BS ISO 12505-1-2014 Skin barrier for ostomy aids Test methods Size surface pH and water-absorbency《造口术辅助器用皮肤屏障 试验方法 尺寸 表面pH值和吸水性》.pdf
《BS ISO 12505-1-2014 Skin barrier for ostomy aids Test methods Size surface pH and water-absorbency《造口术辅助器用皮肤屏障 试验方法 尺寸 表面pH值和吸水性》.pdf》由会员分享,可在线阅读,更多相关《BS ISO 12505-1-2014 Skin barrier for ostomy aids Test methods Size surface pH and water-absorbency《造口术辅助器用皮肤屏障 试验方法 尺寸 表面pH值和吸水性》.pdf(24页珍藏版)》请在麦多课文档分享上搜索。
1、BSI Standards PublicationBS ISO 12505-1:2014Skin barrier for ostomy aids Test methodsPart 1: Size, surface pH and water-absorbencyBS ISO 12505-1:2014 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of ISO 12505-1:2014.The UK participation in its preparation was entrus
2、ted 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 necessaryprovisions of a contract. Users are responsible for its correctapplica
3、tion. The British Standards Institution 2014. Published by BSI StandardsLimited 2014ISBN 978 0 580 76251 2ICS 11.180.20Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStandards Policy and Strategy Committee
4、 on 28 February 2014.Amendments issued since publicationDate Text affectedBS ISO 12505-1:2014 ISO 2014Skin barrier for ostomy aids Test methods Part 1: Size, surface pH and water-absorbencyBarrire cutane pour appareillages stomiques Mthodes dessai Partie 1: Taille, pH de surface et absorbance deauIN
5、TERNATIONAL STANDARDISO12505-1First edition2014-02-15Reference numberISO 12505-1:2014(E)BS ISO 12505-1:2014ISO 12505-1:2014(E)ii ISO 2014 All rights reservedCOPYRIGHT PROTECTED DOCUMENT ISO 2014All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized
6、 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 requested from either ISO at the address below or ISOs member body in the country of the requester.ISO copyright of
7、ficeCase postale 56 CH-1211 Geneva 20Tel. + 41 22 749 01 11Fax + 41 22 749 09 47E-mail copyrightiso.orgWeb www.iso.orgPublished in SwitzerlandBS ISO 12505-1:2014ISO 12505-1:2014(E) ISO 2014 All rights reserved iiiContents PageForeword ivIntroduction v1 Scope . 12 Normative references 13 Terms and de
8、finitions . 14 Evaluation of skin barriers 24.1 General . 24.2 General conditions of test 24.3 Measurement of size 24.4 Measurement of surface pH . 74.5 Water absorbency test 84.6 Test report 10Bibliography .12BS ISO 12505-1:2014ISO 12505-1:2014(E)ForewordISO (the International Organization for Stan
9、dardization) 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
10、 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.The procedures u
11、sed to develop this document and those intended 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
12、 of the ISO/IEC Directives, Part 2 (see www.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 identifi
13、ed during the development of the document 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 t
14、he meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISOs adherence to the WTO principles in the Technical Barriers to Trade (TBT) see the following URL: Foreword - Supplementary informationThe committee responsible for this document is ISO/
15、TC 173, Assistive products 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 s
16、trengthiv ISO 2014 All rights reservedBS ISO 12505-1:2014ISO 12505-1:2014(E)IntroductionSkin barriers are made to seal the ostomy bag to the skin and stay on, protecting the peristomal skin from excrements and secretion, and keeping the skin physiology intact by absorbing or permeating sweat.The ski
17、n characteristics vary from person to person, and the products behave differently from each other depending on type of stoma, purpose of use, atmosphere, and other environmental factors, care techniques, the users way of daily living etc. These make the testing situation complex and a number of test
18、 methods have been developed laboratory and clinically based. But despite the efforts and improvements made, there are still problems for the user of the products trial and error can still be the prime method to find an adequate product.The problem that we primarily focus upon is the possibility for
19、 the users purchasers, professional staffs, persons 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 shall be flexible, erosion-re
20、sistant, skin-friendly, and having adhesion properties that allows the bag to stay in place and be removed. 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 con
21、sumers with the best products.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 metho
22、ds found in other International Standards were not developed for skin barriers but for industrial tapes. Methods found elsewhere differ by manufacturer, consumer, and medical professional.The test methods found in this International Standard covers the evaluation of size, pH, and absorption. The met
23、hods have been specifically designed for skin barriers for ostomy products. ISO 2014 All rights reserved vBS ISO 12505-1:2014BS ISO 12505-1:2014Skin barrier for ostomy aids Test methods Part 1: Size, surface pH and water-absorbency1 ScopeThis part of ISO 12505 specifies test methods dealing with a f
24、ace plate of skin barriers for ostomy aids.It does not cover medical properties (cytotoxicity, sensitization, irritation/intracutaneous reactivity, buffering effect, microbiological effects, etc).The test methods do not individually or collectively define or recommend a product of a specific design,
- 1.请仔细阅读文档,确保文档完整性,对于不预览、不比对内容而直接下载带来的问题本站不予受理。
- 2.下载的文档,不会出现我们的网址水印。
- 3、该文档所得收入(下载+内容+预览)归上传者、原创作者;如果您是本文档原作者,请点此认领!既往收益都归您。
下载文档到电脑,查找使用更方便
10000 积分 0人已下载
下载 | 加入VIP,交流精品资源 |
- 配套讲稿:
如PPT文件的首页显示word图标,表示该PPT已包含配套word讲稿。双击word图标可打开word文档。
- 特殊限制:
部分文档作品中含有的国旗、国徽等图片,仅作为作品整体效果示例展示,禁止商用。设计者仅对作品中独创性部分享有著作权。
- 关 键 词:
- BSISO1250512014SKINBARRIERFOROSTOMYAIDSTESTMETHODSSIZESURFACEPHANDWATERABSORBENCY 造口术 辅助 器用 皮肤 屏障 试验

链接地址:http://www.mydoc123.com/p-583874.html