AS/NZS 3551:2004
Technical management programs for medical devices
Specifies procedures for procurement, acceptance, fault management, routine testing and disposal of medical devices.
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AS/NZS 3551:2004 TECHNICAL MANAGEMENT PROGRAMS FOR MEDICAL DEVICES
PREFACE
CONTENTS
SECTION 1 SCOPE AND GENERAL
1.1 SCOPE
1.2 APPLICATION
1.3 REFERENCED DOCUMENTS
1.4 DEFINITIONS
1.4.1 Acceptance procedure
1.4.2 Applied part
1.4.3 Class I electrical equipment
1.4.4 Class II electrical equipment
1.4.5 Earth leakage current
1.4.6 Essential safety performance parameter
1.4.7 Fixed equipment
1.4.8 Internally powered devices
1.4.9 Mains part
1.4.10 Measuring device (MD)
1.4.11 Medical device (hereinafter also referred to as ‚equipment™)
1.4.12 Medical equipment system
1.4.13 Patient circuit
1.4.14 Patient connection
1.4.15 Permanently installed equipment
1.4.16 Signal input/signal output part
1.4.17 Type approval
1.4.18 Type test
1.5 FURTHER SOURCES OF INFORMATION
SECTION 2 MEDICAL DEVICE MANAGEMENT PROGRAM
2.1 GENERAL
2.2 MAJOR FUNCTIONS
2.3 OTHER FUNCTIONS
2.3.1 Management of device failure or faults
2.3.2 Hazard and safety recalls
2.3.3 Modification of equipment
2.3.4 Documentation
2.4 SELECTION AND REVIEW OF SERVICE PROVIDER
2.5 RESOURCES
2.5.1 Human
2.5.2 Environmental
2.5.3 Equipment and technical resources
2.5.4 Data storage
SECTION 3 PROCUREMENT
3.1 SCOPE
3.2 PROCUREMENT PROCEDURES
3.2.1 General
3.2.2 Regulatory compliance
3.2.3 Pre-purchase evaluation
3.2.4 Tenders and quotations
SECTION 4 ACCEPTANCE
4.1 SCOPE AND GENERAL
4.2 ACCEPTANCE CHECK AND INSPECTION
4.2.1 General
4.2.2 Initial inspection
4.2.3 General acceptance inspection
4.2.4 Device markings
4.2.5 Permanently installed equipment
4.2.6 Suspended masses
4.3 TEST SELECTION
4.3.1 Electrical safety tests
4.3.2 Essential safety and performance parameter tests
4.4 FREQUENCY OF TESTING
4.5 ACCEPTANCE TESTING
4.6 DOCUMENTATION OF RESULTS
4.7 FORMAL ACCEPTANCE PROCEDURES
4.7.1 General
4.7.2 Identification of equipment
4.7.3 Test status of equipment
4.7.4 Testing at remote sites
4.7.5 Failed equipment
SECTION 5 SAFETY AND PERFORMANCE TESTING
5.1 GENERAL
5.2 INSPECTIONS
5.2.1 General inspection
5.2.2 Equipment marking
5.2.3 Mains supply conductors
5.2.4 Equipment with liquid or gas containers
5.2.5 Permanently installed equipment
5.2.6 Suspended masses
5.2.7 Medical electrical systems
5.3 ELECTRICAL SAFETY TESTS
5.3.1 General
5.3.2 Notation
5.3.3 Protective earthing tests
5.3.4 Insulation resistance
5.3.5 Earth leakage current
5.3.6 Applied part leakage current
5.3.7 Mains contact current test
5.4 PERFORMANCE TESTING
5.5 DOCUMENTATION
5.6 FAULT RECTIFICATION
5.7 TEST EQUIPMENT
APPENDIX A - MEASURING DEVICE
APPENDIX B - EXAMPLE-FAULT REPORT
APPENDIX C - ESSENTIAL SAFETY AND PERFORMANCE PARAMETERS
APPENDIX D - EXAMPLE-PURCHASE/ACCEPTANCE RECORD
APPENDIX E - AS/NZS 3551 TEST LABEL
APPENDIX F - EXAMPLE-PERFORMANCE VERIFICATION REPORT- INFUSION PUMP
APPENDIX G - EXAMPLE-PERFORMANCE VERIFICATION REPORT- SYRINGE PUMP
APPENDIX H - EXAMPLE-PERFORMANCE VERIFICATION REPORT-DEFIBRILLATOR
APPENDIX I - EXAMPLE-PERFORMANCE VERIFICATION REPORT- BABY INCUBATORS
APPENDIX J - EXAMPLE-ELECTRICAL SAFETY TEST REPORT
APPENDIX K - APPLIED PARTS OF MEDICAL ELECTRICAL EQUIPMENT
0 K1 APPLIED PARTS OF MEDICAL ELECTRICAL EQUIPMENT
0 K2 ELECTRICAL REQUIREMENTS
0 K3 ELECTRIC SHOCK PROTECTION
0 K4 PROTECTION IN FAULT CONDITIONS
0 K5 APPLICATIONS
0 K6 DEFIBRILLATOR-PROOF APPLIED PARTS
APPENDIX L - CONTACT INFORMATION
Amendments
Previous versions
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References
Approval and test specification - Medical electrical equipment - General requirements for safety - Collateral Standard - Electromagnetic compatibility - Requirements and tests
Approval and test specification - Medical electrical equipment - Particular requirements for safety - Cardiac defibrillators and cardiac defibrillator-monitors
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AS/NZS 3551:2004 TECHNICAL MANAGEMENT PROGRAMS FOR MEDICAL DEVICES
PREFACE
CONTENTS
SECTION 1 SCOPE AND GENERAL
1.1 SCOPE
1.2 APPLICATION
1.3 REFERENCED DOCUMENTS
1.4 DEFINITIONS
1.4.1 Acceptance procedure
1.4.2 Applied part
1.4.3 Class I electrical equipment
1.4.4 Class II electrical equipment
1.4.5 Earth leakage current
1.4.6 Essential safety performance parameter
1.4.7 Fixed equipment
1.4.8 Internally powered devices
1.4.9 Mains part
1.4.10 Measuring device (MD)
1.4.11 Medical device (hereinafter also referred to as ‚equipment™)
1.4.12 Medical equipment system
1.4.13 Patient circuit
1.4.14 Patient connection
1.4.15 Permanently installed equipment
1.4.16 Signal input/signal output part
1.4.17 Type approval
1.4.18 Type test
1.5 FURTHER SOURCES OF INFORMATION
SECTION 2 MEDICAL DEVICE MANAGEMENT PROGRAM
2.1 GENERAL
2.2 MAJOR FUNCTIONS
2.3 OTHER FUNCTIONS
2.3.1 Management of device failure or faults
2.3.2 Hazard and safety recalls
2.3.3 Modification of equipment
2.3.4 Documentation
2.4 SELECTION AND REVIEW OF SERVICE PROVIDER
2.5 RESOURCES
2.5.1 Human
2.5.2 Environmental
2.5.3 Equipment and technical resources
2.5.4 Data storage
SECTION 3 PROCUREMENT
3.1 SCOPE
3.2 PROCUREMENT PROCEDURES
3.2.1 General
3.2.2 Regulatory compliance
3.2.3 Pre-purchase evaluation
3.2.4 Tenders and quotations
SECTION 4 ACCEPTANCE
4.1 SCOPE AND GENERAL
4.2 ACCEPTANCE CHECK AND INSPECTION
4.2.1 General
4.2.2 Initial inspection
4.2.3 General acceptance inspection
4.2.4 Device markings
4.2.5 Permanently installed equipment
4.2.6 Suspended masses
4.3 TEST SELECTION
4.3.1 Electrical safety tests
4.3.2 Essential safety and performance parameter tests
4.4 FREQUENCY OF TESTING
4.5 ACCEPTANCE TESTING
4.6 DOCUMENTATION OF RESULTS
4.7 FORMAL ACCEPTANCE PROCEDURES
4.7.1 General
4.7.2 Identification of equipment
4.7.3 Test status of equipment
4.7.4 Testing at remote sites
4.7.5 Failed equipment
SECTION 5 SAFETY AND PERFORMANCE TESTING
5.1 GENERAL
5.2 INSPECTIONS
5.2.1 General inspection
5.2.2 Equipment marking
5.2.3 Mains supply conductors
5.2.4 Equipment with liquid or gas containers
5.2.5 Permanently installed equipment
5.2.6 Suspended masses
5.2.7 Medical electrical systems
5.3 ELECTRICAL SAFETY TESTS
5.3.1 General
5.3.2 Notation
5.3.3 Protective earthing tests
5.3.4 Insulation resistance
5.3.5 Earth leakage current
5.3.6 Applied part leakage current
5.3.7 Mains contact current test
5.4 PERFORMANCE TESTING
5.5 DOCUMENTATION
5.6 FAULT RECTIFICATION
5.7 TEST EQUIPMENT
APPENDIX A - MEASURING DEVICE
APPENDIX B - EXAMPLE-FAULT REPORT
APPENDIX C - ESSENTIAL SAFETY AND PERFORMANCE PARAMETERS
APPENDIX D - EXAMPLE-PURCHASE/ACCEPTANCE RECORD
APPENDIX E - AS/NZS 3551 TEST LABEL
APPENDIX F - EXAMPLE-PERFORMANCE VERIFICATION REPORT- INFUSION PUMP
APPENDIX G - EXAMPLE-PERFORMANCE VERIFICATION REPORT- SYRINGE PUMP
APPENDIX H - EXAMPLE-PERFORMANCE VERIFICATION REPORT-DEFIBRILLATOR
APPENDIX I - EXAMPLE-PERFORMANCE VERIFICATION REPORT- BABY INCUBATORS
APPENDIX J - EXAMPLE-ELECTRICAL SAFETY TEST REPORT
APPENDIX K - APPLIED PARTS OF MEDICAL ELECTRICAL EQUIPMENT
0 K1 APPLIED PARTS OF MEDICAL ELECTRICAL EQUIPMENT
0 K2 ELECTRICAL REQUIREMENTS
0 K3 ELECTRIC SHOCK PROTECTION
0 K4 PROTECTION IN FAULT CONDITIONS
0 K5 APPLICATIONS
0 K6 DEFIBRILLATOR-PROOF APPLIED PARTS
APPENDIX L - CONTACT INFORMATION
Amendments
Previous versions
AS/NZS 3551:2004
Online Library subscription information
Online library subscriptions provide a cost-effective solution for organisations of any size to access the latest standards, offering 24/7 access to a personalised catalogue. The service ensures subscribers have have the most up-to-date version of selected standards, incluing automatic updates for any amendments or versions. Pricing is dependent on the chosen standards and the number of concurrent users, with discounts applied from the standards PDF price. For customised subscriptions or further inquiries, contact the Online Library team.