SANS 15883-1-2008 Washer-disinfectors Part 1 General requirements terms and definitions and tests《洗衣机消毒剂 第1部分 一般要求、术语及定义及测试》.pdf

1、 Collection of SANS standards in electronic format (PDF) 1. Copyright This standard is available to staff members of companies that have subscribed to the complete collection of SANS standards in accordance with a formal copyright agreement. This document may reside on a CENTRAL FILE SERVER or INTRA

2、NET SYSTEM only. Unless specific permission has been granted, this document MAY NOT be sent or given to staff members from other companies or organizations. Doing so would constitute a VIOLATION of SABS copyright rules. 2. Indemnity The South African Bureau of Standards accepts no liability for any

3、damage whatsoever than may result from the use of this material or the information contain therein, irrespective of the cause and quantum thereof. ISBN 978-0-626-22067-9 SANS 15883-1:2008Edition 1 ISO 15883-1:2006Edition 1SOUTH AFRICAN NATIONAL STANDARD Washer-disinfectors Part 1: General requiremen

4、ts, terms and definitions and tests This national standard is the identical implementation of ISO 15883-1:2006 and is adopted with the permission of the International Organization for Standardization. Published by SABS Standards Division 1 Dr Lategan Road Groenkloof Private Bag X191 Pretoria 0001Tel

5、: +27 12 428 7911 Fax: +27 12 344 1568 www.sabs.co.za SABS SANS 15883-1:2008 Edition 1 ISO 15883-1:2006 Edition 1 Table of changes Change No. Date Scope National foreword This South African standard was approved by National Committee SABS SC 1039E, Medical devices Healthcare devices and materials fo

6、r use in clinics and hospitals, in accordance with procedures of the SABS Standards Division, in compliance with annex 3 of the WTO/TBT agreement. This SANS document was published in December 2008. Reference numberISO 15883-1:2006(E)ISO 2006INTERNATIONAL STANDARD ISO15883-1First edition2006-04-15Was

7、her-disinfectors Part 1: General requirements, terms and definitions and tests Laveurs dsinfecteurs Partie 1: Exigences gnrales, termes et dfinitions et essais SANS 15883-1:2008This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .ISO 15883-1:2006(

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11、 2006 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISOs member body in the

12、country of the requester. ISO copyright office Case postale 56 CH-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax + 41 22 749 09 47 E-mail copyrightiso.org Web www.iso.org Published in Switzerland ii ISO 2006 All rights reservedSANS 15883-1:2008This s tandard may only be used and printed by approved subsc

13、ription and freemailing clients of the SABS .ISO 15883-1:2006(E) ISO 2006 All rights reserved iiiContents Page Foreword. v Introduction . vi 1 Scope . 1 2 Normative references . 1 3 Terms and definitions. 2 4 Performance requirements 8 4.1 General. 8 4.2 Cleaning. 10 4.3 Disinfection . 10 4.4 Rinsin

14、g. 11 4.5 Drying. 11 4.6 Process chemicals 12 5 Mechanical and process requirements 12 5.1 Materials, design and manufacture/construction 12 5.2 Safety . 14 5.3 Calorifiers and tanks 14 5.4 Loading and unloading doors and their controls 15 5.5 Pipework and fittings 17 5.6 Spray systems. 17 5.7 Dosin

15、g systems 18 5.8 Load temperature protection. 18 5.9 Process temperature control limits 19 5.10 Switches, gauges and indicating devices 20 5.11 Process verification 20 5.12 Instrumentation and controls 21 5.13 Temperature indicating systems. 22 5.14 Pressure indicating systems . 23 5.15 Timing equip

16、ment. 23 5.16 Operating cycle indicating equipment 23 5.17 Recording instruments (if fitted). 23 5.18 Control systems 25 5.19 Override of automatic control . 26 5.20 Microprocessor control systems 27 5.21 Access to software . 27 5.22 Fault indication systems 27 5.23 Water supply . 28 5.24 Venting an

17、d drainage systems 28 5.25 Drainage. 29 5.26 Air filters installed within the WD 29 5.27 Load handling and supports for use within the WD . 29 5.28 Trolleys 30 5.29 Environment 31 6 Testing for conformity 31 6.1 General. 31 6.2 Test equipment . 34 6.3 Tests on doors, interlocks and fault indications

18、. 35 6.4 Tests on water quality and water volume 37 6.5 Tests on pipework 39 6.6 Tests on instrumentation fitted to the WD .41 SANS 15883-1:2008This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .ISO 15883-1:2006(E) iv ISO 2006 All rights reserve

19、d6.7 Tests on load carriers. 42 6.8 Thermometric tests. 43 6.9 Chemical dosing tests 46 6.10 Tests of cleaning efficacy 47 6.11 Tests of air quality 48 6.12 Load dryness test . 49 6.13 Automatic control test 49 7 Documentation 50 8 Information to be supplied by the manufacturer . 50 8.1 General . 50

20、 8.2 Before delivery of the WD and for installation. 51 8.3 At delivery of the WD 51 9 Marking, labelling and packaging . 53 9.1 Marking and labelling . 53 9.2 Packaging 53 10 Information to be requested from the purchaser by the supplier of the WD 53 Annex A (informative) Test programme . 55 Annex

21、B (informative) A0concept Comparative lethality of moist heat processes 59 Annex C (normative) Test methods for the detection and assessment of residual proteinaceous contamination 63 Annex D (normative) Microbiological recovery medium for estimation of bacterial contamination of water. 68 Bibliogra

22、phy . 69 SANS 15883-1:2008This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .ISO 15883-1:2006(E) ISO 2006 All rights reserved vForeword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodi

23、es (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations

24、, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the IS

25、O/IEC Directives, Part 2. The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the

26、member bodies casting a vote. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 15883-1 was prepared by the European Committee for Standardization

27、(CEN) Technical Committee CEN/TC 102, Sterilizers for medical purposes, in collaboration with Technical Committee ISO/TC 198, Sterilization of health care products, in accordance with the Agreement on technical cooperation between ISO and CEN (Vienna Agreement). ISO 15883 consists of the following p

28、arts, under the general title Washer-disinfectors: Part 1: General requirements, terms and definitions and tests Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc.

29、Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes Part 5: Test soils and methods for demonstrating cleaning efficacy Techn

30、ical Specification SANS 15883-1:2008This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .ISO 15883-1:2006(E) vi ISO 2006 All rights reservedIntroduction This part of ISO 15883 is the first of a series of standards specifying the performance of was

31、her-disinfectors and specifies the general requirements for performance applicable to all washer-disinfectors. The requirements given in this part of ISO 15883 are applicable to all washer-disinfectors specified in subsequent parts of the ISO 15883 series, except insofar as they may be modified or a

32、dded to by a subsequent part, in which case the requirements of that particular part will apply. Fields of application within the scope of ISO 15883 series include laboratory, veterinary, dental and pharmaceutical applications and other specific applications, such as washer-disinfectors for bedstead

33、s and transport carts and the disinfection of crockery and cutlery intended for use with immunologically compromised patients. Washer-disinfectors should be used only for processing the type of loads specified by the manufacturer of the washer-disinfector. In selecting the appropriate washer-disinfe

34、ctor, reference should be made both to this part of ISO 15883 and to the relevant subsequent parts of ISO 15883 series. It is the users responsibility to ensure that the choice of type of washer-disinfector, operating cycle or quality of services or process chemicals is appropriate for any particula

35、r load. Safety requirements for washer-disinfectors are given in IEC 61010-2-045. This part of ISO 15883 has been prepared on the basis that each individual washer-disinfector will be subject to validation tests (commissioning and performance qualification on first installation) and that in use cont

36、inued compliance will be established by periodic tests carried out by, or on behalf of, the user. Verification of cleaning efficacy is a key aspect of establishing satisfactory performance of a washer-disinfector. The current state of knowledge has not permitted development of a single test method.

37、As an interim measure reference has been made to test methods which are currently being applied in a number of different countries. The specification for these test methods including their test soils can be found in ISO/TS 15883-5. It remains the intention of the Technical Committee of TC 198 to dev

38、elop a single test method. In respect of the potential adverse effects on the quality of water intended for human consumption caused by the washer-disinfector: a) it should be noted that, until verifiable European criteria are adopted, existing national regulations concerning the use and/or the char

39、acteristics of the washer-disinfector remain in force; b) the ISO 15883 series of standards provides no information as to whether the washer-disinfector may be used without restrictions in any of the member states of the EU or EFTA. SANS 15883-1:2008This s tandard may only be used and printed by app

40、roved subscription and freemailing clients of the SABS .INTERNATIONAL STANDARD ISO 15883-1:2006(E) ISO 2006 All rights reserved 1Washer-disinfectors Part 1: General requirements, terms and definitions and tests 1 Scope This part of ISO 15883 specifies general performance requirements for washer-disi

41、nfectors (WD) and their accessories that are intended to be used for cleaning and disinfection of re-usable medical devices and other articles used in the context of medical, dental, pharmaceutical and veterinary practice. It specifies performance requirements for cleaning and disinfection as well a

42、s for the accessories which can be required to achieve the necessary performance. The methods and instrumentation required for validation, routine control and monitoring and re-validation, periodically and after essential repairs, are also specified. The requirements for washer-disinfectors intended

43、 to process specific loads are specified in subsequent parts of this standard. For washer-disinfectors intended to process loads of two or more different types the requirements of all relevant parts of this standard apply. This part of ISO 15883 does not specify requirements intended for machines fo

44、r use for laundry or general catering purposes. This part of ISO 15883 does not include requirements for machines which are intended to sterilize the load, or which are designated as “sterilizers”, these are specified in other standards e.g. EN 285. The specified performance requirements of this sta

45、ndard may not ensure the inactivation or removal of the causative agent(s) (prion protein) of transmissible spongiform encephalopathies. NOTE If it is considered that prion protein can be present, particular care is needed in the choice of disinfectants and cleaning agents to ensure that the chemica

46、ls used do not react with the prion protein in a manner that may inhibit its removal or inactivation. This part of ISO 15883 may be used by prospective purchasers and manufacturers as the basis of agreement on the specification of a WD. The test methods for demonstration of compliance with the requi

47、rements of this part of ISO 15883 may also be employed by users to demonstrate continued compliance of the installed WD throughout its working life. Guidance on a routine test programme is given in Annex A. 2 Normative references The following referenced documents are indispensable for the applicati

48、on of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 228-1, Pipe threads where pressure-tight joints are not made on the threads Part 1: Dimensions, tolerances and desi

49、gnation ISO 7000, Graphical symbols for use on equipment Index and synopsis SANS 15883-1:2008This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .ISO 15883-1:2006(E) 2 ISO 2006 All rights reservedISO 10012, Measurement management systems Requirements for measurement processes and measuring equipment ISO 14644-3:2005, Cleanrooms and associated controlled environments Part 3: Test methods ISO 14971, Medical devices Application of risk management to medical devices ISO