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Стандарт и/или проект находящийся в компетенции ISO/TC 210 Секретариата Этап ICS
ISO 594-1:1986
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
Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment — Part 2: Lock fittings
95.99
ISO 13485:1996
Quality systems — Medical devices — Particular requirements for the application of ISO 9001
95.99
ISO 13485:2003
Medical devices — Quality management systems — Requirements for regulatory purposes
95.99
ISO 13485:2003/Cor 1:2009
Medical devices — Quality management systems — Requirements for regulatory purposes — Technical Corrigendum 1
95.99
ISO 13485:2016
Medical devices — Quality management systems — Requirements for regulatory purposes
90.60
ISO 13488:1996
Quality systems — Medical devices — Particular requirements for the application of ISO 9002
95.99
ISO 14969:1999
Quality systems — Medical devices — Guidance on the application of ISO 13485 and ISO 13488
95.99
ISO/TR 14969:2004
Medical devices — Quality management systems — Guidance on the application of ISO 13485: 2003
95.99
ISO 14971
Medical devices — Application of risk management to medical devices
60.00
ISO 14971-1:1998
Medical devices — Risk management — Part 1: Application of risk analysis
95.99
ISO 14971:2000
Medical devices — Application of risk management to medical devices
95.99
ISO 14971:2000/Amd 1:2003
Medical devices — Application of risk management to medical devices — Amendment 1: Rationale for requirements
95.99
ISO 14971:2007
Medical devices — Application of risk management to medical devices
90.92
ISO 15223-1:2007
Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements
95.99
ISO 15223-1:2007/Amd 1:2008
Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements — Amendment 1
95.99
ISO 15223-1:2012
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
90.92
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 15223:2000
Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied
95.99
ISO 15223:2000/Amd 1:2002
Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Amendment 1
95.99
ISO 15223:2000/Amd 2:2004
Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Amendment 2
95.99
ISO/CD 15223-1
Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements
30.60
ISO/TR 15223:1998
Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied
95.99
ISO 15225:2000
Nomenclature — Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange
95.99
ISO 15225:2000/Amd 1:2004
Nomenclature — Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange — Amendment 1
95.99
ISO 15225:2010
Medical devices — Quality management — Medical device nomenclature data structure
95.99
ISO 15225:2016
Medical devices — Quality management — Medical device nomenclature data structure
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/TR 16142:1999
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
Medical devices — Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices
95.99
ISO 18250-1:2018
Medical devices — Connectors for reservoir delivery systems for healthcare applications — Part 1: General requirements and common test methods
60.60
ISO 18250-3:2018
Medical devices — Connectors for reservoir delivery systems for healthcare applications — Part 3: Enteral applications
60.60
ISO 18250-6:2019
Medical devices — Connectors for reservoir delivery systems for healthcare applications — Part 6: Neural applications
60.60
ISO 18250-7:2018
Medical devices — Connectors for reservoir delivery systems for healthcare applications — Part 7: Connectors for intravascular infusion
60.60
ISO 18250-8:2018
Medical devices — Connectors for reservoir delivery systems for healthcare applications — Part 8: Citrate-based anticoagulant solution for apheresis applications
60.60
ISO/TS 19218-1:2011
Medical devices — Hierarchical coding structure for adverse events — Part 1: Event-type codes
90.93
ISO/TS 19218-1:2011/Amd 1:2013
Medical devices — Hierarchical coding structure for adverse events — Part 1: Event-type codes — Amendment 1
60.60
ISO/TS 19218-2:2012
Medical devices — Hierarchical coding structure for adverse events — Part 2: Evaluation codes
90.93
ISO/TS 19218:2005
Medical devices — Coding structure for adverse event type and cause
95.99
ISO/TS 20225:2001
Global medical device nomenclature for the purpose of regulatory data exchange
95.99
ISO/CD TR 20416
Medical devices — Post-market surveillance for manufacturers
30.60
ISO/DIS 20417
Medical devices — Information to be provided by the manufacturer
40.60
ISO/DTR 24971
Medical devices — Guidance on the application of ISO 14971
30.60
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
IEC 62304:2006/Amd 1:2015
Medical device software — Software life cycle processes — Amendment 1
60.60
IEC 62366-1:2015
Medical devices — Part 1: Application of usability engineering to medical devices
60.60
IEC 62366-1:2015/Cor 1:2016
Medical devices — Part 1: Application of usability engineering to medical devices — Technical Corrigendum 1
60.60
IEC 62366-1:2015/DAmd 1
Medical devices — Part 1: Application of usability engineering to medical devices — Amendment 1
40.60
IEC 62366:2007
Medical devices — Application of usability engineering to medical devices
95.99
IEC 62366:2007/Amd 1:2014
Medical devices — Application of usability engineering to medical devices — Amendment 1
95.99
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
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/TR 80002-2:2017
Medical device software — Part 2: Validation of software for medical device quality systems
60.60
IEC 80369-5:2016
Small-bore connectors for liquids and gases in healthcare applications — Part 5: Connectors for limb cuff inflation applications
60.60
IEC 80369-5:2016/Cor 1:2017
Small-bore connectors for liquids and gases in healthcare applications — Part 5: Connectors for limb cuff inflation applications — Technical Corrigendum 1
60.60
ISO 80369-1:2010
Small-bore connectors for liquids and gases in healthcare applications — Part 1: General requirements
95.99
ISO 80369-1:2018
Small-bore connectors for liquids and gases in healthcare applications — Part 1: General requirements
60.60
ISO 80369-20:2015
Small-bore connectors for liquids and gases in healthcare applications — Part 20: Common test methods
60.60
ISO 80369-3:2016
Small-bore connectors for liquids and gases in healthcare applications — Part 3: Connectors for enteral applications
90.92
ISO 80369-3:2016/Amd 1:2019
Small-bore connectors for liquids and gases in healthcare applications — Part 3: Connectors for enteral applications — Amendment 1
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
90.92
ISO/DIS 80369-7
Small-bore connectors for liquids and gases in healthcare applications — Part 7: Connectors with 6 % (Luer) taper for intravascular or hypodermic applications
40.20

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