AS/NZS 3200.1.4:1997

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.

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.

First published as AS/NZS 3200.1.4:1997.