ISO-15883-3-2006.pdf

Reference number ISO 15883-3:2006(E) © ISO 2006 INTERNATIONAL STANDARD ISO 15883-3 First edition 2006-04-15 Washer-disinfectors Part 3: Requirements and tests for washer- disinfectors employing thermal disinfection for human waste containers Laveurs désinfecteurs Partie 3: Exigences et essais pour laveurs désinfecteurs destinés à la désinfection thermale de récipients à déjections humaines Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/20/2007 03:01:57 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 15883-3:2006(E) PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobe's licensing 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 Adobe's licensing policy. The ISO Central 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 taken 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 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 ISO's 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 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 03:01:57 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 15883-3:2006(E) © ISO 2006 All rights reserved iii Contents Page Foreword iv Introduction v 1 Scope . 1 2 Normative references. 1 3 Terms and definitions. 1 4 Performance requirements 2 4.1 General. 2 4.2 Chemical dosing systems 2 4.3 Emptying 3 4.4 Cleaning. 3 4.4.1 Flushing. 3 4.4.2 Washing. 3 4.4.3 Test requirements. 3 4.5 Disinfecting . 3 4.6 Rinsing. 4 4.7 Drying. 4 5 Mechanical and control requirements 4 5.1 Instrumentation and control 4 5.2 Process 4 5.3 Venting, draining and purging. 4 5.4 Water quality . 5 6 Testing for conformity 5 6.1 General. 5 6.2 Test for drain seal integrity 5 6.3 Test for flushing of non-absorbent materials 5 6.4 Test for flushing of absorbent material (toilet tissue) 5 6.5 Test for loading/emptying of containers 5 6.5.1 Automatic emptying . 5 6.5.2 Manual emptying. 6 6.6 Tests for soil removal from chamber walls, load carrier and load 6 7 Information to be supplied by the manufacturer. 6 8 Information to be requested from the purchaser by the supplier of the WD 7 Annex A (informative) Summary of test programmes 8 Annex B (normative) Specification for toilet tissue for use in tests on washer-disinfectors for human-waste containers 9 Annex C (informative) Measurement of water absorbency of toilet tissue by the basket method 10 Bibliography. 11 Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/20/2007 03:01:57 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 15883-3:2006(E) iv © ISO 2006 All rights reserved Foreword ISO (the International Organization for Standardization) is a 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 represented 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 drafted 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 Standard 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 15883-3 was prepared 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 Agreement). 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, bowls, 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 methods 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 03:01:57 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 15883-3:2006(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. This part of ISO 15883 is the third of a series of standards specifying the performance of washer-disinfectors and specifies the general requirements for performance applicable to bedpan washer-disinfectors. The requirements given in this part apply to washer-disinfectors used for emptying, flushing, cleaning and thermally disinfecting human waste containers intended for re-use such as: portable sanitary pans; supports for single-use bed pans; hospital bowls; urine bottles; suction bottles; and products similar to the above and used for similar purposes. 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 use with immunologically compromised patients. Requirements for washer-disinfectors for other applications are specified in other parts the ISO 15883 series of standards. Bedpan washer disinfectors are loaded manually. In order to reduce the risk of spillage and the generation of aerosols most machines incorporate means to empty human waste containers automatically e.g. by the action of closing the door. Where equipment does not provide automatic emptying facilities, extra care is needed by the user to avoid exposure to human waste and contamination of the work environment including the generation of aerosols. The reliability of a bedpan washer-disinfector may be adversely affected if the machine is connected to a poorly designed or constructed drainage system. The purchaser is therefore recommended to ensure that the drainage system complies with the manufacturers recommendations in all respects. Safety requirements for washer-disinfectors are given in IEC 61010-2-045. In respect of the potential adverse effects 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 provides no information 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 03:01:57 MDTNo reproduction or networking permitted without license from IHS -,-,- Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/20/2007 03:01:57 MDTNo reproduction or networking permitted without license from IHS -,-,- INTERNATIONAL STANDARD ISO 15883-3:2006(E) © ISO 2006 All rights reserved 1 Washer-disinfectors Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers 1 Scope This part of ISO 15883 specifies particular requirements for washer-disinfectors (WD) that are intended to be used for emptying, flushing, cleaning and thermal disinfection of containers used to hold human waste for disposal by one operating cycle. This part of ISO 15883 is to be applied in conjunction with ISO 15883-1. 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) applies. ISO 15883-1:2006, Washer-disinfectors Part 1: General requirements, definitions and tests ISO/TS 15883-5, Washer-disinfectors Part 5: Test soils and methods for demonstrating cleaning efficacy 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 the 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 emptying discharging the contents of a container by gravity 3.3 human waste excretions and body fluids including faeces, urine, blood, pus, vomit and mucus Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/20/2007 03:01:57 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 15883-3:2006(E) 2 © ISO 2006 All rights reserved 3.4 human waste container re-usable vessel for holding and transporting human waste 4 Performance requirements 4.1 General 4.1.1 The requirements of ISO 15883-1:2006 apply with the exception of its subclause 4.3.2 (which refers to chemical disinfection, see Scope of this part of ISO 15883); subclause 4.3.3 (which refers to the maximum range of temperatures permitted on the load items, see 4.1.4 of this part of ISO 15883); subclause 5.3.1.2 (which refers to the use of a machine purging and disinfection); subclause 5.7.4 (which refers to verification of the dose of process chemical admitted); subclause 5.7.5 (which specifies the accuracy and reproducibility of chemical dosing systems); subclause 5.8 (which refers to load temperature protection); subclause 5.9 (which refers to control of temperatures on the load and chamber walls, see 4.5.3 and 4.5.4 of this part of ISO 15883); subclause 6.8.5 (which refers to tests for load temperature protection); subclause 6.10.3.2 (which refers to protein residue tests, see also ISO 15883-1:2006, Table A.1 (load, 6.10.3) and Annex A of this part of ISO 15883). 4.1.2 The WD shall be designed to process either one type of human waste container or a variety of types of human waste container and the re-usable supports for single-use bedpans. NOTE This can require the use of two or more types of load carrier. 4.1.3 The WD shall be designed to process either one human waste container per cycle, or several human waste containers per cycle. 4.1.4 The temperature attained on the surfaces of the load during the disinfection stage shall not be less than the disinfection temperature. 4.2 Chemical dosing systems 4.2.1 Provision shall be made for the installation of a chemical dosing system, when specified by the purchaser, to allow for the injection of a descalant, detergent and/or rinse aid. 4.2.2 The means to control the volume of additive(s) admitted shall be adjustable and shall deliver the set volume to an accuracy of ± 10 % or better. 4.2.3 The WD shall either be fitted with means to ensure that a fault is indicated when insufficient process chemical(s) has/have been admitted, or it shall be possible for the operator to visually verify that the required amount of process chemical(s) has/have been used. Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/20/2007 03:01:57 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 15883-3:2006(E) © ISO 2006 All rights reserved 3 4.3 Emptying 4.3.1 The manufacturer shall require the purchaser to specify whether the containers are required to be emptied manually or automatically. Manual emptying of containers should be avoided whenever possible. 4.3.2 When the container(s) are to be emptied automatically the emptying system shall ensure that there is no spillage of the container contents or discharge of aerosols of the contents of containers during automatic emptying. Check for compliance in accordance with 6.5.1. 4.3.3 When the container(s) are to be emptied manually into the WD the door aperture and load support system shall be designed to enable the container to be emptied and then located in the load carrier without spillage or splashing. Check fo