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Standard and/or project Stage TC
ISO/IEC Guide 63:2019
Guide to the development and inclusion of aspects of safety in International Standards for medical devices
60.60 ISO/TMBG
ISO 13485:1996
Quality systems — Medical devices — Particular requirements for the application of ISO 9001
95.99 ISO/TC 210
ISO 13485:2003
Medical devices — Quality management systems — Requirements for regulatory purposes
95.99 ISO/TC 210
ISO 13485:2003/Cor 1:2009
Medical devices — Quality management systems — Requirements for regulatory purposes — Technical Corrigendum 1
95.99 ISO/TC 210
ISO 13485:2016
Medical devices — Quality management systems — Requirements for regulatory purposes
90.60 ISO/TC 210
ISO 13488:1996
Quality systems — Medical devices — Particular requirements for the application of ISO 9002
95.99 ISO/TC 210
ISO 14969:1999
Quality systems — Medical devices — Guidance on the application of ISO 13485 and ISO 13488
95.99 ISO/TC 210
ISO/TR 14969:2004
Medical devices — Quality management systems — Guidance on the application of ISO 13485: 2003
95.99 ISO/TC 210
ISO 14971
Medical devices — Application of risk management to medical devices
60.00 ISO/TC 210
ISO 14971-1:1998
Medical devices — Risk management — Part 1: Application of risk analysis
95.99 ISO/TC 210
ISO 14971:2000
Medical devices — Application of risk management to medical devices
95.99 ISO/TC 210
ISO 14971:2000/Amd 1:2003
Medical devices — Application of risk management to medical devices — Amendment 1: Rationale for requirements
95.99 ISO/TC 210
ISO 14971:2007
Medical devices — Application of risk management to medical devices
90.92 ISO/TC 210
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/TC 210
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/TC 210
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/TC 210
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/TC 210
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/TC 210
ISO 15223:2000
Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied
95.99 ISO/TC 210
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/TC 210
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/TC 210
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/TC 210
ISO/TR 15223:1998
Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied
95.99 ISO/TC 210
ISO 15225:2000
Nomenclature — Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange
95.99 ISO/TC 210
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/TC 210
ISO 15225:2010
Medical devices — Quality management — Medical device nomenclature data structure
95.99 ISO/TC 210
ISO 15225:2016
Medical devices — Quality management — Medical device nomenclature data structure
95.99 ISO/TC 210
ISO 15378:2006
Primary packaging materials for medicinal products — Particular requirements for the application of ISO 9001:2000, with reference to Good Manufacturing Practice (GMP)
95.99 ISO/TC 76
ISO 15378:2011
Primary packaging materials for medicinal products — Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP)
95.99 ISO/TC 76
ISO 15378:2015
Primary packaging materials for medicinal products — Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP)
95.99 ISO/TC 76
ISO 15378:2017
Primary packaging materials for medicinal products — Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP)
60.60 ISO/TC 76
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/TC 210
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/TC 210
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/TC 210
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/TC 210
ISO/PAS 18761:2013
Use and handling of medical devices covered by the scope of ISO/TC 84 — Risk assessment on mucocutaneous blood exposure
90.93 ISO/TC 84
ISO/TS 19218-1:2011
Medical devices — Hierarchical coding structure for adverse events — Part 1: Event-type codes
90.93 ISO/TC 210
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/TC 210
ISO/TS 19218-2:2012
Medical devices — Hierarchical coding structure for adverse events — Part 2: Evaluation codes
90.93 ISO/TC 210
ISO/TS 19218:2005
Medical devices — Coding structure for adverse event type and cause
95.99 ISO/TC 210
ISO/TR 19244:2014
Guidance on transition periods for standards developed by ISO/TC 84 — Devices for administration of medicinal products and catheters
60.60 ISO/TC 84
ISO 20069:2019
Guidance for assessment and evaluation of changes to drug delivery systems
60.60 ISO/TC 84
ISO/TS 20225:2001
Global medical device nomenclature for the purpose of regulatory data exchange
95.99 ISO/TC 210
ISO/CD TR 20416
Medical devices — Post-market surveillance for manufacturers
30.60 ISO/TC 210
ISO/DIS 20417
Medical devices — Information to be provided by the manufacturer
40.60 ISO/TC 210
ISO/DTR 24971
Medical devices — Guidance on the application of ISO 14971
30.60 ISO/TC 210
ISO/TR 24971:2013
Medical devices — Guidance on the application of ISO 14971
90.92 ISO/TC 210
IEC 62304:2006
Medical device software — Software life cycle processes
90.92 ISO/TC 210
IEC 62304:2006/Amd 1:2015
Medical device software — Software life cycle processes — Amendment 1
60.60 ISO/TC 210
IEC/DIS 62304.2
Health software — Software life cycle processes
40.20 ISO/TC 215
IEC 62366-1:2015
Medical devices — Part 1: Application of usability engineering to medical devices
60.60 ISO/TC 210
IEC 62366-1:2015/Cor 1:2016
Medical devices — Part 1: Application of usability engineering to medical devices — Technical Corrigendum 1
60.60 ISO/TC 210
IEC 62366-1:2015/DAmd 1
Medical devices — Part 1: Application of usability engineering to medical devices — Amendment 1
40.60 ISO/TC 210
IEC 62366:2007
Medical devices — Application of usability engineering to medical devices
95.99 ISO/TC 210
IEC 62366:2007/Amd 1:2014
Medical devices — Application of usability engineering to medical devices — Amendment 1
95.99 ISO/TC 210
IEC/TR 62366-2:2016
Medical devices — Part 2: Guidance on the application of usability engineering to medical devices
60.60 ISO/TC 210
IEC 80001-1:2010
Application of risk management for IT-networks incorporating medical devices — Part 1: Roles, responsibilities and activities
90.92 ISO/TC 215
IEC/DIS 80001-1
Application of risk management for IT-networks incorporating medical devices — Part 1: Roles, responsibilities and activities
40.00 ISO/TC 215
IEC/TR 80001-2-1:2012
Application of risk management for IT-networks incorporating medical devices — Part 2-1: Step by Step Risk Management of Medical IT-Networks; Practical Applications and Examples
60.60 ISO/TC 215
IEC/TR 80001-2-2:2012
Application of risk management for IT-networks incorporating medical devices — Part 2-2: Guidance for the communication of medical device security needs, risks and controls
60.60 ISO/TC 215
IEC/TR 80001-2-3:2012
Application of risk management for IT-networks incorporating medical devices — Part 2-3: Guidance for wireless networks
60.60 ISO/TC 215
IEC/TR 80001-2-4:2012
Application of risk management for IT-networks incorporating medical devices — Part 2-4: General implementation guidance for Healthcare Delivery Organizations
60.60 ISO/TC 215
IEC/TR 80001-2-5:2014
Application of risk management for IT-networks incorporating medical devices — Part 2-5: Application guidance — Guidance for distributed alarm systems
60.60 ISO/TC 215
IEC/TR 80001-2-8:2016
Application of risk management for IT-networks incorporating medical devices — Part 2-8: Application guidance — Guidance on standards for establishing the security capabilities identified in IEC 80001-2-2
60.60 ISO/TC 215
IEC/TR 80001-2-9:2017
Application of risk management for IT-networks incorporating medical devices — Part 2-9: Application guidance — Guidance for use of security assurance cases to demonstrate confidence in IEC/TR 80001-2-2 security capabilities
60.60 ISO/TC 215
ISO/TR 80001-2-6:2014
Application of risk management for IT-networks incorporating medical devices — Part 2-6: Application guidance — Guidance for responsibility agreements
60.60 ISO/TC 215
ISO/TR 80001-2-7:2015
Application of risk management for IT-networks incorporating medical devices — Application guidance — Part 2-7: Guidance for healthcare delivery organizations (HDOs) on how to self-assess their conformance with IEC 80001-1
60.60 ISO/TC 215
IEC/TR 80002-1:2009
Medical device software — Part 1: Guidance on the application of ISO 14971 to medical device software
60.60 ISO/TC 210
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/TC 210
ISO/TR 80002-2:2017
Medical device software — Part 2: Validation of software for medical device quality systems
60.60 ISO/TC 210
IEC 80601-2-77:2019
Medical electrical equipment — Part 2-77: Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment
60.60 ISO/TC 299
IEC 80601-2-78:2019
Medical electrical equipment — Part 2-78: Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation
60.60 ISO/TC 299

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