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EN ISO 14971:2012

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
Superseded date

01-15-2022

Published date

07-04-2012

Foreword
Introduction
1 Scope
2 Terms and definitions
3 General requirements for risk management
4 Risk analysis
5 Risk evaluation
6 Risk control
7 Evaluation of overall residual risk acceptability
8 Risk management report
9 Production and post-production information
Annex A (informative) - Rationale for requirements
Annex B (informative) - Overview of the risk management
        process for medical devices
Annex C (informative) - Questions that can be used to
        identify medical device characteristics that
        could impact on safety
Annex D (informative) - Risk concepts applied to
        medical devices
Annex E (informative) - Examples of hazards, foreseeable
        sequences of events and hazardous situations
Annex F (informative) - Risk management plan
Annex G (informative) - Information on risk management
        techniques
Annex H (informative) - Guidance on risk management for
        in vitro diagnostic medical devices
Annex I (informative) - Guidance on risk analysis process
        for biological hazards
Annex J (informative) - Information for safety and information
        about residual risk
Bibliography
Annex ZA (informative) - Relationship between this European
         Standard and Requirements of EU Directive 93/42/EE
         on Medical Devices
Annex ZB (informative) - Relationship between this European
         Standard and Requirements of EU Directive
         90/385/EEC on Active Implantable Medical Devices
Annex ZC (informative) - Relationship between this European
         Standard and Requirements of EU Directive 98/79/EC
         on In Vitro Diagnostic Medical Devices

ISO 14971:2007 specifies a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.The requirements of ISO 14971:2007 are applicable to all stages of the life-cycle of a medical device.

DevelopmentNote
Supersedes EN 1441. (03/2001)
DocumentType
Standard
PublisherName
Comite Europeen de Normalisation
Status
Superseded
SupersededBy

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 Symbols for use in the labelling of medical devices
BS EN 1642:2011 Dentistry. Medical devices for dentistry. Dental implants
DIN EN ISO 80369-7:2017-10 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 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 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 Dentistry - Guidelines for handling methacrylate-based materials in the dental laboratory
CEN/TS 14507-2 : 2003 INHALATIONAL NITRIC OXIDE SYSTEMS - PART 2: SUPPLY SYSTEMS
DIN EN ISO 14155-2:2009-11 CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - PART 2: CLINICAL INVESTIGATION PLANS
CEN/TS 15277:2006 Non-active surgical implants - Injectable implants
EN 13532:2002 General requirements for in vitro diagnostic medical devices for self-testing
UNI EN 1789 : 2014 MEDICAL VEHICLES AND THEIR EQUIPMENT - ROAD AMBULANCES
EN 61010-2-101:2017 Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment
UNE-EN 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

93/68/EEC : 1993 AMD 2 1998 COUNCIL DIRECTIVE 93/68/EEC OF 22.7.93 AMENDING DIRECTIVES 87/404/EEC, 88/378/EEC, 89/106/EEC, 89/336/EEC, 89/392/EEC, 89/686/EEC, 90/384/EEC, 90/385/EEC, 90/396/EEC, 91/263/EEC, 92/42/EEC AND 73/23/EEC
IEC 61025:2006 Fault tree analysis (FTA)
ISO 14155-2:2003 Clinical investigation of medical devices for human subjects Part 2: Clinical investigation plans
IEC 60812:2006 Analysis techniques for system reliability - Procedure for failure mode and effects analysis (FMEA)
ISO 18113-1:2009 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions and general requirements
IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
EN 1441 : 1997 MEDICAL DEVICES - RISK ANALYSIS
ISO 15189:2012 Medical laboratories — Requirements for quality and competence
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 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
ISO 14155-1:2003 Clinical investigation of medical devices for human subjects Part 1: General requirements
ISO/TR 14969:2004 Medical devices Quality management systems Guidance on the application of ISO 13485: 2003
ISO 10993-2:2006 Biological evaluation of medical devices — Part 2: Animal welfare requirements
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
IEC TR 60513:1994 Fundamental aspects of safety standards for medical electrical equipment
ISO 15198:2004 Clinical laboratory medicine — In vitro diagnostic medical devices — Validation of user quality control procedures by the manufacturer
ISO 18153:2003 In vitro diagnostic medical devices Measurement of quantities in biological samples Metrological traceability of values for catalytic concentration of enzymes assigned calibrators and control materials
IEC 62366:2007+AMD1:2014 CSV Medical devices - Application of usability engineering to medical devices
ISO 19001:2013 In vitro diagnostic medical devices — Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology
ISO/IEC Guide 51:2014 Safety aspects Guidelines for their inclusion in standards
ISO 17511:2003 In vitro diagnostic medical devices Measurement of quantities in biological samples Metrological traceability of values assigned to calibrators and control materials
AS 3695.2:2019 Wheelchairs Requirements and test methods for electrically powered wheelchairs (including mobility scooters)
ISO 10993-17:2002 Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances
ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
IEC 60300-3-9:1995 Dependability management - Part 3: Application guide - Section 9: Risk analysis of technological systems
ISO 17593:2007 Clinical laboratory testing and in vitro medical devices Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
ISO 9000:2015 Quality management systems — Fundamentals and vocabulary
ISO/IEC Guide 2:2004 Standardization and related activities General vocabulary
EN 12442-1 : 2000 ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 1: ANALYSIS AND MANAGEMENT OF RISK
ISO 15197:2013 In vitro diagnostic test systems — Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
IEC 60601-1-4:1996+AMD1:1999 CSV Medical electrical equipment - Part 1-4: General requirements for safety - Collateral Standard: Programmable electrical medical systems
ISO 9000-3:1997 Quality management and quality assurance standards Part 3: Guidelines for the application of ISO 9001:1994 to the development, supply, installation and maintenance of computer software

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