Category
Standard
Organisation
ID
IEC 81001-5-1:2021
Type
Standard
Version
1
Access
Fees apply to access
Status
Active
Created
Dec 2021
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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