International Standards and Conformity Assessment for all electrical, electronic and related technologies

SC 62A

Common aspects of electrical equipment used in medical practice

 
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SC 62A Project files (127)

Project

Reference

Current

Stage

Language

Frcst

Date

CLC

Document

Reference

Downloads
PNW 62A-130-8 Ed. 1.0

20 graphical symbols for general use

DEL
  • DEL
  • Deleted items
E 62A(NL)53
PNW 62A-130-9 Ed. 1.0

22 graphical symbols f0r use on medical equipment

DEL
  • DEL
  • Deleted items
E 62A(NL)54
PNW 62A-130-10 Ed. 1.0

14 graphical symbols indicating movement for use on medical equipment

DEL
  • DEL
  • Deleted items
E 62A(NL)55
PNW 62A-218 Ed. 1.0

Medical devices - Risk management - Application of risk management to medical devices

DEL
  • DEL
  • Deleted items
E 62A/218
PNW 62A-287 Ed. 1.0

Medical electrical equipment - x. Collateral Standard: Safety requirements for networked medical systems

DEL
  • DEL
  • Deleted items
E 62A/287
PNW 62A-580 Ed. 1.0

Medical devices and medical systems - Basic safety and essential performance of the patient-centric integrated clinicaenvironment (ICE) Part 1: General requirements for network controls

DEL
  • DEL
  • Deleted items
E 62A/580
PNW 62A-672 Ed. 1.0

Medical electrical equipment - Electromagnetic compatibility and safety with regard to electromagnetic disturbances - Requirements and tests

DEL
  • DEL
  • Deleted items
E 62A/672
IEC 60417 f46 Ed. 1.0

Amendment to IEC 417 and revision (or new edition) of IEC 60878

DEL
  • DEL
  • Deleted items
E
IEC 60417 f47 Ed. 1.0

Amendment to IEC 60417 and revision (or new edition) of IEC 60878

DEL
  • DEL
  • Deleted items
E
IEC 60417 f48 Ed. 1.0

Amendment to IEC 60417 and revision (or new edition) of IEC 60878

DEL
  • DEL
  • Deleted items
E
IEC/TR 60513 Ed. 2.0

Fundamental aspects of safety standards for medical electrical equipment

PPUB
  • PPUB
  • Publication issued
B Webstore
IEC/TR 60513 Ed. 3.0

Fundamental aspects of safety standards for medical electrical equipment

AMW
  • AMW
  • Approved Maintenance Work
E 2017-01 no 62A/983
IEC/TR 60513 f1 Ed. 3.0

Standardization of medical electrical equipment safety

MERGED
  • MERGED
  • Merged project
E 2011-01 no
IEC 60601-1 Ed. 1.0

Medical electrical equipment. Part 1: General requirements

DELPUB
  • DELPUB
  • Deleted Publication
B
IEC 60601-1 Ed. 2.0

Medical electrical equipment - Part 1: General requirements for safety

DELPUB
  • DELPUB
  • Deleted Publication
B
IEC 60601-1 Ed. 3.0

Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

PPUB
  • PPUB
  • Publication issued
B yes Webstore
IEC 60601-1 f1 Ed. 3.0

Third edition of IEC 601-1 - Additional Clauses to Clauses 2, 37, 41.5 and 43

MERGED
  • MERGED
  • Merged project
E 62A(DE)77
IEC 60601-1 f11 Ed. 3.0

Medical electrical equipment - Part 1: General requirements for safety and essential performance

MERGED
  • MERGED
  • Merged project
E yes
IEC 60601-1 f2 Ed. 3.0

Exception to the requirement regarding failure of components - Sub-clause 52.5.9 -Failure of components- of IEC 601-1

DEL
  • DEL
  • Deleted items
E 62A(SE)48
IEC 60601-1 f3 Ed. 3.0

Amendment to IEC 601-1 to clarify Clause 19 regarding leakage currents

MERGED
  • MERGED
  • Merged project
E 62A(IT)28
IEC 60601-1 fC1 Ed. 3.0

Corrigendum 1 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

PPUB
  • PPUB
  • Publication issued
B Webstore
IEC 60601-1 fC2 Ed. 3.0

Corrigendum 2 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

PPUB
  • PPUB
  • Publication issued
B Webstore
IEC 60601-1 fI1 Ed. 3.0

Interpretation sheet 1 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

PPUB
  • PPUB
  • Publication issued
B 2008-05 Webstore
IEC 60601-1 fI2 Ed. 3.0

Interpretation sheet 2 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

PPUB
  • PPUB
  • Publication issued
B 2009-02 Webstore
IEC 60601-1 fI3 Ed. 3.0

Interpretation sheet 3 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

PPUB
  • PPUB
  • Publication issued
B 2013-05 Webstore
DELPUB
  • DELPUB
  • Deleted Publication
B 62A(C.O.)36
IEC 60601-1 am1 Ed. 3.0

Amendment 1 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

PPUB
  • PPUB
  • Publication issued
B 2012-08 yes Webstore
IEC 60601-1 am1 fC1 Ed. 3.0

Corrigendum 1 - Amendment 1 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

PPUB
  • PPUB
  • Publication issued
B Webstore
DELPUB
  • DELPUB
  • Deleted Publication
B yes
IEC 60601-1-1 Ed. 1.0

Medical electrical equipment - Part 1: General requirements for safety - Section 1: Collateral standard: Safety requirements for medical electrical systems

DELPUB
  • DELPUB
  • Deleted Publication
B 62A(C.O.)38
IEC 60601-1-1 Ed. 2.0

Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems

WPUB
  • WPUB
  • Publication withdrawn
B 1999-10 yes
DELPUB
  • DELPUB
  • Deleted Publication
B yes
IEC 60601-1-2 Ed. 1.0

Medical electrical equipment - Part 1: General requirements for safety - 2. Collateral Standard: Electromagnetic compatibility - Requirements and tests

DELPUB
  • DELPUB
  • Deleted Publication
B
IEC 60601-1-2 Ed. 2.0

Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests

DELPUB
  • DELPUB
  • Deleted Publication
B yes
IEC 60601-1-2 Ed. 2.1

Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests

DELPUB
  • DELPUB
  • Deleted Publication
B
IEC 60601-1-2 Ed. 3.0

Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests

DELPUB
  • DELPUB
  • Deleted Publication
B 2007-03 yes
IEC 60601-1-2 Ed. 4.0

Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests

PPUB
  • PPUB
  • Publication issued
B 2014-03 yes Webstore
IEC 60601-1-2 fF Ed. 2.0

Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests

MERGED
  • MERGED
  • Merged project
B
IEC 60601-1-2 fF Ed. 2.1

Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests

MERGED
  • MERGED
  • Merged project
B
IEC 60601-1-2 fI1 Ed. 3.0

Interpretation sheet 1 - Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests

DELPUB
  • DELPUB
  • Deleted Publication
B 2010-03 62A/685
IEC 60601-1-2 am1 Ed. 2.0

Amendment 1 - Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests

DELPUB
  • DELPUB
  • Deleted Publication
B yes
IEC 60601-1-2 am1 fF Ed. 2.0

Amendment 1 - Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests

MERGED
  • MERGED
  • Merged project
B
IEC 60601-1-6 Ed. 1.0

Medical electrical equipment - Part 1-6: General requirements for safety - Collateral standard: Usability

DELPUB
  • DELPUB
  • Deleted Publication
B yes
IEC 60601-1-6 Ed. 2.0

Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability

DELPUB
  • DELPUB
  • Deleted Publication
B 2006-12 yes
IEC 60601-1-6 Ed. 3.0

Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability

PPUB
  • PPUB
  • Publication issued
B 2010-02 yes Webstore
IEC 60601-1-6 am1 Ed. 3.0

Amendment 1 - Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability

PPUB
  • PPUB
  • Publication issued
B 2013-10 yes Webstore
IEC 60601-1-8 Ed. 1.0

Medical electrical equipment - Part 1-8: General requirements for safety - Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems

DELPUB
  • DELPUB
  • Deleted Publication
B yes
IEC 60601-1-8 Ed. 2.0

Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems

PPUB
  • PPUB
  • Publication issued
B 2007-03 yes Webstore
IEC 60601-1-8 fF Ed. 1.0

Medical electrical equipment - Part 1-8: General requirements for safety - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems

MERGED
  • MERGED
  • Merged project
B
IEC 60601-1-8 am1 Ed. 1.0

Amendment 1 - Medical electrical equipment - Part 1-8: General requirements for safety - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems

DELPUB
  • DELPUB
  • Deleted Publication
B 2006-03 yes
IEC 60601-1-8 am1 Ed. 2.0

Amendment 1 - Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems

PPUB
  • PPUB
  • Publication issued
B 2012-11 yes Webstore
IEC 60601-1-9 Ed. 1.0

Medical electrical equipment - Part 1-9: General requirements for basic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design

PPUB
  • PPUB
  • Publication issued
B 2007-08 yes Webstore
IEC 60601-1-9 am1 Ed. 1.0

Amendment 1 - Medical electrical equipment - Part 1-9: General requirements for basic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design

PPUB
  • PPUB
  • Publication issued
B 2013-06 yes Webstore
IEC 60601-1-10 Ed. 1.0

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

PPUB
  • PPUB
  • Publication issued
B 2007-12 yes Webstore
IEC 60601-1-10 am1 Ed. 1.0

Amendment 1 - 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

PPUB
  • PPUB
  • Publication issued
B 2013-10 yes Webstore
IEC 60601-1-11 Ed. 1.0

Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment

DELPUB
  • DELPUB
  • Deleted Publication
B 2010-04 yes
IEC 60601-1-11 Ed. 2.0

Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment

PPUB
  • PPUB
  • Publication issued
B 2015-01 yes Webstore
IEC 60601-1-11 fC1 Ed. 1.0

Corrigendum 1 - Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment

DELPUB
  • DELPUB
  • Deleted Publication
B
IEC 60601-1-12 Ed. 1.0

Medical electrical equipment - Part 1-12: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment

PPUB
  • PPUB
  • Publication issued
B 2014-07 yes Webstore
IEC/TR 60601-4-1 Ed. 1.0

Medical electrical equipment - Part 4-1: Guidance and interpretation - Medical electrical equipment and medical electrical systems employing a degree of autonomy

APUB
  • APUB
  • Draft approved for publication
E 2017-07 no
IEC/TR 60601-4-2 Ed. 1.0

Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems

PPUB
  • PPUB
  • Publication issued
E 2016-06 no Webstore
IEC/TR 60601-4-3 Ed. 1.0

Medical electrical equipment - Part 4-3: Guidance and interpretation - Considerations of unaddressed safety aspects in the third edition of IEC 60601-1 and proposals for new requirements

PPUB
  • PPUB
  • Publication issued
E 2015-04 no Webstore
IEC/TR 60601-4-4 Ed. 1.0

Medical electrical equipment - Part 4-4: Guidance and interpretation - Guidance for writers of particular standards - Creating alarm system-related requirements

ACDV
  • ACDV
  • Draft approved for Committee Draft with Vote
E 2017-07 no 62A/1090
IEC 60788 Ed. 1.0

Medical radiology - Terminology

DELPUB
  • DELPUB
  • Deleted Publication
B
DEL 60878 f6 Ed. 2.0

Elements on graphical symbols in medical radiology

DEL
  • DEL
  • Deleted items
E 62A(Sec.)119
DEL 60878 f9 Ed. 2.0

Specific symbols for NMR - Specific symbols for ultrasonic diagnostic equipment - Specific symbols for cardiac pacemaker and for monitoring equipment

DEL
  • DEL
  • Deleted items
B
IEC/TR 60878 Ed. 1.0

Graphical symbols for electrical equipment in medical practice

DELPUB
  • DELPUB
  • Deleted Publication
B
IEC/TR 60878 Ed. 2.0

Graphical symbols for electrical equipment in medical practice

DELPUB
  • DELPUB
  • Deleted Publication
B 2004-05 no
IEC/TR 60878 Ed. 3.0

Graphical symbols for electrical equipment in medical practice

PPUB
  • PPUB
  • Publication issued
B 2015-09 no Webstore
DEL 60878 am1 f1 Ed. 2.0

8 graphical symbols for data processing on medical equipment

DEL
  • DEL
  • Deleted items
E 62A/213
DEL 60878 am1 f2 Ed. 2.0

12 graphical symbols for radiologic equipment

DEL
  • DEL
  • Deleted items
E 62A/214
DEL 60878 am1 f3 Ed. 2.0

14 graphical symbols for medical monitoring equipment

DEL
  • DEL
  • Deleted items
E 62A/215
IEC 60878 am1 f1 Ed. 1.0

Graphical symbols for use on medical equipment - Part 2: Nuclear medicine

MERGED
  • MERGED
  • Merged project
B yes
IEC 60878 am1 f2 Ed. 1.0

Graphical symbols for use on medical equipment - Part 3: Radiological equipment

MERGED
  • MERGED
  • Merged project
B yes
IEC 60878 am1 f3 Ed. 1.0

Graphical symbols for use on medical equipment - Part 1: General

MERGED
  • MERGED
  • Merged project
B yes
IEC/TR 60878 am1 f2 Ed. 1.0

VOTING FORM to Graphical symbol: Multi-pulse (60417-IEC-5842 Pr)

MERGED
  • MERGED
  • Merged project
E 62A/299
IEC/TR 60878 am1 f3 Ed. 1.0

VOTING FORM to Graphical symbol: Target position (60417-IEC-5843 Pr)

MERGED
  • MERGED
  • Merged project
E 62A/300
IEC/TR 60878 am1 f4 Ed. 1.0

VOTING FORM to Graphical symbol: Body temperature (60417-IEC-5844 Pr)

MERGED
  • MERGED
  • Merged project
E 62A/301
IEC/TR 60878 am1 f5 Ed. 1.0

VOTING FORM to Graphical symbol: Inner diameter (60417-IEC-5845 Pr)

MERGED
  • MERGED
  • Merged project
E 62A/302
IEC/TR 60878 am1 f6 Ed. 1.0

VOTING FORM to Graphical symbol: Outer diameter (60417-IEC-5846 Pr)

MERGED
  • MERGED
  • Merged project
E 62A/303
IEC/TR 60878 am1 f7 Ed. 1.0

VOTING FORM to Graphical symbol: Trend (60417-IEC-5847 Pr)

MERGED
  • MERGED
  • Merged project
E 62A/304
IEC/TR 60930 Ed. 1.0

Guidelines for administrative, medical, and nursing staff concerned with the safe use of medical electrical equipment

DELPUB
  • DELPUB
  • Deleted Publication
B
IEC/TR 60930 Ed. 2.0

Guidelines for administrative, medical and nursing staff concerned with the safe use of medical electrical equipment and medical electrical systems

PPUB
  • PPUB
  • Publication issued
E 2008-09 no Webstore
IEC/TR 60930 f1 Ed. 2.0

Systematic review of IEC 930 (1988)

DEL
  • DEL
  • Deleted items
B
IEC/TR 61258 Ed. 1.0

Guidelines for the development and use of medical electrical equipment educational materials

DELPUB
  • DELPUB
  • Deleted Publication
B 62A(Sec.)102
IEC/TR 61258 Ed. 2.0

Guidelines for the development and use of medical electrical equipment educational materials

PPUB
  • PPUB
  • Publication issued
E 2008-09 no Webstore
IEC 61961 Ed. 1.0

Safe technology management of electrical equipment for medical use within health care

DEL
  • DEL
  • Deleted items
E 62A/198
IEC/TR 62296 Ed. 1.0

Considerations of unaddressed safety aspects in the Second Edition of IEC 60601-1 and proposals for new requirements

DELPUB
  • DELPUB
  • Deleted Publication
E 2003-10 no
IEC/TR 62296 Ed. 2.0

Considerations of unaddressed safety aspects in the second edition of IEC 60601-1 and proposals for new requirements

PPUB
  • PPUB
  • Publication issued
E 2009-01 no Webstore
IEC 62304 Ed. 1.0

Medical device software - Software life cycle processes

PPUB
  • PPUB
  • Publication issued
B 2006-06 yes Webstore
IEC 62304 Ed. 2.0

Review report of IEC 62304 Ed. 2: Health software - Software life cycle processes

CDM
  • CDM
  • Committee Draft to be discussed at Meeting
E 2019-12 yes
IEC 62304 f1 Ed. 2.0

Medical device software - Software life cycle processes

MERGED
  • MERGED
  • Merged project
E 2014-01 yes
IEC 62304 am1 Ed. 1.0

Amendment 1 - Medical device software - Software life cycle processes

PPUB
  • PPUB
  • Publication issued
E 2015-06 yes Webstore
IEC/TR 62348 Ed. 1.0

Mapping between the clauses of the third edition of IEC 60601-1 and the 1988 edition as amended

DELPUB
  • DELPUB
  • Deleted Publication
B 2006-07 no
IEC/TR 62348 Ed. 2.0

Assessment of the impact of the most significant changes in Amendment 1 to IEC 60601-1:2005 and mapping of the clauses of IEC 60601-1:2005 to the previous edition

PPUB
  • PPUB
  • Publication issued
E 2013-01 no Webstore
IEC 62353 Ed. 1.0

Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment

DELPUB
  • DELPUB
  • Deleted Publication
B 2007-05 yes
IEC 62353 Ed. 2.0

Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment

PPUB
  • PPUB
  • Publication issued
B 2014-09 yes Webstore
IEC/TR 62354 Ed. 1.0

General testing procedures for medical electrical equipment

DELPUB
  • DELPUB
  • Deleted Publication
B 2006-02 no
IEC/TR 62354 Ed. 2.0

General testing procedures for medical electrical equipment

DELPUB
  • DELPUB
  • Deleted Publication
E 2009-10 no
IEC/TR 62354 Ed. 3.0

General testing procedures for medical electrical equipment

PPUB
  • PPUB
  • Publication issued
E 2014-10 no Webstore
IEC 62366 Ed. 1.0

Medical devices - Application of usability engineering to medical devices

DELPUB
  • DELPUB
  • Deleted Publication
B 2007-10 yes
IEC 62366 am1 Ed. 1.0

Amendment 1 - Medical devices - Application of usability engineering to medical devices

DELPUB
  • DELPUB
  • Deleted Publication
B 2013-11 yes
IEC 62366-1 Ed. 1.0

Medical devices - Part 1: Application of usability engineering to medical devices

PPUB
  • PPUB
  • Publication issued
B 2015-03 yes Webstore
IEC 62366-1 fC1 Ed. 1.0

Corrigendum 1 - Medical devices - Part 1: Application of usability engineering to medical devices

PPUB
  • PPUB
  • Publication issued
B Webstore
IEC/TR 62366-2 Ed. 1.0

Medical devices - Part 2: Guidance on the application of usability engineering to medical devices

PPUB
  • PPUB
  • Publication issued
E 2016-05 no Webstore
IEC 80001-1 Ed. 1.0

Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities

PPUB
  • PPUB
  • Publication issued
B 2010-10 yes Webstore
IEC 80001-1 Ed. 2.0

Safety, effectiveness and security in the implementation and use of connected medical devices or connected health software - Part 1: Application of risk management

AMW
  • AMW
  • Approved Maintenance Work
E 2020-01 yes 62A/1139
IEC/TR 80001-2-1 Ed. 1.0

Application of risk management for IT-networks incorporating medical devices - Part 2-1: Step by step risk management of medical IT-networks - Pratical applications and examples

PPUB
  • PPUB
  • Publication issued
E 2012-07 no Webstore
IEC/TR 80001-2-2 Ed. 1.0

Application of risk management for IT-networks incorporating medical devices - Part 2-2: Guidance for the disclosure and communication of medical device security needs, risks and controls

PPUB
  • PPUB
  • Publication issued
E 2012-07 no Webstore
IEC/TR 80001-2-3 Ed. 1.0

Application of risk management for IT-networks incorporating medical devices - Part 2-3: Guidance for wireless networks

PPUB
  • PPUB
  • Publication issued
E 2012-07 no Webstore
IEC/TR 80001-2-4 Ed. 1.0

Application of risk management for IT-networks incorporating medical devices - Part 2-4: Application guidance - General implementation guidance for healthcare delivery organizations

PPUB
  • PPUB
  • Publication issued
E 2012-12 Webstore
IEC/TR 80001-2-5 Ed. 1.0

Application of risk management for IT-networks incorporating medical devices - Part 2-5: Application guidance - Guidance on distributed alarm systems

PPUB
  • PPUB
  • Publication issued
E 2014-12 no Webstore
IEC/TR 80001-2-8 Ed. 1.0

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 TR 80001-2-2

PPUB
  • PPUB
  • Publication issued
E 2016-06 no Webstore
IEC/TR 80001-2-9 Ed. 1.0

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

APUB
  • APUB
  • Draft approved for publication
E 2017-07 no
IEC/TR 80002-1 Ed. 1.0

Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software

PPUB
  • PPUB
  • Publication issued
E 2009-10 no Webstore
IEC/TR 80002-3 Ed. 1.0

Medical device software - Part 3: Process reference model of medical device software life cycle processes (IEC 62304)

PPUB
  • PPUB
  • Publication issued
E 2014-06 no Webstore
IEC 82304-1 Ed. 1.0

Health Software - Part 1: General requirements for product safety

CDIS
  • CDIS
  • Draft circulated as FDIS
B 2016-12 yes
ISO 14971 Ed. 1.0

ISO/DIS 14971: Medical devices - Risk management - Application of risk management to medical devices

PPUB
  • PPUB
  • Publication issued
B yes
ISO 14971 Ed. 2.0

Medical devices - Application of risk management to medical devices

PPUB
  • PPUB
  • Publication issued
B 2007-04 no
ISO 14971 am1 Ed. 1.0

ISO 14971 Am. 1 Ed. 1: Medical devices - Application of risk management to medical devices

PPUB
  • PPUB
  • Publication issued
E no
ISO/TR 17791 Ed. 1.0

Health informatics - Guidance on Standards for Enabling Safety in Health Software

PPUB
  • PPUB
  • Publication issued
E 2014-02 no Webstore
ISO/TR 24971 Ed. 1.0

Guidance on the application of ISO 14971

PPUB
  • PPUB
  • Publication issued
E 2013-06 no Webstore
ISO/TR 80001-2-6 Ed. 1.0

Application of risk management for IT-networks incorporating medical devices - Part 2-6: Guidance for responsibility agreements

PPUB
  • PPUB
  • Publication issued
E 2014-03 no Webstore
ISO/TR 80001-2-7 Ed. 1.0

Application of risk management for IT-networks incorporating medical devices - Part 2-7: Application Guidance - Guidance for Healthcare Delivery Organizations (HDOs) on how to self-assess their conformance with IEC 80001-1

PPUB
  • PPUB
  • Publication issued
E 2015-03 no Webstore
ISO/TR 80002-2 Ed. 1.0

Medical device software - Part 2: Validation of software for medical device quality systems

APUB
  • APUB
  • Draft approved for publication
E 2017-07 no
ISO 81001-1 Ed. 1.0

Health software and health IT systems safety, effectiveness and security - Foundational principles, concepts and terms

ANW
  • ANW
  • Approved New Work
E 2020-12 62A/1096