Category
Standard
Organisation
ID
IEC 81001-5-1:2021
Type
Standard
Version
1
Access
Fees apply to access
Status
Active
Created
Dec-21
This document defines the life cycle requirements for development and maintenance of health software needed to support conformance to IEC 62443-4-1, which concerns security for industrial automation and control systems.
The set of processes, activities and tasks described in this document establishes a common framework for secure health software life cycle processes and end products. The balance between safety, effectiveness and security, as set out in ISO 81001-1, is considered.
Main sections:
· Structure
· Field of application
· Conformance
· Scope
· Normative references
· General requirements
· Software development process
· Security risk management process
· Software configuration management
· Software problem resolution process
The set of processes, activities and tasks described in this document establishes a common framework for secure health software life cycle processes and end products. The balance between safety, effectiveness and security, as set out in ISO 81001-1, is considered.
Main sections:
· Structure
· Field of application
· Conformance
· Scope
· Normative references
· General requirements
· Software development process
· Security risk management process
· Software configuration management
· Software problem resolution process
Access Health software and health IT systems safety, effectiveness and security – Part 5-1: Security – Activities in the product life cycle
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