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AS/NZS 3551:2012
[Pending Revision]Management programs for medical equipment
Specifies procedures required to develop equipment management programs for medical equipment. Includes procedures for procurement, acceptance, fault management, routine testing and disposal of medical equipment. Intended to cover all medical equipment, whether hospital property, privately owned, on loan or on trial, except for the commissioning requirements for permanently installed medical electrical equipment in cardiac and body-protected patient pre-treatment areas.
Published: 31/10/2012
Pages: 83
Table of contents
Cited references
Content history
Table of contents
Header
About this publication
Preface
Foreword
1 Scope and general
1.1 Scope
1.2 Application
1.3 Referenced documents
1.4 Definitions
2 Medical equipment management program
2.1 General
2.2 Program support functions
2.2.1 Responsibility, authority and communication
2.2.2 Resources
2.2.2.1 General
2.2.2.2 Human resources
2.2.2.3 Technical training
2.2.2.4 Training records
2.2.2.5 Work environment
2.2.2.6 Infrastructure
2.3 Test equipment
2.3.1 General
2.3.2 Traceability of test equipment in use
2.4 Documentation requirements
2.4.1 Control of documentation
2.4.2 Operations manual
2.4.3 Supporting documentation
2.4.4 Hazard and recall notices
2.5 Equipment database
2.5.1 General
2.5.2 Medical equipment details
2.5.3 History
2.5.4 Recording of medical electrical systems
2.5.5 Document control
2.6 Major program functions
3 Regulatory compliance
3.1 General evidence of regulatory compliance
3.2 Marketing authorization
3.3 Electromagnetic compatibility
3.4 Medical equipment for clinical trial
4 Procurement
4.1 Scope
4.2 Procurement procedures
4.2.1 General
4.2.2 Regulatory compliance
4.2.3 Medical equipment devices on loan, lease or hire
4.2.4 Pre-purchase evaluation
4.2.5 Tenders and quotations
5 Acceptance
5.1 Scope
5.2 General
5.3 Acceptance check and inspection
5.3.1 General
5.3.2 General acceptance inspection
5.3.3 Medical equipment markings and documentation
5.3.4 Medical equipment configuration
5.3.5 Permanently installed medical equipment
5.3.6 Suspended masses
5.3.7 Wall and ceiling mounted masses
5.4 Test selection and acceptance testing
5.4.1 General
5.4.2 Electrical tests
5.4.3 Non-electrical tests
5.4.4 Ongoing testing requirements
5.4.5 Identification of medical equipment
5.4.6 Test status of medical equipment
5.5 Documentation of results
5.6 Failed medical equipment
6 Performance verification and maintenance
6.1 General
6.2 Documenting of performance verification
6.3 Performance verification
6.3.1 General
6.3.2 Physical inspection
6.3.3 Functional testing
6.3.3.1 General
6.3.3.2 Basic functional testing
6.3.3.3 Other functional testing
6.3.3.3.1 General
6.3.3.3.2 Radiation
6.3.3.3.3 Mechanical
6.3.3.3.4 Gas and/or liquids
6.3.4 Electrical testing
6.3.5 Performance verification of medical equipment at remote sites
6.4 Preventive maintenance
6.4.1 General
6.4.2 Scheduling of preventive maintenance
6.4.3 Testing after preventive maintenance activities
6.4.4 Recording of preventive maintenance activities
6.5 Management of medical equipment failure or faults
6.6 Configurable medical equipment
6.6.1 General
6.6.2 Restoration of configuration settings
6.6.3 Documentation
6.7 Review and recording of results
6.7.1 Medical equipment labelling
6.7.2 When assessment and testing are delayed
6.7.3 Reporting to the responsible organization
6.7.4 Review of program activities
6.8 Disposal
6.9 Safety-related notifications, alerts and recalls
6.10 Medical equipment adverse event or failure
6.10.1 Investigations
6.10.2 Adverse incident reporting
7 Medical electrical systems
7.1 General
7.2 Types of medical electrical system
7.2.1 Multiple socket-outlets
7.2.2 Functional interconnected equipment
7.3 Testing configuration
7.3.1 General
7.3.2 Electrical safety testing
7.3.3 Medical electrical systems incorporating information and communication technology equipment
8 Medical devices on loan, lease or hire
8.1 Hire or loan medical equipment
8.2 Hire or loan to the responsible organization
8.3 Hire or loan from the responsible organization
8.4 Medical equipment on trial in the organization
9 Modification of medical equipment
10 Assessment intervals
Appendix A
A1 Scope
A2 Risk management
A3 Technology assessment
A4 Technology manufacture
A5 Technology purchasing
A6 Incoming installation, commissioning and acceptance
A7 Initial performance verification test selection
A8 Review of performance verification test selection
A9 Post repair performance verification
A10 Prioritization of preventive maintenance program and performance verification program
A11 Medical equipment modification and use of non-OEM spare parts
A12 Risk management of medical equipment during its clinical life
Appendix B
B1 General
B2 Notation
B3 Order of testing
B4 Interrelationship with AS/NZS 3760
B5 Testing of individual items of equipment
B6 Testing of medical electrical systems
B7 Visual inspection of external mains supply components
B8 Protective earthing test
B8.1 General
B8.2 Plug-in Class I electrical equipment with a non-detachable supply cord
B8.3 Plug-in Class I electrical equipment with an appliance inlet
B8.4 Detachable power supply cord
B8.5 Medical electrical systems
B8.6 Allowable values of protective earthing resistance
B9 Insulation resistance test
B9.1 General
B9.2 Test protocol
B9.3 Allowable values of insulation resistance
B10 Touch current
B10.1 General
B10.2 Plug-in Class I electrical equipment
B10.3 Permanently wired electrical equipment
B10.4 Medical electrical systems
B10.5 Allowable values of touch current
B11 Earth leakage current test
B11.1 General
B11.2 Plug-in Class I electrical equipment with a non-detachable supply cord
B11.3 Plug-in Class I electrical equipment with an appliance inlet
B11.4 Permanently wired Class I electrical equipment
B11.5 Medical electrical systems
B11.6 Allowable values of earth leakage current
B12 Patient leakage current test
B12.1 General
B12.2 Patient leakage current test
B12.2.1 General
B12.2.2 Test equipment
B12.2.3 Medical electrical equipment (including permanently wired equipment)
B12.2.4 Allowable values of patient leakage current
B12.3 Patient leakage current—Mains voltage on the Applied Parts
B12.3.1 General
B12.3.2 Test equipment
B12.3.3 Medical electrical equipment (including permanently wired equipment)
B12.3.4 Allowable values of patient leakage current—Mains voltage on the Applied Parts
B12.3.5 Medical electrical systems
B12.3.6 Isolation transformer
Appendix C
Appendix D
Appendix E
Appendix F
Appendix G
Appendix H
Appendix I
Appendix J
Appendix K
Appendix L
L1 Applied parts of medical electrical equipment
L2 Electrical requirements
L3 Electric shock protection
L4 Protection in fault conditions
L5 Applications
L6 Defibrillator-proof Applied Parts
Appendix M
Amendment control sheet
AS/NZS 3551:2012
Amendment No. 1 (2013)
Correction
Amendment No. 2 (2016)
Revised text
Cited references in this standard
[Current]
Corrigendum 3 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
Content history
[Current]
[Superseded]
[Superseded]
DR 10023
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