AS/NZS 3551:2004

Specifies procedures required to develop equipment management programs for medical devices. Includes procedures for procurement, acceptance, fault management, routine testing and disposal of medical devices. Intended to cover all medical devices, whether hospital property, privately owned, on loan or on trial, except for the commissioning requirements for permanently installed medical electrical devices in cardiac and body-protected patient pre-treatment areas.

This Standard specifies procedures required to develop equipment management programs for medical devices. These include procedures for procurement, acceptance, fault management, routine testing and disposal of medical devices.This Standard deals with essential safety and performance testing. Section 4 details how to identify the safety and performance parameters that are essential for the safe operation of each device and how to determine appropriate test intervals. For the purposes of an equipment management program, the scope of this Standard covers non-electrical medical devices, such as ventilators, which may be solely pneumatic or fluidic in operation. Many tests in this Standard concern medical electrical devices and are derived from the tests specified in AS/NZS 3200.1.0 and in no case are intended to be more stringent than those in that document. Where acceptance values of a AS/NZS 3200 Part 2 Standard for particular medical devices are not in agreement with the requirements of this Standard, the Part 2 Standard overrides this document. For example, the normal limit (specified in AS/NZS 3200.1.0) for mains contact current is 50 µ A per applied part, while AS/NZS 3200.2.4 specifies an allowable current of 100 µ A for Type CF defibrillator applied parts. NOTE: This Standard is intended to cover all medical devices, whether hospital property, privately owned, on loan, on trial, or donated, except for the commissioning requirements of permanently installed medical electrical devices in cardiac- and body-protected patient treatment areas, for which requirements are specified in AS/NZS 3003.

First published as AS 3551-1988.
Jointly revised and designated as AS/NZS 3551:1996.
Third edition 2004.