AS/NZS 3551:1996

1 - AS/NZS 3551:1996 TECHNICAL MANAGEMENT PROGRAMS FOR MEDICAL DEVICES
4 - PREFACE
6 - CONTENTS
8 - SECTION 1 SCOPE AND GENERAL
8 - 1.1 SCOPE
8 - 1.2 APPLICATION
8 - 1.3 REFERENCED DOCUMENTS
9 - 1.4 DEFINITIONS
9 - 1.4.1 Acceptance procedure
9 - 1.4.2 Applied part
10 - 1.4.3 Class I electrical equipment
10 - 1.4.4 Class II electrical equipment
10 - 1.4.5 Fixed equipment
10 - 1.4.6 Internally powered devices
10 - 1.4.7 Mains part
10 - 1.4.8 Measuring device
10 - 1.4.9 Medical device
10 - 1.4.10 Patient circuit
10 - 1.4.11 Earth leakage current
10 - 1.4.12 Patient connection
10 - 1.4.13 Permanently installed equipment
10 - 1.4.14 Signal input/signal output part
10 - 1.4.15 Type approval
11 - 1.4.16 Type test
11 - 1.5 FURTHER SOURCES OF INFORMATION
12 - SECTION 2 MEDICAL DEVICE MANAGEMENT PROGRAM
12 - 2.1 GENERAL
12 - 2.2 RESOURCES
12 - 2.2.1 Human
12 - 2.2.2 Environmental
12 - 2.2.3 Equipment and technical resources
12 - 2.2.4 Data storage
12 - 2.3 MAJOR FUNCTIONS
12 - 2.4 OTHER FUNCTIONS
12 - 2.4.1 Management of device failure or faults
13 - 2.4.2 Hazard and safety recalls
13 - 2.4.3 Documentation
13 - 2.5 IMPLEMENTATION OF THIS STANDARD
15 - SECTION 3 PROCUREMENT
15 - 3.1 SCOPE
15 - 3.2 PROCUREMENT PROCEDURES
15 - 3.2.1 General
15 - 3.2.2 Compliance with safety Standards-Type Approval
16 - 3.2.3 Pre-purchase evaluation
16 - 3.2.4 Tenders and quotations
17 - SECTION 4 ACCEPTANCE
17 - 4.1 SCOPE AND GENERAL
17 - 4.2 ACCEPTANCE CHECK AND INSPECTION
17 - 4.2.1 Initial inspection
17 - 4.2.2 General acceptance inspection
18 - 4.2.3 Equipment markings
18 - 4.2.4 Permanently installed equipment
18 - 4.2.5 Suspended masses
19 - 4.3 TEST SELECTION
19 - 4.3.1 Electrical safety tests
20 - 4.3.2 Essential safety and performance parameter tests
21 - 4.4 FREQUENCY OF TESTING
21 - 4.5 ACCEPTANCE TESTING
21 - 4.6 DOCUMENTATION OF RESULTS
21 - 4.7 FORMAL ACCEPTANCE PROCEDURES
21 - 4.7.1 General
22 - 4.7.2 Identification of equipment
22 - 4.7.3 Addition of the device to the equipment database
22 - 4.7.4 Testing at remote sites
22 - 4.7.5 Failed equipment
23 - SECTION 5 SAFETY AND PERFORMANCE TESTING
23 - 5.1 SCOPE AND GENERAL
23 - 5.2 INSPECTIONS
23 - 5.2.1 General inspection
23 - 5.2.2 Equipment marking
23 - 5.2.3 Mains supply conductors
24 - 5.2.4 Equipment with liquid or gas containers
24 - 5.2.5 Permanently installed equipment
24 - 5.2.6 Suspended masses
25 - 5.3 ELECTRICAL SAFETY TESTS
25 - 5.3.1 General
27 - 5.3.2 Protective earthing tests
30 - 5.3.3 Insulation resistance
31 - 5.3.4 Earth leakage current
32 - 5.3.5 Applied part leakage current
33 - 5.3.6 Mains contact current test
34 - 5.4 PERFORMANCE TESTING
34 - 5.5 DOCUMENTATION
34 - 5.6 EVALUATION OF TESTING
34 - 5.7 TEST EQUIPMENT
35 - APPENDIX A - MEASURING DEVICE
36 - APPENDIX B - EXAMPLE FAULT REPORT
37 - APPENDIX C - LIST OF CURRENT MEDICAL ELECTRICAL STANDARD
37 - C1 INTRODUCTION
37 - C2 THE GENERAL STANDARD
37 - C3 COLLATERAL STANDARDS
37 - C4 SPECIFIC REQUIREMENTS
38 - C5 SUPPLEMENTS OR MODIFIES IEC 601-1/AS 3200.1
38 - C6 FUTURE PROJECTS
40 - APPENDIX D - ESSENTIAL SAFETY AND PERFORMANCE PARAMETERS
40 - D1 INTRODUCTION
44 - APPENDIX E - EXAMPLE PURCHASE/ACCEPTANCE RECORD
46 - APPENDIX F - AS 3551 TEST LABEL
47 - APPENDIX G - EXAMPLE - ELECTRICAL SAFETY TEST REPORT
49 - APPENDIX H1 - EXAMPLE - PERFORMANCE VERIFICATION REPORT- INFUSION PUMP
50 - APPENDIX H2 - EXAMPLE - PERFORMANCE VERIFICATION REPORT- SYRINGE PUMP
51 - APPENDIX H3 - EXAMPLE - PERFORMANCE VERIFICATION REPORT- DEFIBRILLATOR
52 - APPENDIX H4 - EXAMPLE - PERFORMANCE VERIFICATION REPORT BABY INCUBATORS
53 - APPENDIX I - APPLIED PARTS OF MEDICAL ELECTRICAL EQUIPMENT
53 - I.1 APPLIED PARTS OF MEDICAL ELECTRICAL EQUIPMENT
53 - I.2 Electrical requirements
53 - I.3 Electric shock protection
53 - I.4 Protection in fault conditions
54 - I.5 Applications
54 - I.6 Defibrillator-proof applied parts
55 - APPENDIX J - CONTACT INFORMATION

Specifies procedures required to develop equipment management programs for medical devices. Some of these include procedures for procurement, acceptance, fault management, routine testing and disposal of medical devices. It now requires essential safety and performance testing in addition to the electrical safety tests prescribed by the first edition of this Standard.

This Standard specifies procedures required to develop equipment management programs for medical devices. Some of these include procedures for procurement, acceptance, fault management, routine testing and disposal of medical devices.This Standard now requires essential safety and performance testing in addition to the electrical safety tests prescribed in the first edition. 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.The scope of this Standard exceeds that of the previous edition and of the AS/NZS 3200.2 series of Standards by covering certain non-electrical medical devices, such as ventilators, which may be solely pneumatic or fluidic in operation.This Standard is to be seen as a document defining good practice in the management of medical devices.Many tests in this Standard concern medical electrical devices and are derived from the parallel type approval tests specified in AS 3200.1.0/NZS 6150, Approval and test specification-Medical electrical equipment, Part 1.0- 1990: General requirements for safety- Parent Standard (as amended) and in no case are intended to be more stringent than those in that document. Where acceptance values of a part 2 Standard for particular medical devices are not in agreement with the specifications of this Standard, the Part 2 Standard overrides this document. For example, the normal limit for mains contact current is 50 mA per patient connection, while in AS/NZS 3200.2.4 which specifies an allowable current of 100 mA for Type CF defibrillator applied parts.NOTES:1 This Standard is intended to cover all medical devices, whether hospital property, privately owned, on loan or on trial, except for the commissioning requirements of permanently installed medical electrical devices in cardiac- and body-protected patient treatment areas, for which reference shall be made to AS 3003.2 The principles and recommendations specified herein have been framed in a manner considered suitable for application by most service organizations, hospital and private, supporting the use of medical devices.

First published in Australia as AS 3551-1988.
Jointly revised and designated as Joint Standard AS/NZS 3551:1996.