AS NZS 3551-2004 Technical management programs for medical devices《医学设备的技术管理程序》.pdf

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1、 AS/NZS 3551:2004 Australian/New Zealand StandardTechnical management programs for medical devices AS/NZS 3551 Accessed by ISONET - CHINA STATE BUREAU OF TECHNICAL SUPERVIS on 28 Jul 2005AS/NZS 3551:2004 This Joint Australian/New Zealand Standard was prepared by Joint Technical Committee HE-003, Med

2、ical Electrical Equipment. It was approved on behalf of the Council of Standards Australia on 23 February 2004 and on behalf of the Council of Standards New Zealand on 5 March 2004. It was published on 11 June 2004. The following are represented on Committee HE-003: Auckland District Health Board, N

3、ew Zealand Australasian College of Physical Scientists and Engineers in Medicine Australian and New Zealand College of Anaesthetists Australian Society for Ultrasound in Medicine Australian Chamber of Commerce and Industry Australian Dental Association Australian Institute of Radiography Australian

4、Radiation Protection and Nuclear Safety Agency Canterbury District Health Board, New Zealand College of Biomedical EngineeringInstitution of Engineers Australia Commonwealth Department of Health and Ageing Department of Defence (Australia) Ministry of Economic Development, New Zealand Royal Australa

5、sian College of Radiologists Testing Interests (Australia) Keeping Standards up-to-date Standards are living documents which reflect progress in science, technology and systems. To maintain their currency, all Standards are periodically reviewed, and new editions are published. Between editions, ame

6、ndments may be issued. Standards may also be withdrawn. It is important that readers assure themselves they are using a current Standard, which should include any amendments which may have been published since the Standard was purchased. Detailed information about joint Australian/New Zealand Standa

7、rds can be found by visiting the Standards Web Shop at .au or Standards New Zealand web site at www.standards.co.nz and looking up the relevant Standard in the on-line catalogue. Alternatively, both organizations publish an annual printed Catalogue with full details of all current Standards. For mor

8、e frequent listings or notification of revisions, amendments and withdrawals, Standards Australia and Standards New Zealand offer a number of update options. For information about these services, users should contact their respective national Standards organization. We also welcome suggestions for i

9、mprovement in our Standards, and especially encourage readers to notify us immediately of any apparent inaccuracies or ambiguities. Please address your comments to the Chief Executive of either Standards Australia International or Standards New Zealand at the address shown on the back cover. This St

10、andard was issued in draft form for comment as DR 01404.Accessed by ISONET - CHINA STATE BUREAU OF TECHNICAL SUPERVIS on 28 Jul 2005AS/NZS 3551:2004 Australian/New Zealand StandardTechnical management programs for medical devicesOriginated as AS 35511988. Previous edition AS/NZS 3551:1996. Third edi

11、tion 2004. COPYRIGHT Standards Australia/Standards New Zealand All rights are reserved. No part of this work may be reproduced or copied in any form or by any means, electronic or mechanical, including photocopying, without the written permission of the publisher. Jointly published by Standards Aust

12、ralia International Ltd, GPO Box 5420, Sydney, NSW 2001 and Standards New Zealand, Private Bag 2439, Wellington 6020 ISBN 0 7337 6075 9 Accessed by ISONET - CHINA STATE BUREAU OF TECHNICAL SUPERVIS on 28 Jul 2005AS/NZS 3551:2004 2 PREFACE This Standard was prepared by the Joint Standards Australia/S

13、tandards New Zealand Subcommittee HE-003-01-02, Technical Management Programs for Medical Equipment, under the responsibility of Committee HE-003, Medical Electrical Equipment, to supersede AS/NZS 3551:1996. The following interests played a major role in the preparation of this Standard: Biomedical

14、Services, New Zealand New South Wales Department of Public Works and Services Prince of Wales Hospital, N.S.W. Queensland Health Royal North Shore Hospital, N.S.W. The principal differences between this edition and the previous edition are as follows: (a) The introduction of a definition for essenti

15、al safety and performance parameter. (b) Detailing information on repair using non-OEM spares, manufacturer approved modification and other modifications. (c) Amendment of the previous Compliance with Standards section on regulatory compliance to take into account the Therapeutic Goods Act and the M

16、edical Device Directives. (d) The mains contact current test is required only at acceptance and when the mains isolation barrier is part of a repair. (e) With regard to frequency of testing, the introduction of risk management principles in assessing risks and hazards. A 12-monthly maximum interval

17、is required if risk assessment is not followed. The Standard was prepared for users of medical devices who need to (i) ensure that the device purchased complies with the Essential Principles of Safety and Performance; (ii) inspect and test new devices, before commissioning, in order to ensure agains

18、t manufacturing defects; and (iii) perform routine inspections or tests on medical devices, or both, during their service life, in order to ensure their continued safety and performance. The safe application of medical devices depends on a variety of factors. The minimum requirements are as follows:

19、 (A) Medical electrical devices are used only in a patient area provided with appropriate protection and the reticulated mains wiring in accordance with AS/NZS 3003, Electrical installationsPatient treatment areas of hospitals and medical and dental practices. (B) Appropriate equipment is used for e

20、ach particular application and in accordance with an appropriate set of rules linking the type of procedure with the class of device and the electrical safety facilities provided in the patient area. (C) Each new item of equipment is (1) acceptance tested prior to clinical use; (2) subjected to rout

21、ine performance testing during its useable life to detect damage, wear, component failure or changed component value which might render it unsafe; and (3) maintained with reference to the manufacturers instructions using formal risk analysis. Accessed by ISONET - CHINA STATE BUREAU OF TECHNICAL SUPE

22、RVIS on 28 Jul 20053 AS/NZS 3551:2004 (D) The users of the device have to know, not only the medical procedure, but also the safety characteristics and operational details of the device. This can be achieved by learning and training under the supervision of either the manufacturer, the local represe

23、ntative, or users, or in biomedical engineering departments. (E) Users and, where applicable, the biomedical engineering department or service provider, need to ensure that safety and performance of the device is maintained by an effective maintenance scheme with regular servicing in accordance with

24、 this Standard. Many tests in this Standard are derived from the tests specified in AS/NZS 3200.1.0, Medical electrical equipment, Part 1.0: General requirements for safetyParent Standard, and in no case are intended to be more stringent than those in AS/NZS 3200.1.0. Recommendations linking the typ

25、e of medical procedures with the appropriate type and class of medical electrical equipment and the type of protective facilities in the reticulated mains wiring are not covered in this Standard but are published as AS/NZS 2500, Guide to safe use of electricity in patient care. Design requirements f

26、or type examination and approval of medical electrical devices are not considered in this Standard but are set out in AS/NZS 3200.1.0 and Collateral Standards, and the relevant Part 2 Standards in the AS/NZS 3200 series. In this regard, it is important to note the following: (1) The test requirement

27、s of the AS/NZS 3200 Part 2 Standards can be applied to a sample of the device to verify that the basic design and manufacture complies with these Standards before the device is introduced to the market. (2) Many of the tests in the AS/NZS 3200 Part 2 Standards are too extensive to be applied on a r

28、outine basis to each item of equipment delivered to a hospital or health care facility. Some inspection and testing requirements of the AS/NZS 3200 Part 2 Standards are potentially destructive of the device or its components. Some of those type tests, if applied to each item of equipment purchased,

29、would render the device inoperative or unsafe for use. (3) Few organizations and health care facilities have the resources to carry out type testing to the full requirements of the AS/NZS 3200 Part 2 Standards. (4) For the reasons outlined above, it is not appropriate, nor would it be cost effective

30、, to carry out all the inspection and testing required in the AS/NZS 3200 Part 2 Standards on every item of equipment to be commissioned. (5) The AS/NZS 3200 Part 2 Standards modify the Parent Standard and are totally dependent on AS/NZS 3200.1.0 for the bulk of requirements. Accessed by ISONET - CH

31、INA STATE BUREAU OF TECHNICAL SUPERVIS on 28 Jul 2005AS/NZS 3551:2004 4 CONTENTS Page SECTION 1 SCOPE AND GENERAL 1.1 SCOPE 6 1.2 APPLICATION . 6 1.3 REFERENCED DOCUMENTS 6 1.4 DEFINITIONS 7 1.5 FURTHER SOURCES OF INFORMATION 10 SECTION 2 MEDICAL DEVICE MANAGEMENT PROGRAM 2.1 GENERAL 11 2.2 MAJOR FU

32、NCTIONS. 11 2.3 OTHER FUNCTIONS. 11 2.4 SELECTION AND REVIEW OF SERVICE PROVIDER. 13 2.5 RESOURCES 14 SECTION 3 PROCUREMENT 3.1 SCOPE 15 3.2 PROCUREMENT PROCEDURES . 15 SECTION 4 ACCEPTANCE 4.1 SCOPE AND GENERAL 18 4.2 ACCEPTANCE CHECK AND INSPECTION 18 4.3 TEST SELECTION . 20 4.4 FREQUENCY OF TESTI

33、NG 22 4.5 ACCEPTANCE TESTING 23 4.6 DOCUMENTATION OF RESULTS. 23 4.7 FORMAL ACCEPTANCE PROCEDURES 23 SECTION 5 SAFETY AND PERFORMANCE TESTING 5.1 GENERAL 25 5.2 INSPECTIONS . 25 5.3 ELECTRICAL SAFETY TESTS. 27 5.4 PERFORMANCE TESTING. 36 5.5 DOCUMENTATION. 36 5.6 FAULT RECTIFICATION 36 5.7 TEST EQUI

34、PMENT 36 APPENDICES A MEASURING DEVICE 37 B EXAMPLEFAULT REPORT 38 C ESSENTIAL SAFETY AND PERFORMANCE PARAMETERS. 39 D EXAMPLEPURCHASE/ACCEPTANCE RECORD. 43 E AS/NZS 3551 TEST LABEL. 45 F EXAMPLEPERFORMANCE VERIFICATION REPORT INFUSION PUMP. 46 G EXAMPLEPERFORMANCE VERIFICATION REPORT SYRINGE PUMP 4

35、7 H EXAMPLEPERFORMANCE VERIFICATION REPORT DEFIBRILLATOR 48 Accessed by ISONET - CHINA STATE BUREAU OF TECHNICAL SUPERVIS on 28 Jul 20055 AS/NZS 3551:2004 Page I EXAMPLEPERFORMANCE VERIFICATION REPORT BABY INCUBATORS 49 J EXAMPLEELECTRICAL SAFETY TEST REPORT. 51 K APPLIED PARTS OF MEDICAL ELECTRICAL

36、 EQUIPMENT. 53 L CONTACT INFORMATION 55 Accessed by ISONET - CHINA STATE BUREAU OF TECHNICAL SUPERVIS on 28 Jul 2005AS/NZS 3551:2004 6 COPYRIGHT STANDARDS AUSTRALIA/STANDARDS NEW ZEALAND Australian/New Zealand Standard Technical management programs for medical devices SECTION 1 SCOPE AND GENERAL 1.1

37、 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.

38、 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, su

39、ch 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 o

40、f 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.

41、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 ele

42、ctrical devices in cardiac- and body-protected patient treatment areas, for which requirements are specified in AS/NZS 3003. 1.2 APPLICATION This Standard is intended for use by those persons involved in the procurement, testing, installation, maintenance, calibration and operation of medical device

43、s. 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. T

44、he 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. 1.3 REFERENCED DOCUMENTS This Standard has been designed, as far as practicable, as a stand-alone

45、 document capable of implementation without reference to other Standards. However, the following documents are referred to in this Standard: AS 2125 General conditions of tendering and form of tender 2472 Valves for medical gas cylinders (including pin-indexed outlet) Accessed by ISONET - CHINA STAT

46、E BUREAU OF TECHNICAL SUPERVIS on 28 Jul 20057 AS/NZS 3551:2004 COPYRIGHT AS/NZS 2500 Guide to the safe use of electricity in patient care 3003 Electrical installationsPatient treatment areas of hospitals and medical dentalpractices and dialyzing locations 3200 Medical electrical equipment 3200.1.0

47、Part 1.0 General requirements for safetyParent Standard 3200.1.1 Part 1.1: General requirements for safetyCollateral Standard: Safety requirements for medical electrical systems 3200.1.2 Part 1.2: General requirements for safetyCollateral Standard: Electromagnetic compatibilityRequirements and tests

48、 3200.2.4 Part 2.4: Particular requirements for safetyCardiac defibrillators and cardiac defibrillator-monitors 3760 In-service safety inspection and testing of electrical equipment 1.4 DEFINITIONS For the purpose of this Standard, the definitions below apply. 1.4.1 Acceptance procedure A set of pro

49、cesses required to be performed before a new medical device is released for clinical use. 1.4.2 Applied part 1.4.2.1 General definition A part of a medical device which, in normal use (a) necessarily comes into physical contact with the patient for the device to perform its function; or (b) can be brought into contact with the patient; or (c) needs to be touched by the patient. Excluded are other parts which are only likely to be contacted following an unnecessary action by the patient. For the purpose of this definition, the medica