMENT - PART 2-12: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CRITICAL CARE VENTILATORS |
EN ISO 3826-2:2008 | Plastics collapsible containers for human blood and blood components - Part 2: Graphical symbols for use on labels and instruction leaflets (ISO 3826-2:2008) |
EN ISO 3826-4:2015 | Plastics collapsible containers for human blood and blood components - Part 4: Aphaeresis blood bag systems with integrated features (ISO 3826-4:2015) |
EN ISO 8536-9:2015 | Infusion equipment for medical use - Part 9: Fluid lines for single use with pressure infusion equipment (ISO 8536-9:2015) |
EN ISO 18113-1:2011 | In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009) |
ONORM EN ISO 15798 : 2013 AMD 1 2018 | OPHTHALMIC IMPLANTS - OPHTHALMIC VISCOSURGICAL DEVICES (ISO 15798:2013) |
EN 45502-1:2015 | IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL REQUIREMENTS FOR SAFETY, MARKING AND FOR INFORMATION TO BE PROVIDED BY THE MANUFACTURER |
UNI EN ISO 17510-2 : 2009 | SLEEP APNOEA BREATHING THERAPY - PART 2: MASKS AND APPLICATION ACCESSORIES |
UNI EN ISO 11979-4 : 2012 | OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 4: LABELLING AND INFORMATION |
UNI EN ISO 6873 : 2013 | DENTISTRY - GYPSUM PRODUCTS |
UNI EN ISO 10079-3 : 2014 | MEDICAL SUCTION EQUIPMENT - PART 3: SUCTION EQUIPMENT POWERED FROM A VACUUM OR POSITIVE PRESSURE GAS SOURCE |
ONORM EN ISO 10079-2 : 2014 | MEDICAL SUCTION EQUIPMENT - PART 2: MANUALLY POWERED SUCTION EQUIPMENT (ISO 10079-2:2014) |
UNI EN ISO 11499 : 2014 | DENTISTRY - SINGLE-USE CARTRIDGES FOR LOCAL ANAESTHETICS |
EN 868-4:2017 | Packaging for terminally sterilized medical devices - Part 4: Paper bags - Requirements and test methods |
UNI EN ISO 3630-2 : 2013 | DENTISTRY - ENDODONTIC INSTRUMENTS - PART 2: ENLARGERS |
UNI EN ISO 10079-2 : 2014 | MEDICAL SUCTION EQUIPMENT - PART 2: MANUALLY POWERED SUCTION EQUIPMENT |
UNI EN ISO 7885 : 2010 | DENTISTRY - STERILE INJECTION NEEDLES FOR SINGLE USE |
ONORM EN ISO 10079-3 : 2014 | MEDICAL SUCTION EQUIPMENT - PART 3: SUCTION EQUIPMENT POWERED FROM A VACUUM OR POSITIVE PRESSURE GAS SOURCE (ISO 10079-3:2014) |
UNI EN 14180 : 2014 | STERILIZERS FOR MEDICAL PURPOSES - LOW TEMPERATURE STEAM AND FORMALDEHYDE STERILIZERS - REQUIREMENTS AND TESTING |
UNE-EN ISO 5361:2017 | Anaesthetic and respiratory equipment - Tracheal tubes and connectors (ISO 5361:2016) |
DIN EN ISO 16061:2015-09 | Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2015) |
DIN EN ISO 3665:2013-07 | PHOTOGRAPHY - INTRA-ORAL DENTAL RADIOGRAPHIC FILM AND FILM PACKETS - MANUFACTURER SPECIFICATIONS (ISO 3665:2011) |
I.S. EN ISO 13958:2015 | CONCENTRATES FOR HAEMODIALYSIS AND RELATED THERAPIES (ISO 13958:2014) |
I.S. EN ISO 80601-2-56:2017 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-56: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CLINICAL THERMOMETERS FOR BODY TEMPERATURE MEASUREMENT (ISO 80601-2-56:2017) |
ISO 18746:2016 | Traditional Chinese medicine — Sterile intradermal acupuncture needles for single use |
ANSI/AAMI HA60601-1-11:2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-11: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS USED IN THE HOME HEALTHCARE ENVIRONMENT |
DIN EN ISO 13504:2012-10 | DENTISTRY - GENERAL REQUIREMENTS FOR INSTRUMENTS AND RELATED ACCESSORIES USED IN DENTAL IMPLANT PLACEMENT AND TREATMENT (ISO 13504:2012) |
BS EN ISO 3630-5:2011 | Dentistry. Endodontic instruments Shaping and cleaning instruments |
17/30338756 DC : 0 | BS ISO 80601-2-80 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-80: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF VENTILATORY SUPPORT EQUIPMENT FOR VENTILATORY INSUFFICIENCY |
15/30282343 DC : 0 | BS ISO 18746 - TRADITIONAL CHINESE MEDICINE - INTRADERMAL ACUPUNCTURE NEEDLES |
ISO 18190:2016 | Anaesthetic and respiratory equipment — General requirements for airways and related equipment |
08/30184486 DC : DRAFT JUNE 2008 | BS EN ISO 1135-4 - TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 4: TRANSFUSION SETS FOR SINGLE USE |
PREN 17180 : DRAFT 2017 | STERILIZERS FOR MEDICAL PURPOSES - LOW TEMPERATURE VAPORIZED HYDROGEN PEROXIDE STERILIZERS - REQUIREMENTS AND TESTING |
I.S. EN ISO 13079:2011 | LABORATORY GLASS AND PLASTICS WARE - TUBES FOR THE MEASUREMENT OF THE ERYTHROCYTE SEDIMENTATION RATE BY THE WESTERGREN METHOD |
BS ISO 11040-7:2015 | Prefilled syringes Packaging systems for sterilized subassembled syringes ready for filling |
18/30372409 DC : DRAFT APR 2018 | BS EN ISO 3630-1 - DENTISTRY - ENDODONTIC INSTRUMENTS - PART 1: GENERAL REQUIREMENTS |
BS ISO 16142-2:2017 | Medical devices. Recognized essential principles of safety and performance of medical devices General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards |
09/30186527 DC : 0 | BS EN ISO 23908-1 - SHARPS INJURY PROTECTION - REQUIREMENTS AND TEST METHODS - PART 1: SHARPS PROTECTION FEATURES FOR SINGLE-USED HYPODERMIC NEEDLES, CATHETERS, INTRODUCERS FOR CATHETERS AND NEEDLES USED FOR BLOOD SAMPLING |
I.S. EN ISO 5367:2014 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - BREATHING SETS AND CONNECTORS (ISO 5367:2014) |
14/30251609 DC : 0 | BS EN ISO 12417-1 - CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR DEVICE-DRUG COMBINATION PRODUCTS - PART 1: GENERAL REQUIREMENTS |
DIN EN 1865-1:2015-08 | PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 1: GENERAL STRETCHER SYSTEMS AND PATIENT HANDLING EQUIPMENT |
BS ISO 18835:2015 | Inhalational anaesthesia systems. Draw-over anaesthetic systems |
I.S. EN 556-2:2015 | STERILIZATION OF MEDICAL DEVICES - REQUIREMENTS FOR MEDICAL DEVICES TO BE DESIGNATED 'STERILE' - PART 2: REQUIREMENTS FOR ASEPTICALLY PROCESSED MEDICAL DEVICES |
DIN EN ISO 18113-5:2013-01 | In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009) |
13/30264413 DC : 0 | BS EN ISO 80601-2-72 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-72: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HOME HEALTHCARE ENVIRONMENT VENTILATORS FOR VENTILATOR-DEPENDENT PATIENTS |
BS EN ISO 13504:2012 | Dentistry. General requirements for instruments and related accessories used in dental implant placement and treatment |
BS EN ISO 18397:2016 | Dentistry. Powered scaler |
UNI EN ISO 18113-2 : 2012 | IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 2: IN VITRO DIAGNOSTIC REAGENTS FOR PROFESSIONAL USE |
BS EN ISO 13958:2015 | Concentrates for haemodialysis and related therapies |
PREN 455-3 : DRAFT 2013 | MEDICAL GLOVES FOR SINGLE USE - PART 3: REQUIREMENTS AND TESTING FOR BIOLOGICAL EVALUATION |
15/30289037 DC : 0 | BS EN ISO 7886-1 - STERILE HYPODERMIC SYRINGES FOR SINGLE USE - PART 1: SYRINGES FOR MANUAL USE |
12/30245174 DC : 0 | BS EN 60601-1-12 - MEDICAL ELECTRICAL EQUIPMENT - PART 1-12: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS INTENDED FOR USE IN THE EMERGENCY MEDICAL SERVICES ENVIRONMENT |
14/30295064 DC : 0 | BS EN ISO 16672 - OPHTHALMIC IMPLANTS - OCULAR ENDOTAMPONADES |
14/30296389 DC : 0 | BS EN ISO 7864 - STERILE HYPODERMIC NEEDLES FOR SINGLE USE - REQUIREMENTS AND TEST METHODS |
13/30259011 DC : 0 | BS ISO 17218 - STERILE ACUPUNCTURE NEEDLES FOR SINGLE USE |
UNE-EN 15986:2011 | Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates |
14/30281859 DC : 0 | BS ISO 5361 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - TRACHEAL TUBES AND CONNECTORS |
DIN EN ISO 1135-3 E : 2017 | TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 3: BLOOD-TAKING SETS FOR SINGLE USE (ISO 1135-3:2016) |
AAMI ISO 8637 : 2010 | CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - HEMODIALYZERS, HEMODIAFILTERS, HEMOFILTERS AND HEMOCONCENTRATORS |
16/30310674 DC : 0 | BS EN ISO 14457 - DENTISTRY - HANDPIECES AND MOTORS |
UNE-EN ISO 3630-4:2010 | Dentistry - Root canal instruments - Part 4: Auxiliary instruments (ISO 3630-4:2009) |
13/30233325 DC : 0 | BS EN 45502-1 - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL REQUIREMENTS FOR SAFETY, MARKING AND INFORMATION TO BE PROVIDED BY THE MANUFACTURER |
UNI EN ISO 13504 : 2012 | DENTISTRY - GENERAL REQUIREMENTS FOR INSTRUMENTS AND RELATED ACCESSORIES USED IN DENTAL IMPLANT PLACEMENT AND TREATMENT |
CEI EN 60601-2-4 : 2012 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-4: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CARDIAC DEFIBRILLATORS |
I.S. EN ISO 18113-1:2011 | IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 1: TERMS, DEFINITIONS AND GENERAL REQUIREMENTS (ISO 18113-1:2009) |
BS EN ISO 5361:2016 | Anaesthetic and respiratory equipment. Tracheal tubes and connectors |
13/30272807 DC : 0 | BS ISO 18835 - INHALATIONAL ANAESTHESIA SYSTEMS - DRAW-OVER VAPORIZERS AND ASSOCIATED EQUIPMENT |
BS EN ISO 18113-5:2011 | In vitro diagnostic medical Devices. Information supplied by the manufacturer (labelling) In vitro diagnostic instruments for self-testing |
PREN ISO 80601-2-55 : DRAFT 2009 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-55: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY GAS MONITORS |
14/30287632 DC : 0 | BS EN ISO 12836:2012/AMD 1 - DENTISTRY - DIGITIZING DEVICES FOR CAD/CAM SYSTEMS FOR INDIRECT DENTAL RESTORATIONS - TEST METHODS FOR ASSESSING ACCURACY |
DIN EN 1865-3:2015-05 | PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 3: HEAVY DUTY STRETCHER |
16/30331653 DC : 0 | BS EN ISO 8637-2 - EXTRACORPOREAL SYSTEMS FOR BLOOD PURIFICATION - PART 2: EXTRACORPOREAL BLOOD CIRCUIT FOR HAEMODIALYSERS, HAEMODIAFILTERS AND HAEMOFILTERS |
BS EN ISO 22413:2013 | Transfer sets for pharmaceutical preparations. Requirements and test methods |
NF EN ISO 80601-2-12 : 2011 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-12: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CRITICAL CARE VENTILATORS |
CSA C22.2 No. 60601.2.49:2011 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-49: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF MULTIFUNCTION PATIENT MONITORING EQUIPMENT |
I.S. EN ISO 9687:2015 | DENTISTRY - GRAPHICAL SYMBOLS FOR DENTAL EQUIPMENT (ISO 9687:2015) |
BS EN ISO 16061:2015 | Instrumentation for use in association with non-active surgical implants. General requirements |
AAMI ISO 14708-4 : 2008 | IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 4: IMPLANTABLE INFUSION PUMPS |
BS EN 60601-2-4:2011 | Medical electrical equipment Particular requirements for the basic safety and essential performance of cardiac defibrillators |
BS ISO 16628:2008 | Tracheobronchial tubes. Sizing and marking |
I.S. EN 60601-2-4:2011 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-4: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CARDIAC DEFIBRILLATORS |
UNE-EN ISO 12417-1:2016 | Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products - Part 1: General requirements (ISO 12417-1:2015) |
ISO/TR 12417-2:2017 | Cardiovascular implants and extracorporeal systems — Vascular device-drug combination products — Part 2: Local regulatory information |
UNI EN ISO 13079 : 2011 | LABORATORY GLASS AND PLASTICS WARE - TUBES FOR THE MEASUREMENT OF THE ERYTHROCYTE SEDIMENTATION RATE BY THE WESTERGREN METHOD |
AAMI ISO 12417-1 : 2015 | CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR DEVICE-DRUG COMBINATION PRODUCTS - PART 1: GENERAL REQUIREMENTS |
ISO 80601-2-56:2017 | Medical electrical equipment — Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement |
UNE-EN ISO 21563:2014 | Dentistry - Hydrocolloid impression materials (ISO 21563:2013) |
ISO 80601-2-67:2014 | Medical electrical equipment Part 2-67: Particular requirements for basic safety and essential performance of oxygen-conserving equipment |
BS EN ISO 17664:2017 | Processing of health care products. Information to be provided by the medical device manufacturer for the processing of medical devices |
PD IEC/TR 60601-4-3:2015 | Medical electrical equipment Guidance and interpretation. Considerations of unaddressed safety aspects in the third edition of IEC 60601-1 and proposals for new requirements |
UNI EN ISO 8638 : 2014 | CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - EXTRACORPOREAL BLOOD CIRCUIT FOR HAEMODIALYSERS, HAEMODIAFILTERS AND HAEMOFILTERS |
CSA C22.2 No. 80601-2-69 : 2016 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-69: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF OXYGEN CONCENTRATOR EQUIPMENT |
BS EN 14683:2014 | Medical face masks. Requirements and test methods |
UNI CEI EN 15986 : 2011 | SYMBOL FOR USE IN THE LABELLING OF MEDICAL DEVICES - REQUIREMENTS FOR LABELLING OF MEDICAL DEVICES CONTAINING PHTHALATES |
I.S. EN ISO 15798:2013 | OPHTHALMIC IMPLANTS - OPHTHALMIC VISCOSURGICAL DEVICES (ISO 15798:2013) |
I.S. EN ISO 13017:2012 | DENTISTRY - MAGNETIC ATTACHMENTS (ISO 13017:2012) |
I.S. EN ISO 18113-4:2011 | IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 4: IN VITRO DIAGNOSTIC REAGENTS FOR SELF-TESTING (ISO 18113-4:2009) |
I.S. EN ISO 7886-1:1998 | STERILE HYPODERMIC SYRINGES FOR SINGLE USE - PART 1: SYRINGES FOR MANUAL USE (ISO 7886-1:2017) |
I.S. EN ISO 3826-2:2008 | PLASTICS COLLAPSIBLE CONTAINERS FOR HUMAN BLOOD AND BLOOD COMPONENTS - PART 2: GRAPHICAL SYMBOLS FOR USE ON LABELS AND INSTRUCTION LEAFLETS |
AAMI ISO 27185 : 2012 | CARDIAC RHYTHM MANAGEMENT DEVICES - SYMBOLS TO BE USED WITH CARDIAC RHYTHM MANAGEMENT DEVICE LABELS, AND INFORMATION TO BE SUPPLIED - GENERAL REQUIREMENTS |
I.S. EN 60601-2-49:2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-49: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF MULTIFUNCTION PATIENT MONITORING EQUIPMENT |
I.S. EN ISO 25539-1:2017 | CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES (ISO 25539-1:2017) |
CAN/CSA-C22.2 NO. 80601-2-67:17 | Medical electrical equipment — Part 2-67: Particular requirements for basic safety and essential performance of oxygen conserving equipment (Adopted ISO 80601-2-67:2014, first edition, 2014-06-01, with Canadian deviations) |
ANSI/AAMI/ISO 14708-1:2014 | IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL REQUIREMENTS FOR SAFETY, MARKING AND FOR INFORMATION TO BE PROVIDED BY THE MANUFACTURER |
I.S. EN ISO 80601-2-72:2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-72: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HOME HEALTHCARE ENVIRONMENT VENTILATORS FOR VENTILATOR-DEPENDENT PATIENTS (ISO 80601-2-72:2015) |
I.S. EN 1865-1:2010 | PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 1: GENERAL STRETCHER SYSTEMS AND PATIENT HANDLING EQUIPMENT |
I.S. EN 60601-1:2006&A1:2013&AC:2014&A12:2014 | MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE |
I.S. EN 60601-2-34:2014 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-34: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INVASIVE BLOOD PRESSURE MONITORING EQUIPMENT |
ISO 17218:2014 | Sterile acupuncture needles for single use |
17/30360908 DC : 0 | BS EN 868-5 - PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 5: SEALABLE POUCHES AND REELS OF POROUS MATERIALS AND PLASTIC FILM CONSTRUCTION - REQUIREMENTS AND TEST METHODS |
UNI EN ISO 17510-1 : 2009 | SLEEP APNOEA BREATHING THERAPY - PART 1: SLEEP APNOEA BREATHING THERAPY EQUIPMENT |
UNE-EN ISO 23908:2013 | Sharps injury protection - Requirements and test methods - Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling (ISO 23908:2011) |
PREN ISO 3826-1 : DRAFT 2010 | PLASTICS COLLAPSIBLE CONTAINERS FOR HUMAN BLOOD AND BLOOD COMPONENTS - PART 1: CONVENTIONAL CONTAINERS |
ISO 17510:2015 | Medical devices — Sleep apnoea breathing therapy — Masks and application accessories |
ISO 14708-4:2008 | Implants for surgery Active implantable medical devices Part 4: Implantable infusion pumps |
17/30359567 DC : 0 | BS EN 14683 - MEDICAL FACE MASKS - REQUIREMENTS AND TEST METHODS |
AAMI ISO 26782 : 2015 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - SPIROMETERS INTENDED FOR THE MEASUREMENT OF TIME FORCED EXPIRED VOLUMES IN HUMANS |
EN ISO 28319:2018 | Dentistry - Laser welding and filler materials (ISO 28319:2018) |
EN 14683:2014 | Medical face masks - Requirements and test methods |
DIN EN ISO 10650:2016-02 | DENTISTRY - POWERED POLYMERIZATION ACTIVATORS (ISO 10650:2015) |
EN ISO 20608:2018 | Dentistry - Powder jet handpieces and powders (ISO 20608:2018) |
ISO 15223-2:2010 | Medical devices — Symbols to be used with medical device labels, labelling, and information to be supplied — Part 2: Symbol development, selection and validation |
I.S. EN 14683:2014 | MEDICAL FACE MASKS - REQUIREMENTS AND TEST METHODS |
EN ISO 8637:2014 | Cardiovascular implants and extracorporeal systems - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637:2010, including Amendment 1 2013-04-01) |
ISO 80601-2-12:2011 | Medical electrical equipment Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators |
I.S. EN ISO 8536-4:2013 | INFUSION EQUIPMENT FOR MEDICAL USE - PART 4: INFUSION SETS FOR SINGLE USE, GRAVITY FEED (ISO 8536-4:2010) |
BS EN ISO 8536-4 : 2013 | INFUSION EQUIPMENT FOR MEDICAL USE - PART 4: INFUSION SETS FOR SINGLE USE, GRAVITY FEED |
DIN EN ISO 8536-11:2015-11 | INFUSION EQUIPMENT FOR MEDICAL USE - PART 11: INFUSION FILTERS FOR SINGLE USE WITH PRESSURE INFUSION EQUIPMENT (ISO 8536-11:2015) |
DIN EN 14180:2014-09 | STERILIZERS FOR MEDICAL PURPOSES - LOW TEMPERATURE STEAM AND FORMALDEHYDE STERILIZERS - REQUIREMENTS AND TESTING |
DIN EN ISO 10079-1:2016-05 | MEDICAL SUCTION EQUIPMENT - PART 1: ELECTRICALLY POWERED SUCTION EQUIPMENT (ISO 10079-1:2015) |
DIN EN ISO 8536-4:2013-07 | INFUSION EQUIPMENT FOR MEDICAL USE - PART 4: INFUSION SETS FOR SINGLE USE, GRAVITY FEED (ISO 8536-4:2010 + AMD 1:2013) |
DIN EN ISO 14534:2015-08 | Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2011) |
DIN EN ISO 10079-2:2014-09 | Medical suction equipment - Part 2: Manually powered suction equipment (ISO 10079-2:2014); German version EN ISO 10079-2:2014 |
ISO 13504:2012 | Dentistry — General requirements for instruments and related accessories used in dental implant placement and treatment |
UNE-EN ISO 1135-4:2016 | Transfusion equipment for medical use - Part 4: Transfusion sets for single use, gravity feed (ISO 1135-4:2015) |
BS EN 60601-1 : 2006 | MEDICAL ELECTRICAL EQUIPMENT PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE |
BS EN ISO 17510-1:2009 | Sleep apnoea breathing therapy Sleep apnoea breathing therapy equipment |
ISO 18113-2:2009 | In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 2: In vitro diagnostic reagents for professional use |
ISO 21563:2013 | Dentistry Hydrocolloid impression materials |
BS EN 868-2:2017 | Packaging for terminally sterilized medical devices Sterilization wrap. Requirements and test methods |
UNE-EN ISO 8537:2016 | Sterile single-use syringes, with or without needle, for insulin (ISO 8537:2016) |
UNE-EN 556-2:2016 | Sterilization of medical devices - Requirements for medical devices to be designated 'STERILE" - Part 2: Requirements for aseptically processed medical devices |
UNE-EN ISO 10079-3:2014 | Medical suction equipment - Part 3: Suction equipment powered from a vacuum or positive pressure gas source (ISO 10079-3:2014) |
ISO 3630-4:2009 | Dentistry — Root canal instruments — Part 4: Auxiliary instruments |
IEC 60601-1:2005+AMD1:2012 CSV | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
ISO 8536-10:2015 | Infusion equipment for medical use Part 10: Accessories for fluid lines for single use with pressure infusion equipment |
ISO 1135-3:2016 | Transfusion equipment for medical use Part 3: Blood-taking sets for single use |
ISO 16061:2015 | Instrumentation for use in association with non-active surgical implants General requirements |
ISO 3826-2:2008 | Plastics collapsible containers for human blood and blood components — Part 2: Graphical symbols for use on labels and instruction leaflets |
ISO 17510-2:2007 | Sleep apnoea breathing therapy Part 2: Masks and application accessories |
ISO 3826-1:2013 | Plastics collapsible containers for human blood and blood components Part 1: Conventional containers |
ISO 26782:2009 | Anaesthetic and respiratory equipment — Spirometers intended for the measurement of time forced expired volumes in humans |
ISO 11138-1:2017 | Sterilization of health care products — Biological indicators — Part 1: General requirements |
DIN EN ISO 11979-4:2013-01 | OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 4: LABELLING AND INFORMATION (ISO 11979-4:2008 + AMD.1:2012) |
ISO 7885:2010 | Dentistry Sterile injection needles for single use |
UNE-EN ISO 13017:2013 | Dentistry - Magnetic attachments (ISO 13017:2012) |
BS EN ISO 3826-1:2013 | Plastics collapsible containers for human blood and blood components Conventional containers |
BS EN ISO 10079-3:2014 | Medical suction equipment Suction equipment powered from a vacuum or positive pressure gas source |
BS EN ISO 9680:2014 | Dentistry. Operating lights |
ISO 80601-2-72:2015 | Medical electrical equipment — Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients |
BS EN ISO 6873:2013 | Dentistry. Gypsum products |
ISO 20072:2009 | Aerosol drug delivery device design verification Requirements and test methods |
UNE-EN ISO 4074:2016 | Natural rubber latex male condoms - Requirements and test methods (ISO 4074:2015) |
ISO 3630-3:2015 | Dentistry Endodontic instruments Part 3: Compactors: pluggers and spreaders |
BS EN 455-2:2015 | Medical gloves for single use Requirements and testing for physical properties |
ISO 1135-4:2015 | Transfusion equipment for medical use — Part 4: Transfusion sets for single use, gravity feed |
UNE-EN 455-3:2015 | Medical gloves for single use - Part 3: Requirements and testing for biological evaluation |
EN 13718-1:2014 | Medical vehicles and their equipment - Air ambulances - Part 1: Requirements for medical devices used in air ambulances |
UNE-EN ISO 11138-1:2017 | Sterilization of health care products - Biological indicators - Part 1: General requirements (ISO 11138-1:2017) |
UNE-EN ISO 8536-10:2015 | Infusion equipment for medical use - Part 10: Accessories for fluid lines for single use with pressure infusion equipment (ISO 8536-10:2015) |
UNE-EN ISO 22413:2013 | Transfer sets for pharmaceutical preparations - Requirements and test methods (ISO 22413:2010) |
BS EN ISO 8537:2016 | Sterile single-use syringes, with or without needle, for insulin |
UNE-EN 60601-2-49:2016 | Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment |
BS EN 1789 : 2007 | MEDICAL VEHICLES AND THEIR EQUIPMENT - ROAD AMBULANCES |
UNE-EN ISO 3826-1:2013 | Plastics collapsible containers for human blood and blood components - Part 1: Conventional containers (ISO 3826-1:2013) |
ISO 14408:2016 | Tracheal tubes designed for laser surgery — Requirements for marking and accompanying information |
ISO 7864:2016 | Sterile hypodermic needles for single use — Requirements and test methods |
ISO 3665:2011 | Photography Intra-oral dental radiographic film and film packets Manufacturer specifications |
ISO 16672:2015 | Ophthalmic implants Ocular endotamponades |
I.S. EN 13718-1:2014 | MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 1: REQUIREMENTS FOR MEDICAL DEVICES USED IN AIR AMBULANCES |
UNE-EN 1789:2007 | Medical vehicles and their equipment - Road ambulances |
ISO 22674:2016 | Dentistry — Metallic materials for fixed and removable restorations and appliances |
ISO 14534:2011 | Ophthalmic optics Contact lenses and contact lens care products Fundamental requirements |
ISO 18113-4:2009 | In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 4: In vitro diagnostic reagents for self-testing |
BS EN ISO 3630-1:2008 | Dentistry. Root-canal instruments General requirements and test methods |
BS EN ISO 14408:2016 | Tracheal tubes designed for laser surgery. Requirements for marking and accompanying information |
BS EN 285:2015 | Sterilization. Steam sterilizers. Large sterilizers |
I.S. EN 455-3:2015 | MEDICAL GLOVES FOR SINGLE USE - PART 3: REQUIREMENTS AND TESTING FOR BIOLOGICAL EVALUATION |
ISO 8536-8:2015 | Infusion equipment for medical use Part 8: Infusion sets for single use with pressure infusion apparatus |
ISO 5361:2016 | Anaesthetic and respiratory equipment — Tracheal tubes and connectors |
I.S. EN 455-2:2015 | MEDICAL GLOVES FOR SINGLE USE - PART 2: REQUIREMENTS AND TESTING FOR PHYSICAL PROPERTIES |
ISO 7439:2015 | Copper-bearing contraceptive intrauterine devices — Requirements and tests |
ISO 24234:2015 | Dentistry Dental amalgam |
ISO 18113-1:2009 | In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions and general requirements |
ISO 23747:2015 | Anaesthetic and respiratory equipment Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans |
UNE-EN ISO 14534:2015 | Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2011) |
ISO 8536-9:2015 | Infusion equipment for medical use Part 9: Fluid lines for single use with pressure infusion equipment |
ISO 8536-4:2010 | Infusion equipment for medical use Part 4: Infusion sets for single use, gravity feed |
BS EN ISO 24234 : 2004 | DENTISTRY - DENTAL AMALGAM |
ISO 13017:2012 | Dentistry Magnetic attachments |
ISO 11979-4:2008 | Ophthalmic implants — Intraocular lenses — Part 4: Labelling and information |
ISO 80601-2-13:2011 | Medical electrical equipment Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation |
ISO 8537:2016 | Sterile single-use syringes, with or without needle, for insulin |
ISO 8536-11:2015 | Infusion equipment for medical use Part 11: Infusion filters for single use with pressure infusion equipment |
BS EN 14180:2014 | Sterilizers for medical purposes. Low temperature steam and formaldehyde sterilizers. Requirements and testing |
UNE-EN 455-2:2015 | Medical gloves for single use - Part 2: Requirements and testing for physical properties |
BS EN 868-4:2017 | Packaging for terminally sterilized medical devices Paper bags. Requirements and test methods |
UNE-EN ISO 10079-2:2014 | Medical suction equipment - Part 2: Manually powered suction equipment (ISO 10079-2:2014) |
ISO 18113-3:2009 | In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 3: In vitro diagnostic instruments for professional use |
ISO 12836:2015 | Dentistry Digitizing devices for CAD/CAM systems for indirect dental restorations Test methods for assessing accuracy |
ISO 12417-1:2015 | Cardiovascular implants and extracorporeal systems — Vascular device-drug combination products — Part 1: General requirements |
ISO 10079-3:2014 | Medical suction equipment Part 3: Suction equipment powered from a vacuum or positive pressure gas source |
ISO 11499:2014 | Dentistry — Single-use cartridges for local anaesthetics |
NF EN ISO 17510-1 : 2009 | SLEEP APNOEA BREATHING THERAPY - PART 1: SLEEP APNOEA BREATHING THERAPY EQUIPMENT |
UNE-EN ISO 7864:2017 | Sterile hypodermic needles for single use - Requirements and test methods (ISO 7864:2016) |
ISO 4074:2015 | Natural rubber latex male condoms Requirements and test methods |
ISO 23908:2011 | Sharps injury protection Requirements and test methods Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling |
ONORM EN ISO 80601-2-13 : 2013 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-13: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF AN ANAESTHETIC WORKSTATION (ISO 80601-2-13:2011) |
ISO 9680:2014 | Dentistry Operating lights |
UNI EN ISO 80601-2-13 : 2013 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-13: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF AN ANAESTHETIC WORKSTATION |
EN 30-1-2:2012 | Domestic cooking appliances burning gas - Safety - Part 1-2: Appliances having forced-convection ovens and/or grills |
EN ISO 3665:2013 | Photography - Intra-oral dental radiographic film and film packets - Manufacturer specifications (ISO 3665:2011) |
EN 868-2:2017 | Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods |
EN 16372:2014 | Aesthetic surgery services |
EN ISO 24234:2015 | Dentistry - Dental amalgam (ISO 24234:2015) |
EN ISO 1135-3:2017 | Transfusion equipment for medical use - Part 3: Blood-taking sets for single use (ISO 1135-3:2016) |
EN ISO 80601-2-72:2015 | Medical electrical equipment - Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients (ISO 80601-2-72:2015) |
EN ISO 6873:2013 | Dentistry - Gypsum products (ISO 6873:2013) |
EN 1865-2:2010+A1:2015 | Patient handling equipment used in road ambulances - Part 2: Power assisted stretcher |
EN ISO 22674:2016 | Dentistry - Metallic materials for fixed and removable restorations and appliances (ISO 22674:2016) |
EN ISO 18113-5:2011 | In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009) |
EN ISO 5361:2016 | Anaesthetic and respiratory equipment - Tracheal tubes and connectors (ISO 5361:2016) |
EN ISO 11138-1:2017 | Sterilization of health care products - Biological indicators - Part 1: General requirements (ISO 11138-1:2017) |
EN ISO 3630-1:2008 | Dentistry - Root-canal instruments - Part 1: General requirements and test methods (ISO 3630-1:2008) |
UNI EN ISO 9680 : 2015 | DENTISTRY - OPERATING LIGHTS |
EN ISO 8536-10:2015 | Infusion equipment for medical use - Part 10: Accessories for fluid lines for single use with pressure infusion equipment (ISO 8536-10:2015) |
EN ISO 10079-2:2014 | Medical suction equipment - Part 2: Manually powered suction equipment (ISO 10079-2:2014) |
EN ISO 17510-2:2009 | Sleep apnoea breathing therapy - Part 2: Masks and application accessories (ISO 17510-2:2007) |
EN ISO 11499:2014 | Dentistry - Single-use cartridges for local anaesthetics (ISO 11499:2014) |
EN ISO 8536-8:2015 | Infusion equipment for medical use - Part 8: Infusion sets for single use with pressure infusion apparatus (ISO 8536-8:2015) |
EN ISO 7864:2016 | Sterile hypodermic needles for single use - Requirements and test methods (ISO 7864:2016) |
EN 556-2:2015 | Sterilization of medical devices - Requirements for medical devices to be designated 'STERILE" - Part 2: Requirements for aseptically processed medical devices |
EN 455-2:2015 | Medical gloves for single use - Part 2: Requirements and testing for physical properties |
EN ISO 10079-3:2014 | Medical suction equipment - Part 3: Suction equipment powered from a vacuum or positive pressure gas source (ISO 10079-3:2014) |
EN 455-3:2015 | Medical gloves for single use - Part 3: Requirements and testing for biological evaluation |
EN ISO 13079:2011 | Laboratory glass and plastics ware - Tubes for the measurement of the erythrocyte sedimentation rate by the Westergren method (ISO 13079:2011) |
EN ISO 3630-2:2013 | Dentistry - Endodontic instruments - Part 2: Enlargers (ISO 3630-2:2013) |
EN ISO 12836:2015 | Dentistry - Digitizing devices for CAD/CAM systems for indirect dental restorations - Test methods for assessing accuracy (ISO 12836:2015) |
EN ISO 13958:2015 | Concentrates for haemodialysis and related therapies (ISO 13958:2014) |
EN 1865-3:2012+A1:2015 (edition 2) | Patient handling equipment used in road ambulances - Part 3: Heavy duty stretcher |
EN ISO 21531:2009 | Dentistry - Graphical symbols for dental instruments (ISO 21531:2009) |
EN ISO 14408:2016 | Tracheal tubes designed for laser surgery - Requirements for marking and accompanying information (ISO 14408:2016) |
EN ISO 20072:2013 | Aerosol drug delivery device design verification - Requirements and test methods (ISO 20072:2009) |
EN ISO 23908:2013 | Sharps injury protection - Requirements and test methods - Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling (ISO 23908:2011) |
EN ISO 8537:2016 | Sterile single-use syringes, with or without needle, for insulin (ISO 8537:2016) |
EN 1865-1:2010+A1:2015 | Patient handling equipment used in road ambulances - Part 1: General stretcher systems and patient handling equipment |
EN ISO 8536-11:2015 | Infusion equipment for medical use - Part 11: Infusion filters for single use with pressure infusion equipment (ISO 8536-11:2015) |
EN ISO 10524-4:2008 | Pressure regulators for use with medical gases - Part 4: Low-pressure regulators (ISO 10524-4:2008) |
EN ISO 14534:2015 | Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2011) |
EN 15986:2011 | Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates |
EN 14180:2014 | Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing |
EN ISO 1135-5:2015 | Transfusion equipment for medical use - Part 5: Transfusion sets for single use with pressure infusion apparatus (ISO 1135-5:2015) |
EN 980:2008 | Symbols for use in the labelling of medical devices |
EN ISO 12417-1:2015 | Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products - Part 1: General requirements (ISO 12417-1:2015) |
EN ISO 23747:2015 | Anaesthetic and respiratory equipment - Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans (ISO 23747:2015) |
EN ISO 4074:2015 | Natural rubber latex male condoms - Requirements and test methods (ISO 4074:2015) |
EN ISO 18397:2016 | Dentistry - Powered scaler (ISO 18397:2016) |
EN ISO 5367:2014 | Anaesthetic and respiratory equipment - Breathing sets and connectors (ISO 5367:2014) |
EN ISO 7439:2015 | Copper-bearing contraceptive intrauterine devices - Requirements and tests (ISO 7439:2015) |
EN ISO 13504:2012 | Dentistry - General requirements for instruments and related accessories used in dental implant placement and treatment (ISO 13504:2012) |
EN ISO 3630-4:2009 | Dentistry - Root canal instruments - Part 4: Auxiliary instruments (ISO 3630-4:2009) |
EN ISO 7885:2010 | Dentistry - Sterile injection needles for single use (ISO 7885:2010) |
EN ISO 3826-1:2013 | Plastics collapsible containers for human blood and blood components - Part 1: Conventional containers (ISO 3826-1:2013) |
DIN EN ISO 10524-4:2008-09 | PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 4: LOW-PRESSURE REGULATORS |
I.S. EN ISO 10650:2015 | DENTISTRY - POWERED POLYMERIZATION ACTIVATORS (ISO 10650:2015) |
I.S. EN ISO 80601-2-61:2011 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-61: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF PULSE OXIMETER EQUIPMENT |
ISO 80601-2-61:2017 | Medical electrical equipment Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment |
12/30210881 DC : DRAFT APR 2012 | BS EN ISO 5367 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - BREATHING SETS AND CONNECTORS |
DIN EN ISO 81060-1:2012-08 | Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type (ISO 81060-1:2007) |
ISO 14708-1:2014 | Implants for surgery — Active implantable medical devices — Part 1: General requirements for safety, marking and for information to be provided by the manufacturer |
DIN EN ISO 20072:2013-10 | AEROSOL DRUG DELIVERY DEVICE DESIGN VERIFICATION - REQUIREMENTS AND TEST METHODS (ISO 20072:2009) |
DIN EN ISO 18397:2016-09 | DENTISTRY - POWERED SCALER (ISO 18397:2016) |
UNI EN ISO 3630-4 : 2009 | DENTISTRY - ROOT CANAL INSTRUMENTS - PART 4: AUXILIARY INSTRUMENTS |
CSA ISO 27427 : 2014 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - NEBULIZING SYSTEMS AND COMPONENTS |
BS EN ISO 25539-1:2017 | Cardiovascular implants. Endovascular devices Endovascular prostheses |
ISO 8536-12:2007 | Infusion equipment for medical use Part 12: Check valves |
11/30193833 DC : 0 | BS EN ISO 3630-2 - DENTISTRY - ENDODONTIC INSTRUMENTS - PART 2: ENLARGERS |
15/30328959 DC : 0 | BS ISO 16142-2 - MEDICAL DEVICES - RECOGNIZED ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE OF MEDICAL DEVICES - PART 2: GENERAL ESSENTIAL PRINCIPLES AND ADDITIONAL SPECIFIC ESSENTIAL PRINCIPLES FOR ALL IVD MEDICAL DEVICES AND GUIDANCE ON THE SELECTION OF STANDARDS |
I.S. EN 980:2008 | SYMBOLS FOR USE IN THE LABELLING OF MEDICAL DEVICES |
PREN 45502-1 : DRAFT 2013 | ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL REQUIREMENTS FOR SAFETY, MARKING AND INFORMATION TO BE PROVIDED BY THE MANUFACTURER |
13/30290370 DC : 0 | BS ISO 17510 - MEDICAL DEVICES - SLEEP APNOEA BREATHING THERAPY - MASKS AND APPLICATION ACCESSORIES |
BS EN ISO 9687 : 2015 | DENTISTRY - GRAPHICAL SYMBOLS FOR DENTAL EQUIPMENT |
BS EN 16372:2014 | Aesthetic surgery services |
I.S. EN ISO 14155:2011 | CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - GOOD CLINICAL PRACTICE (ISO 14155:2011) |
16/30331656 DC : 0 | BS ISO 8637-3 - EXTRACORPOREAL SYSTEMS FOR BLOOD PURIFICATION - PART 3: PLASMAFILTERS |
BS EN ISO 1135-3:2017 | Transfusion equipment for medical use Blood-taking sets for single use |
10/30233840 DC : 0 | BS ISO 3826-1 - PLASTICS COLLAPSIBLE CONTAINERS FOR HUMAN BLOOD AND BLOOD COMPONENTS - PART 1: CONVENTIONAL CONTAINERS |
UNI EN ISO 10524-4 : 2008 | PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 4: LOW-PRESSURE REGULATORS |
BS ISO 27427:2013 | Anaesthetic and respiratory equipment. Nebulizing systems and components |
DIN EN ISO 12417-1:2016-02 | Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products - Part 1: General requirements (ISO 12417-1:2015) |
BIP 0113 : 2012 | GUIDE TO EUROPEAN MEDICAL DEVICE TRIALS AND BS EN ISO 14155 |
14/30273278 DC : 0 | BS EN ISO 18397 - DENTISTRY - POWERED SCALER |
DIN EN ISO 18113-1:2013-01 | In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009) |
BS ISO 27185:2012 | Cardiac rhythm management devices. Symbols to be used with cardiac rhythm management device labels, and information to be supplied. General requirements |
13/30267665 DC : 0 | BS EN ISO 24234 - DENTISTRY - DENTAL AMALGAM |
I.S. EN ISO 13504:2012 | DENTISTRY - GENERAL REQUIREMENTS FOR INSTRUMENTS AND RELATED ACCESSORIES USED IN DENTAL IMPLANT PLACEMENT AND TREATMENT (ISO 13504:2012) |
BS EN ISO 10524-4:2008 | Pressure regulators for use with medical gases Low-pressure regulators |
BS EN 15986:2011 | Symbol for use in the labelling of medical devices. Requirements for labelling of medical devices containing phthalates |
I.S. EN ISO 18397:2016 | DENTISTRY - POWERED SCALER (ISO 18397:2016) |
10/30195943 DC : 0 | BS ISO 12891-1 - IMPLANTS FOR SURGERY - RETRIEVAL AND ANALYSIS OF SURGICAL IMPLANTS - PART 1: RETRIEVAL AND HANDLING |
BS EN ISO 18113-1:2011 | In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) Terms, definitions and general requirements |
BS ISO 20749 : 2017 | DENTISTRY - PRE-CAPSULATED DENTAL AMALGAM |
DIN EN ISO 1135-3:2014-12 (Draft) | TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 3: BLOOD-TAKING SETS FOR SINGLE USE (ISO 1135-3:2016) |
DIN EN ISO 21531:2009-08 | DENTISTRY - GRAPHICAL SYMBOLS FOR DENTAL INSTRUMENTS |
14/30281856 DC : 0 | BS EN ISO 14408 - TRACHEAL TUBES DESIGNED FOR LASER SURGERY - REQUIREMENTS FOR MARKING AND ACCOMPANYING INFORMATION |
CAN/CSA-C22.2 NO. 80601-2-70:17 | Medical electrical equipment — Part 2-70: Particular requirements for basic safety and essential performance of sleep apnoea breathing therapy equipment (Adopted ISO 80601-2-70:2015, first edition, 2015-01 , with Canadian deviations) |
BS EN ISO 3826-4:2015 | Plastics collapsible containers for human blood and blood components Aphaeresis blood bag systems with integrated features |
PD ISO/IEC GUIDE 51:2014 | Safety aspects. Guidelines for their inclusion in standards |
PREN ISO 11499 : DRAFT 2013 | DENTISTRY - SINGLE-USE CARTRIDGES FOR LOCAL ANAESTHETICS (ISO/DIS 11499:2013) |
ISO 11040-6:2012 | Prefilled syringes Part 6: Plastic barrels for injectables |
13/30268148 DC : 0 | BS EN ISO 11978 - OPHTHALMIC OPTICS - CONTACT LENSES AND CONTACT LENS CARE PRODUCTS - LABELLING |
16/30310949 DC : 0 | BS ISO 5910 - CARDIOVASCULAR IMPLANTS AND EXTRACOPOREAL SYSTEMS - CARDIAC VALVE REPAIR DEVICES |
DIN EN ISO 9687:2015-05 | DENTISTRY - GRAPHICAL SYMBOLS FOR DENTAL EQUIPMENT (ISO 9687:2015) |
DIN ISO 8536-12:2013-04 | Infusion equipment for medical use - Part 12: Check valves (ISO 8536-12:2007 + Amd. 1:2012) |
ISO 16628:2008 | Tracheobronchial tubes Sizing and marking |
AAMI IEC 60601-2-4 : 2010 : R2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-4: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CARDIAC DEFIBRILLATORS |
CSA ISO 8638 : 2012 | CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - EXTRACORPOREAL BLOOD CIRCUIT FOR HAEMODIALYSERS, HAEMODIAFILTERS AND HAEMOFILTERS |
BS ISO 22413:2010 | Transfer sets for pharmaceutical preparations. Requirements and test methods |
DIN EN ISO 8836:2015-02 | Suction catheters for use in the respiratory tract (ISO 8836:2014); German version EN ISO 8836:2014 |
16/30316718 DC : 0 | BS EN ISO 80601-2-61 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-61: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF PULSE OXIMETER EQUIPMENT |
13/30283694 DC : 0 | BS EN ISO 1135-5 - TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 5: TRANSFUSION SETS FOR SINGLE USE WITH PRESSURE INFUSION APPARATUS |
I.S. EN ISO 18113-2:2011 | IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 2: IN VITRO DIAGNOSTIC REAGENTS FOR PROFESSIONAL USE (ISO 18113-2:2009) |
DIN EN ISO 5367:2015-02 | Anaesthetic and respiratory equipment - Breathing sets and connectors (ISO 5367:2014) |
ISO/TS 17137:2014 | Cardiovascular implants and extracorporeal systems Cardiovascular absorbable implants |
I.S. EN ISO 3826-4:2015 | PLASTICS COLLAPSIBLE CONTAINERS FOR HUMAN BLOOD AND BLOOD COMPONENTS - PART 4: APHAERESIS BLOOD BAG SYSTEMS WITH INTEGRATED FEATURES (ISO 3826-4:2015) |
CSA Z10524-4 : 2012 | PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 4: LOW-PRESSURE REGULATORS |
I.S. EN ISO 1135-3:2017 | TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 3: BLOOD-TAKING SETS FOR SINGLE USE (ISO 1135-3:2016) |
AAMI ISO 14708-4:2008(R2011) | IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 4: IMPLANTABLE INFUSION PUMPS |
16/30328610 DC : 0 | BS ISO 20749 - DENTISTRY - PRE-CAPSULATED DENTAL AMALGAM |
UNI EN ISO 18113-3 : 2012 | IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 3: IN VITRO DIAGNOSTIC INSTRUMENTS FOR PROFESSIONAL USE |
PREN 868-5 : DRAFT 2017 | PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 5: SEALABLE POUCHES AND REELS OF POROUS MATERIALS AND PLASTIC FILM CONSTRUCTION - REQUIREMENTS AND TEST METHODS |
CSA ISO 8637 : 2012 : INC : AMD 1 : 2015 : R2017 | CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS AND HAEMOCONCENTRATORS |
I.S. EN 60601-1-11:2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-11: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS USED IN THE HOME HEALTHCARE ENVIRONMENT |
CSA C22.2 No. 80601-2-55 : 2014(R2019) | MEDICAL ELECTRICAL EQUIPMENT - PART 2-55: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY GAS MONITORS |
AAMI 13958 : 2014 | CONCENTRATES FOR HEMODIALYSIS AND RELATED THERAPIES |
PREN 13795-2 : DRAFT 2017 | SURGICAL CLOTHING AND DRAPES - REQUIREMENTS AND TEST METHODS - PART 2: CLEAN AIR SUITS |
I.S. EN ISO 12836:2015 | DENTISTRY - DIGITIZING DEVICES FOR CAD/CAM SYSTEMS FOR INDIRECT DENTAL RESTORATIONS - TEST METHODS FOR ASSESSING ACCURACY (ISO 12836:2015) |
EN 60601-1-11:2015 | Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment |
I.S. EN ISO 18113-5:2011 | IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 5: IN VITRO DIAGNOSTIC INSTRUMENTS FOR SELF-TESTING (ISO 18113-5:2009) |
I.S. EN ISO 80601-2-55:2018 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-55: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY GAS MONITORS (ISO 80601-2-55:2018) |
I.S. EN ISO 3630-4:2009 | DENTISTRY - ROOT CANAL INSTRUMENTS - PART 4: AUXILIARY INSTRUMENTS |
I.S. EN ISO 18113-3:2011 | IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 3: IN VITRO DIAGNOSTIC INSTRUMENTS FOR PROFESSIONAL USE (ISO 18113-3:2009) |
I.S. EN ISO 20608:2018 | DENTISTRY - POWDER JET HANDPIECES AND POWDERS (ISO 20608:2018) |
BS EN 1865-1 : 2010 | PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 1: GENERAL STRETCHER SYSTEMS AND PATIENT HANDLING EQUIPMENT |
I.S. EN ISO 16061:2015 | INSTRUMENTATION FOR USE IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS (ISO 16061:2015) |
ISO 11040-7:2015 | Prefilled syringes — Part 7: Packaging systems for sterilized subassembled syringes ready for filling |
ISO 10555-1:2013 | Intravascular catheters — Sterile and single-use catheters — Part 1: General requirements |
ISO/TR 14283:2018 | Implants for surgery Essential principles of safety and performance |
I.S. EN ISO 80601-2-69:2014 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-69: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF OXYGEN CONCENTRATOR EQUIPMENT (ISO 80601-2-69:2014) |
ISO 80601-2-55:2018 | Medical electrical equipment — Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors |
ISO 16671:2015 | Ophthalmic implants — Irrigating solutions for ophthalmic surgery |
ISO 10079-1:2015 | Medical suction equipment Part 1: Electrically powered suction equipment |
ISO 20749:2017 | Dentistry — Pre-capsulated dental amalgam |
BS EN ISO 23908:2013 | Sharps injury protection. Requirements and test methods. Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling |
UNE-EN ISO 10650:2016 | Dentistry - Powered polymerization activators (ISO 10650:2015) |
DIN EN ISO 23908:2013-10 | SHARPS INJURY PROTECTION - REQUIREMENTS AND TEST METHODS - SHARPS PROTECTION FEATURES FOR SINGLE-USE HYPODERMIC NEEDLES, INTRODUCERS FOR CATHETERS AND NEEDLES USED FOR BLOOD SAMPLING (ISO 23908:2011) |
I.S. EN ISO 10079-1:2015 | MEDICAL SUCTION EQUIPMENT - PART 1: ELECTRICALLY POWERED SUCTION EQUIPMENT (ISO 10079-1:2015) |
ISO 20608:2018 | Dentistry — Powder jet handpieces and powders |
ISO 17966:2016 | Assistive products for personal hygiene that support users Requirements and test methods |
I.S. EN ISO 80601-2-13:2012 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-13: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF AN ANAESTHETIC WORKSTATION (ISO 80601-2-13:2011) |
UNI EN ISO 18113-1 : 2012 | IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 1: TERMS, DEFINITIONS AND GENERAL REQUIREMENTS |
UNE-EN 1865-2:2011 | Patient handling equipment used in road ambulances - Part 2: Power assisted stretcher |
UNE-EN ISO 3630-5:2012 | Dentistry - Endodontic instruments - Part 5: Shaping and cleaning instruments (ISO 3630-5:2011) |
BS EN 16844 : 2017 | AESTHETIC MEDICINE SERVICES - NON-SURGICAL MEDICAL TREATMENTS |
EN ISO 17664:2017 | Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices (ISO 17664:2017) |
EN ISO 14457:2017 | Dentistry - Handpieces and motors (ISO 14457:2017) |
EN ISO 80601-2-56:2017 | Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement (ISO 80601-2-56:2017) |
ISO 28620:2010 | Medical devices Non-electrically driven portable infusion devices |
ISO 9687:2015 | Dentistry Graphical symbols for dental equipment |
I.S. EN ISO 20072:2013 | AEROSOL DRUG DELIVERY DEVICE DESIGN VERIFICATION - REQUIREMENTS AND TEST METHODS (ISO 20072:2009) |
IEC 60601-2-34:2011 | Medical electrical equipment - Part 2-34: Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment |
ISO 18835:2015 | Inhalational anaesthesia systems Draw-over anaesthetic systems |
ISO 27427:2013 | Anaesthetic and respiratory equipment — Nebulizing systems and components |
ISO 7886-1:2017 | Sterile hypodermic syringes for single use — Part 1: Syringes for manual use |
ISO 14457:2017 | Dentistry — Handpieces and motors |
DIN EN ISO 11138-1:2015-10 (Draft) | STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 1: GENERAL REQUIREMENTS (ISO 11138-1:2017) |
DIN EN 868-4:2015-08 (Draft) | PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 4: PAPER BAGS - REQUIREMENTS AND TEST METHODS |
DIN EN 868-2:2015-08 (Draft) | PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 2: STERILIZATION WRAP - REQUIREMENTS AND TEST METHODS |
DIN EN ISO 8536-8:2015-11 | INFUSION EQUIPMENT FOR MEDICAL USE - PART 8: INFUSION SETS FOR SINGLE USE WITH PRESSURE INFUSION APPARATUS (ISO 8536-8:2015) |
UNE-EN ISO 8536-11:2015 | Infusion equipment for medical use - Part 11: Infusion filters for single use with pressure infusion equipment (ISO 8536-11:2015) |
UNE-EN 285:2016 | Sterilization - Steam sterilizers - Large sterilizers |
UNE-EN ISO 8536-9:2015 | Infusion equipment for medical use - Part 9: Fluid lines for single use with pressure infusion equipment (ISO 8536-9:2015) |
BS EN ISO 17510-2:2009 | Sleep apnoea breathing therapy Masks and application accessories |
ISO 22413:2010 | Transfer sets for pharmaceutical preparations Requirements and test methods |
ISO 25539-1:2017 | Cardiovascular implants — Endovascular devices — Part 1: Endovascular prostheses |
IEC 60601-2-4:2010+AMD1:2018 CSV | Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators |
ISO 18113-5:2009 | In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 5: In vitro diagnostic instruments for self-testing |
BS EN ISO 8536-11:2015 | Infusion equipment for medical use Infusion filters for single use with pressure infusion equipment |
IEC 60601-2-49:2011 | Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment |
UNE-EN ISO 22674:2016 | Dentistry - Metallic materials for fixed and removable restorations and appliances (ISO 22674:2016) |
BS EN ISO 22674:2016 | Dentistry. Metallic materials for fixed and removable restorations and appliances |
ISO 21531:2009 | Dentistry Graphical symbols for dental instruments |
ISO 17510-1:2007 | Sleep apnoea breathing therapy Part 1: Sleep apnoea breathing therapy equipment |
BS EN 980:2008 | Symbols for use in the labelling of medical devices |
ISO 3826-4:2015 | Plastics collapsible containers for human blood and blood components — Part 4: Aphaeresis blood bag systems with integrated features |
BS EN ISO 16672:2015 | Ophthalmic implants. Ocular endotamponades |
ISO 6873:2013 | Dentistry — Gypsum products |
ISO 10079-2:2014 | Medical suction equipment Part 2: Manually powered suction equipment |
BS EN ISO 4074:2015 | Natural rubber latex male condoms. Requirements and test methods |
ISO 3630-1:2008 | Dentistry Root-canal instruments Part 1: General requirements and test methods |
EN 45502-1 : 2015 | IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL REQUIREMENTS FOR SAFETY, MARKING AND FOR INFORMATION TO BE PROVIDED BY THE MANUFACTURER |
EN ISO 16061:2015 | Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2015) |
EN ISO 81060-1:2012 | Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type (ISO 81060-1:2007) |
DIN EN ISO 10079-2:2000-03 | MEDICAL SUCTION EQUIPMENT - PART 2: MANUALLY POWERED SUCTION EQUIPMENT (ISO 10079-2:2014) |
EN ISO 1135-4 : 2015 COR 2016 | TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 4: TRANSFUSION SETS FOR SINGLE USE, GRAVITY FEED (ISO 1135-4:2015) |
UNI EN ISO 22413 : 2013 | TRANSFER SETS FOR PHARMACEUTICAL PREPARATIONS - REQUIREMENTS AND TEST METHODS |
DIN EN ISO 25539-1:2017-09 | CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES (ISO 25539-1:2017) |
DIN EN ISO 3630-1:2008-04 | DENTISTRY - ROOT-CANAL INSTRUMENTS - PART 1: GENERAL REQUIREMENTS AND TEST METHODS |
EN 61010-2-101:2017 | Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment |
UNI EN 1789 : 2014 | MEDICAL VEHICLES AND THEIR EQUIPMENT - ROAD AMBULANCES |
DIN EN ISO 10079-3:2000-03 | MEDICAL SUCTION EQUIPMENT - PART 3: SUCTION EQUIPMENT POWERED FROM A VACUUM OR POSITIVE PRESSURE GAS SOURCE (ISO 10079-3:2014) |
EN 60601-2-49:2015 | Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment |
CSA C22.2 No. 60601.2.34 : 2012 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-34: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INVASIVE BLOOD PRESSURE MONITORING EQUIPMENT |
CSA C22.2 No. 60601.2.4 : 2012 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-4: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CARDIAC DEFIBRILLATORS |
UNE-EN 1865-3:2012 | Patient handling equipment used in road ambulances - Part 3: Heavy duty stretcher |
CSA C22.2 No. 61010.2.101 : 2015 | SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL AND LABORATORY USE - PART 2-101: PARTICULAR REQUIREMENTS FOR IN VITRO DIAGNOSTIC (IVD) MEDICAL EQUIPMENT |
CSA ISO 5361 : 2014 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - TRACHEAL TUBES AND CONNECTORS |
ANSI/AAMI/ISO 17664-1:2022 | Processing of health care products—Information to be provided by the medical device manufacturer for the processing of medical devices—Part 1: Critical and semi-critical medical devices |
ONORM EN 455-3 : 2015 | MEDICAL GLOVES FOR SINGLE USE - PART 3: REQUIREMENTS AND TESTING FOR BIOLOGICAL EVALUATION |
CSA Z23747:2008 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - PEAK EXPIRATORY FLOW METERS FOR THE ASSESSMENT OF PULMONARY FUNCTION IN SPONTANEOUSLY BREATHING HUMANS |
CSA Z23747 : 2008 : R2013 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - PEAK EXPIRATORY FLOW METERS FOR THE ASSESSMENT OF PULMONARY FUNCTION IN SPONTANEOUSLY BREATHING HUMANS |
CAN/CSA-ISO 10079-1:16 | Medical suction equipment - Part 1: Electrically powered suction equipment (Adopted ISO 10079-1:2015, third edition, 2015-11-01) |
NBR ISO 8536-8 : 2012 | INFUSION EQUIPMENT FOR MEDICAL USE - PART 8: INFUSION EQUIPMENT FOR USE WITH PRESSURE INFUSION APPARATUS |
CSA C22.2 No. 60601.2.4 : 2012 : R2016 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-4: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CARDIAC DEFIBRILLATORS |
ONORM EN 1865-2 : 2015 | PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 2: POWER ASSISTED STRETCHER |
ONORM EN 455-2 : 2015 | MEDICAL GLOVES FOR SINGLE USE - PART 2: REQUIREMENTS AND TESTING FOR PHYSICAL PROPERTIES |
ISO 7010:2011 | Graphical symbols Safety colours and safety signs Registered safety signs |
ISO 15223-2:2010 | Medical devices — Symbols to be used with medical device labels, labelling, and information to be supplied — Part 2: Symbol development, selection and validation |
ISO 18113-1:2009 | In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions and general requirements |
ISO 18113-4:2009 | In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 4: In vitro diagnostic reagents for self-testing |
EN 1041:2008+A1:2013 | Information supplied by the manufacturer of medical devices |
ISO 8601:2004 | Data elements and interchange formats Information interchange Representation of dates and times |
IEC 80416-3:2002+AMD1:2011 CSV | Basic principles for graphical symbols for use on equipment - Part 3: Guidelines for the application of graphical symbols |
IEC 80416-1:2008 | Basic principles for graphical symbols for use on equipment - Part 1: Creation of graphical symbols for registration |
ISO 18113-2:2009 | In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 2: In vitro diagnostic reagents for professional use |
ISO 3864-1:2011 | Graphical symbols Safety colours and safety signs Part 1: Design principles for safety signs and safety markings |
ISO 14971:2007 | Medical devices Application of risk management to medical devices |
ISO 7000:2014 | Graphical symbols for use on equipment Registered symbols |
ISO 18113-5:2009 | In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 5: In vitro diagnostic instruments for self-testing |
ISO 18113-3:2009 | In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 3: In vitro diagnostic instruments for professional use |
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