Type
Standards Development Organisation
Link
Standards Australia is Australia’s leading non-government standards organisation that develops, publishes and maintains nationally recognised voluntary Australian Standards.
Although their focus is the development of standards to support Australian requirements, they also participate in the development of a wide range of international standards through the International Organisation for Standardization (ISO) and International Electrotechnical Commission (IEC). Standards Australia specialise in the development and adoption of internationally-aligned standards and technical specifications in Australia.
Find out more about Standards Australia.
Find out more about the Standards Australia standards development process.
Resources
Health software and health IT systems safety, effectiveness and security - Part 2-1: Coordination - Guidance and requirements for the use of assurance cases for safety and security
Category
Technical Specification
Organisation
Standards Australia
Type
Standard
Access
Fees apply to access
Status
Active
Created
Jan-25
This document establishes requirements and gives guidance on assurance case framework for healthcare delivery organisations (HDOs) and for health software and medical device manufacturers (MDMs) and can be used to support the communication and information transfer between all parties.
Health software and health IT systems safety, effectiveness and security, Part 1: Principles and concepts
Category
Standard
Organisation
Standards Australia
Type
Standard
Access
Fees apply to access
Status
Active
Created
2022
This standard identically adopts ISO 81001 1:2021, which provides the principles, concepts, terms and definitions for health software and health IT systems, key properties of safety, effectiveness and security, across the full life cycle, from concept to decommissioning.
Health software, Part 1: General requirements for product safety
Category
Standard
Organisation
Standards Australia
Type
Standard
Access
Fees apply to access
Status
Active
Created
2022
This standard identically adopts IEC 82304 1:2016, which provides requirements for the safety and security of health software products designed to operate on general computing platforms and intended to be placed on the market without dedicated hardware, with a primary focus on the requirements for manufacturers.