I.S. EN 1041:2008+A1:2013
|
INFORMATION SUPPLIED BY THE MANUFACTURER OF MEDICAL DEVICES |
04/30084857 DC : DRAFT JUN 2004
|
BS EN ISO 10524-1 - PRESSURE REGULATORS FOR USE WITH MEDICAL GAS SYSTEMS - PART 1: PRESSURE REGULATORS AND PRESSURE REGULATORS WITH FLOW-METERING DEVICES |
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 |
09/30193293 DC : DRAFT MAR 2009
|
BS EN 12184 - ELECTRICALLY POWERED WHEELCHAIRS, SCOOTERS AND THEIR CHARGERS - REQUIREMENTS AND TEST METHODS |
I.S. EN ISO 14155-2:2009
|
CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - PART 2: CLINICAL INVESTIGATION PLANS |
06/30123163 DC : 0
|
BS EN 1041 - INFORMATION SUPPLIED BY THE MANUFACTURER WITH MEDICAL DEVICES |
DIN EN 14931 E : 2006
|
PRESSURE VESSELS FOR HUMAN OCCUPANCY (PVHO) - MULTI-PLACE PRESSURE CHAMBER SYSTEMS FOR HYPERBARIC THERAPY - PERFORMANCE, SAFETY REQUIREMENTS AND TESTING |
12/30261215 DC : 0
|
BS EN 13060 - SMALL STEAM STERILIZERS |
BS EN 16372:2014
|
Aesthetic surgery services |
UNI EN 1865-4 : 2012
|
PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 4: FOLDABLE PATIENT TRANSFER CHAIR |
PD CEN/TR 16386:2013
|
Dentistry. Guidelines for handling methacrylate-based materials in the dental laboratory |
11/30252448 DC : 0
|
BS EN 1422 - STERILIZERS FOR MEDICAL PURPOSES - ETHYLENE OXIDE STERILIZERS - REQUIREMENTS AND TEST METHODS |
08/30184612 DC : DRAFT SEP 2008
|
BS EN 1641 - DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - MATERIALS |
UNE-EN 15908:2011
|
Anaesthetic and respiratory equipment - Non-interchangeable screw-threaded (NIST) low-pressure connectors for medical gases |
PREN 14180 : DRAFT 2012
|
STERILIZERS FOR MEDICAL PURPOSES - LOW TEMPERATURE STEAM AND FORMALDEHYDE STERILIZERS - REQUIREMENTS AND TESTING |
DIN EN 1865-4:2012-09
|
PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 4: FOLDABLE PATIENT TRANSFER CHAIR |
I.S. EN 60601-1-10:2008
|
MEDICAL ELECTRICAL EQUIPMENT - PART 1-10: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR THE DEVELOPMENT OF PHYSIOLOGIC CLOSED-LOOP CONTROLLERS |
15/30278540 DC : 0
|
BS ISO 18562-4 - BIOCOMPATIBILITY EVALUATION OF BREATHING GAS PATHWAYS IN HEALTHCARE APPLICATIONS - PART 4: TESTS FOR LEACHABLES IN CONDENSATE |
BS EN 61326-2-6:2013
|
Electrical equipment for measurement, control and laboratory use. EMC requirements Particular requirements. In vitro diagnostic (IVD) medical equipment |
02/563808 DC : DRAFT SEP 2002
|
BS EN 1639 - DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - INSTRUMENTS |
02/563845 DC : DRAFT SEP 2002
|
BS EN 1642 - DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - DENTAL IMPLANTS |
05/30128373 DC : DRAFT JAN 2005
|
ISO 7396-2 - MEDICAL GAS PIPELINE SYSTEMS - PART 2: ANAESTHETIC GAS SCAVENGING DISPOSAL SYSTEMS - BASIC REQUIREMENTS |
PREN 285 : DRAFT 2013
|
STERILIZATION - STEAM STERILIZERS - LARGE STERILIZERS |
BS EN 14931:2006
|
Pressure vessels for human occupancy (PVHO). Multi-place pressure chambers for hyperbaric therapy. Performance, safety requirements and testing |
CEI EN 60601-1-2 : 2016
|
MEDICAL ELECTRICAL EQUIPMENT - PART 1-2: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: ELECTROMAGNETIC DISTURBANCES - REQUIREMENTS AND TESTS |
04/30107378 DC : DRAFT JUL 2004
|
EN 12184 - ELECTRICALLY POWERED WHEELCHAIRS, SCOOTERS AND THEIR CHARGERS - REQUIREMENTS AND TEST METHODS |
BS EN 62353:2014
|
Medical electrical equipment. Recurrent test and test after repair of medical electrical equipment |
I.S. EN 14931:2006
|
PRESSURE VESSELS FOR HUMAN OCCUPANCY (PVHO) - MULTI-PLACE PRESSURE CHAMBER SYSTEMS FOR HYPERBARIC THERAPY - PERFORMANCE, SAFETY REQUIREMENTS AND TESTING |
BS EN 62366 : 2008
|
MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES |
I.S. CEN TS 15277:2006
|
NON-ACTIVE SURGICAL IMPLANTS - INJECTABLE IMPLANTS |
PREN 13060 : DRAFT 2012
|
SMALL STEAM STERILIZERS |
I.S. EN 62570:2015
|
STANDARD PRACTICE FOR MARKING MEDICAL DEVICES AND OTHER ITEMS FOR SAFETY IN THE MAGNETIC RESONANCE ENVIRONMENT |
CEI EN 61326-2-6 : 2014
|
ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL AND LABORATORY USE - EMC REQUIREMENTS - PART 2-6: PARTICULAR REQUIREMENTS - IN VITRO DIAGNOSTIC (IVD) MEDICAL EQUIPMENT |
I.S. EN ISO 7198:2017
|
CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR PROSTHESES - TUBULAR VASCULAR GRAFTS AND VASCULAR PATCHES (ISO 7198:2016) |
BS EN 60601-1-6 : 2010
|
MEDICAL ELECTRICAL EQUIPMENT - PART 1-6: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: USABILITY |
DIN EN 12183:2014-06
|
Manual wheelchairs - Requirements and test methods |
UNI EN 12183 : 2014
|
MANUAL WHEELCHAIRS - REQUIREMENTS AND TEST METHODS |
I.S. EN 80601-2-35:2009
|
MEDICAL ELECTRICAL EQUIPMENT - PART 2-35: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HEATING DEVICES USING BLANKETS, PADS AND MATTRESSES AND INTENDED FOR HEATING IN MEDICAL USE |
NF EN 45502-2-3 : 2010
|
ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 2-3: PARTICULAR REQUIREMENTS FOR COCHLEAR AND AUDITORY BRAINSTEM IMPLANT SYSTEMS |
UNI CEI EN 980 : 2009
|
SYMBOLS FOR USE IN THE LABELLING OF MEDICAL DEVICES |
I.S. EN 1865-2:2010
|
PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 2: POWER ASSISTED STRETCHER |
EN 285:2015
|
Sterilization - Steam sterilizers - Large sterilizers |
DIN EN 1422:2014-08
|
STERILIZERS FOR MEDICAL PURPOSES - ETHYLENE OXIDE STERILIZERS - REQUIREMENTS AND TEST METHODS |
DIN EN 1642:2012-06
|
Dentistry - Medical devices for dentistry - Dental implants |
BS EN 13718-1:2014
|
Medical vehicles and their equipment. Air ambulances Requirements for medical devices used in air ambulances |
BS EN 556-1:2001
|
Sterilization of medical devices. Requirements for medical devices to be designated \'STERILE\' Part 1. Requirements for terminally sterilized medical devices |
BS EN 455-3:2015
|
Medical gloves for single use Requirements and testing for biological evaluation |
ISO/IEEE 11073-00103:2015
|
Health informatics Personal health device communication Part 00103: Overview |
UNE-EN ISO 16672:2016
|
Ophthalmic implants - Ocular endotamponades (ISO 16672:2015) |
ISO 13408-1:2008
|
Aseptic processing of health care products — Part 1: General requirements |
DIN EN 1422:1997-11
|
STERILIZERS FOR MEDICAL PURPOSES - ETHYLENE OXIDE STERILIZERS - REQUIREMENTS AND TEST METHODS |
DIN EN 14931:2006-08
|
Pressure vessels for human occupancy (PVHO) - Multi-place pressure chamber systems for hyperbaric therapy - Performance, safety requirements and testing |
DIN EN ISO 14155-2:2003-09
|
CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - PART 2: CLINICAL INVESTIGATION PLANS |
EN ISO 11979-8:2017
|
Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements (ISO 11979-8:2017) |
EN 12182:2012
|
Assistive products for persons with disability - General requirements and test methods |
EN 60601-1-2:2015
|
Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests |
EN 62366 : 2008 AMD 1 2015
|
MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES (IEC 62366:2007/A1:2014) |
CEN/TR 12401:2009
|
Dentistry - Guidance on the classification of dental devices and accessories |
DIN EN 15908:2011-01
|
ANAESTHETIC AND RESPIRATORY EQUIPMENT - NON-INTERCHANGEABLE SCREW-THREADED (NIST) LOW-PRESSURE CONNECTORS FOR MEDICAL GASES |
CR 12401 : 1996
|
DENTISTRY - GUIDANCE ON THE CLASSIFICATION OF DENTAL DEVICES AND ACCESSORIES |
CEN/TS 15260:2006
|
Health informatics - Classification of safety risks from health informatics products |
EN 13544-1:2007+A1:2009
|
Respiratory therapy equipment - Part 1: Nebulizing systems and their components |
EN 62570:2015
|
Standard practice for marking medical devices and other items for safety in the magnetic resonance environment |
EN 62353:2014
|
Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment |
VDI 5703:2015-09
|
Systematical development for a model-based testing of medical devices |
VDI 5700 Blatt 1:2015-04
|
Reprocessing hazards - Risk management in reprocessing of medical devices - Measures for risk control |
PREN 1422 : DRAFT 2011
|
STERILIZERS FOR MEDICAL PURPOSES - ETHYLENE OXIDE STERILIZERS - REQUIREMENTS AND TEST METHODS |
10/30215051 DC : DRAFT JUNE 2010
|
BS EN 1865-4 - PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 4: MECHANICAL ASSISTED TRANSFER CHAIR |
I.S. EN ISO 11073-00103:2017
|
HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 00103: OVERVIEW (ISO/IEEE 11073-00103:2015) |
I.S. EN 285:2015
|
STERILIZATION - STEAM STERILIZERS - LARGE STERILIZERS |
BS EN ISO 26722:2015
|
Water treatment equipment for haemodialysis applications and related therapies |
BS EN 16442:2015
|
Controlled environment storage cabinet for processed thermolabile endoscopes |
BS EN ISO 5359 : 2014
|
ANAESTHETIC AND RESPIRATORY EQUIPMENT - LOW-PRESSURE HOSE ASSEMBLIES FOR USE WITH MEDICAL GASES |
BS ISO/IEEE 11073-00103 : 2015
|
HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 00103: OVERVIEW |
12/30262894 DC : 0
|
BS EN 14180 - STERILIZERS FOR MEDICAL PURPOSES - LOW TEMPERATURE STEAM AND FORMALDEHYDE STERILIZERS - REQUIREMENTS AND TESTING |
I.S. EN 1865-3:2012
|
PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 3: HEAVY DUTY STRETCHER |
10/30215054 DC : DRAFT JUNE 2010
|
BS EN 1865-3 - PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 3: HEAVY DUTY STRETCHER |
16/30339543 DC : 0
|
BS EN 62820-3-2 ED 1.0 - BUILDING INTERCOM SYSTEMS - PART 3-2: APPLICATION GUIDELINES - ADVANCED SECURITY BUILDING INTERCOM |
04/30057165 DC : 0
|
BS EN 14931 - PRESSURE VESSELS FOR HUMAN OCCUPANCY (PVHO) - MULTI-PLACE PRESSURE CHAMBERS FOR HYPERBARIC THERAPY - PERFORMANCE, SAFETY REQUIREMENTS AND TESTING |
13/30278952 DC : 0
|
BS EN 16372 - AESTHETIC SURGERY AND AESTHETIC NON-SURGICAL MEDICAL SERVICES |
DIN EN ISO 13408-1:2015-12
|
ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 1: GENERAL REQUIREMENTS (ISO 13408-1:2008, INCLUDING AMD 1:2013) |
13/30281504 DC : 0
|
BS EN 455-3 - MEDICAL GLOVES FOR SINGLE USE - PART 3: REQUIREMENTS AND TESTING FOR BIOLOGICAL EVALUATION |
14/30270614 DC : 0
|
BS EN 14065 - TEXTILES - LAUNDRY PROCESSED TEXTILES - BIOCONTAMINATION CONTROL SYSTEM |
13/30278676 DC : 0
|
BS EN 285 - STERILIZATION - STEAM STERILIZERS - LARGE STERILIZERS |
DIN EN ISO 13958:2016-03
|
CONCENTRATES FOR HAEMODIALYSIS AND RELATED THERAPIES (ISO 13958:2014) |
13/30276231 DC : 0
|
BS EN 13718-1 - MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 1: REQUIREMENTS FOR MEDICAL DEVICES USED IN AIR AMBULANCES |
BS EN 45502-2-3:2010
|
Active implantable medical devices Particular requirements for cochlear and auditory brainstem implant systems |
BS ISO 15001 : 2003 AMD 15145
|
ANAESTHETIC AND RESPIRATORY EQUIPMENT - COMPATIBILITY WITH OXYGEN |
CEI EN 80369-5 : 1ED 2017
|
SMALL-BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 5: CONNECTORS FOR LIMB CUFF INFLATION APPLICATIONS |
BS EN 61010-2-040:2015
|
Safety requirements for electrical equipment for measurement, control, and laboratory use Particular requirements for sterilizers and washer-disinfectors used to treat medical materials |
I.S. EN 12183:2014
|
MANUAL WHEELCHAIRS - REQUIREMENTS AND TEST METHODS |
S.R. CEN/CLC/TR 14060:2014
|
MEDICAL DEVICE TRACEABILITY ENABLED BY UNIQUE DEVICE IDENTIFICATION (UDI) |
PREN 12183 : DRAFT 2004
|
MANUAL WHEELCHAIRS - REQUIREMENTS AND TEST METHODS |
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 |
S.R. CWA 16697:2013
|
CAR-ADAPTATIONS FOR DISABLED DRIVERS - REQUIREMENTS, TEST METHODS AND BEST PRACTISE GUIDELINES |
AAMI ISO 14155-2 : 2003
|
CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - PART 2: CLINICAL INVESTIGATION PLANS |
I.S. EN 62366-1:2015&AC:2015
|
MEDICAL DEVICES - PART 1: APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES |
I.S. EN 60601-1-6:2010
|
MEDICAL ELECTRICAL EQUIPMENT - PART 1-6: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: USABILITY |
BS EN ISO 13408-1:2015
|
Aseptic processing of health care products General requirements |
S.R. CEN TR 12401:2009
|
DENTISTRY - GUIDANCE ON THE CLASSIFICATION OF DENTAL DEVICES AND ACCESSORIES |
MEDDEV 2.7-1 : REV 4 2016
|
CLINICAL EVALUATION: A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES UNDER DIRECTIVES 93/42/EEC AND 90/385/EEC |
CEI UNI EN 1041 : 2014
|
INFORMATION SUPPLIED BY THE MANUFACTURER OF MEDICAL DEVICES |
PREN 12182 : 2009-06
|
ASSISTIVE PRODUCTS FOR PERSONS WITH DISABILITY - GENERAL REQUIREMENTS AND TEST METHODS |
I.S. EN 16442:2015
|
CONTROLLED ENVIRONMENT STORAGE CABINET FOR PROCESSED THERMOLABILE ENDOSCOPES |
EN 12183:2009
|
Manual wheelchairs - Requirements and test methods |
I.S. EN 556-1:2002
|
STERILISATION OF MEDICAL DEVICES - REQUIREMENTS FOR MEDICAL DEVICES TO BE DESIGNATED STERILE - PART 1: REQUIREMENTS FOR TERMINALLY STERILISED MEDICAL DEVICES |
EN 61010-2-040:2015
|
Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-040 Particular requirements for sterilizers and washer-disinfectors used to treat medical materials |
DIN EN 1639:2010-02
|
Dentistry - Medical devices for dentistry - Instruments |
DIN EN 1641:2010-02
|
Dentistry - Medical devices for dentistry - Materials |
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 1041:2013-12
|
Information supplied by the manufacturer of medical devices (includes Amendment A1:2013) |
DIN EN 12182:2012-07
|
Assistive products for persons with disability - General requirements and test methods |
DIN EN 1640:2010-02
|
Dentistry - Medical devices for dentistry - Equipment |
DIN EN 12184:2014-06
|
Electrically powered wheelchairs, scooters and their chargers - Requirements and test methods |
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 14065:2017
|
Textiles - Laundry processed textiles - Biocontamination control system |
BS EN 1640:2009
|
Dentistry. Medical devices for dentistry. 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 |
BS EN ISO 11979-8:2017
|
Ophthalmic implants. Intraocular lenses Fundamental requirements |
BS EN 1639:2009
|
Dentistry. Medical devices for dentistry. Instruments |
I.S. EN ISO 15197:2015
|
IN VITRO DIAGNOSTIC TEST SYSTEMS - REQUIREMENTS FOR BLOOD-GLUCOSE MONITORING SYSTEMS FOR SELF-TESTING IN MANAGING DIABETES MELLITUS (ISO 15197:2013) |
I.S. EN 12184:2014
|
ELECTRICALLY POWERED WHEELCHAIRS, SCOOTERS AND THEIR CHARGERS - REQUIREMENTS AND TEST METHODS |
I.S. EN 14065:2016
|
TEXTILES - LAUNDRY PROCESSED TEXTILES - BIOCONTAMINATION CONTROL SYSTEM |
I.S. EN 12182:2012
|
ASSISTIVE PRODUCTS FOR PERSONS WITH DISABILITY - GENERAL REQUIREMENTS AND TEST METHODS |
I.S. EN ISO 8537:2016
|
STERILE SINGLE-USE SYRINGES, WITH OR WITHOUT NEEDLE, FOR INSULIN (ISO 8537:2016) |
I.S. EN 1642:2011
|
DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - DENTAL IMPLANTS |
I.S. EN 1639:2009
|
DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - INSTRUMENTS |
I.S. EN 1640:2009
|
DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - EQUIPMENT |
I.S. EN 14180:2014
|
STERILIZERS FOR MEDICAL PURPOSES - LOW TEMPERATURE STEAM AND FORMALDEHYDE STERILIZERS - REQUIREMENTS AND TESTING |
UNI EN 13718-1 : 2014
|
MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 1: REQUIREMENTS FOR MEDICAL DEVICES USED IN AIR AMBULANCES |
I.S. EN 1422:2014
|
STERILIZERS FOR MEDICAL PURPOSES - ETHYLENE OXIDE STERILIZERS - REQUIREMENTS AND TEST METHODS |
I.S. EN 1641:2009
|
DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - MATERIALS |
DIN EN 14180:2003-10
|
STERILIZERS FOR MEDICAL PURPOSES - LOW TEMPERATURE STEAM AND FORMALDEHYDE STERILIZERS - REQUIREMENTS AND TESTING |
I.S. EN ISO 11979-8:2017
|
OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 8: FUNDAMENTAL REQUIREMENTS (ISO 11979-8:2017) |
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 7864:2016
|
STERILE HYPODERMIC NEEDLES FOR SINGLE USE - REQUIREMENTS AND TEST METHODS (ISO/DIS 7864:2014) |
I.S. EN ISO 16672:2015
|
OPHTHALMIC IMPLANTS - OCULAR ENDOTAMPONADES (ISO 16672:2015) |
UNI EN 1642 : 2012
|
DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - DENTAL IMPLANTS |
VDI 5702 Blatt 1:2017-04
|
Medical device software - Medical SPICE Process assessment model |
VDI 4007:2012-06
|
Reliability goals - Determination, check, review, certificate |
VDI 4003:2007-03
|
Reliability management |
PREN 556-2 : DRAFT 2014
|
STERILIZATION OF MEDICAL DEVICES - REQUIREMENTS FOR MEDICAL DEVICES TO BE DESIGNATED 'STERILE' - PART 2: REQUIREMENTS FOR ASEPTICALLY PROCESSED MEDICAL DEVICES |
12/30248648 DC : DRAFT AUG 2012
|
BS EN 16442 - CONTROLLED ENVIRONMENT STORAGE CABINET FOR DISINFECTED THERMOLABILE ENDOSCOPES |
DIN EN 1865-2:2015-05
|
PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 2: POWER ASSISTED STRETCHER |
08/30184602 DC : DRAFT SEP 2008
|
BS EN 1639 - DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - INSTRUMENTS |
14/30289772 DC : 0
|
BS EN 1789:2007+A1:2010/A2 - MEDICAL VEHICLES AND THEIR EQUIPMENT - ROAD AMBULANCES |
15/30317874 DC : 0
|
BS EN 16844 - AESTHETIC MEDICINE SERVICES - NON-SURGICAL MEDICAL PROCEDURES |
BS EN ISO 80369-7:2017
|
Small-bore connectors for liquids and gases in healthcare applications Connectors for intravascular or hypodermic applications |
UNE-EN 1865-1:2011
|
Patient handling equipment used in road ambulances - Part 1: General stretcher systems and patient handling equipment |
I.S. EN 61326-2-6:2013
|
ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL AND LABORATORY USE - EMC REQUIREMENTS - PART 2-6: PARTICULAR REQUIREMENTS - IN VITRO DIAGNOSTIC (IVD) MEDICAL EQUIPMENT (IEC 61326-2-6:2012 (EQV)) |
BS EN 15908:2010
|
Anaesthetic and respiratory equipment. Non-interchangeable screw-threaded (NIST) low-pressure connectors for medical gases |
EN 1041:2008+A1:2013
|
Information supplied by the manufacturer of medical devices |
09/30201992 DC : 0
|
BS EN 12182 - ASSISTIVE PRODUCTS FOR PERSONS WITH DISABILITY - GENERAL REQUIREMENTS AND TEST METHODS |
DIN EN 16442 E : 2015
|
CONTROLLED ENVIRONMENT STORAGE CABINET FOR PROCESSED THERMOLABILE ENDOSCOPES |
DD CEN/TS 14507-2:2003
|
Inhalational nitric oxide systems Supply systems |
08/30184615 DC : DRAFT SEP 2008
|
BS EN 1642 - DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - DENTAL IMPLANTS |
UNE-EN 16372:2015
|
Aesthetic surgery services |
BS EN 62570:2015
|
Standard practice for marking medical devices and other items for safety in the magnetic resonance environment |
03/317861 DC : DRAFT OCT 2003
|
EN ISO 22523 - EXTERNAL LIMB PROSTHESES AND EXTERNAL ORTHOSES - REQUIREMENTS AND TEST METHODS |
12/30254927 DC : 0
|
BS EN 16372 - AESTHETIC SURGERY SERVICES |
I.S. EN 16844:2017+A2:2019
|
Aesthetic medicine services - Non-surgical medical treatments |
UNE-EN 60601-1-6:2010
|
Medical electrical equipment -- Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability |
BS EN 60601-1-10 : 2008
|
MEDICAL ELECTRICAL EQUIPMENT - PART 1-10: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR THE DEVELOPMENT OF PHYSIOLOGIC CLOSED-LOOP CONTROLLERS |
I.S. CEN TS 15260:2006
|
HEALTH INFORMATICS - CLASSIFICATION OF SAFETY RISKS FROM HEALTH INFORMATICS PRODUCTS |
UNE-EN 80369-5:2017
|
Small-bore connectors for liquids and gases in healthcare applications - Part 5: Connectors for limb cuff inflation applications |
DIN EN ISO 80369-7 E : 2017
|
SMALL-BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 7: CONNECTORS FOR INTRAVASCULAR OR HYPODERMIC APPLICATIONS (ISO 80369-7:2016, CORRECTED VERSION 2016-12-01) |
I.S. EN ISO 80369-7:2017 COR 2017
|
SMALL-BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 7: CONNECTORS FOR INTRAVASCULAR OR HYPODERMIC APPLICATIONS (ISO 80369-7:2016, CORRECTED VERSION 2016-12-01) |
UNE-EN ISO 7198:2017
|
Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches (ISO 7198:2016) |
EN ISO 16671:2015/A1:2017
|
OPHTHALMIC IMPLANTS - IRRIGATING SOLUTIONS FOR OPHTHALMIC SURGERY (ISO 16671:2015/AMD 1:2017) |
BS EN 1865-2 : 2010
|
PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 2: POWER ASSISTED STRETCHER |
EN 13060:2014
|
Small steam sterilizers |
I.S. EN 62366-1:2015
|
MEDICAL DEVICES - PART 1: APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES |
EN 80601-2-35:2009/A1:2016
|
MEDICAL ELECTRICAL EQUIPMENT - PART 2-35: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HEATING DEVICES USING BLANKETS, PADS AND MATTRESSES AND INTENDED FOR HEATING IN MEDICAL USE (IEC 80601-2-35:2009/A1:2016) |
I.S. EN 16372:2014
|
AESTHETIC SURGERY SERVICES |
EN 60601-1-10:2008/A1:2015
|
MEDICAL ELECTRICAL EQUIPMENT - PART 1-10: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR THE DEVELOPMENT OF PHYSIOLOGIC CLOSED-LOOP CONTROLLERS (IEC 60601-1-10:2007) |
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 13060:2014
|
SMALL STEAM STERILIZERS |
PREN 12184 : DRAFT 2011
|
ELECTRICALLY POWERED WHEELCHAIRS, SCOOTERS AND THEIR CHARGERS - REQUIREMENTS AND TEST METHODS |
CEN/CLC/TR 14060:2014
|
Medical device traceability enabled by unique device identification (UDI) |
EN 16844:2017
|
Aesthetic medicine services - Non-surgical medical treatments |
I.S. EN 60601-1-2:2015
|
MEDICAL ELECTRICAL EQUIPMENT - PART 1-2: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: ELECTROMAGNETIC DISTURBANCES - REQUIREMENTS AND TESTS |
I.S. EN ISO 16671:2015
|
OPHTHALMIC IMPLANTS - IRRIGATING SOLUTIONS FOR OPHTHALMIC SURGERY (ISO 16671:2015) |
DIN EN 13060:2015-03
|
SMALL STEAM STERILIZERS |
DIN EN 13544-1:2009-12
|
RESPIRATORY THERAPY EQUIPMENT - PART 1: NEBULIZING SYSTEMS AND THEIR COMPONENTS |
DIN EN 285:2016-05
|
Sterilization - Steam sterilizers - Large sterilizers |
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 |
BS EN ISO 14155-2:2009
|
Clinical investigation of medical devices for human subjects Clinical investigation plans |
ISO 15197:2013
|
In vitro diagnostic test systems — Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus |
I.S. EN 1789:2007
|
MEDICAL VEHICLES AND THEIR EQUIPMENT - ROAD AMBULANCES |
EN 1789:2007+A2:2014
|
Medical vehicles and their equipment - Road ambulances |
I.S. EN 13544-1:2007
|
RESPIRATORY THERAPY EQUIPMENT - PART 1: NEBULIZING SYSTEMS AND THEIR COMPONENTS |
EN 62366-1:2015/AC:2015
|
MEDICAL DEVICES - PART 1: APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES (IEC 62366-1:2015) |
EN ISO 11608-7:2017
|
Needle-based injection systems for medical use - Requirements and test methods - Part 7: Accessibility for persons with visual impairment (ISO 11608-7:2016) |
UNI EN 1641 : 2010
|
DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - MATERIALS |
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 1640 : 2010
|
DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - EQUIPMENT |
UNI EN 1639 : 2010
|
DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - INSTRUMENTS |
UNI EN 12184 : 2014
|
ELECTRICALLY POWERED WHEELCHAIRS, SCOOTERS AND THEIR CHARGERS - REQUIREMENTS AND TEST METHODS |
UNI EN ISO 14155-2 : 2009
|
CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - PART 2: CLINICAL INVESTIGATION PLANS |
UNI EN 13544-1 : 2009
|
RESPIRATORY THERAPY EQUIPMENT - PART 1: NEBULIZING SYSTEMS AND THEIR COMPONENTS |
UNI CEI EN 45502-2-3 : 2010
|
ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 2-3: PARTICULAR REQUIREMENTS FOR COCHLEAR AND AUDITORY BRAINSTEM IMPLANT SYSTEMS |
UNI EN 14180 : 2014
|
STERILIZERS FOR MEDICAL PURPOSES - LOW TEMPERATURE STEAM AND FORMALDEHYDE STERILIZERS - REQUIREMENTS AND TESTING |
UNI EN 1422 : 2014
|
STERILIZERS FOR MEDICAL PURPOSES - ETHYLENE OXIDE STERILIZERS - REQUIREMENTS AND TEST METHODS |
UNI EN 12182 : 2012
|
ASSISTIVE PRODUCTS FOR PERSONS WITH DISABILITY - GENERAL REQUIREMENTS AND TEST METHODS |
UNI EN 15908 : 2010
|
ANAESTHETIC AND RESPIRATORY EQUIPMENT - NON-INTERCHANGEABLE SCREW-THREADED (NIST) LOW-PRESSURE CONNECTORS FOR MEDICAL GASES |
PREN 17180 : DRAFT 2017
|
STERILIZERS FOR MEDICAL PURPOSES - LOW TEMPERATURE VAPORIZED HYDROGEN PEROXIDE STERILIZERS - REQUIREMENTS AND TESTING |
04/30088537 DC : DRAFT SEP 2004
|
PREN ISO 7396-1 - MEDICAL GAS PIPELINE SYSTEMS - PART 1: PIPELINES FOR COMPRESSED MEDICAL GASES AND VACUUM |
EN ISO 5359:2014/A1:2017
|
ANAESTHETIC AND RESPIRATORY EQUIPMENT - LOW-PRESSURE HOSE ASSEMBLIES FOR USE WITH MEDICAL GASES (ISO 5359:2014/AMD 1:2017) |
BS EN ISO 25539-1:2017
|
Cardiovascular implants. Endovascular devices Endovascular prostheses |
UNI CEN/TS 15277 : 2007
|
NON-ACTIVE SURGICAL IMPLANTS - INJECTABLE IMPLANTS |
DIN EN 1865-1:2015-08
|
PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 1: GENERAL STRETCHER SYSTEMS AND PATIENT HANDLING EQUIPMENT |
I.S. EN 16844:2017
|
AESTHETIC MEDICINE SERVICES - NON-SURGICAL MEDICAL PROCEDURES |
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 |
07/30147572 DC : DRAFT SEP 2007
|
BS ISO 27427 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - NEBULIZING SYSTEMS AND COMPONENTS |
02/563832 DC : DRAFT SEP 2002
|
BS EN 1641 - DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - MATERIALS |
PREN 455-3 : DRAFT 2013
|
MEDICAL GLOVES FOR SINGLE USE - PART 3: REQUIREMENTS AND TESTING FOR BIOLOGICAL EVALUATION |
MEDDEV 2.7-4:2010
|
GUIDELINES ON CLINICAL INVESTIGATIONS: A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES |
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 |
I.S. EN 61010-2-040:2015
|
SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL, AND LABORATORY USE - PART 2-040: PARTICULAR REQUIREMENTS FOR STERILIZERS AND WASHER-DISINFECTORS USED TO TREAT MEDICAL MATERIALS |
UNI CEI EN 1041 : 2013
|
INFORMATION SUPPLIED BY THE MANUFACTURER OF MEDICAL DEVICES |
EN 61326-2-6:2013
|
Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment |
BS EN ISO 5361:2016
|
Anaesthetic and respiratory equipment. Tracheal tubes and connectors |
15/30278530 DC : 0
|
BS ISO 18562-1 - BIOCOMPATIBILITY EVALUATION OF BREATHING GAS PATHWAYS IN HEALTHCARE APPLICATIONS - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS |
BS EN ISO 11073-00103:2017
|
Health informatics. Personal health device communication Overview |
18/30349834 DC : 0
|
BS ISO 21802 - ASSISTIVE PRODUCTS - GUIDELINES ON COGNITIVE ACCESSIBILITY - DAILY TIME MANAGEMENT |
BS EN 60601-1-2:2015
|
Medical electrical equipment General requirements for basic safety and essential performance. Collateral Standard. Electromagnetic disturbances. Requirements and tests |
BS EN 1865-4:2012
|
Patient handling equipment used in road ambulances Foldable patient transfer chair |
DIN EN 1865-3:2015-05
|
PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 3: HEAVY DUTY STRETCHER |
EN 12184:2014
|
Electrically powered wheelchairs, scooters and their chargers - Requirements and test methods |
11/30237926 DC : 0
|
BS EN 12184 - ELECTRICALLY POWERED WHEELCHAIRS, SCOOTERS AND THEIR CHARGERS - REQUIREMENTS AND TEST METHODS |
UNE-EN 1865-4:2012
|
Patient handling equipment used in road ambulances - Part 4: Foldable patient transfer chair |
02/563818 DC : DRAFT SEP 2002
|
BS EN 1640 - DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - EQUIPMENT |
DD CEN/TS 15260:2006
|
Health informatics. Classification of safety risks from health informatics products |
DIN EN 16442:2015-05
|
CONTROLLED ENVIRONMENT STORAGE CABINET FOR PROCESSED THERMOLABILE ENDOSCOPES |
15/30278537 DC : 0
|
BS ISO 18562-3 - BIOCOMPATIBILITY EVALUATION OF BREATHING GAS PATHWAYS IN HEALTHCARE APPLICATIONS - PART 3: TESTS FOR EMISSIONS OF VOLATILE ORGANIC COMPOUNDS (VOCS) |
I.S. EN ISO 15798:2013
|
OPHTHALMIC IMPLANTS - OPHTHALMIC VISCOSURGICAL DEVICES (ISO 15798:2013) |
S.R. CEN/TR 16386:2013
|
DENTISTRY - GUIDELINES FOR HANDLING METHACRYLATE-BASED MATERIALS IN THE DENTAL LABORATORY |
UNE-EN 16442:2015
|
Controlled environment storage cabinet for processed thermolabile endoscopes |
I.S. EN ISO 25539-1:2017
|
CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES (ISO 25539-1:2017) |
EN 60601-1-6:2010/A1:2015
|
MEDICAL ELECTRICAL EQUIPMENT - PART 1-6: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: USABILITY (IEC 60601-1-6:2010/A1:2013) |
I.S. EN ISO 26722:2015
|
WATER TREATMENT EQUIPMENT FOR HAEMODIALYSIS APPLICATIONS AND RELATED THERAPIES (ISO 26722:2014) |
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 15908:2010
|
ANAESTHETIC AND RESPIRATORY EQUIPMENT - NON-INTERCHANGEABLE SCREW-THREADED (NIST) LOW-PRESSURE CONNECTORS FOR MEDICAL GASES |
I.S. EN 80369-5:2016
|
SMALL-BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 5: CONNECTORS FOR LIMB CUFF INFLATION APPLICATIONS |
BS EN 12183:2014
|
Manual wheelchairs. Requirements and test methods |
PREN 14065 : DRAFT 2014
|
TEXTILES - LAUNDRY PROCESSED TEXTILES - BIOCONTAMINATION CONTROL SYSTEM |
ISO 16671:2015
|
Ophthalmic implants — Irrigating solutions for ophthalmic surgery |
UNE-EN 12183:2014
|
Manual wheelchairs - Requirements and test methods |
I.S. EN ISO 15223-1:2016
|
MEDICAL DEVICES - SYMBOLS TO BE USED WITH MEDICAL DEVICE LABELS, LABELLING AND INFORMATION TO BE SUPPLIED - PART 1: GENERAL REQUIREMENTS (ISO 15223-1:2016, CORRECTED VERSION 2017-03) |
BS EN ISO 11197:2009
|
Medical supply units |
BS EN ISO 16671 : 2015
|
OPHTHALMIC IMPLANTS - IRRIGATING SOLUTIONS FOR OPHTHALMIC SURGERY |
I.S. EN ISO 13408-1:2015
|
ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 1: GENERAL REQUIREMENTS (ISO 13408-1:2008, INCLUDING AMD 1:2013) |
I.S. CEN/TS 14507-2:2003
|
INHALATIONAL NITRIC OXIDE SYSTEMS - PART 2: SUPPLY SYSTEMS |
DIN EN 14180:2014-09
|
STERILIZERS FOR MEDICAL PURPOSES - LOW TEMPERATURE STEAM AND FORMALDEHYDE STERILIZERS - REQUIREMENTS AND TESTING |
BS EN 60601-1 : 2006
|
MEDICAL ELECTRICAL EQUIPMENT PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE |
UNE-EN ISO 8537:2016
|
Sterile single-use syringes, with or without needle, for insulin (ISO 8537:2016) |
BS EN 13532:2002
|
General requirements for in vitro diagnostic medical devices for self-testing |
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 |
ISO 14155-2:2003
|
Clinical investigation of medical devices for human subjects Part 2: Clinical investigation plans |
BS EN 13544-1 : 2007
|
RESPIRATORY THERAPY EQUIPMENT - PART 1: NEBULIZING SYSTEMS AND THEIR COMPONENTS |
BS EN 12184:2014
|
Electrically powered wheelchairs, scooters and their chargers. Requirements and test methods |
EN 13718-1:2014
|
Medical vehicles and their equipment - Air ambulances - Part 1: Requirements for medical devices used in air ambulances |
UNE-EN 1041:2009
|
Information supplied by the manufacturer of medical devices |
UNE-EN 455-3:2015
|
Medical gloves for single use - Part 3: Requirements and testing for biological evaluation |
BS EN ISO 8537:2016
|
Sterile single-use syringes, with or without needle, for insulin |
BS EN 1789 : 2007
|
MEDICAL VEHICLES AND THEIR EQUIPMENT - ROAD AMBULANCES |
ISO 7864:2016
|
Sterile hypodermic needles for single use — Requirements and test methods |
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 |
UNE-EN 1642:2012
|
Dentistry - Medical devices for dentistry - Dental implants |
BS EN 13060 : 2014
|
SMALL STEAM STERILIZERS |
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 |
BS EN 1041 : 2008
|
INFORMATION SUPPLIED BY THE MANUFACTURER OF MEDICAL DEVICES |
ISO 8537:2016
|
Sterile single-use syringes, with or without needle, for insulin |
UNE-EN 12184:2014
|
Electrically powered wheelchairs, scooters and their chargers - Requirements and test methods |
BS EN 14180:2014
|
Sterilizers for medical purposes. Low temperature steam and formaldehyde sterilizers. Requirements and testing |
UNE-EN 45502-2-3:2010
|
Active implantable medical devices -- Part 2-3: Particular requirements for cochlear and auditory brainstem implant systems |
BS EN 14065:2016
|
Textiles. Laundry processed textiles. Biocontamination control system |
BS EN 12182:2012
|
Assistive products for persons with disability. General requirements and test methods |
BS EN 1641:2004
|
Dentistry. Medical devices for dentistry. Materials |
DIN EN 80369-5:2017-10
|
SMALL-BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 5: CONNECTORS FOR LIMB CUFF INFLATION APPLICATIONS (IEC 80369-5:2016 + COR.1:2017) |
EN 15908:2010
|
Anaesthetic and respiratory equipment - Non-interchangeable screw-threaded (NIST) low-pressure connectors for medical gases |
EN 16372:2014
|
Aesthetic surgery services |
EN ISO 11073-00103:2017
|
Health informatics - Personal health device communication - Part 00103: Overview (ISO/IEEE 11073-00103:2015) |
EN 1865-2:2010+A1:2015 (edition 2)
|
Patient handling equipment used in road ambulances - Part 2: Power assisted stretcher |
EN ISO 26722:2015
|
Water treatment equipment for haemodialysis applications and related therapies (ISO 26722:2014) |
EN ISO 13408-1:2015
|
Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013) |
EN ISO 7198:2017
|
Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches (ISO 7198:2016) |
EN ISO 15197:2015
|
In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2013) |
EN ISO 14155-2:2009
|
Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans (ISO 14155-2:2003) |
EN 1641:2009
|
Dentistry - Medical devices for dentistry - Materials |
EN 45502-2-3:2010
|
Active implantable medical devices - Part 2-3: Particular requirements for cochlear and auditory brainstem implant systems |
EN 1642:2011
|
Dentistry - Medical devices for dentistry - Dental implants |
EN ISO 7864:2016
|
Sterile hypodermic needles for single use - Requirements and test methods (ISO 7864:2016) |
EN 1639:2009
|
Dentistry - Medical devices for dentistry - Instruments |
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 1865-4:2012
|
Patient handling equipment used in road ambulances - Part 4: Foldable patient transfer chair |
EN 14065:2016
|
Textiles - Laundry processed textiles - Biocontamination control system |
EN 14931:2006
|
Pressure vessels for human occupancy (PVHO) - Multi-place pressure chamber systems for hyperbaric therapy - Performance, safety requirements and testing |
EN 1640:2009
|
Dentistry - Medical devices for dentistry - Equipment |
EN 1422:2014
|
Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods |
EN 455-3:2015
|
Medical gloves for single use - Part 3: Requirements and testing for biological evaluation |
EN 1865-3:2012+A1:2015 (edition 2)
|
Patient handling equipment used in road ambulances - Part 3: Heavy duty stretcher |
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 14180:2014
|
Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing |
EN 980:2008
|
Symbols for use in the labelling of medical devices |
EN 16442:2015
|
Controlled environment storage cabinet for processed thermolabile endoscopes |
MEDDEV 2.12-1 : REV 8 : 2013
|
GUIDELINES ON A MEDICAL DEVICES VIGILANCE SYSTEM |
BS EN 1865-3 : 2012
|
PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 3: HEAVY DUTY STRETCHER |
08/30184608 DC : DRAFT SEP 2008
|
BS EN 1640 - DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - EQUIPMENT |
PD CEN/TR 12401:2009
|
Dentistry. Guidance on the classification of dental devices and accessories |
DIN EN 80369-5 E : 2017
|
SMALL-BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 5: CONNECTORS FOR LIMB CUFF INFLATION APPLICATIONS (IEC 80369-5:2016 + COR.1:2017) |
MEDDEV 2.7-2 : REV 2
|
GUIDELINES FOR COMPETENT AUTHORITIES FOR MAKING A VALIDATION/ASSESSMENT OF A CLINICAL INVESTIGATION APPLICATION UNDER DIRECTIVES 90/385/EEC AND 93/42/EC |
06/30116855 DC : 0
|
BS ISO 10524-4 - PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 4: LOW-PRESSURE REGULATORS INTENDED FOR INCORPORATION INTO MEDICAL EQUIPMENT |
DIN EN ISO 13958 E : 2016
|
CONCENTRATES FOR HAEMODIALYSIS AND RELATED THERAPIES (ISO 13958:2014) |
CEI EN 61082-1 : 2016
|
PREPARATION OF DOCUMENTS USED IN ELECTROTECHNOLOGY - PART 1: RULES |
BS EN ISO 7198:2017
|
Cardiovascular implants and extracorporeal systems. Vascular prostheses. Tubular vascular grafts and vascular patches |
02/124462 DC : DRAFT DEC 2002
|
BS EN 285 - STERILIZATION - STEAM STERILIZERS - LARGE STERILIZERS |
PREN 45502-1 : DRAFT 2013
|
ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL REQUIREMENTS FOR SAFETY, MARKING AND INFORMATION TO BE PROVIDED BY THE MANUFACTURER |
I.S. EN 980:2008
|
SYMBOLS FOR USE IN THE LABELLING OF MEDICAL DEVICES |
MEDDEV 2.12-2 : REV 2012
|
POST MARKET CLINICAL FOLLOW-UP STUDIES - A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES |
BS EN ISO 11608-7:2017
|
Needle-based injection systems for medical use. Requirements and test methods Accessibility for persons with visual impairment |
09/30193290 DC : DRAFT MAR 2009
|
BS EN 12183 - MANUAL WHEELCHAIRS - REQUIREMENTS AND TEST METHODS |
UNE-EN ISO 80369-7:2017
|
Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications (ISO 80369-7:2016, Corrected version 2016-12-01) |
DIN EN 15908 E : 2011
|
ANAESTHETIC AND RESPIRATORY EQUIPMENT - NON-INTERCHANGEABLE SCREW-THREADED (NIST) LOW-PRESSURE CONNECTORS FOR MEDICAL GASES |
14/30273161 DC : 0
|
BS EN 556-2 - STERILIZATION OF MEDICAL DEVICES - REQUIREMENTS FOR MEDICAL DEVICES TO BE DESIGNATED ''STERILE'' - PART 2: REQUIREMENTS FOR ASEPTICALLY PROCESSED MEDICAL DEVICES |
EN ISO 80369-7:2017
|
Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications (ISO 80369-7:2016, Corrected version 2016-12-01) |
DIN EN ISO 11608-7 E : 2017
|
NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 7: ACCESSIBILITY FOR PERSONS WITH VISUAL IMPAIRMENT (ISO 11608-7:2016) |
BS EN 80601-2-35 : 2009
|
MEDICAL ELECTRICAL EQUIPMENT - PART 2-35: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HEATING DEVICES USING BLANKETS, PADS AND MATTRESSES AND INTENDED FOR HEATING IN MEDICAL USE |
04/30107372 DC : DRAFT AUG 2004
|
BS EN 12183 - MANUAL WHEELCHAIRS - REQUIREMENTS AND TEST METHODS |
15/30278534 DC : 0
|
BS ISO 18562-2 - BIOCOMPATIBILITY EVALUATION OF BREATHING GAS PATHWAYS IN HEALTHCARE APPLICATIONS - PART 2: TESTS FOR EMISSIONS OF PARTICULATE MATTER |
BS EN 62366-1:2015
|
Medical devices Application of usability engineering to medical devices |
07/30169858 DC : 0
|
BS EN 1865-1 - SPECIFICATIONS FOR PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 1: GENERAL STRETCHER SYSTEMS AND PATIENT HANDLING EQUIPMENT |
CEI EN 61010-2-101 : 2003
|
SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL AND LABORATORY USE - PART 2-101: PARTICULAR REQUIREMENTS FOR IN VITRO DIAGNOSTIC (IVD) MEDICAL EQUIPMENT |
06/30122245 DC : 0
|
EN 980 - SYMBOLS FOR USE IN THE LABELLING OF MEDICAL DEVICES |
PD CR 12401:2003
|
Dentistry. Guidance on the classification of dental devices and accessories |
UNE-EN ISO 16671:2016
|
Ophthalmic implants - Irrigating solutions for ophthalmic surgery (ISO 16671:2015) |
IEEE 11073-00103-2012
|
Health informatics - Personal health device communication Part 00103: Overview |
I.S. EN 1865-4:2012
|
PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 4: FOLDABLE PATIENT TRANSFER CHAIR |
BS EN 1865-1 : 2010
|
PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 1: GENERAL STRETCHER SYSTEMS AND PATIENT HANDLING EQUIPMENT |
CEI EN 62570 : 2016
|
STANDARD PRACTICE FOR MARKING MEDICAL DEVICES AND OTHER ITEMS FOR SAFETY IN THE MAGNETIC RESONANCE ENVIRONMENT |
I.S. EN 45502-2-3:2010
|
ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 2-3: PARTICULAR REQUIREMENTS FOR COCHLEAR AND AUDITORY BRAINSTEM IMPLANT SYSTEMS |
BS EN 62304 : 2006
|
MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE-CYCLE PROCESSES |
I.S. EN ISO 11608-7:2017
|
NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 7: ACCESSIBILITY FOR PERSONS WITH VISUAL IMPAIRMENT (ISO 11608-7:2016) |
EN ISO 15798:2013/A1:2017
|
OPHTHALMIC IMPLANTS - OPHTHALMIC VISCOSURGICAL DEVICES (ISO 15798:2013/AMD 1:2017) |
UNE-EN 1865-2:2011
|
Patient handling equipment used in road ambulances - Part 2: Power assisted stretcher |
DIN EN ISO 11608-7:2015-08 (Draft)
|
NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 7: ACCESSIBILITY FOR PERSONS WITH VISUAL IMPAIRMENT (ISO 11608-7:2016) |
UNE-EN 13060:2015
|
Small steam sterilizers |
BS EN 16844 : 2017
|
AESTHETIC MEDICINE SERVICES - NON-SURGICAL MEDICAL TREATMENTS |
ASTM E 2363 : 2014 : REDLINE
|
Standard Terminology Relating to Process Analytical Technology in the Pharmaceutical Industry |
I.S. EN 62366:2009
|
MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES |
DIN EN 14065:2016-08
|
TEXTILES - LAUNDRY PROCESSED TEXTILES - BIOCONTAMINATION CONTROL SYSTEM |
UNE-EN 285:2016
|
Sterilization - Steam sterilizers - Large sterilizers |
BS EN 1422:2014
|
Sterilizers for medical purposes. Ethylene oxide sterilizers. Requirements and test methods |
UNE-EN ISO 15197:2015
|
In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2013) |
BS EN 980:2008
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Symbols for use in the labelling of medical devices |
BS EN 1642:2011
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Dentistry. Medical devices for dentistry. Dental implants |
DIN EN ISO 80369-7:2017-10
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Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications (ISO 80369-7:2016, Corrected version 2016-12-01) |
EN 45502-1 : 2015
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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 11608-7:2017-10
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NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 7: ACCESSIBILITY FOR PERSONS WITH VISUAL IMPAIRMENT (ISO 11608-7:2016) |
CEN/TR 16386:2013
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Dentistry - Guidelines for handling methacrylate-based materials in the dental laboratory |
CEN/TS 14507-2 : 2003
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INHALATIONAL NITRIC OXIDE SYSTEMS - PART 2: SUPPLY SYSTEMS |
DIN EN ISO 14155-2:2009-11
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CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - PART 2: CLINICAL INVESTIGATION PLANS |
CEN/TS 15277:2006
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Non-active surgical implants - Injectable implants |
EN 13532:2002
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General requirements for in vitro diagnostic medical devices for self-testing |
UNI EN 1789 : 2014
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MEDICAL VEHICLES AND THEIR EQUIPMENT - ROAD AMBULANCES |
EN 61010-2-101:2017
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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 1865-3:2012
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Patient handling equipment used in road ambulances - Part 3: Heavy duty stretcher |
UNE-EN 13544-1:2007
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Respiratory therapy equipment - Part 1: Nebulizing systems and their components |