IEC TS 81001-2-2:2025

Health software and health IT systems safety, effectiveness and security - Part 2-2: Coordination - Guidance for the implementation, disclosure and communication of security needs, risks and controls

IEC 60601-1:2024 SER

Medical electrical equipment - ALL PARTS

IEC 61847:2025

Ultrasonics - Surgical systems - Measurement and declaration of the basic output characteristics

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 80601-2-78:2019/AMD1:2024

Amendment 1 - Medical electrical equipment - Part 2-78: Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation

IEC 80601-2-78:2019+AMD1:2024 CSV (Consolidated Version)

Medical electrical equipment - Part 2-78: Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation

IEC 80601-2-26:2019/AMD1:2024

Amendment 1 - Medical electrical equipment - Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs

IEC 80601-2-26:2019+AMD1:2024 CSV (Consolidated Version)

Medical electrical equipment - Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs

IEC 60601-2-35:2020/AMD1:2023

Amendment 1 - Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads or mattresses and intended for heating in medical use

IEC 60601-2-35:2020+AMD1:2023 CSV (Consolidated Version)

Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads or mattresses and intended for heating in medical use

IEC 80601-2-77:2019/AMD1:2023

Amendment 1 - Medical electrical equipment - Part 2-77: Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment

IEC 80601-2-77:2019+AMD1:2023 CSV (Consolidated Version)

Medical electrical equipment - Part 2-77: Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment

IEC 60601-2-75:2017/AMD1:2023

Amendment 1 - Medical electrical equipment - Part 2-75: Particular requirements for the basic safety and essential performance of photodynamic therapy and photodynamic diagnosis equipment

IEC 60601-2-75:2017+AMD1:2023 CSV (Consolidated Version)

Medical electrical equipment - Part 2-75: Particular requirements for the basic safety and essential performance of photodynamic therapy and photodynamic diagnosis equipment

IEC 60601-1:2005/COR3:2022

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

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 80601-2-26:2019/COR1:2021

Corrigendum 1 - Medical electrical equipment - Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs

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

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