Standards catalogue

11.040.01 - Medical equipment in general

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Standard and/or project Stage TC
ISO/IEC CD Guide 63 [Under development]
Guide to the development and inclusion of aspects of safety in international standards for medical devices
30.00 ISO/TMBG
ISO 13485:1996 [Withdrawn]
Quality systems -- Medical devices -- Particular requirements for the application of ISO 9001
95.99 ISO/TC 210
ISO 13485:2003 [Withdrawn]
Medical devices -- Quality management systems -- Requirements for regulatory purposes
95.99 ISO/TC 210
95.99 ISO/TC 210
ISO 13485:2016
Medical devices -- Quality management systems -- Requirements for regulatory purposes
60.60 ISO/TC 210
ISO 13488:1996 [Withdrawn]
Quality systems -- Medical devices -- Particular requirements for the application of ISO 9002
95.99 ISO/TC 210
ISO 14969:1999 [Withdrawn]
Quality systems -- Medical devices -- Guidance on the application of ISO 13485 and ISO 13488
95.99 ISO/TC 210
ISO/TR 14969:2004 [Withdrawn]
Medical devices -- Quality management systems -- Guidance on the application of ISO 13485: 2003
95.99 ISO/TC 210
ISO 14971:2000 [Withdrawn]
Medical devices -- Application of risk management to medical devices
95.99 ISO/TC 210
ISO 14971:2000/Amd 1:2003 [Withdrawn]
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/NP 14971 [Under development]
Medical devices -- Application of risk management to medical devices
10.99 ISO/TC 210
ISO 14971-1:1998 [Withdrawn]
Medical devices -- Risk management -- Part 1: Application of risk analysis
95.99 ISO/TC 210
ISO 15223:2000 [Withdrawn]
Medical devices -- Symbols to be used with medical device labels, labelling and information to be supplied
95.99 ISO/TC 210
95.99 ISO/TC 210
95.99 ISO/TC 210
ISO/TR 15223:1998 [Withdrawn]
Medical devices -- Symbols to be used with medical device labels, labelling and information to be supplied
95.99 ISO/TC 210
ISO 15223-1:2007 [Withdrawn]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 ISO/TC 210
95.99 ISO/TC 210
ISO 15223-1:2012 [Withdrawn]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/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
60.60 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 15225:2000 [Withdrawn]
Nomenclature -- Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange
95.99 ISO/TC 210
95.99 ISO/TC 210
ISO 15225:2010 [Withdrawn]
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
95.60 ISO/TC 210
ISO 15378:2006 [Withdrawn]
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 [Withdrawn]
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 [Withdrawn]
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/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/TC 210
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/TC 210
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/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 19218:2005 [Withdrawn]
Medical devices -- Coding structure for adverse event type and cause
95.99 ISO/TC 210
ISO/TS 19218-1:2011
Medical devices -- Hierarchical coding structure for adverse events -- Part 1: Event-type codes
90.93 ISO/TC 210
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/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/CD 20069 [Under development]
Change assessment of devices intended for administration of medicinal products
30.60 ISO/TC 84
ISO/TS 20225:2001 [Withdrawn]
Global medical device nomenclature for the purpose of regulatory data exchange
95.99 ISO/TC 210
ISO/NP TR 24971 [Under development]
Medical devices -- Guidance on the application of ISO 14971
10.99 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
60.60 ISO/TC 210
IEC/CD 62304 [Under development]
Health software -- Software life cycle processes
30.60 ISO/TC 215
IEC 62366:2007 [Withdrawn]
Medical devices -- Application of usability engineering to medical devices
95.99 ISO/TC 210
95.99 ISO/TC 210
IEC 62366-1:2015
Medical devices -- Part 1: Application of usability engineering to medical devices
60.60 ISO/TC 210
60.60 ISO/TC 210
IEC 62366-1:2015/NP Amd 1 [Under development]
10.99 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
90.93 ISO/TC 215
IEC/NP 80001-1 [Under development]
Safety, effectiveness and security in the implementation and clinical use of connected medical devices or connected health software -- Part 1: Application of risk management
10.99 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
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
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
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 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
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
ISO/TR 80002-2:2017
Medical device software -- Part 2: Validation of software for medical device quality systems
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
IEC/DIS 80601-2-77 [Under development]
Medical electrical equipment -- Part 2-77: Particular requirements for the basic safety and essential performance of medical robots for surgery
40.00 ISO/TC 299
IEC/DIS 80601-2-78 [Under development]
Medical electrical equipment -- Part 2-78: Particular requirements for the basic safety and essential performance of medical robots for rehabilitation, compensation or alleviation of disease, injury or disability
40.00 ISO/TC 299

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