BS ISO 12505-2-2016 Skin barrier for ostomy aids Test methods Wet integrity and adhesive strength《造口术辅助器用皮肤屏障 试验方法 湿完整性和胶粘强度》.pdf
《BS ISO 12505-2-2016 Skin barrier for ostomy aids Test methods Wet integrity and adhesive strength《造口术辅助器用皮肤屏障 试验方法 湿完整性和胶粘强度》.pdf》由会员分享,可在线阅读,更多相关《BS ISO 12505-2-2016 Skin barrier for ostomy aids Test methods Wet integrity and adhesive strength《造口术辅助器用皮肤屏障 试验方法 湿完整性和胶粘强度》.pdf(24页珍藏版)》请在麦多课文档分享上搜索。
1、BS ISO 12505-2:2016Skin barrier for ostomy aids T e s t m e t h o d sPart 2: Wet integrity and adhesive strengthBSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06BS ISO 12505-2:2016 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of ISO
2、12505-2:2016.The UK participation in its preparation was entrusted to TechnicalCommittee CH/173/-/3, Aids for ostomy and incontinence.A list of organizations represented on this committee can beobtained on request to its secretary.This publication does not purport to include all the necessaryprovisi
3、ons of a contract. Users are responsible for its correctapplication. The British Standards Institution 2016.Published by BSI Standards Limited 2016ISBN 978 0 580 90227 7ICS 11.180.20Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published un
4、der the authority of theStandards Policy and Strategy Committee on 31 October 2016.Amendments/corrigenda issued since publicationDate T e x t a f f e c t e dBS ISO 12505-2:2016 ISO 2016Skin barrier for ostomy aids Test methods Part 2: Wet integrity and adhesive strengthBarrire cutane pour appareilla
5、ges stomiques Mthodes dessai Partie 2: Rsistance des adhsifs et intgrit une fois mouillsINTERNATIONAL STANDARDISO12505-2First edition2016-10-15Reference numberISO 12505-2:2016(E)BS ISO 12505-2:2016ISO 12505-2:2016(E)ii ISO 2016 All rights reservedCOPYRIGHT PROTECTED DOCUMENT ISO 2016, Published in S
6、witzerlandAll rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior written permission. Permission can be
7、 requested from either ISO at the address below or ISOs member body in the country of the requester.ISO copyright officeCh. de Blandonnet 8 CP 401CH-1214 Vernier, Geneva, SwitzerlandTel. +41 22 749 01 11Fax +41 22 749 09 47copyrightiso.orgwww.iso.orgBS ISO 12505-2:2016ISO 12505-2:2016(E)Foreword ivI
8、ntroduction v1 Scope . 12 Normative references 13 Terms and definitions . 14 Evaluation of skin barriers 1Bibliography .12 ISO 2016 All rights reserved iiiContents PageBS ISO 12505-2:2016ISO 12505-2:2016(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of
9、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. Inte
10、rnational 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.The procedures used to develop this document and those int
11、ended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the different types of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see ww
12、w.iso.org/directives).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. Details of any patent rights identified during the development of the document
13、will be in the Introduction and/or on the ISO list of patent declarations received (see www.iso.org/patents).Any trade name used in this document is information given for the convenience of users and does not constitute an endorsement.For an explanation on the meaning of ISO specific terms and expre
14、ssions related to conformity assessment, as well as information about ISOs adherence to the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following URL: www.iso.org/iso/foreword.html.The committee responsible for this document is ISO/TC 173, Assistive pro
15、ducts for persons with disability, Subcommittee SC 3, Aids for ostomy and incontinence.ISO 12505 consists of the following parts, under the general title Skin barrier for ostomy aids Test methods: Part 1: Size, surface pH and water-absorbency Part 2: Wet integrity and adhesive strengthiv ISO 2016 Al
16、l rights reservedBS ISO 12505-2:2016ISO 12505-2:2016(E)IntroductionSkin barriers are made to seal the ostomy bag to the skin and stay on, protecting the peristomal skin from stoma effluent and keeping the skin physiology intact by absorbing or permeating sweat.The skin characteristics vary from pers
17、on to person, and the products behave differently from each other depending on type of stoma, purpose of use, environmental factors, care techniques, the users way of daily living, etc. These make the testing situation complex and a number of test methods have been developed, based on laboratory and
18、 clinical testing. But despite the efforts and improvements made, there are still problems for the user of the products; trial and error may still be the prime method to find an adequate product.The problem that we primarily focus upon is the ability for the users purchasers, professional staffs, pe
19、rsons with stoma, etc. to rationally evaluate the products and the test methods used.The skin barrier is an important part of an ostomy product. It protects the peristomal skin and holds the ostomy bag in place. Skin barriers are flexible, erosion-resistant, skin-friendly and have adhesion propertie
20、s that allow the bag to stay in place during use and be removed following use. Skin barriers are manufactured in a number of shapes and degrees of convexity and flexibility. Understanding how skin barriers are designed and work will help to provide ostomy patients or consumers with the best products
21、.The properties of skin barriers differ and there is a need to evaluate them properly. Skin barriers can be evaluated by either clinical trials or by laboratory test methods. Clinical trials are not covered here but in other International Standards. Laboratory test methods found in other Internation
22、al Standards for adhesive products were not developed for skin barriers but for industrial tapes. The test methods found in this part of ISO 12505 cover the evaluation of wet integrity and adhesion. The methods have been specifically designed for skin barriers for ostomy aids. ISO 2016 All rights re
23、served vBS ISO 12505-2:2016BS ISO 12505-2:2016Skin barrier for ostomy aids Test methods Part 2: Wet integrity and adhesive strengthCAUTION These test methods may not provide design information as there may be no direct relationship between laboratory test results and functional requirements. Data sh
24、all not be interpreted as applying to clinical use of the skin barrier because of variations in the skin and in the users pouching techniques.1 ScopeThis part of ISO 12505 specifies test methods dealing with face plates of skin barriers for ostomy aids.This part of ISO 12505 does not cover medical p
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