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AS
AS/NZS 3200.1.4:1997

AS/NZS 3200.1.4:1997

Withdrawn

Withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

Approval and test specification - Medical electrical equipment General requirements for safety - Collateral Standard: Programmable electrical medical systems

Available format(s)

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

Withdrawn date

30-03-2022

Language(s)

English

Published date

05-07-1997

Publisher

Standards Australia

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Hardcopy - English
PDF 1 User - English
PDF 3 Users - English
PDF 5 Users - English
PDF 9 Users - English
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1 - AS/NZS 3200.1.4:1997 APPROVAL AND TEST SPECIFICATION-MEDICAL ELECTRICAL EQUIPMENT - GENERAL REQUIREMENTS FOR SAFETY-COLLATERAL..
4 - PREFACE
7 - CONTENTS
8 - INTRODUCTION
9 - SECTION 1: GENERAL
9 - 1 Scope, object and relationship to other standards
9 - 1.201 Scope
9 - 1.202 Object
9 - 1.203 Relationship to other standards
9 - 1.203.1 IEC 601-1
10 - 1.203.2 Particular Standards
10 - 1.203.3 Normative references
10 - 2 Terminology and definitions
10 - 2.201 Defined terms
10 - 2.201.1 DEVELOPMENT LIFE-CYCLE:
10 - 2.201.2 HAZARD ANALYSIS:
11 - 2.201.3 MAXIMUM TOLERABLE RISK:
11 - 2.201.4 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEM (PEMS):
11 - 2.201.5 PROGRAMMABLE ELECTRONIC SUBSYSTEM (PESS):
11 - 2.201.6 RESIDUAL RISK:
11 - 2.201.7 RISK:
11 - 2.201.8 RI SK MANAGEMENT FI LE:
11 - 2201. 9 RISK MANAGEMENT SUMMARY:
11 - 2.201.10 SAFETY:
11 - 2.201.11 SAFETY HAZARD (hereinafter referred to as HAZARD):
11 - 2.201.12 SAFETY INTEGRITY:
11 - 2.201.13 SEVERITY:
11 - 2.201.14 VALIDATION:
11 - 2201. 15 VERIFICATION:
11 - 2.202 Degrees of requirements and miscellaneous terms
12 - 6 Identification, marking and documents
12 - 6.8 ACCOMPANYING DOCUMENTS
12 - SECTION 9: ABNORMAL OPERATION AND FAULT CONDITIONS; ENVIRONMENTAL TESTS
12 - 52 Abnormal operation and fault conditions
12 - 52.201 Documentation
14 - 52.202 RISK management plan
14 - 52.203 DEVELOPMENT LIFE-CYCLE
14 - 52.204 RISK management process
16 - 52.205 Qualification of personnel
16 - 52.206 Requirement specification
17 - 52.207 Architecture
17 - 52.208 Design and implementation
17 - 52.209 VERIFICATION
17 - 52.210 VALIDATION
18 - 52.211 Modification
18 - 52.212 Assessment
19 - Annex AAA - Terminology - Index of defined terms
20 - Annex BBB - Rationale
22 - Annex CCC - RISK concepts
28 - Annex DDD - DEVELOPMENT LIFE-CYCLE model
32 - Annex EEE - Examples for PEMS/PESS structures
34 - Annex FFF - Bibliography

Specifies requirements for the process by which a programmable electrical medical system is designed. This Standard is supplementary to AS 3200.1.0-1990, and is identical with and reproduced from IEC 60601-1-4:1996.

Committee
HE-003
DocumentType
Standard
ISBN
0 7337 1229 0
Pages
26
PublisherName
Standards Australia
Status
Withdrawn
Supersedes

This Collateral Standard applies to the SAFETY of MEDICAL ELECTRICAL EQUIPMENT and MEDICALELECTRICAL SYSTEMS incorporating PROGRAMMABLE ELECTRONIC SUBSYSTEMS (PESS), hereinafter referred to as PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS).NOTE - Some systems which incorporate software and are used for medical purposes fall outside the scope of this Collateral Standard, e.g. many medical informatics systems. The distinguishing factor/criterion is whether or not the system satisfies the definition of MEDICA L ELECTRIC AL EQUIPMENT in 2.2.15 of IEC 601-1 or the definition of MEDICA L ELECTRIC AL SYSTEM In 2.203 of IEC 601-1-1.

Standards Relationship
IEC 60601-1-4:1996 Identical
IEC 60601-1-4:1996+AMD1:1999 CSV Identical

First published as AS/NZS 3200.1.4:1997.

AS/NZS 4513:1995 Medical electrical equipment - Fundamental aspects of safety standards (Reconfirmed 2022)
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 3900.3-1993 Quality management and quality assurance Standards - Guidelines for the application of ISO 9001 to the development, supply and maintenance of software
AS/NZS ISO 9001:1994 Quality systems - Model for quality assurance in design, development, production, installation and servicing
AS/NZS 3200.1.0-1998 Medical electrical equipment General requirements for safety - Parent Standard

AS 3979-2006 Hydrotherapy pools (Reconfirmed 2018)
AS/NZS 60335.2.90:2006 Household and Similar Electrical Appliances - Safety Particular requirements for commercial microwave ovens
AS/NZS 3200.2.1:1999 Medical electrical equipment Particular requirements for safety - Electron accelerators in the range 1 MeV to 50 MeV
AS/NZS 4173:2018 Safe use of lasers and intense light sources in health care
AS/NZS 3200.2.23:2001 Medical electrical equipment Particular requirements for safety - Transcutaneous partial pressure monitoring equipment
AS/NZS 3200.2.5:2002 Medical electrical equipment Particular requirements for safety - Ultrasonic physiotherapy equipment (IEC 60601-2-5:2000, MOD)
AS/NZS 60745.1:2009 Hand-held motor-operated electric tools-Safety General requirements (IEC 60745-1 Ed 4, MOD) (Reconfirmed 2020)
AS/NZS 3200.1.0-1998 Medical electrical equipment General requirements for safety - Parent Standard
AS/NZS 3200.2.38:2007 Medical electrical equipment Particular requirements for safety - Electrically and manually operated medical beds for adult use (IEC 60601-2-38, Ed.1.0(1996) MOD)
AS/NZS 3200.2.33:2005 Medical electrical equipment Particular requirements for safety - Magnetic resonance equipment for medical diagnosis
AS/NZS 3200.2.30:2001 Medical electrical equipment Particular requirements for safety - Automatic cycling non-invasive blood pressure monitoring equipment (IEC 60601-2-30:1999, MOD)
AS/NZS 60598.2.25:2001 Luminaires Particular requirements - Luminaires for use in clinical areas of hospitals and health care buildings (IEC 60598.2.25:1994, MOD) (Reconfirmed 2013) (Reconfirmed 2024)
AS 4774.2-2002 Work in compressed air and hyperbaric facilities - Hyperbaric oxygen facilities
AS/NZS 3200.2.26:2005 Medical electrical equipment Particular requirements for safety - Electroencephalographs

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