Adopts ISO 13485:2016 to specify requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related...

AS/NZS 10535:2024 identically adopts and modifies ISO 10535:2021 which specifies requirements and test methods applicable to hoists for the transfer of people with disabilities.

Specifies administrative responsibilities associated with a hearing protector program; the selection, use and maintenance of various types of hearing protectors; and training and motivation in...

This document adopts ISO 14971:2019, which specifies terminology, principles and a process for risk management of medical devices, including software as a medical device and...

Provides guidance and explanatory material which will assist with the implementation of the requirements of AS 4485.1. Designed to assist in the development of effective...