Standards, Guidance & Notices
Showing 1–6 of 6
IEC
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
Withdraws and replaces IEC TR 80001-2-2. Provides guidance for communication of security needs, risks and controls for health software connected to IT networks.
Published: 2025-10-01
IEC
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
Establishes a common framework for secure health software life cycle processes. Defines security activities and tasks to increase cybersecurity of health software.
Published: 2021-12-01
IEC
IEC 62366-1:2015+AMD1:2020
Medical devices — Part 1: Application of usability engineering to medical devices
Specifies a process for a manufacturer to analyse, specify, develop and evaluate the usability of a medical device as it relates to safety.
Published: 2020-06-01
IEC
IEC 82304-1:2016
Health software — Part 1: General requirements for product safety
Applies to health software intended to be operated on general-purpose computing platforms. Covers product safety requirements for the complete life cycle.
Published: 2016-10-01
IEC
IEC 62304:2006+AMD1:2015
Medical device software — Software life cycle processes
Defines life cycle requirements for software in medical devices and in vitro diagnostic medical devices. Applies to development and maintenance of medical device software.
Published: 2015-06-01
IEC
IEC/TR 80002-1:2009
Medical device software — Part 1: Guidance on the application of ISO 14971 to medical device software
Provides guidance on the application of ISO 14971 to medical device software, addressing software-specific aspects of risk management.
Published: 2009-08-01