IEC 62304:2006+AMD1:2015 CSV (Consolidated Version)

Medical device software - Software life cycle processes

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

IEC 62366-1:2015

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

IEC 60601-1-11:2015

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

IEC 60601-1-11:2015 RLV

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

IEC TR 80001-2-5:2014

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

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

IEC TR 62354:2014

General testing procedures for medical electrical equipment

IEC 62353:2014

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

IEC 60601-1:2005/AMD1:2012/COR1:2014

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

IEC 60601-1-12:2014

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

IEC TR 80002-3:2014

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

IEC 60601-1-2:2014

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

ISO TR 17791:2013

Health informatics -- Guidance on standards for enabling safety in health software

IEC 60601-1-10:2007+AMD1:2013 CSV (Consolidated Version)

Medical electrical equipment - Part 1-10: General requirements forbasic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loopcontrollers

IEC 60601-1-10:2007/AMD1:2013

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

IEC 60601-1-6:2010/AMD1:2013

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

IEC 60601-1-6:2010+AMD1:2013 CSV (Consolidated Version)

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

IEC 60601-1-9:2007+AMD1:2013 CSV (Consolidated Version)

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

IEC 60601-1-9:2007/AMD1:2013

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