SANS 15883-4-2008 Washer-disinfectors Part 4 Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes《洗衣机消毒剂 第4部分 不耐热内窥镜化学消毒的洗衣机消毒.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 978-0-626-22069-3 SANS 15883-4:2008Edition 1 ISO 15883-4:2008Edition 1SOUTH AFRICAN NATIONAL STANDARD Washer-disinfectors Part 4: Requirements and t

4、ests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes This national standard is the identical implementation of ISO 15883-4:2008 and is adopted with the permission of the International Organization for Standardization. Published by SABS Standards Division 1 Dr Late

5、gan Road Groenkloof Private Bag X91 Pretoria 0001 Tel: +27 12 428 7911 Fax: +27 12 344 1568 www.sabs.co.za SABS SANS 15883-4:2008 Edition 1 ISO 15883-4:2008 Edition 1 Table of changes Change No. Date Scope National foreword This South African standard was approved by National Committee SABS SC 1039E

6、, Medical devices Healthcare devices and materials for 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 15883-4:2008(E)ISO 2008INTERN

7、ATIONAL STANDARD ISO15883-4First edition2008-05-01Washer-disinfectors Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopesLaveurs dsinfecteurs Partie 4: Exigences et essais pour les laveurs dsinfecteurs destins la dsinfection chimique des

8、 endoscopes thermolabiles SANS 15883-4:2008This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .ISO 15883-4:2008(E) PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobes licensing policy, this file may be printed o

9、r viewed but shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In downloading this file, parties accept therein the responsibility of not infringing Adobes licensing policy. The ISO Central Secretariat accepts no liabili

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11、able for use by ISO member bodies. In the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below. COPYRIGHT PROTECTED DOCUMENT ISO 2008 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or u

12、tilized 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 country of the requester. ISO copyright office Case postale 56 CH-1211 Geneva 20 Tel. + 41 22 749 01 11 F

13、ax + 41 22 749 09 47 E-mail copyrightiso.org Web www.iso.org Published in Switzerland ii ISO 2008 All rights reservedSANS 15883-4:2008This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .ISO 15883-4:2008(E) ISO 2008 All rights reserved iiiContents

14、 Page Foreword. v Introduction . vi 1 Scope . 1 2 Normative references . 2 3 Terms and definitions. 2 4 Performance requirements 3 4.1 General. 3 4.2 Systems for leak testing 4 4.3 Cleaning. 6 4.4 Disinfecting . 7 4.5 Final (post-disinfection) rinsing 9 4.6 Purging to remove rinse water 9 4.7 Drying

15、. 9 4.8 Self-disinfection 10 4.9 Water treatment equipment . 11 5 Mechanical and process requirements 12 5.1 Materials Design, manufacture and construction. 12 5.2 Device channel irrigation system 12 5.3 Venting and drainage systems 13 5.4 Temperature control. 14 5.5 Process chemicals 14 5.6 Process

16、 verification 14 5.7 Dosing systems 14 6 Testing for conformity 14 6.1 General. 14 6.2 Test equipment . 15 6.3 Water used for final (post-disinfection) rinsing. 15 6.4 Hardness of water used during type testing 15 6.5 Leak test 16 6.6 Channels non-obstruction test 18 6.7 Channels non-connection test

17、 19 6.8 Load dryness. 20 6.9 Thermometric tests. 20 6.10 Chemical dosing tests 21 6.11 Tests of cleaning efficacy 22 6.12 Test of disinfection efficacy 23 7 Documentation and inspection . 27 8 Information to be supplied by the manufacturer. 27 9 Marking, labelling and packaging . 28 10 Information t

18、o be requested from the purchaser by the manufacturer 28 Annex A (informative) Summary of activities covered by this Part of ISO 15883 29 Annex B (normative) Microbiological testing of the efficacy of chemical disinfection of the load. 31 Annex C (informative) Summary of test programmes 34 Annex D (

19、normative) Methods for microbiological evaluation of disinfection of liquid transport system 35 SANS 15883-4:2008This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .ISO 15883-4:2008(E) iv ISO 2008 All rights reservedAnnex E (normative) Tests for

20、microbial contamination of post-disinfection rinse water. 40 Annex F (informative) Typical specifications of trumpet valves and connection ports 41 Annex G (informative) Additional notes on microbiological testing of chemical disinfection processes. 46 Bibliography . 48 SANS 15883-4:2008This s tanda

21、rd may only be used and printed by approved subscription and freemailing clients of the SABS .ISO 15883-4:2008(E) ISO 2008 All rights reserved vForeword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of pr

22、eparing 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, governmental and non-governmental, i

23、n 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 ISO/IEC Directives, Part 2. The main tas

24、k 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 member bodies casting a vote. Attentio

25、n 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 15883-4 was prepared by Technical Committee ISO/TC 198, Sterilization of health care products. ISO 15883

26、consists of the following parts, 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,

27、 utensils, glassware, etc. 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 demonstrat

28、ing cleaning efficacy SANS 15883-4:2008This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .ISO 15883-4:2008(E) vi ISO 2008 All rights reservedIntroduction It is recommended that this introduction be read in conjunction with the introduction to IS

29、O 15883-1. The washer-disinfectors specified in this part of ISO 15883 are intended to process devices which can be immersed in water or aqueous solutions. For some devices this will require that, prior to processing, relevant parts of the device are protected from immersion in accordance with the d

30、evice manufacturers operating instructions. Fields of application within the scope of the ISO 15883 series include laboratory, veterinary, dental and pharmaceutical applications and other specific applications, such as washer-disinfectors for bedsteads and transport carts and the disinfection of cro

31、ckery and cutlery intended for use with immunologically compromised patients. Requirements for washer-disinfectors for other applications are specified in other parts of ISO 15883. Safety requirements for washer-disinfectors are given in IEC 61010-2-040. With respect to the potential adverse effects

32、 on the quality of water intended for human consumption caused by the washer-disinfectors: a) note that, until verifiable European criteria are adopted, existing national regulations concerning the use and/or the characteristics of the washer-disinfectors remain in force; b) this part of ISO 15883 p

33、rovides no information as to whether the washer-disinfectors may be used without restriction in any of the member states of the EU or EFTA. SANS 15883-4:2008This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .INTERNATIONAL STANDARD ISO 15883-4:20

34、08(E) ISO 2008 All rights reserved 1Washer-disinfectors Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes 1 Scope This part of ISO 15883 specifies the particular requirements, including performance, for washer-disinfectors (WDs) that a

35、re intended to be used for cleaning and chemical disinfection of thermolabile endoscopes. This part of ISO 15883 also specifies the performance requirements for the cleaning and disinfection of the washer-disinfector and its components and accessories which may be required to achieve the necessary p

36、erformance. The methods, instrumentation and instructions required for type testing, works testing, validation (installation, operational and performance qualification on first installation), routine control and monitoring and re-validation, periodically and after essential repairs, are also specifi

37、ed. NOTE 1 In addition, Annex A gives guidance on an appropriate division of responsibility for the range of activities covered by this part of ISO 15883. NOTE 2 WDs complying with this part of ISO 15883 can also be used for cleaning and chemical disinfection of other thermolabile re-usable medical

38、devices for which the device manufacturer has recommended this method of disinfection. WDs complying with the requirements of this part of ISO 15883 are not intended for cleaning and disinfection of medical devices, including endoscopic accessories, which are heat stable and can be disinfected or st

39、erilized by thermal methods (see ISO 15883-1:2006, 4.1.5). The specified performance requirements of this part of ISO 15883 may not ensure the inactivation or removal of the causative agent(s) (prion protein) of transmissible spongiform encephalopathies. NOTE 3 If it is considered that prion protein

40、 might be present, particular care is needed in the choice of disinfectants and cleaning agents to ensure that the chemicals used do not react with the prion protein in a manner that may inhibit its removal or inactivation from the load or washer-disinfector. This part of ISO 15883 can be used by pr

41、ospective purchasers and manufacturers as the basis of agreement on the specification of WD manufacturers of endoscopes, cleaning products, disinfecting products, and also by users. SANS 15883-4:2008This s tandard may only be used and printed by approved subscription and freemailing clients of the S

42、ABS .ISO 15883-4:2008(E) 2 ISO 2008 All rights reserved2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (includ

43、ing any amendments) applies. ISO 11731-2, Water quality Detection and enumeration of Legionella Part 2: Direct membrane filtration method for waters with low bacterial counts ISO 15883-1:2006, Washer-disinfectors Part 1: General requirements, terms and definitions and tests ISO/TS 15883-5:2005, Wash

44、er-disinfectors Part 5: Test soils and methods for demonstrating cleaning efficacy IEC 61010-2-040, Safety requirements for electrical equipment for measurement, control, and laboratory use Part 2-040: Particular requirements for sterilizers and washer-disinfectors used to treat medical materials 3

45、Terms and definitions For the purposes of this document, the terms and definitions given in ISO 15883-1 and the following apply. 3.1 air break physical separation in water supply pipes to prevent back syphonage into the water supply from a device connected to it NOTE See EN 1717. 3.2 inoculated carr

46、ier supporting material on or in which a defined number of viable test organisms has been deposited ISO 11138-1:2006, definition 3.10 3.3 leak test test intended to establish that the surface covering the device and/or lining a device channel is intact to the extent necessary to maintain a slightly

47、positive pressure 3.4 liquid transport systems those components of the washer-disinfector used to store, pump or transport water and/or solutions within the washer-disinfector, excluding pipework before the air break 3.5 microbial inactivation factor measured change in microbial population, expresse

48、d as log10, caused by the lethal effect of the disinfectant 3.6 microbial reduction factor measured change in microbial population expressed as log10caused by the combination of the microbial inactivation factor and the physical removal of microorganisms 3.7 obstruction partial or complete blockage

49、SANS 15883-4:2008This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .ISO 15883-4:2008(E) ISO 2008 All rights reserved 33.8 self-disinfection cycle operating cycle under the control of the automatic controller, for use without any load in the washer-disinfector, which is intended to disinfect all liquid transport systems piping, chamber(s), tanks and other components which come into contact with the water and/or solutions used for cleaning, disinfecting and r