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1、 AS/NZS 4187:2003 Australian/New Zealand Standard Cleaning, disinfecting and sterilizing reusable medical and surgical instruments and equipment, and maintenance of associated environments in health care facilities AS/NZS 4187 Accessed by UNIVERSITY OF SOUTH AUSTRALIA on 12 Dec 2008 AS/NZS 4187:2003
2、 This Joint Australian/New Zealand Standard was prepared by Joint Technical Committee HE-023, Processing of Medical and Surgical Instruments and Equipment. It was approved on behalf of the Council of Standards Australia on 9 December 2002 and on behalf of the Council of Standards New Zealand on 13 D
3、ecember 2002. It was published on 28 January 2003. The following are represented on Committee HE-023: Australian Chamber of Commerce and Industry Australian College of Operating Room Nurses Australian Dental Association Australian Dental Industry Association Australian General Practice Accreditation
4、 Ltd Australian Health Care Association Australian Health Industry Inc. Australian Infection Control Association Australian Medical Association Australian Nursing Federation Commonwealth Department of Health and Ageing Dental Assistants Association of Australia Department of Defence Department of Hu
5、man Services, Vic. Federation of Sterilizing Research and Advisory Councils of Australia Gastroenterological Nurses College of Australia Health Department of Western Australia Medical Industry Association of Australia Ministry of Health, New Zealand New Zealand Nurses Organisation New Zealand Steril
6、e Services Association N.S.W. Health Department Queensland Health Royal Australasian College of Surgeons Royal Australian College of General Practitioners Rural Doctors Association of Australia South Australian Health Commission Additional interests participating in the preparation of this Standard:
7、 Australian Association of Practice Managers Infection Control Review and Certification Service, N.S.W. 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
8、editions are published. Between editions, amendments 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 Standards may also be withdrawn.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 informat
9、ion about joint Australian/New Zealand Standards can be found by visiting the Standards Australia web site 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 Catalo
10、gue with full details of all current Standards. For more 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 St
11、andards organization. We also welcome suggestions for improvement 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
12、Zealand at the address shown on the back cover. This Standard was issued in draft form for comment as DR 01114. Accessed by UNIVERSITY OF SOUTH AUSTRALIA on 12 Dec 2008 A AS/NZS 4187:2003 Australian/New Zealand Standard Cleaning, disinfecting and sterilizing reusable medical and surgical instruments
13、 and equipment, and maintenance of associated environments in health care facilities Originated as AS 41871994. Previous edition 1998. Jointly revised and designated as AS/NZS 4187:2003. COPYRIGHT Standards Australia/Standards New Zealand All rights are reserved. No part of this work may be reproduc
14、ed 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 Australia International Ltd, GPO Box 5420, Sydney, NSW 2001 and Standards New Zealand, Private Bag 2439, Wellington 6020 ISBN 0
15、7337 5024 9 Accessed by UNIVERSITY OF SOUTH AUSTRALIA on 12 Dec 2008 AS/NZS 4187:2003 2 PREFACE This Standard was prepared by the Joint Standards Australia/Standards New Zealand Committee HE-023, Processing of Medical and Surgical Instruments and Equipment, to supersede AS 41871998, Cleaning, disinf
16、ecting and sterilizing reusable medical and surgical instruments and equipment, and maintenance of associated environments in health care facilities. The objective of this Standard is to ensure that items intended for reprocessing are cleaned, disinfected or sterilized so that they can be safely reu
17、sed without risk of infection transmission. The principal differences between this edition and the 1998 edition are as follows: (a) Table 7.1 has been modified. (b) A new appendix (Appendix A) has been included to provide a rationale for some of the requirements of the Standard. Relevant clauses are
18、 indicated by a footnote to the clause title. (c) An appendix on validation protocol for moist heat sterilization process has been included (Appendix H) as well as a new appendix on handwashing (Appendix J). (d) The appendix on care and handling of flexible and rigid endoscopes has been rewritten. (
19、e) The appendix on the method for measurement of temperature and pressure in steam sterilizers, or temperature only in any heat sterilizers, has been expanded. Persons having responsibility for the safe delivery of sterile health care products should be aware of available sterilization processes, me
20、thods of control, and physical characteristics of the product to be sterilized. Even when products are produced under controlled conditions, they will have microorganisms on them and are, by definition, non-sterile. The purpose of sterilization is to destroy these microbiological contaminants. After
21、 sterilization, however, there is always a finite probability that a microorganism could survive regardless of the treatment applied. As a consequence, sterility of a processed item is defined in terms of the probability of the occurrence of a single viable microorganism surviving on the item. Quali
22、ty system requirements covering the various aspects for design, development, production, supply, installation and servicing are given in AS/NZS ISO 9001:2000, Quality management systemsRequirements, and these requirements can be applied to health care products. Certain processes used in the manufact
23、ure of health care products are considered to be special (as described in the AS/NZS ISO 9000 series of Standards) in that the result cannot be fully verified by subsequent inspection or testing of the product. Sterilization is an example of a special process because efficacy cannot be verified by i
24、nspection or testing of the product. For this reason, sterilization processes must be validated before use, the process routinely monitored and controlled, and the equipment maintained. There are many references in this Standard to using the manufacturers written instructions. However, there are occ
25、asions when such instructions may still be inadequate and it is recommended that on-site testing be undertaken. Further clarification of these instructions should be sought from the manufacturer. The terms normative and informative have been used in the Standard to define the application of the Appe
26、ndix to which they apply. A normative appendix in an integral part of a Standard, whereas an informative appendix is only for information and guidance. Accessed by UNIVERSITY OF SOUTH AUSTRALIA on 12 Dec 2008 AS/NZS 4187:2003 3 In addition to the referenced documents appearing in Clause 1.2, Appendi
27、x K lists additional documents which are considered useful sources of information on the subject of this Standard. Mandatory statements in footnotes to Tables are deemed to be requirements of this Standard. Accessed by UNIVERSITY OF SOUTH AUSTRALIA on 12 Dec 2008 AS/NZS 4187:2003 4 CONTENTS Page FOR
28、EWORD7 SECTION 1 SCOPE AND GENERAL 1.1 SCOPE.9 1.2 REFERENCED DOCUMENTS.9 1.3 DEFINITIONS.11 1.4 PROCESSING ENVIRONMENT16 1.5 REPROCESSING OF INSTRUMENTS AND EQUIPMENT16 SECTION 2 CLEANING AND HANDLING OF USED ITEMS 2.1 WATER QUALITY FOR CLEANING .17 2.2 INITIAL TREATMENT OF USED ITEMS.17 2.3 COLLEC
29、TION PROCEDURES.18 2.4 COLLECTION EQUIPMENT .18 2.5 CLEANING AREA18 2.6 SORTING OF ITEMS IN THE STERILIZING PROCESSING FACILITY PRIOR TO CLEANING.19 2.7 CLEANING PRECAUTIONS19 2.8 CLEANING AGENTS.20 2.9 CLEANING METHODS21 2.10 DRYING OF ITEMS .26 2.11 MONITORING OF CLEANING PROCESSES.27 SECTION 3 PA
30、CKAGING AND WRAPPING OF ITEMS PRIOR TO STERILIZATION 3.1 GENERAL.28 3.2 PACK SIZE28 3.3 LABELLING OF PACKS AND BAGS PRIOR TO STERILIZATION.28 3.4 SPECIFIC PACKAGING AND WRAPPING REQUIREMENTS.28 3.5 METHODS OF WRAPPING.30 3.6 SEALING OF PACKS AND BAGS 33 SECTION 4 STERILIZING EQUIPMENT 4.1 GENERAL.35
31、 4.2 STEAM STERILIZERS.35 4.3 DRY HEAT STERILIZERS.39 4.4 LOW TEMPERATURE STERILIZERS AND LIQUID STERILANTS39 SECTION 5 LOADING OF STERILIZERS 5.1 FOR STEAM STERILIZATION41 5.2 FOR DRY HEAT STERILIZATION .41 5.3 FOR ETHYLENE OXIDE GAS STERILIZATION.42 5.4 FOR HYDROGEN PEROXIDE PLASMA STERILIZATION42
32、 5.5 FOR PERACETIC ACID LIQUID CHEMICAL STERILIZATION .42 5.6 EFFECT OF LOAD CONTENT AND MANNER OF LOADING.42 SECTION 6 UNLOADING OF STERILIZERS 6.1 STEAM STERILIZERS.43 6.2 DRY HEAT STERILIZERS.43 6.3 ETHYLENE OXIDE STERILIZERS.43 Accessed by UNIVERSITY OF SOUTH AUSTRALIA on 12 Dec 2008 AS/NZS 4187
33、:2003 5 6.4 HYDROGEN PEROXIDE PLASMA STERILIZERS44 6.5 PERACETIC ACID LIQUID CHEMICAL STERILIZATION SYSTEM44 6.6 MONITORING OF THE UNLOADING PROCEDURE .45 SECTION 7 PURCHASING, VALIDATION, MONITORING AND MAINTENANCE OF STERILIZERS AND ASSOCIATED EQUIPMENT 7.1 GENERAL.46 7.2 PURCHASING STERILIZERS AN
34、D ASSOCIATED EQUIPMENT .46 7.3 VALIDATION.46 7.4 RECOMMISSIONING AND PERFORMANCE REQUALIFICATION OF THE STERILIZER .48 7.5 CALIBRATION OF STERILIZER48 7.6 MONITORING OF STERILIZERS.49 7.7 MAINTENANCE OF STERILIZERS57 7.8 ASSOCIATED EQUIPMENT57 SECTION 8 QUALITY MANAGEMENT 8.1 STERILIZING PROCESSING
35、FACILITY MANAGEMENT.61 8.2 DOCUMENTATION.61 8.3 PERFORMANCE MANAGEMENT .61 8.4 EDUCATION AND TRAINING .62 8.5 MATERIALS MANAGEMENT63 8.6 MONITORING STERILIZING CYCLES65 8.7 VALIDATION PROCESSES.69 8.8 CRITERIA FOR RELEASE OF PROCESSED ITEMS.69 8.9 MONITORING OF PACKAGING FOLLOWING STERILIZATION 70 8
36、.10 OCCUPATIONAL HEALTH AND SAFETY .70 8.11 ENVIRONMENTAL CONTROL71 8.12 EVALUATION, FEEDBACK AND OUTCOMES71 8.13 OFF-SITE REPROCESSING.71 SECTION 9 STORAGE AND HANDLINGOF PROCESSED ITEMS 9.1 GENERAL.72 9.2 STORAGE AREAS FOR STERILE ITEMS72 9.3 PLASTIC DUST COVERS73 9.4 TRANSPORTATION/DISTRIBUTION O
37、F STERILE ITEMS.73 9.5 COMMERCIALLY PREPARED ITEMS74 9.6 SHELF-LIFE/ROTATION OF STOCK.74 SECTION 10 DISINFECTION 10.1 GENERAL.75 10.2 MEANS OF DISINFECTION75 SECTION 11 CLEANING OF THE STERILIZING PROCESSING FACILITY AND ASSOCIATED EQUIPMENT 11.1 GENERAL.77 11.2 EQUIPMENT.77 11.3 WASTE DISPOSAL77 Ac
38、cessed by UNIVERSITY OF SOUTH AUSTRALIA on 12 Dec 2008 AS/NZS 4187:2003 6 SECTION 12 SELECTION AND CARE OF INSTRUMENTS 12.1 GENERAL.78 12.2 GENERAL CONSIDERATIONS 78 12.3 SPECIAL CONSIDERATIONS.79 12.4 SPECIALIZED INSTRUMENTS 80 12.5 USE OF INSTRUMENT SHEATHS/SLEEVES82 SECTION 13 USE OF OPERATING RO
39、OM TEXTILES 13.1 GENERAL.83 13.2 SPECIFIC CONSIDERATIONS83 13.3 INSPECTION 83 13.4 MENDING.83 13.5 EQUIPMENT.84 APPENDICES A RATIONALE.85 B CARE AND HANDLING OF POWERED TOOLS.100 C CARE AND HANDLING OF FLEXIBLE AND RIGID ENDOSCOPES, ACCESSORY ITEMS AND ASSOCIATED EQUIPMENT102 D GUIDE TO THE SELECTIO
40、N OF CLEANING AGENTS.111 E SELECTION AND USE OF RIGID REUSABLE STERILIZATION CONTAINERS 112 F HEAT SEALING EQUIPMENT115 G GUIDELINES FOR THE SELECTION OF PORTABLE (BENCHTOP) STERILIZERS IN HEALTH CARE FACILITIES.116 H VALIDATION PROTOCOL FOR MOIST HEAT STERILIZATION PROCESS.117 I METHOD FOR MEASUREM
41、ENT OF TEMPERATURE AND PRESSURE IN STEAM STERILIZERS, OR TEMPERATURE ONLY IN DRY HEAT STERILIZERS.121 J HANDWASHING125 K BIBLIOGRAPHY127 Accessed by UNIVERSITY OF SOUTH AUSTRALIA on 12 Dec 2008 AS/NZS 4187:2003 7 FOREWORD This Standard reflects the conscientious efforts of health care professionals
42、representing national and state health authorities, professional associations and interested manufacturers in Australia and New Zealand, to develop minimum standards in the processing of items which are required to be clean, disinfected or sterile. It is intended that the principles of this Standard
43、 be taken as universally applicable. Therefore, this Standard should be used as a basis by those responsible for sterilizing items in health care facilities to work towards a situation of excellence and adapt it to the special needs of their particular facility. There are a number of agents availabl
44、e to health care facilities to free items from viable organisms. They include the following: (a) Moist heatsteam under pressure. (b) Dry heathot air sterilization. (c) Chemicalethylene oxide gas and other low temperature sterilizing processes, e.g. hydrogen peroxide plasma peracetic acid. (d) Filtra
45、tionfilter treatment. Moist heat, in the form of steam under pressure, is the most dependable, quickest and most economical medium known for the destruction of microbial life. In the 1930s, with the advent of thermometers being added to steam sterilizer drain lines, sterilization ceased to be the un
46、scientific guesswork it had been previously. Pressure was the only indication of control with no means for measuring the temperature developed by the steam or the degree of air elimination. Since then, a clear understanding of the scientific principles of sterilization has emerged with the result th
47、at supplies in health care facilities can now be sterilized with greater economy, increased safety, and a higher degree of precision than ever before. The process, by which microorganisms are destroyed when subjected to this form of heat, is closely linked to the alteration by coagulation of the pro
48、tein matter in the microbial cell. Dry heat sterilization, using hot dry air, has been used since the latter part of the nineteenth century. Sterilizers of today are made with specially designed perforated convection chambers with heating elements and fans. The process by which microorganisms are de
49、stroyed, when subjected to this form of heat, is by oxidation. Chemical sterilization, involving ethylene oxide gas, has been used as a fumigant since its discovery in the latter part of the nineteenth century. However, it was not until the late 1930s that it was used as an effective sterilizing agent. Due to its high toxicity, the use of ethylene oxide gas in health care facilities is restricted (see Federal and State regulations). The process by which microorganisms are destroyed, when subjected to this medium, is by alkylation of the protein m