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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