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 978-0-626-22068-6 SANS 15883-2:2008Edition 1 ISO 15883-2:2006Edition 1SOUTH AFRICAN NATIONAL STANDARD Washer-disinfectors Part 2: Requirements and t
4、ests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc. This national standard is the identical implementation of ISO 15883-2:2006 and is adopted with the permission of the International Organiza
5、tion for Standardization. Published by SABS Standards Division 1 Dr Lategan Road Groenkloof Private Bag X191 Pretoria 0001Tel: +27 12 428 7911 Fax: +27 12 344 1568 www.sabs.co.za SABS SANS 15883-2:2008 Edition 1 ISO 15883-2:2006 Edition 1 Table of changes Change No. Date Scope National foreword This
6、 South African standard was approved by National Committee SABS SC 1039E, 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 publi
7、shed in December 2008. Reference numberISO 15883-2:2006(E)ISO 2006INTERNATIONAL STANDARD ISO15883-2First edition2006-04-15Washer-disinfectors Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receiver
8、s, utensils, glassware, etc. Laveurs dsinfecteurs Partie 2: Exigences et essais pour laveurs dsinfecteurs destins la dsinfection thermale des instruments chirurgicaux, du matriel danesthsie, des rcipients, des ustensiles et de la verrerie, etc. SANS 15883-2:2008This s tandard may only be used and pr
9、inted by approved subscription and freemailing clients of the SABS .ISO 15883-2:2006(E) PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobes licensing policy, this file may be printed or viewed but shall not be edited unless the typefaces which are embedded are lice
10、nsed 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 liability in this area. Adobe is a trademark of Adobe Systems Incorporated. Details of t
11、he software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In the unlikely event that a problem relating
12、to it is found, please inform the Central Secretariat at the address given below. ISO 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 p
13、ermission 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 Fax + 41 22 749 09 47 E-mail copyrightiso.org Web www.iso.org Published in Switzerland ii ISO 2006 All rights r
14、eservedSANS 15883-2:2008This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .ISO 15883-2:2006(E) ISO 2006 All rights reserved iiiContents Page Foreword iv Introduction v 1 Scope . 1 2 Normative references . 1 3 Terms and definitions. 2 4 Performan
15、ce requirements 2 4.1 General. 2 4.2 Cleaning. 3 4.3 Disinfecting . 3 4.4 Temperature of internal surfaces of processed devices 4 5 Mechanical and control requirements 4 5.1 Load connectors . 4 5.2 Control systems 5 5.3 Process verification 5 6 Testing for conformity 5 6.1 General. 5 6.2 Tests for s
16、oil removal from chamber walls, load carrier and load 5 6.3 Thermometric tests. 6 7 Information to be supplied by the manufacturer. 8 8 Information to be requested from the purchaser by the supplier of the WD 8 Annex A (informative) Summary of test programmes 9 Bibliography . 10 SANS 15883-2:2008Thi
17、s s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .ISO 15883-2:2006(E) iv ISO 2006 All rights reservedForeword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The
18、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, governmental and non-gover
19、nmental, 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 ISO/IEC Directives, Part 2. Th
20、e 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 member bodies casting a vote
21、. 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 15883-2 was prepared by the European Committee for Standardization (CEN) Technical Committee CE
22、N/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 parts, under the general titl
23、e 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. Part 3: Requirements and tes
24、ts 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 Technical specification SANS 1588
25、3-2:2008This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .ISO 15883-2:2006(E) ISO 2006 All rights reserved vIntroduction It is recommended that this Introduction be read in conjunction with the introduction to ISO 15883-1:2006. This part of ISO
26、 15883 is the second of a series of standards specifying the performance of washer-disinfectors and specifies the general requirements for performance applicable to instrument washer-disinfectors. The requirements given in this part apply to washer-disinfectors used for cleaning and thermal disinfec
27、tion of medical devices intended for re-use such as: surgical instruments; powered devices; instrument trays; instruments for minimally invasive surgery; lumen devices and tubing; rigid endoscopes; anaesthetic and respiratory equipment; bowls, dishes and receivers; glassware; containers for transit.
28、 Fields of application within the scope of the ISO 15883 series of standards include laboratory, veterinary, dental and pharmaceutical applications and other specific applications, such as washer-disinfectors for bedsteads and transport carts and the disinfection of crockery and cutlery intended for
29、 use with immunologically compromised patients. Requirements for washer-disinfectors for other applications are specified in other parts of the ISO 15883 series of standards. When processed in the instrument washer-disinfector, the medical devices might be intended for immediate use or might be inte
30、nded for packing and sterilization. In both cases, the efficacy of the cleaning and disinfection is of major importance. In either case, this is for the well being of the patient. In the latter case, it is also for the safety of the staff who handles the instruments in the process of inspection, tes
31、ting and packing as well as ensuring that the sterilization process is not unduly challenged by residual soil. The efficacy of disinfection can be impaired if soil removal is incomplete before the start of the disinfection process. Users should be aware that some medical devices might require pre-tr
32、eatment e.g. soaking, brushing, ultra sonic pre-cleaning, lumen irrigation or any combination of these techniques. Reference should be made to the medical manufacturers instructions for reprocessing (see also ISO 17664). Safety requirements for washer-disinfectors are given in IEC 61010-2-045. SANS
33、15883-2:2008This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .ISO 15883-2:2006(E) vi ISO 2006 All rights reservedIn respect of the potential adverse effects on the quality of water intended for human consumption caused by the washer-disinfector
34、s: a) it should be noted 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) the ISO 15883 series of standards provides no information as to whether the washer-disinfectors ma
35、y be used without restriction in any of the member states of the EU or EFTA. SANS 15883-2:2008This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .INTERNATIONAL STANDARD ISO 15883-2:2006(E) ISO 2006 All rights reserved 1Washer-disinfectors Part 2:
36、 Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc. 1 Scope This part of ISO 15883 specifies particular requirements for washer-disinfectors (WD) that are intended for use
37、for the cleaning and thermal disinfection, in a single operating cycle, of re-usable medical devices such as surgical instruments, anaesthetic equipment, bowls, dishes and receivers, utensils and glassware. NOTE 1 Thermal disinfection can be achieved by rinsing the load with hot water, exposure to s
38、team or combination of the two. The requirements specified in this part of ISO 15883 are applicable in conjunction with the general requirements specified in ISO 15883-1. The specified performance requirements of this part of ISO 15883 may not ensure the inactivation or removal of the causative agen
39、t(s) (prion protein) of transmissible spongiform encephalopathies. NOTE 2 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 chemicals used do not react with the prion protein in a manner that may inh
40、ibit its removal or inactivation. 2 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 (including any amendments) a
41、pplies. ISO 4017, Hexagon head screws Product grades A and B ISO 5356-2, Anaesthetic and respiratory equipment Conical connectors Part 2: Screw-threaded weight-bearing connectors ISO 5361, Anaesthetic and respiratory equipment Tracheal tubes and connectors ISO 5362, Anaesthetic reservoir bags ISO 53
42、67, Breathing tubes intended for use with anaesthetic apparatus and ventilators ISO 15883-1:2006, Washer-disinfectors Part 1: General requirements, definitions and tests ISO 17664, Sterilization of medical devices Information to be provided by the manufacturer for the processing of resterilizable me
43、dical devices SANS 15883-2:2008This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .ISO 15883-2:2006(E) 2 ISO 2006 All rights reservedISO/TS 15883-5:2005, Washer-disinfectors Part 5: Test soils and methods for demonstrating cleaning efficacy EN 10
44、088-2, Stainless steels Part 2: Technical delivery conditions for sheet/plate and strip for general purposes 3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO 15883-1 and the following apply. 3.1 A0equivalent time in seconds at 80 C, delivered by the d
45、isinfection process, with reference to a microorganism with a z value of 10 K ISO 15883-1:2006, definition 3.1 NOTE See also ISO 15883-1:2006, Annex B. 3.2 anaesthetic and respiratory accessories respiratory tubes, anaesthetic reservoir bags and other anaesthetic products that will not be sufficient
46、ly flushed by rotating spray nozzles, but which require positioning over fixed spray/jet nozzles 3.3 lumen device device that consists of tubes, pipes (either single or coaxial combined) which require connecting to the WD by means of dedicated connectors 3.4 powered device surgical instrument which
47、gives a rotating and/or oscillating movement to other surgical instruments NOTE The power applied to the driven instrument can be mechanical (from a motor, either through direct coupling, flexible axle or belt) or by the flow of a pressurized fluid or compressed air. EXAMPLES Dental hand pieces, ort
48、hopaedic saws and drills. 3.5 washing temperature minimum temperature of the washing temperature band 3.6 washing temperature band range of temperatures, expressed as the washing temperature and the maximum allowable temperature which may prevail throughout the load during the washing time 3.7 washi
49、ng time period for which the cycle variables (e.g. temperature of the load, detergent concentration in the chamber) are maintained at or above the values specified for washing 4 Performance requirements 4.1 General 4.1.1 The requirements of ISO 15883-1:2006 apply with the exception of its SANS 15883-2:2008This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .ISO 15883-2:2006(E) ISO 2006 All rights reserved 3 subclause 4.3.2 (whic
