IEC 60601-1:2021 SER

Medical electrical equipment - ALL PARTS

IEC 81001-5-1:2021

Health software and health IT systems safety, effectiveness and security - Part 5-1: Security - Activities in the product life cycle

IEC 80001-1:2021

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

ISO TS 82304-2:2021

Health software - Part 2: Health and wellness apps - Quality and reliability

ISO 81001-1:2021

Health software and health IT systems safety, effectiveness and security - Part 1: Principles and concepts

IEC 60601-1:2005/AMD1:2012/ISH1:2021

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

IEC TR 60601-4-5:2021

Medical electrical equipment - Part 4-5: Guidance and interpretation - Safety-related technical security specifications

IEC 60601-1-2:2014+AMD1:2020 CSV (Consolidated Version)

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

IEC 60601-1-2:2014/AMD1:2020

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

IEC 60601-1:2005/AMD2:2020

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

IEC 60601-1:2005+AMD1:2012+AMD2:2020 CSV (Consolidated Version)

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

IEC 60601-1-8:2006/AMD2:2020

Amendment 2 - 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

IEC 60601-1-8:2006+AMD1:2012+AMD2:2020 CSV (Consolidated Version)

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

IEC 60601-1-10:2007/AMD2:2020

Amendment 2 - 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

Amendment 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

IEC 60601-1-12:2014/AMD1:2020

Amendment 1 - 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 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