Standards catalogue

ISO/TC 210

Quality management and corresponding general aspects for medical devices

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Standard and/or project under the direct responsibility of ISO/TC 210 Secretariat Stage ICS
ISO 594-1:1986 [Withdrawn]
Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment -- Part 1: General requirements
95.99
ISO 594-2:1998 [Withdrawn]
Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment -- Part 2: Lock fittings
95.99
ISO 13485:1996 [Withdrawn]
Quality systems -- Medical devices -- Particular requirements for the application of ISO 9001
95.99
ISO 13485:2003 [Withdrawn]
Medical devices -- Quality management systems -- Requirements for regulatory purposes
95.99
95.99
ISO 13485:2016
Medical devices -- Quality management systems -- Requirements for regulatory purposes
60.60
ISO 13488:1996 [Withdrawn]
Quality systems -- Medical devices -- Particular requirements for the application of ISO 9002
95.99
ISO 14969:1999 [Withdrawn]
Quality systems -- Medical devices -- Guidance on the application of ISO 13485 and ISO 13488
95.99
ISO/TR 14969:2004 [Withdrawn]
Medical devices -- Quality management systems -- Guidance on the application of ISO 13485: 2003
95.99
ISO 14971:2000 [Withdrawn]
Medical devices -- Application of risk management to medical devices
95.99
ISO 14971:2000/Amd 1:2003 [Withdrawn]
Rationale for requirements
95.99
ISO 14971:2007
Medical devices -- Application of risk management to medical devices
90.92
ISO/NP 14971 [Under development]
Medical devices -- Application of risk management to medical devices
10.99
ISO 14971-1:1998 [Withdrawn]
Medical devices -- Risk management -- Part 1: Application of risk analysis
95.99
ISO 15223:2000 [Withdrawn]
Medical devices -- Symbols to be used with medical device labels, labelling and information to be supplied
95.99
95.99
95.99
ISO/TR 15223:1998 [Withdrawn]
Medical devices -- Symbols to be used with medical device labels, labelling and information to be supplied
95.99
ISO 15223-1:2007 [Withdrawn]
Medical devices -- Symbols to be used with medical device labels, labelling and information to be supplied -- Part 1: General requirements
95.99
95.99
ISO 15223-1:2012 [Withdrawn]
Medical devices -- Symbols to be used with medical device labels, labelling and information to be supplied -- Part 1: General requirements
95.99
ISO 15223-1:2016
Medical devices -- Symbols to be used with medical device labels, labelling and information to be supplied -- Part 1: General requirements
60.60
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
90.93
ISO 15225:2000 [Withdrawn]
Nomenclature -- Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange
95.99
95.99
ISO 15225:2010 [Withdrawn]
Medical devices -- Quality management -- Medical device nomenclature data structure
95.99
ISO 15225:2016 [Withdrawn]
Medical devices -- Quality management -- Medical device nomenclature data structure
95.99
ISO/TR 16142:1999 [Withdrawn]
Medical devices -- Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices
95.99
ISO/TR 16142:2006 [Withdrawn]
Medical devices -- Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices
95.99
ISO 16142-1:2016
Medical devices -- Recognized essential principles of safety and performance of medical devices -- Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
60.60
ISO 16142-2:2017
Medical devices -- Recognized essential principles of safety and performance of medical devices -- Part 2: General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards
60.60
ISO/DIS 18250-1 [Under development]
Connectors for reservoir delivery systems for healthcare applications -- Part 1: General requirements and common test methods
40.60
ISO/DIS 18250-3 [Under development]
Connectors for reservoir delivery systems for healthcare applications -- Part 3: Enteral applications
40.99
ISO/CD 18250-6 [Under development]
Connectors for reservoir delivery systems for healthcare applications -- Part 6: Neural applications
30.99
ISO/DIS 18250-7 [Under development]
Connectors for reservoir delivery systems for healthcare applications -- Part 7: Conectors for Intravascular Infusion
40.60
ISO/DIS 18250-8 [Under development]
Connectors for reservoir delivery systems for healthcare applications -- Part 8: Citrate-based anticoagulant solution for apheresis applications
40.99
ISO/TS 19218:2005 [Withdrawn]
Medical devices -- Coding structure for adverse event type and cause
95.99
ISO/TS 19218-1:2011
Medical devices -- Hierarchical coding structure for adverse events -- Part 1: Event-type codes
90.93
60.60
ISO/TS 19218-2:2012
Medical devices -- Hierarchical coding structure for adverse events -- Part 2: Evaluation codes
90.93
ISO/TS 20225:2001 [Withdrawn]
Global medical device nomenclature for the purpose of regulatory data exchange
95.99
ISO/AWI TR 20416 [Under development]
Medical devices -- Post-market surveillance for manufacturers
20.00
ISO/NP 20417 [Under development]
Medical Devices -- Requirements for general information to be provided by the manufacturer
10.99
ISO/NP TR 24971 [Under development]
Medical devices -- Guidance on the application of ISO 14971
10.99
ISO/TR 24971:2013
Medical devices -- Guidance on the application of ISO 14971
90.92
IEC 62304:2006
Medical device software -- Software life cycle processes
90.92
60.60
IEC 62366:2007 [Withdrawn]
Medical devices -- Application of usability engineering to medical devices
95.99
95.99
IEC 62366-1:2015
Medical devices -- Part 1: Application of usability engineering to medical devices
60.60
IEC 62366-1:2015/CD Amd 1 [Under development]
30.99
60.60
IEC/TR 62366-2:2016
Medical devices -- Part 2: Guidance on the application of usability engineering to medical devices
60.60
IEC/TR 80002-1:2009
Medical device software -- Part 1: Guidance on the application of ISO 14971 to medical device software
60.60
ISO/TR 80002-2:2017
Medical device software -- Part 2: Validation of software for medical device quality systems
60.60
IEC/TR 80002-3:2014
Medical device software -- Part 3: Process reference model of medical device software life cycle processes (IEC 62304)
60.60
ISO 80369-1:2010
Small-bore connectors for liquids and gases in healthcare applications -- Part 1: General requirements
90.92
ISO/FDIS 80369-1 [Under development]
Small-bore connectors for liquids and gases in healthcare applications -- Part 1: General requirements
50.92
ISO 80369-3:2016
Small-bore connectors for liquids and gases in healthcare applications -- Part 3: Connectors for enteral applications
90.92
40.98
40.98
40.98
ISO/DIS 80369-3 [Under development]
Small-bore connectors for liquids and gases in healthcare applications -- Part 3: Connectors for enteral applications
40.99
IEC 80369-5:2016
Small-bore connectors for liquids and gases in healthcare applications -- Part 5: Connectors for limb cuff inflation applications
60.60
60.60
ISO 80369-6:2016
Small bore connectors for liquids and gases in healthcare applications -- Part 6: Connectors for neuraxial applications
60.60
ISO 80369-7:2016
Small-bore connectors for liquids and gases in healthcare applications -- Part 7: Connectors for intravascular or hypodermic applications
60.60
ISO 80369-20:2015
Small-bore connectors for liquids and gases in healthcare applications -- Part 20: Common test methods
60.60

No matching records found