ISO TS 81001-2-1:2025

Health software and health IT systems safety, effectiveness and security - Part 2-1: Coordination - Guidance for the use of assurance cases for safety and security

IEC TS 60601-4-6:2024

Medical electrical equipment - Part 4-6: Guidance and interpretation - Voluntary guidance to help achieve basic safety and essential performance with regard to the possible effects of electromagnetic disturbances

IEC TS 60601-4-2:2024

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

IEC 60601-1:2024 SER

Medical electrical equipment - ALL PARTS

IEC TR 60878:2022/COR1:2023

Corrigendum 1 - Graphical symbols for electrical equipment in medical practice

IEC 60601-1:2005/COR3:2022

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

IEC TR 60878:2022

Graphical symbols for electrical equipment in medical practice

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