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1、 Reference number ISO 15883-2:2006(E) ISO 2006 INTERNATIONAL STANDARD ISO 15883-2 First edition 2006-04-15 Washer-disinfectors Part 2: Requirements and tests for washer- disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, g
2、lassware, 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. Copyright International Organization for Standardization Provided by
3、IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/20/2007 03:01:51 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 15883-2:2006(E) PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobes licensing
4、 policy, this file may be printed or 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 Cen
5、tral Secretariat accepts no liability in this area. Adobe is a trademark of Adobe Systems Incorporated. Details of the 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 ta
6、ken to ensure that the file is suitable 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. ISO 2006 All rights reserved. Unless otherwise specified, no part of this publication may be reproduce
7、d 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 country of the requester. ISO copyright office Case postale 56 CH-1211 Geneva 20 Tel. + 41 22 749 0
8、1 11 Fax + 41 22 749 09 47 E-mail copyrightiso.org Web www.iso.org Published in Switzerland ii ISO 2006 All rights reserved Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/20/2007 03:01:
9、51 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 15883-2:2006(E) ISO 2006 All rights reserved iii Contents Page Foreword iv Introduction v 1 Scope . 1 2 Normative references. 1 3 Terms and definitions. 2 4 Performance requirements 2 4.1 General. 2 4.2 Cleaning. 3 4.3
10、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 soil removal from chamber walls, load carrier and load
11、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 Copyright International Organization for Standardization Provided by IHS un
12、der license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/20/2007 03:01:51 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 15883-2:2006(E) iv ISO 2006 All rights reserved Foreword ISO (the International Organization for Standardization) is a
13、 worldwide federation of national standards bodies (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 represente
14、d on that committee. International organizations, 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 draf
15、ted in accordance with the rules given in the ISO/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 Sta
16、ndard requires approval by at least 75 % of the 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 15883-2 was prepare
17、d by the European Committee for Standardization (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 A
18、greement). ISO 15883 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, bowl
19、s, dishes, receivers, 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 m
20、ethods for demonstrating cleaning efficacy Technical specification Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/20/2007 03:01:51 MDTNo reproduction or networking permitted without lic
21、ense from IHS -,-,- ISO 15883-2:2006(E) ISO 2006 All rights reserved v Introduction It is recommended that this Introduction be read in conjunction with the introduction to ISO 15883-1:2006. This part of ISO 15883 is the second of a series of standards specifying the performance of washer- disinfect
22、ors 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 disinfection of medical devices intended for re-use such as: surgical instruments; powered devices;
23、 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. Fields of application within the scope of the ISO 15883 series of standards include labora
24、tory, 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 use with immunologically compromised patients. Requirements for washer-disinfectors for ot
25、her 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 intended for packing and sterilization. In both cases, the efficacy of the cleaning and disinfe
26、ction 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, testing and packing as well as ensuring that the sterilization process is not unduly challenge
27、d 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-treatment e.g. soaking, brushing, ultra sonic pre-cleaning, lumen irrigation or any combinati
28、on 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. Copyright International Organization for Standardization Provided by IHS under license with ISO
29、Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/20/2007 03:01:51 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 15883-2:2006(E) vi ISO 2006 All rights reserved In respect of the potential adverse effects on the quality of water intended for human cons
30、umption caused by the washer-disinfectors: 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
31、as to whether the washer-disinfectors may be used without restriction in any of the member states of the EU or EFTA. Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/20/2007 03:01:51 MDTN
32、o reproduction or networking permitted without license from IHS -,-,- INTERNATIONAL STANDARD ISO 15883-2:2006(E) ISO 2006 All rights reserved 1 Washer-disinfectors Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, b
33、owls, dishes, receivers, utensils, glassware, etc. 1 Scope This part of ISO 15883 specifies particular requirements for washer-disinfectors (WD) that are intended for use for the cleaning and thermal disinfection, in a single operating cycle, of re-usable medical devices such as surgical instruments
34、, 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 steam or combination of the two. The requirements specified in this part of ISO 15883 are applicable in conjunction with the gener
35、al 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 agent(s) (prion protein) of transmissible spongiform encephalopathies. NOTE 2 If it is considered that prion protein can be present,
36、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. 2 Normative references The following referenced documents are indispensable for the application
37、 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 4017, Hexagon head screws Product grades A and B ISO 5356-2, Anaesthetic and respiratory equipment Conical connectors
38、 Part 2: Screw-threaded weight- bearing connectors ISO 5361, Anaesthetic and respiratory equipment Tracheal tubes and connectors ISO 5362, Anaesthetic reservoir bags ISO 5367, Breathing tubes intended for use with anaesthetic apparatus and ventilators ISO 15883-1:2006, Washer-disinfectors Part 1: Ge
39、neral requirements, definitions and tests ISO 17664, Sterilization of medical devices Information to be provided by the manufacturer for the processing of resterilizable medical devices Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Tech
40、nical Standards 1/9972545001 Not for Resale, 04/20/2007 03:01:51 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 15883-2:2006(E) 2 ISO 2006 All rights reserved ISO/TS 15883-5:2005, Washer-disinfectors Part 5: Test soils and methods for demonstrating cleaning efficacy EN
41、 10088-2, 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 A0 equivalent time in seconds at 80 C, delivered by t
42、he disinfection 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 suffic
43、iently 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 wh
44、ich 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,
45、 orthopaedic 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 w
46、ashing 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 Copyri
47、ght International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/20/2007 03:01:51 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 15883-2:2006(E) ISO 2006 All rights reserved 3 su
48、bclause 4.3.2 (which refers to chemical disinfection, see Scope of this part of ISO 15883); subclause 5.7.5 (which refers to the accuracy of dosing systems; see 4.1.6 of this part of ISO 15883). 4.1.2 The WD shall be designed to clean and thermally disinfect specified medical devices that are intended by the device manufacturer to be reused and are designated as compatible with the WD process cycle in accordance with the device m