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AS/NZS 3551:2004

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Technical management programs for medical devices
Available format(s)

Hardcopy , PDF 1 User , PDF 3 Users , PDF 5 Users , PDF 9 Users

Superseded date

03-06-2023

Published date

06-11-2004

Preview

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.

Committee
HE-003
DocumentType
Standard
ISBN
0 7337 6075 9
Pages
50
PublisherName
Standards Australia
Status
Superseded
SupersededBy
Supersedes
UnderRevision

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

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AS/NZS 3200.1.0-1998 Medical electrical equipment General requirements for safety - Parent Standard
AS/NZS 2500:2004 Guide to the safe use of electricity in patient care
AS/NZS 3200.2.4:1993 Medical electrical equipment - Approval and test specification Particular requirement for safety - Cardiac defibrillators and cardiac defibrillator-monitors
AS/NZS 3200.2.4:2006 Medical electrical equipment Particular requirements for safety - Cardiac defibrillators
AS/NZS 3760:2003 In-service safety inspection and testing of electrical equipment
AS 2472-1996 Valves for medical gas cylinders (Including pin-indexed outlet)
AS/NZS 3200.1.2:2005 Medical electrical equipment General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests
AS/NZS 3003:2003 Electrical installations - Patient treatment areas of hospitals and medical, dental practices and dialyzing locations
AS/NZS 3200.1.1:1995 Approval and test specification - Medical electrical equipment General requirements for safety - Collateral Standard: Safety requirements for medical electrical systems
AS/NZS 2500:1995 Guide to the safe use of electricity in patient care

AS/NZS 5761:2011 In-service safety inspection and testing - Second-hand equipment prior to sale
AS 3200-1986 Approval and test specification - Electromedical equipment - General requirements
AS/NZS 5762:2011 In-service safety inspection and testing - Repaired electrical equipment
AS/NZS 5761:2005 In-service safety inspection and testing - Second-hand electrical equipment prior to sale
AS/NZS 3003:2011 Electrical installations - Patient areas
AS/NZS 5762:2005 In-service safety inspection and testing - Repaired electrical equipment
AS/NZS 4173:2004 Guide to the safe use of lasers in health care
AS/NZS 2500:2004 Guide to the safe use of electricity in patient care
AS/NZS 3760:2010 In-service safety inspection and testing of electrical equipment
AS/NZS 3200.2.201:2000 Medical electrical equipment Particular requirements for safety - Dento-maxillofacial X-ray equipment

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