Table of Contents

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

Abstract

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.

Scope

This Collateral Standard applies to the SAFETY of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL
ELECTRICAL 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.

General Product Information

Published
Document Type	Standard
Status	Current
Publisher	Standards Australia
Pages
ISBN
Committee	HE-003
Supersedes	DR 96553 CP