SC 62A

Safe, effective, and secure health software and health IT systems - Assurance cases
Application guidance — Guidance for the use of assurance cases – safety & security

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

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

IEC 62304 Ed. 2: Health software - Software life cycle processes

Refurbishment of medical electrical equipment, medical electrical systems and sub-assemblies and reuse of components as part of the extended life-cycle

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

Health Software and health IT systems safety, effectiveness and security – Part 5-1: Security - Activities in the product lifecycle

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

Health software - Part 2: Health and wellness apps - Quality criteria across the life cycle - Code of practice