IEC 60601-1-6:2010/AMD2:2020

Amendment 2 - Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability

IEC 60601-1-9:2007/AMD2:2020

Amendment 2 - Medical electrical equipment - Part 1-9: General requirements for basic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design

IEC 60601-1-6:2010+AMD1:2013+AMD2:2020 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+AMD2:2020 CSV (Consolidated Version)

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

IEC 60601-1-10:2007+AMD1:2013+AMD2:2020 CSV (Consolidated Version)

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 60601-1-11:2015+AMD1:2020 CSV (Consolidated Version)

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 60601-1-12:2014+AMD1:2020 CSV (Consolidated Version)

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 62366-1:2015+AMD1:2020 CSV (Consolidated Version)

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

IEC 62366-1:2015/AMD1:2020

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

ISO TR 24971:2020

Medical devices - Guidance on the application of ISO 14971

ISO 14971:2019

Medical devices - Application of risk management to medical devices

IEC TR 60601-4-3:2018

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

IEC TR 60601-4-3:2018 RLV

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

IEC TR 60601-4-4:2017

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

ISO TR 80002-2:2017

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

IEC TR 60601-4-1:2017

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

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

IEC 82304-1:2016

Health software - Part 1: General requirements for product safety

IEC 62366-1:2015/COR1:2016

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

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 TR 80001-2-2