DIN EN ISO 10524-4:2008-09
|
PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 4: LOW-PRESSURE REGULATORS |
CSA C22.2 No. 60601-2-66 : 2015
|
MEDICAL ELECTRICAL EQUIPMENT - PART 2-66: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HEARING INSTRUMENTS AND HEARING INSTRUMENT SYSTEMS |
I.S. EN ISO 80369-1:2010
|
SMALL BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 1: GENERAL REQUIREMENTS |
NF 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 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 |
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 |
CSA ISO 15197 : 2015
|
IN VITRO DIAGNOSTIC TEST SYSTEMS - REQUIREMENTS FOR BLOOD-GLUCOSE MONITORING SYSTEMS FOR SELF-TESTING IN MANAGING DIABETES MELLITUS |
CSA ISO 5361 : 2014
|
ANAESTHETIC AND RESPIRATORY EQUIPMENT - TRACHEAL TUBES AND CONNECTORS |
14/30270462 DC : 0
|
BS EN ISO 5840-1 - CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 1: GENERAL REQUIREMENTS |
ANSI/AAMI/ISO 80369-3:2016
|
SMALL-BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 3: CONNECTORS FOR ENTERAL APPLICATIONS |
NF EN ISO 7494-1 : 2011
|
DENTISTRY - DENTAL UNITS - PART 1: GENERAL REQUIREMENTS AND TEST METHODS |
BS EN ISO 5840-2:2015
|
Cardiovascular implants. Cardiac valve prostheses Surgically implanted heart valve substitutes |
14/30298693 DC : 0
|
BS ISO 18250-8 - CONNECTORS FOR RESERVOIR DELIVERY SYSTEMS FOR HEALTHCARE APPLICATIONS - PART 8: CITRATE-BASED ANTICOAGULANT SOLUTION FOR APHERESIS APPLICATIONS |
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 |
PD IEC/TR 62366-2:2016
|
Medical devices Guidance on the application of usability engineering to medical devices |
AAMI ISO 80369-1 : 2010
|
SMALL-BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 1: GENERAL REQUIREMENTS |
PD ISO/TS 17518:2015
|
Medical laboratories. Reagents for staining biological material. Guidance for users |
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 |
17/30303094 DC : 0
|
BS EN ISO 10524-3 - PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 3: PRESSURE REGULATORS INTEGRATED WITH CYLINDER VALVES |
13/30268585 DC : 0
|
BS EN ISO 10079-1 - MEDICAL SUCTION EQUIPMENT - PART 1: ELECTRICALLY POWERED SUCTION EQUIPMENT |
13/30242951 DC : 0
|
BS ISO 16571 - MEDICAL GAS SYSTEMS - SYSTEMS FOR EVACUATION OF PLUME GENERATED BY MEDICAL DEVICES |
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) |
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 |
13/30245306 DC : 0
|
BS EN ISO 9680 - DENTISTRY - OPERATING LIGHTS |
DIN EN ISO 80601-2-69 E : 2014
|
MEDICAL ELECTRICAL EQUIPMENT - PART 2-69: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF OXYGEN CONCENTRATOR EQUIPMENT (ISO 80601-2-69:2014) |
10/30205392 DC : 0
|
BS ISO 7494-1 - DENTISTRY - DENTAL UNITS - PART 1: GENERAL REQUIREMENTS AND TEST METHODS |
09/30191860 DC : 0
|
BS EN 60601-1-6 - MEDICAL ELECTRICAL EQUIPMENT - PART 1-6: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD - USABILITY |
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) |
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) |
BS EN 62083:2009
|
Medical electrical equipment. Requirements for the safety of radiotherapy treatment planning systems |
BS EN ISO 18113-3:2011
|
In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) In vitro diagnostic instruments for professional use |
CSA ISO 14971 : 2007
|
MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES |
BIS IS/ISO 15197 : 2013
|
IN VITRO DIAGNOSTIC TEST SYSTEMS - REQUIREMENTS FOR BLOOD-GLUCOSE MONITORING SYSTEM FOR SELF-TESTING IN MANAGING DIABETES MELLITUS |
DIN EN ISO 5840-3:2013-06
|
Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques (ISO 5840-3:2013) |
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) |
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) |
ONORM EN ISO 5840-3 : 2013
|
CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 3: HEART VALVE SUBSTITUTES IMPLANTED BY TRANSCATHETER TECHNIQUES (ISO 5840-3:2013) |
ANSI/AAMI/ISO 5840-3:2013
|
CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 3: HEART VALVE SUBSTITUTES IMPLANTED BY TRANSCATHETER TECHNIQUES |
AAMI HE75 : 2009(R2013)
|
HUMAN FACTORS ENGINEERING - DESIGN OF MEDICAL DEVICES |
AAMI ISO 5361 : 2012
|
ANAESTHETIC AND RESPIRATORY EQUIPMENT - TRACHEAL TUBES AND CONNECTORS |
ISO 16571:2014
|
Systems for evacuation of plume generated by medical devices |
I.S. EN ISO 10524-4:2008
|
PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 4: LOWPRESSURE REGULATORS |
I.S. EN 60601-2-66:2015
|
MEDICAL ELECTRICAL EQUIPMENT - PART-2-66: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HEARING INSTRUMENTS AND HEARING INSTRUMENT SYSTEMS |
BS EN ISO 80601-2-12:2011
|
Medical electrical equipment Particular requirements for basic safety and essential performance of critical care ventilators |
BS EN 60601-1-6 : 2010
|
MEDICAL ELECTRICAL EQUIPMENT - PART 1-6: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: USABILITY |
ISO/TS 17137:2014
|
Cardiovascular implants and extracorporeal systems Cardiovascular absorbable implants |
UNI CEI EN ISO 80369-1 : 2011
|
SMALL BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 1: GENERAL REQUIREMENTS |
AAMI ISO 14971 : 2007 : INC : ERR 1 : 2007
|
MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES |
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) |
CSA C22.2 No. 60601.2.1 : 2011
|
MEDICAL ELECTRICAL EQUIPMENT - PART 2-1: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF ELECTRON ACCELERATORS IN THE RANGE 1 MEV TO 50 MEV |
I.S. EN 1865-2:2010
|
PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 2: POWER ASSISTED STRETCHER |
PD ISO/TS 17137:2014
|
Cardiovascular implants and extracorporeal systems. Cardiovascular absorbable implants |
ASTM F 2761 : 2009 : R2013
|
Medical Devices and Medical Systems - Essential safety requirements for equipment comprising the patient-centric integrated clinical environment (ICE) - Part 1: General requirements and conceptual model |
EN 285:2015
|
Sterilization - Steam sterilizers - Large sterilizers |
DIN EN ISO 9680 E : 2015
|
DENTISTRY - OPERATING LIGHTS (ISO 9680:2014) |
BS EN 1782 : 1998
|
TRACHEAL TUBES AND CONNECTORS |
ISO 10524-4:2008
|
Pressure regulators for use with medical gases — Part 4: Low-pressure regulators |
BS EN 13718-1:2014
|
Medical vehicles and their equipment. Air ambulances Requirements for medical devices used in air ambulances |
ISO 7494-2:2015
|
Dentistry — Stationary dental units — Part 2: Air, water, suction and wastewater systems |
UNE-EN ISO 11608-1:2015
|
Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems (ISO 11608-1:2014) |
ISO/IEEE 11073-00103:2015
|
Health informatics Personal health device communication Part 00103: Overview |
ISO 80369-3:2016
|
Small-bore connectors for liquids and gases in healthcare applications — Part 3: Connectors for enteral applications |
BS EN 12342 : 1998
|
BREATHING TUBES INTENDED FOR USE WITH ANAESTHETIC APPARATUS AND VENTILATORS |
I.S. EN ISO 11608-1:2015
|
NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 1: NEEDLE-BASED INJECTION SYSTEMS (ISO 11608-1:2014) |
DIN EN 12342:1998-09
|
BREATHING TUBES INTENDED FOR USE WITH ANAESTHETIC APPARATUS AND VENTILATORS |
DIN EN 12342:2010-01
|
BREATHING TUBES INTENDED FOR USE WITH ANAESTHETIC APPARATUS AND VENTILATORS |
EN ISO 15002:2008
|
Flow-metering devices for connection to terminal units of medical gas pipeline systems (ISO 15002:2008) |
EN 60601-2-16:2015
|
Medical electrical equipment - Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment |
EN ISO 9680:2014
|
Dentistry - Operating lights (ISO 9680:2014) |
EN 13544-1:2007+A1:2009
|
Respiratory therapy equipment - Part 1: Nebulizing systems and their components |
ONORM EN ISO 11608-5 : 2012
|
NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 5: AUTOMATED FUNCTIONS (ISO 11608-5:2012) |
BS EN ISO 15002:2008
|
Flow-metering devices for connection to terminal units of medical gas pipeline systems |
CAN/CSA-ISO 16571:16
|
SYSTEMS FOR EVACUATION OF PLUME GENERATED BY MEDICAL DEVICES |
UNE-EN ISO 80369-1:2011
|
Small bore connectors for liquids and gases in healthcare applications - Part 1: General requirements (ISO 80369-1:2010) |
09/30173644 DC : 0
|
BS EN ISO 80369-1 - SMALL BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 1: GENERAL REQUIREMENTS |
I.S. EN 285:2015
|
STERILIZATION - STEAM STERILIZERS - LARGE STERILIZERS |
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 |
UNE-EN ISO 11608-5:2013
|
Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated functions (ISO 11608-5:2012) |
15/30280196 DC : 0
|
BS ISO/IEC 25022 - SYSTEMS AND SOFTWARE ENGINEERING - SYSTEMS AND SOFTWARE QUALITY REQUIREMENTS AND EVALUATION (SQUARE) - MEASUREMENT OF QUALITY IN USE |
NF EN ISO 80369-1 : 2011
|
SMALL BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 1: GENERAL REQUIREMENTS |
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 |
UNI EN ISO 5367 : 2015
|
ANAESTHETIC AND RESPIRATORY EQUIPMENT - BREATHING SETS AND CONNECTORS |
16/30216785 DC : 0
|
BS EN 62667 - MEDICAL ELECTRICAL EQUIPMENT - MEDICAL LIGHT ION BEAM EQUIPMENT - PERFORMANCE CHARACTERISTICS |
DIN EN ISO 11608-5:2013-01
|
Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated functions (ISO 11608-5:2012) |
I.S. EN 1865-3:2012
|
PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 3: HEAVY DUTY STRETCHER |
11/30206856 DC : 0
|
BS EN 60601-1-8:2007/A1 - MEDICAL ELECTRICAL EQUIPMENT - PART 1-8: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: GENERAL REQUIREMENTS, TESTS AND GUIDANCE FOR ALARM SYSTEMS IN MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS |
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) |
AAMI IEC 80601-2-30 : 2009
|
MEDICAL ELECTRICAL EQUIPMENT - PART 2-30: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF AUTOMATED NON-INVASIVE SPHYGMOMANOMETERS |
06/30146526 DC : 0
|
BS ISO 18113-5 - CLINICAL LABORATORY TESTING AND IN VITRO DIAGNOSTIC MEDICAL SYSTEMS - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 5: IN VITRO DIAGNOSTIC INSTRUMENTS FOR SELF-TESTING |
14/30315340 DC : 0
|
BS EN 60601-2-66 ED.2 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-66: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HEARING INSTRUMENTS AND HEARING INSTRUMENT SYSTEMS |
I.S. EN ISO 5840-3:2013
|
CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 3: HEART VALVE SUBSTITUTES IMPLANTED BY TRANSCATHETER TECHNIQUES (ISO 5840-3:2013) |
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 |
BS EN ISO 80369-1:2010
|
Small bore connectors for liquids and gases in healthcare applications General requirements |
UNE-EN 60601-2-66:2016
|
Medical electrical equipment - Part 2-66: Particular requirements for the basic safety and essential performance of hearing instruments and hearing instrument systems |
14/30281560 DC : 0
|
BS EN ISO 5840-2 - CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 2: SURGICALLY IMPLANTED HEART VALVE SUBSTITUTES |
PD ISO/TS 19218-2:2012
|
Medical devices. Hierarchical coding structure for adverse events Evaluation codes |
DIN EN ISO 15002:2008-11
|
FLOW-METERING DEVICES FOR CONNECTION TO TERMINAL UNITS OF MEDICAL GAS PIPELINE SYSTEMS |
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 |
CAN/CSA-Z15002:12 (R2017)
|
Flow-metering devices for connection to terminal units of medical gas pipeline systems (Adopted ISO 15002:2008, second edition, 2008-07-01, with Canadian deviations) |
BS EN 60601-2-66:2015
|
Medical electrical equipment Particular requirements for the basic safety and essential performance of hearing instruments and hearing instrument systems |
12/30271196 DC : 0
|
BS EN 60601-1-10:2007/A1 - 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 |
14/30294895 DC : 0
|
BS EN ISO 8537 - STERILE SINGLE-USE SYRINGES, WITH OR WITHOUT NEEDLE, FOR INSULIN |
CSA Z1500:2012
|
FLOW-METERING DEVICES FOR CONNECTION TO TERMINAL UNITS OF MEDICAL GAS PIPELINE SYSTEMS |
CSA C22.2 No. 60601.1.8 : 2008 : R2014
|
MEDICAL ELECTRICAL EQUIPMENT - PART 1-8: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: GENERAL REQUIREMENTS, TESTS AND GUIDANCE FOR ALARM SYSTEMS IN MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS |
BS EN ISO 80369-3:2016
|
Small-bore connectors for liquids and gases in healthcare applications Connectors for enteral applications |
NF 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 |
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 5840-3 : 2013
|
CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 3: HEART VALVE SUBSTITUTES IMPLANTED BY TRANSCATHETER TECHNIQUES |
UNE-EN ISO 10079-1:2016
|
Medical suction equipment - Part 1: Electrically powered suction equipment (ISO 10079-1:2015) |
UNE-EN ISO 20072:2013
|
Aerosol drug delivery device design verification - Requirements and test methods (ISO 20072:2009) |
I.S. EN 60601-1-6:2010
|
MEDICAL ELECTRICAL EQUIPMENT - PART 1-6: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: USABILITY |
AAMI ISO 5367 : 2015
|
ANAESTHETIC AND RESPIRATORY EQUIPMENT - BREATHING SETS AND CONNECTORS |
BS EN 60601-1-8 : 2007
|
MEDICAL ELECTRICAL EQUIPMENT - PART 1-8: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: GENERAL REQUIREMENTS, TESTS AND GUIDANCE FOR ALARM SYSTEMS IN MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS (IEC 60601-1-8:2006) |
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) |
UNE-EN ISO 7494-1:2012
|
Dentistry - Dental units - Part 1: General requirements and test methods (ISO 7494-1:2011) |
AAMI IEC 60601-2-16 : 2012
|
MEDICAL ELECTRICAL EQUIPMENT - PART 2-16: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HEMODIALYSIS, HEMODIAFILTRATION AND HEMOFILTRATION EQUIPMENT |
AAMI ISO TIR 17137 : 2014
|
CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - CARDIOVASCULAR ABSORBABLE IMPLANTS |
I.S. EN ISO 80369-3:2016
|
SMALL-BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 3: CONNECTORS FOR ENTERAL APPLICATIONS (ISO/IEC/DIS 80369-3:2014) |
I.S. EN ISO 5840-1:2015
|
CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 1: GENERAL REQUIREMENTS (ISO 5840-1:2015) |
EN 60601-1-8:2007/A11:2017
|
MEDICAL ELECTRICAL EQUIPMENT - PART 1-8: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: GENERAL REQUIREMENTS, TESTS AND GUIDANCE FOR ALARM SYSTEMS IN MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS (IEC 60601-1-8:2006/A1:2012) |
CEI UNI EN ISO 80369-1 : 2011
|
SMALL BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 1: GENERAL REQUIREMENTS |
ISO 7494-1:2011
|
Dentistry Dental units Part 1: General requirements and test methods |
CSA C22.2 No. 60601.1.8 : 2008
|
MEDICAL ELECTRICAL EQUIPMENT - PART 1-8: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: GENERAL REQUIREMENTS, TESTS AND GUIDANCE FOR ALARM SYSTEMS IN MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS |
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) |
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 |
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 |
CSA ISO 10079-2 : 2014
|
MEDICAL SUCTION EQUIPMENT - PART 2: MANUALLY POWERED SUCTION EQUIPMENT |
I.S. EN 60601-2-16:2015
|
MEDICAL ELECTRICAL EQUIPMENT - PART 2-16: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HAEMODIALYSIS, HAEMODIAFILTRATION AND HAEMOFILTRATION EQUIPMENT |
UNE-EN ISO 14457:2013
|
Dentistry - Handpieces and motors (ISO 14457:2012) |
BS EN ISO 5367:2014
|
Anaesthetic and respiratory equipment. Breathing sets and connectors |
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 |
CSA C22.2 No. 60601-1-10 : 2009 : R2014
|
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 |
ISO 14971:2007
|
Medical devices Application of risk management to medical devices |
CEI UNI EN ISO 14971 : 2013
|
MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES |
IEC TR 61258:2008
|
Guidelines for the development and use of medical electrical equipment educational materials |
I.S. EN 62083:2009
|
MEDICAL ELECTRICAL EQUIPMENT - REQUIREMENTS FOR THE SAFETY OF RADIOTHERAPY TREATMENT PLANNING SYSTEMS |
ISO 5367:2014
|
Anaesthetic and respiratory equipment — Breathing sets and connectors |
I.S. EN ISO 14971:2012
|
MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES (ISO 14971:2007, CORRECTED VERSION 2007-10-01) |
DIN EN ISO 6875:2011-10
|
DENTISTRY - PATIENT CHAIR |
DIN EN 1782:2009-12
|
TRACHEAL TUBES AND CONNECTORS |
DIN EN ISO 7494-2:2015-08
|
Dentistry - Dental units - Part 2: Air, water, suction and wastewater systems (ISO 7494-2:2015) |
DIN EN ISO 14971:2013-04
|
MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES (ISO 14971:2007) |
DIN EN ISO 5840-2 E : 2016
|
CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 2: SURGICALLY IMPLANTED HEART VALVE SUBSTITUTES (ISO 5840-2:2015) |
BS EN ISO 7494-2:2015
|
Dentistry. Dental units Air, water, suction and wastewater systems |
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 10079-2:2014
|
Medical suction equipment Manually powered suction equipment |
14/30311240 DC : 0
|
BS EN 61010-1 ED 3 AMD 1 - SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL, AND LABORATORY USE - PART 1: GENERAL REQUIREMENTS |
DIN EN ISO 9680:2015-02
|
Dentistry - Operating lights (ISO 9680:2014) |
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 ISO 6875:2011
|
DENTISTRY - PATIENT CHAIR |
EN ISO 5840-2:2015
|
Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes (ISO 5840-2:2015) |
I.S. EN ISO 10079-2:2014
|
MEDICAL SUCTION EQUIPMENT - PART 2: MANUALLY POWERED SUCTION EQUIPMENT (ISO 10079-2:2014) |
I.S. EN ISO 9680:2014
|
DENTISTRY - OPERATING LIGHTS (ISO 9680:2014) |
EN ISO 5840-1:2015
|
Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements (ISO 5840-1:2015) |
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 ISO 7494-2:2015
|
DENTISTRY - DENTAL UNITS - PART 2: AIR, WATER, SUCTION AND WASTEWATER SYSTEMS (ISO 7494-2:2015) |
EN ISO 5840-3:2013
|
Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques (ISO 5840-3:2013) |
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 10079-3:2014
|
MEDICAL SUCTION EQUIPMENT - PART 3: SUCTION EQUIPMENT POWERED FROM A VACUUM OR POSITIVE PRESSURE GAS SOURCE (ISO 10079-3:2014) |
VDI 5702 Blatt 1:2017-04
|
Medical device software - Medical SPICE Process assessment model |
UNE-EN ISO 5840-2:2016
|
Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes (ISO 5840-2:2015) |
ISO 80601-2-61:2017
|
Medical electrical equipment Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment |
I.S. EN ISO 11073-00103:2017
|
HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 00103: OVERVIEW (ISO/IEEE 11073-00103:2015) |
11/30215841 DC : 0
|
BS EN ISO 14457 - DENTISTRY - HAND PIECES AND MOTORS |
14/30296572 DC : 0
|
BS EN 60601-1-11 - 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 1865-2:2015-05
|
PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 2: POWER ASSISTED STRETCHER |
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 |
ANSI/AAMI/IEC TIR62348:2012
|
ASSESSMENT OF THE IMPACT OF THE MOST SIGNIFICANT CHANGES IN AMENDMENT 1 TO IEC 60601-1:2005 AND MAPPING OF THE CLAUSES OF IEC 60601-1:2005 TO THE PREVIOUS EDITION |
DIN EN ISO 80601-2-72 E : 2016
|
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) |
ISO/TS 17518:2015
|
Medical laboratories — Reagents for staining biological material — Guidance for users |
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 |
13/30255929 DC : 0
|
BS EN ISO 7396-1 - MEDICAL GAS PIPELINE SYSTEMS - PART 1: PIPELINE SYSTEMS FOR COMPRESSED MEDICAL GASES AND VACUUM |
BS ISO 27427:2013
|
Anaesthetic and respiratory equipment. Nebulizing systems and components |
BS EN 60601-2-68:2015
|
Medical electrical equipment Particular requirements for the basic safety and essential performance of X-ray-based image-guided radiotherapy equipment for use with electron accelerators, light ion beam therapy equipment and radionuclide beam therapy equipment |
BS EN ISO 11608-5:2012
|
Needle-based injection systems for medical use. Requirements and test methods Automated functions |
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) |
AAMI ISO TIR 19218-2 : 2012
|
MEDICAL DEVICES - HIERARCHICAL CODING STRUCTURE FOR ADVERSE EVENTS - PART 2: EVALUATION CODES |
14/30281833 DC : 0
|
BS EN ISO 17509 - DENTISTRY - TORQUE TRANSMITTER FOR HANDPIECES USED FOR IMPLANTATION |
12/30246621 DC : 0
|
BS EN 60601-2-68 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-68: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY BASED IMAGE GUIDED RADIOTHERAPY EQUIPMENT FOR USE WITH ELECTRON ACCELERATORS, LIGHT ION BEAM THERAPY EQUIPMENT AND RADIONUCLIDE BEAM THERAPY EQUIPMENT |
10/30208977 DC : 0
|
BS EN ISO 11608-1 - NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 1: NEEDLE-BASED INJECTION SYSTEMS |
BS EN ISO 5840-1:2015
|
Cardiovascular implants. Cardiac valve prostheses General requirements |
UNI EN ISO 20072 : 2013
|
AEROSOL DRUG DELIVERY DEVICE DESIGN VERIFICATION - REQUIREMENTS AND TEST METHODS |
BS EN ISO 5840-3:2013
|
Cardiovascular implants. Cardiac valve prostheses Heart valve substitutes implanted by transcatheter techniques |
CSA Z10524-4 : 2012
|
PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 4: LOW-PRESSURE REGULATORS |
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 |
UNE-EN ISO 5840-1:2016
|
Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements (ISO 5840-1:2015) |
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) |
DIN EN ISO 5840-2:2016-05
|
Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes (ISO 5840-2:2015) |
UNI EN ISO 11608-5 : 2013
|
NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 5: AUTOMATED FUNCTIONS |
I.S. EN ISO 5361:2016
|
ANAESTHETIC AND RESPIRATORY EQUIPMENT - TRACHEAL TUBES AND CONNECTORS (ISO/DIS 5361:2014) |
IEC TR 80002-1:2009
|
Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software |
DIN EN ISO 5840-1:2015-12
|
Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements (ISO 5840-1:2015) |
BS EN 60601-2-49:2015
|
Medical electrical equipment Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment |
BS EN 1865-2 : 2010
|
PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 2: POWER ASSISTED STRETCHER |
PREN ISO 80369-1 : DRAFT 2009
|
SMALL BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 1: GENERAL REQUIREMENTS |
AAMI HE75 : 2009
|
HUMAN FACTORS ENGINEERING - DESIGN OF MEDICAL DEVICES |
I.S. EN ISO 5840-2:2015
|
CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 2: SURGICALLY IMPLANTED HEART VALVE SUBSTITUTES (ISO 5840-2:2015) |
I.S. EN 60601-1-8:2007
|
MEDICAL ELECTRICAL EQUIPMENT - PART 1-8: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: GENERAL REQUIREMENTS, TESTS AND GUIDANCE FOR ALARM SYSTEMS IN MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS |
ISO 10079-1:2015
|
Medical suction equipment Part 1: Electrically powered suction equipment |
I.S. EN 80601-2-30:2010
|
MEDICAL ELECTRICAL EQUIPMENT - PART 2-30: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF AUTOMATED NON-INVASIVE SPHYGMOMANOMETERS |
AAMI ISO 5840-1 : 2016
|
CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 1: GENERAL REQUIREMENTS |
AAMI ISO 14708-5 : 2010
|
IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 5: CIRCULATORY SUPPORT DEVICES |
EN 60601-2-1:2015
|
Medical electrical equipment - Part 2-1: Particular requirements for the basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV |
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) |
UNI EN ISO 5361 : 2013
|
ANAESTHETIC AND RESPIRATORY EQUIPMENT - TRACHEAL TUBES AND CONNECTORS |
ISO/IEC 25022:2016
|
Systems and software engineering Systems and software quality requirements and evaluation (SQuaRE) Measurement of quality in use |
ISO 11040-8:2016
|
Prefilled syringes — Part 8: Requirements and test methods for finished prefilled syringes |
CSA ISO 10079-3 : 2014
|
MEDICAL SUCTION EQUIPMENT - PART 3: SUCTION EQUIPMENT POWERED FROM A VACUUM OR POSITIVE PRESSURE GAS SOURCE |
ISO/TS 19218-2:2012
|
Medical devices Hierarchical coding structure for adverse events Part 2: Evaluation codes |
CSA C22.2 No. 60601-2-68 : 2015
|
MEDICAL ELECTRICAL EQUIPMENT - PART 2-68: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY-BASED IMAGE-GUIDED RADIOTHERAPY EQUIPMENT FOR USE WITH ELECTRON ACCELERATORS, LIGHT ION BEAM THERAPY EQUIPMENT AND RADIONUCLIDE BEAM THERAPY EQUIPMENT |
CSA C22.2 No. 60601.2.1 : 2011 : INC : AMD 1 : 2015 : R2016
|
MEDICAL ELECTRICAL EQUIPMENT - PART 2-1: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF ELECTRON ACCELERATORS IN THE RANGE 1 MEV TO 50 MEV |
CSA C22.2 No. 60601-1-10:2009
|
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 |
EN ISO 80369-1:2010
|
Small bore connectors for liquids and gases in healthcare applications - Part 1: General requirements (ISO 80369-1:2010) |
BS EN ISO 14971:2012
|
Medical devices. Application of risk management to medical devices |
ISO 15002:2008
|
Flow-metering devices for connection to terminal units of medical gas pipeline systems |
IEC 60601-1-8:2006+AMD1:2012 CSV
|
Medical electrical equipment - Part 1-8: General requirements forbasic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems inmedical electrical equipment and medical electrical systems |
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 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 ISO 11608-1:2015-04
|
Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems (ISO 11608-1:2014) |
BS EN 60601-2-16:2015
|
Medical electrical equipment Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment |
ISO 15197:2013
|
In vitro diagnostic test systems — Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus |
IEC 60601-1-6:2010+AMD1:2013 CSV
|
Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability |
ISO 80601-2-69:2014
|
Medical electrical equipment Part 2-69: Particular requirements for basic safety and essential performance of oxygen concentrator equipment |
IEC 60601-2-66:2015
|
Medical electrical equipment - Part 2-66: Particular requirements for the basic safety and essential performance of hearing instruments and hearing instrument systems |
CSA Z8000 : 2011 : R2016
|
CANADIAN HEALTH CARE FACILITIES |
CSA Z8000 : 2011
|
CANADIAN HEALTH CARE FACILITIES |
CSA Z8000 : 2011 : INC : UPD 1 : 2013
|
CANADIAN HEALTH CARE FACILITIES |
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 13544-1:2007
|
RESPIRATORY THERAPY EQUIPMENT - PART 1: NEBULIZING SYSTEMS AND THEIR COMPONENTS |
UNE-EN 1782:1998
|
TRACHEAL TUBES AND CONNECTORS. |
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 7494-2:2015
|
Dentistry - Dental units - Part 2: Air, water, suction and wastewater systems (ISO 7494-2:2015) |
EN 1782:1998+A1:2009
|
Tracheal tubes and connectors |
UNI EN ISO 6875 : 2011
|
DENTISTRY - PATIENT CHAIR |
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 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 10079-2 : 2014
|
MEDICAL SUCTION EQUIPMENT - PART 2: MANUALLY POWERED SUCTION EQUIPMENT |
UNI EN 13544-1 : 2009
|
RESPIRATORY THERAPY EQUIPMENT - PART 1: NEBULIZING SYSTEMS AND THEIR COMPONENTS |
UNI EN 12342 : 2009
|
BREATHING TUBES INTENDED FOR USE WITH ANAESTHETIC APPARATUS AND VENTILATORS |
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 1782 : 2009
|
TRACHEAL TUBES AND CONNECTORS |
UNE-EN ISO 5361:2017
|
Anaesthetic and respiratory equipment - Tracheal tubes and connectors (ISO 5361:2016) |
BS ISO 16571:2014
|
Systems for evacuation of plume generated by medical devices |
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 |
CAN/CSA-C22.2 NO. 60601-1-8:08 (R2018)
|
Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems (Adopted IEC 60601-1-8:2006, second edition, 2006-10) | Appareils électromédicaux - Partie 1-8: Exigences générales pour la sécurité de base et les performances essentielles - Norme collatérale: Exigences générales, essais et guide pour les systèmes d\'alarme des appareils et des systèmes électromédicaux (norme IEC 60601-1-8:2006 adoptée, deuxième édition, 2006-10) |
DIN EN ISO 20072:2013-10
|
AEROSOL DRUG DELIVERY DEVICE DESIGN VERIFICATION - REQUIREMENTS AND TEST METHODS (ISO 20072:2009) |
NF EN 1865-2 : 2011 + A1 2016
|
PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 2: POWER ASSISTED STRETCHERS |
14/30277509 DC : 0
|
BS ISO 18250-3 - CONNECTORS FOR RESERVOIR DELIVERY SYSTEMS - PART 2: ENTERNAL APPLICATIONS |
BS EN ISO 20072:2013
|
Aerosol drug delivery device design verification. Requirements and test methods |
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) |
08/30192448 DC : DRAFT DEC 2008
|
BS ISO 14708-5 - IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 5: CIRCULATORY SUPPORT 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 |
AAMI/IEC TIR80002-1:2009
|
MEDICAL DEVICE SOFTWARE - PART 1: GUIDANCE ON THE APPLICATION OF ISO 14971 TO MEDICAL DEVICE SOFTWARE |
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 |
NF EN 60601-2-66 : 2016
|
MEDICAL ELECTRICAL EQUIPMENT - PART 2-66: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HEARING INSTRUMENTS AND HEARING INSTRUMENT SYSTEMS |
15/30304642 DC : 0
|
BS ISO 11040-8 - PREFILLED SYRINGES - PART 8: REQUIREMENTS AND TEST METHODS FOR FINISHED PRIFILLED SYRINGES |
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 |
11/30208525 DC : 0
|
BS EN ISO 15197 - IN VITRO DIAGNOSTIC TEST SYSTEMS - REQUIREMENTS FOR BLOOD-GLUCOSE MONITORING SYSTEMS FOR SELF-TESTING IN MANAGING DIABETES MELLITUS |
14/30281859 DC : 0
|
BS ISO 5361 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - TRACHEAL TUBES AND CONNECTORS |
09/30176675 DC : 0
|
BS EN ISO 15223-1 - MEDICAL DEVICES - SYMBOLS TO BE USED WITH MEDICAL DEVICE LABELS, LABELLING AND INFORMATION TO BE SUPPLIED - PART 1: GENERAL REQUIREMENTS |
BS EN ISO 80601-2-69:2014
|
Medical electrical equipment Particular requirements for basic safety and essential performance of oxygen concentrator equipment |
IEC 60601-2-68:2014
|
Medical electrical equipment - Part 2-68: Particular requirements for the basic safety and essential performance of X-ray-based image-guided radiotherapy equipment for use with electron accelerators, light ion beam therapy equipment and radionuclide beam therapy equipment |
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 |
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 ISO 27500 : 2016
|
THE HUMAN-CENTRED ORGANIZATION - RATIONALE AND GENERAL PRINCIPLES |
11/30219211 DC : 0
|
BS EN ISO 5840-3 - CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 3: HEART VALVE SUBSTITUTES IMPLANTED BY MINIMALLY INVASIVE TECHNIQUES |
BS EN ISO 5361:2016
|
Anaesthetic and respiratory equipment. Tracheal tubes and connectors |
UNE-EN ISO 80369-3:2017
|
Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications (ISO 80369-3:2016) |
09/30189968 DC : DRAFT JAN 2009
|
BS EN 13544-1 AMD1 - RESPIRATORY THERAPY EQUIPMENT - PART 1: NEBULIZING SYSTEMS AND THEIR COMPONENTS |
BS EN ISO 11073-00103:2017
|
Health informatics. Personal health device communication Overview |
BS EN ISO 18113-5:2011
|
In vitro diagnostic medical Devices. Information supplied by the manufacturer (labelling) In vitro diagnostic instruments for self-testing |
12/30244415 DC : DRAFT APR 2012
|
BS ISO 27427 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - NEBULIZING SYSTEMS AND COMPONENTS |
06/30146511 DC : 0
|
BS ISO 18113-1 - CLINICAL LABORATORY TESTING AND IN VITRO DIAGNOSTIC MEDICAL SYSTEMS - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 1: TERMS, DEFINITIONS AND GENERAL REQUIREMENTS |
DIN EN 1865-3:2015-05
|
PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 3: HEAVY DUTY STRETCHER |
CEI EN 62083 : 2011
|
MEDICAL ELECTRICAL EQUIPMENT - REQUIREMENTS FOR THE SAFETY OF RADIOTHERAPY TREATMENT PLANNING SYSTEMS |
PD IEC/TR 80002-1:2009
|
Medical device software Guidance on the application of ISO 14971 to medical device software |
UNI CEI EN ISO 14971 : 2012
|
MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES |
10/30208681 DC : DRAFT SEP 2010
|
BS ISO/IEC GUIDE 63 - GUIDE TO THE DEVELOPMENT AND INCLUSION OF SAFETY ASPECTS IN INTERNATIONAL STANDARDS FOR MEDICAL DEVICES |
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 |
CSA ISO 27427 : 2014
|
ANAESTHETIC AND RESPIRATORY EQUIPMENT - NEBULIZING SYSTEMS AND COMPONENTS |
BS ISO/IEC 25022:2016
|
Systems and software engineering. Systems and software quality requirements and evaluation (SQuaRE). Measurement of quality in use |
I.S. EN ISO 11608-5:2012
|
NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 5: AUTOMATED FUNCTIONS (ISO 11608-5:2012) |
AAMI ISO 14971 : 2007 : R2010
|
MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES |
CSA C22.2 No. 60601.2.16 : 2014(R2019)
|
MEDICAL ELECTRICAL EQUIPMENT - PART 2-16: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HAEMODIALYSIS, HAEMODIAFILTRATION AND HAEMOFILTRATION EQUIPMENT |
I.S. EN ISO 7494-1:2011
|
DENTISTRY - DENTAL UNITS - PART 1: GENERAL REQUIREMENTS AND TEST METHODS |
CEI EN 60601-2-16 : 2016
|
MEDICAL ELECTRICAL EQUIPMENT - PART 2-16: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HAEMODIALYSIS, HAEMODIAFILTRATION AND HAEMOFILTRATION EQUIPMENT |
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 |
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) |
EN 60601-2-68:2015
|
Medical electrical equipment - Part 2-68: Particular requirements for the basic safety and essential performance of X-ray-based image-guided radiotherapy equipment for use with electron accelerators, light ion beam therapy equipment and radionuclide beam therapy equipment |
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 15002:2008
|
FLOW-METERING DEVICES FOR CONNECTION TO TERMINAL UNITS OF MEDICAL GAS PIPELINE SYSTEMS |
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) |
ISO 5359:2014
|
Anaesthetic and respiratory equipment Low-pressure hose assemblies for use with medical gases |
ISO 14708-5:2010
|
Implants for surgery Active implantable medical devices Part 5: Circulatory support devices |
I.S. EN 60601-2-68:2015
|
MEDICAL ELECTRICAL EQUIPMENT - PART 2-68: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY-BASED IMAGE-GUIDED RADIOTHERAPY EQUIPMENT FOR USE WITH ELECTRON ACCELERATORS, LIGHT ION BEAM THERAPY EQUIPMENT AND RADIONUCLIDE BEAM THERAPY EQUIPMENT |
ISO 80369-1:2010
|
Small-bore connectors for liquids and gases in healthcare applications Part 1: General requirements |
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) |
DIN EN ISO 5367:2015-02
|
Anaesthetic and respiratory equipment - Breathing sets and connectors (ISO 5367:2014) |
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 |
PREN ISO 7494-2 : DRAFT 2013
|
DENTISTRY - DENTAL UNITS - PART 2: MEDIA CHANNELS AND CONNECTIONS (ISO/DIS 7494-2:2013) |
DIN EN ISO 5359:2015-02
|
ANAESTHETIC AND RESPIRATORY EQUIPMENT - LOW-PRESSURE HOSE ASSEMBLIES FOR USE WITH MEDICAL GASES (ISO 5359:2014) |
BS EN ISO 7494-1:2011
|
Dentistry. Dental units General requirements and test methods |
EN ISO 14971:2012
|
Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01) |
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 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 |
DIN EN ISO 80369-1:2015-09 (Draft)
|
SMALL BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 1: GENERAL REQUIREMENTS |
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 60601-2-1:2015
|
MEDICAL ELECTRICAL EQUIPMENT - PART 2-1: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF ELECTRON ACCELERATORS IN THE RANGE 1 MEV TO 50 MEV |
EN ISO 80601-2-12:2011/AC: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) |
ISO 80601-2-12:2011
|
Medical electrical equipment Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators |
DIN EN ISO 15197:2015-12
|
IN VITRO DIAGNOSTIC TEST SYSTEMS - REQUIREMENTS FOR BLOOD-GLUCOSE MONITORING SYSTEMS FOR SELF-TESTING IN MANAGING DIABETES MELLITUS (ISO 15197:2013) |
UNE-EN ISO 6875:2012
|
Dentistry - Patient chair (ISO 6875:2011) |
DIN EN ISO 11608-1 E : 2015
|
NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 1: NEEDLE-BASED INJECTION SYSTEMS (ISO 11608-1:2014) |
DIN EN ISO 10079-1:2016-05
|
MEDICAL SUCTION EQUIPMENT - PART 1: ELECTRICALLY POWERED SUCTION EQUIPMENT (ISO 10079-1:2015) |
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 |
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) |
BS EN 13544-1 : 2007
|
RESPIRATORY THERAPY EQUIPMENT - PART 1: NEBULIZING SYSTEMS AND THEIR COMPONENTS |
BS EN ISO 10079-3:2014
|
Medical suction equipment Suction equipment powered from a vacuum or positive pressure gas source |
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 9680:2014
|
Dentistry. Operating lights |
ISO 20072:2009
|
Aerosol drug delivery device design verification 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 60601-2-49:2016
|
Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment |
ISO 5840-3:2013
|
Cardiovascular implants Cardiac valve prostheses Part 3: Heart valve substitutes implanted by transcatheter techniques |
I.S. EN 13718-1:2014
|
MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 1: REQUIREMENTS FOR MEDICAL DEVICES USED IN AIR AMBULANCES |
ISO 6875:2011
|
Dentistry Patient chair |
BS EN 285:2015
|
Sterilization. Steam sterilizers. Large sterilizers |
ISO 5361:2016
|
Anaesthetic and respiratory equipment — Tracheal tubes and connectors |
IEC 60601-2-1:2009+AMD1:2014 CSV
|
Medical electrical equipment - Part 2-1: Particular requirements for the basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV |
ISO 18113-1:2009
|
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions and general requirements |
BS EN ISO 6875:2011
|
Dentistry. Patient chair |
IEC 60601-1-10:2007+AMD1:2013 CSV
|
Medical electrical equipment - Part 1-10: General requirements forbasic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loopcontrollers |
ISO 5840-2:2015
|
Cardiovascular implants Cardiac valve prostheses Part 2: Surgically implanted heart valve substitutes |
ISO 11608-1:2014
|
Needle-based injection systems for medical use Requirements and test methods Part 1: Needle-based injection systems |
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 |
UNE-EN 62083:2010
|
Medical electrical equipment - Requirements for the safety of radiotherapy treatment planning systems |
ISO 10079-3:2014
|
Medical suction equipment Part 3: Suction equipment powered from a vacuum or positive pressure gas source |
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 |
ISO 9680:2014
|
Dentistry Operating lights |
IEC 62083:2009
|
Medical electrical equipment - Requirements for the safety of radiotherapy treatment planning systems |
ISO 27500:2016
|
The human-centred organization Rationale and general principles |
BS EN ISO 15197:2015
|
In vitro diagnostic test systems. Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus |
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 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 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) |
UNI EN ISO 9680 : 2015
|
DENTISTRY - OPERATING LIGHTS |
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 12342:1998+A1:2009
|
Breathing tubes intended for use with anaesthetic apparatus and ventilators |
EN ISO 10079-2:2014
|
Medical suction equipment - Part 2: Manually powered suction equipment (ISO 10079-2:2014) |
EN ISO 11608-5:2012
|
Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated functions (ISO 11608-5:2012) |
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 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 1865-3:2012+A1:2015 (edition 2)
|
Patient handling equipment used in road ambulances - Part 3: Heavy duty stretcher |
EN ISO 80369-3:2016
|
Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications (ISO 80369-3:2016) |
EN ISO 20072:2013
|
Aerosol drug delivery device design verification - Requirements and test methods (ISO 20072:2009) |
EN ISO 10524-4:2008
|
Pressure regulators for use with medical gases - Part 4: Low-pressure regulators (ISO 10524-4:2008) |
EN ISO 11608-1:2015
|
Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems (ISO 11608-1:2014) |
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) |
EN ISO 5367:2014
|
Anaesthetic and respiratory equipment - Breathing sets and connectors (ISO 5367:2014) |
EN ISO 6875:2011
|
Dentistry - Patient chair (ISO 6875:2011) |
BS EN 1865-3 : 2012
|
PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 3: HEAVY DUTY STRETCHER |
12/30210881 DC : DRAFT APR 2012
|
BS EN ISO 5367 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - BREATHING SETS AND CONNECTORS |
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 5840-1 E : 2015
|
CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 1: GENERAL REQUIREMENTS (ISO 58401:2015) |
PREN 45502-1 : DRAFT 2013
|
ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL REQUIREMENTS FOR SAFETY, MARKING AND INFORMATION TO BE PROVIDED BY THE MANUFACTURER |
UNE-EN 60601-2-1:2017
|
Medical electrical equipment - Part 2-1: Particular requirements for the basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV |
13/30263413 DC : 0
|
BS EN ISO 7494-2 - DENTISTRY - DENTAL UNITS - PART 2: MEDIA CHANNELS AND CONNECTIONS |
UNI EN ISO 10524-4 : 2008
|
PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 4: LOW-PRESSURE REGULATORS |
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) |
UNE-EN ISO 5840-3:2013
|
Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques (ISO 5840-3:2013) |
14/30273278 DC : 0
|
BS EN ISO 18397 - DENTISTRY - POWERED SCALER |
BS EN ISO 10524-4:2008
|
Pressure regulators for use with medical gases Low-pressure regulators |
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 EN ISO 18113-1:2011
|
In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) Terms, definitions and general requirements |
IEC TR 62348:2012
|
Assessment of the impact of the most significant changes in Amendment 1 to IEC 60601-1:2005 and mapping of the clauses of IEC 60601-1:2005 to the previous edition |
10/30213842 DC : 0
|
BS EN ISO 11608-5 - NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 5: AUTOMATED FUNCTIONS |
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 |
16/30310949 DC : 0
|
BS ISO 5910 - CARDIOVASCULAR IMPLANTS AND EXTRACOPOREAL SYSTEMS - CARDIAC VALVE REPAIR DEVICES |
06/30146518 DC : 0
|
BS ISO 18113-3 - CLINICAL LABORATORY TESTING AND IN VITRO DIAGNOSTIC MEDICAL SYSTEMS - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 3: IN VITRO DIAGNOSTIC INSTRUMENTS FOR PROFESSIONAL USE |
BS EN 80601-2-30 : 2010
|
MEDICAL ELECTRICAL EQUIPMENT - PART 2-30: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF AUTOMATED NON-INVASIVE SPHYGMOMANOMETERS |
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 |
I.S. EN ISO 5367:2014
|
ANAESTHETIC AND RESPIRATORY EQUIPMENT - BREATHING SETS AND CONNECTORS (ISO 5367:2014) |
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) |
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 |
CSA ISO 14971 : 2007 : R2017
|
MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES |
CSA ISO 14971 : 2007 : R2012
|
MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES |
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 5367 E : 2015
|
ANAESTHETIC AND RESPIRATORY EQUIPMENT - BREATHING SETS AND CONNECTORS (ISO 5367:2014) |
PREN ISO 11608-1 : DRAFT 2010
|
NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 1: NEEDLE-BASED INJECTION SYSTEMS |
CSA C22.2 No. 60601-1-10 : 2009 : INC : AMD 1 : 2014 : R201400
|
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 |
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 |
IEEE 11073-00103-2012
|
Health informatics - Personal health device communication Part 00103: Overview |
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) |
ISO 80601-2-67:2014
|
Medical electrical equipment Part 2-67: Particular requirements for basic safety and essential performance of oxygen-conserving equipment |
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) |
CSA Z5359 : 2016
|
ANAESTHETIC AND RESPIRATORY EQUIPMENT - LOW-PRESSURE HOSE ASSEMBLIES FOR USE WITH MEDICAL GASES, MEDICAL VACUUM, MEDICAL SUPPORT GASES, AND ANAESTHETIC GAS SCAVENGING SYSTEMS |
BS EN ISO 10079-1:2015
|
Medical suction equipment Electrically powered suction equipment |
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) |
UNI EN ISO 7494-1 : 2011
|
DENTISTRY - DENTAL UNITS - PART 1: GENERAL REQUIREMENTS AND TEST METHODS |
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 |
ANSI/AAMI/IEC 60601-1-8:2006/A2:2021
|
MEDICAL ELECTRICAL EQUIPMENT - PART 1-8: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: GENERAL REQUIREMENTS, TESTS AND GUIDANCE FOR ALARM SYSTEMS IN MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS |
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) |
EN ISO 7494-1:2011
|
Dentistry - Dental units - Part 1: General requirements and test methods (ISO 7494-1:2011) |
NF EN 60601-2-68 : 2015
|
MEDICAL ELECTRICAL EQUIPMENT - PART 2-68: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY-BASED IMAGE-GUIDED RADIOTHERAPY EQUIPMENT FOR USE WITH ELECTRON ACCELERATORS, LIGHT ION BEAM THERAPY EQUIPMENT AND RADIONUCLIDE BEAM THERAPY EQUIPMENT |
ONORM EN ISO 7494-1 : 2011
|
DENTISTRY - DENTAL UNITS - PART 1: GENERAL REQUIREMENTS AND TEST METHODS (ISO 7494-1:2011) |
UNI EN ISO 18113-1 : 2012
|
IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 1: TERMS, DEFINITIONS AND GENERAL REQUIREMENTS |
13/30254355 DC : 0
|
BS ISO 80601-2-70 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-70: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF SLEEP APNEOA BREATHING THERAPY EQUIPMENT |
UNE-EN 1865-2:2011
|
Patient handling equipment used in road ambulances - Part 2: Power assisted stretcher |
DIN EN ISO 7494-1:2011-11
|
DENTISTRY - DENTAL UNITS - PART 1: GENERAL REQUIREMENTS AND TEST METHODS (ISO 7494-1:2011) |
PREN ISO 15197 : DRAFT 2011
|
IN VITRO DIAGNOSTIC TEST SYSTEMS - REQUIREMENTS FOR BLOOD-GLUCOSE MONITORING SYSTEMS FOR SELF-TESTING IN MANAGING DIABETES MELLITUS |
UNI EN ISO 15002 : 2008
|
FLOW-METERING DEVICES FOR CONNECTION TO TERMINAL UNITS OF MEDICAL GAS PIPELINE SYSTEMS |
I.S. EN ISO 5359:2014
|
ANAESTHETIC AND RESPIRATORY EQUIPMENT - LOW-PRESSURE HOSE ASSEMBLIES FOR USE WITH MEDICAL GASES (ISO 5359:2014) |
ISO/IEC Guide 63:2012
|
Guide to the development and inclusion of safety aspects in International Standards for medical devices |
I.S. EN ISO 20072:2013
|
AEROSOL DRUG DELIVERY DEVICE DESIGN VERIFICATION - REQUIREMENTS AND TEST METHODS (ISO 20072:2009) |
ISO 27427:2013
|
Anaesthetic and respiratory equipment — Nebulizing systems and components |
UNE-EN 285:2016
|
Sterilization - Steam sterilizers - Large sterilizers |
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) |
ISO 18113-5:2009
|
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 5: In vitro diagnostic instruments for self-testing |
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 |
EN 60601-2-66:2015
|
Medical electrical equipment - Part 2-66: Particular requirements for the basic safety and essential performance of hearing instruments and hearing instrument systems |
ISO 11608-5:2012
|
Needle-based injection systems for medical use Requirements and test methods Part 5: Automated functions |
BS EN ISO 11608-1:2015
|
Needle-based injection systems for medical use. Requirements and test methods Needle-based injection systems |
IEC 61010-1:2010+AMD1:2016 CSV
|
Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements |
ISO 5840-1:2015
|
Cardiovascular implants Cardiac valve prostheses Part 1: General requirements |
ISO 10079-2:2014
|
Medical suction equipment Part 2: Manually powered suction equipment |
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 |
DIN EN ISO 10079-2:2000-03
|
MEDICAL SUCTION EQUIPMENT - PART 2: MANUALLY POWERED SUCTION EQUIPMENT (ISO 10079-2:2014) |
EN 62083:2009
|
MEDICAL ELECTRICAL EQUIPMENT - REQUIREMENTS FOR THE SAFETY OF RADIOTHERAPY TREATMENT PLANNING SYSTEMS |
EN 80601-2-30:2010/A1:2015
|
MEDICAL ELECTRICAL EQUIPMENT - PART 2-30: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF AUTOMATED NON-INVASIVE SPHYGMOMANOMETERS (IEC 80601-2-30:2009/A1:2013) |
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 |
UNE-EN 1865-3:2012
|
Patient handling equipment used in road ambulances - Part 3: Heavy duty stretcher |
UNE-EN 13544-1:2007
|
Respiratory therapy equipment - Part 1: Nebulizing systems and their components |
ONORM EN ISO 5367 : 2015
|
ANAESTHETIC AND RESPIRATORY EQUIPMENT - BREATHING SETS AND CONNECTORS (ISO 5367:2014) |