Table of Contents
SECTION 1 - SCOPE AND GENERAL
1.1 SCOPE
1.2 APPLICATION
1.3 REFERENCED DOCUMENTS
1.4 DEFINITIONS
1.5 FURTHER SOURCES OF INFORMATION
SECTION 2 - MEDICAL DEVICE MANAGEMENT PROGRAM
2.1 GENERAL
2.2 MAJOR FUNCTIONS
2.3 OTHER FUNCTIONS
2.4 SELECTION AND REVIEW OF SERVICE PROVIDER
2.5 RESOURCES
SECTION 3 - PROCUREMENT
3.1 SCOPE
3.2 PROCUREMENT PROCEDURES
SECTION 4 - ACCEPTANCE
4.1 SCOPE AND GENERAL
4.2 ACCEPTANCE CHECK AND INSPECTION
4.3 TEST SELECTION
4.4 FREQUENCY OF TESTING
4.5 ACCEPTANCE TESTING
4.6 DOCUMENTATION OF RESULTS
4.7 FORMAL ACCEPTANCE PROCEDURES
SECTION 5 - SAFETY AND PERFORMANCE TESTING
5.1 GENERAL
5.2 INSPECTIONS
5.3 ELECTRICAL SAFETY TESTS
5.4 PERFORMANCE TESTING
5.5 DOCUMENTATION
5.6 FAULT RECTIFICATION
5.7 TEST EQUIPMENT
APPENDICES
A - MEASURING DEVICE
B - EXAMPLE - FAULT REPORT
C - ESSENTIAL SAFETY AND PERFORMANCE PARAMETERS
D - EXAMPLE - PURCHASE/ACCEPTANCE RECORD
E - AS/NZS 3551 TEST LABEL
F - EXAMPLE - PERFORMANCE VERIFICATION REPORT
- INFUSION PUMP
G - EXAMPLE - PERFORMANCE VERIFICATION REPORT
- SYRINGE PUMP
H - EXAMPLE - PERFORMANCE VERIFICATION REPORT
- DEFIBRILLATOR
I - EXAMPLE - PERFORMANCE VERIFICATION REPORT
- BABY INCUBATORS
J - EXAMPLE - ELECTRICAL SAFETY TEST REPORT
K - APPLIED PARTS OF MEDICAL ELECTRICAL EQUIPMENT
L - CONTACT INFORMATION
Abstract
Specifies procedures required to develop equipment management programs for medical devices. Includes procedures for procurement, acceptance, fault management, routine testing and disposal of medical devices. Intended to cover all medical devices, whether hospital property, privately owned, on loan or on trial, except for the commissioning requirements for permanently installed medical electrical devices in cardiac and body-protected patient pre-treatment areas.
Scope
This Standard specifies procedures required to develop equipment management programs for medical devices. These include procedures for procurement, acceptance, fault management, routine testing and disposal of medical devices.
This Standard deals with essential safety and performance testing. 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.
For the purposes of an equipment management program, the scope of this Standard covers non-electrical medical devices, such as ventilators, which may be solely pneumatic or fluidic in operation.
Many tests in this Standard concern medical electrical devices and are derived from the tests specified in AS/NZS 3200.1.0 and in no case are intended to be more stringent than those in that document. Where acceptance values of a AS/NZS 3200 Part 2 Standard for particular medical devices are not in agreement with the requirements of this Standard, the Part 2 Standard overrides this document. For example, the normal limit (specified in AS/NZS 3200.1.0) for mains contact current is 50 A per applied part, while AS/NZS 3200.2.4 specifies an allowable current of 100 A for Type CF defibrillator applied parts.
NOTE: This Standard is intended to cover all medical devices, whether hospital property, privately owned, on loan, on trial, or donated, except for the commissioning requirements of permanently installed medical electrical devices in cardiac- and body-protected patient treatment areas, for which requirements are specified in AS/NZS 3003.
Application
This Standard is intended for use by those persons involved in the procurement, testing, installation, maintenance, calibration and operation of medical devices. It is meant to address the disparate needs of teaching hospitals, small hospitals, biomedical engineering service groups and other health care providers. While the operational modes of these groups may differ widely, the overall perspective is one of keeping medical devices safe and functional.
The principles and recommendations specified herein have been framed in a manner considered suitable for application by service organizations, hospital and private, supporting the use of medical devices.
History
First published as AS 3551-1988.
Jointly revised and designated as AS/NZS 3551:1996.
Third edition 2004.