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
25、roperties (cytotoxicity, sensitization, irritation/intracutaneous reactivity, buffering effect, microbiological effects, etc.).2 Normative referencesThe following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated referenc
26、es, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.ISO 24214, Skin barrier for ostomy aids VocabularyISO 12505-1, Skin barrier for ostomy aids Test methods Part 1: Size, surface pH and water-absorbency3 Terms a
27、nd definitionsFor the purposes of this document, the terms and definitions given in ISO 24214, ISO 12505-1 and the following apply.3.1wet integrityability of a skin barrier to maintain its physical form when exposed to fluid3.2adhesive strengthforce required to peel a skin substitute from the surfac
28、e of a skin barrier specimen3.3specimensingle typical part or example taken from the trial sample sheet as a test piece4 Evaluation of skin barriers4.1 GeneralThis part contains the following tests/measurements:Wet integrity test and adhesive strength (resistance upon removal) test.INTERNATIONAL STA
29、NDARD ISO 12505-2:2016(E) ISO 2016 All rights reserved 1BS ISO 12505-2:2016ISO 12505-2:2016(E)The test methods do not individually or collectively define or recommend a product of a specific design, style or size, and do not recommend medical affairs such as treatment, nursing, etc. The test methods
30、 however, shall be utilized for the market need to fulfil the product property of the skin barrier.4.2 General conditions of test4.2.1 Standard conditions of test place: The preferred standard test conditions shall be a temperature of (23 2) C and a relative humidity of (50 5) %. If not available,
31、state the used conditions in the test report.4.2.2 Pretreatment of a sample: The sample is left under the conditions in 4.2.1 for 24 h or more.4.2.3 Accuracy requirement/rounding of test results: The results shall be rounded and expressed by number of digits as shown in Table 1.Table 1 Rounding meth
32、od of test resultsTest items Test results obtainedaWet-integrity (mm) One digit after decimal pointAdhesive-strength (N/cm) Two digits after decimal pointaInteger number position in all.4.3 Wet integrity4.3.1 PrincipleBecause skin barriers absorb water, deform and collapse over time, the test is use
33、d to measure such reaction as the swelling and/or erosion in simulated use. It is measured at the centre of the skin barrier where a stoma hole of 25 mm diameter is punched out, under the influence of physiological saline solution, which is rotated by using a magnetic stirrer process in 24 h incubat
34、ion at 37 C. Such change is observed as discoloration of erosion/swelling around the centre hole and defined as follows. Inner diameter (D1) of the hole after test 25 mm = outward erosion. Inner diameter (D1) of the hole after test 25 mm = inward swelling. Outer diameter (D2) = the outer edge of the
35、 discoloured area = collapsed border.4.3.2 Apparatus4.3.2.1 Test solution, saline or 0,9 % NaCl solution. Test solution shall be pre-warmed to 37 C.4.3.2.2 Stirrer table, magnetic stirrers (4.3.2.3) being able to run from 300 rpm to 600 rpm. Rotation speeds shall be within calibration specifications
36、4.3.2.3 Magnetic stirrer, glass-coated, 8 mm diameter 40 mm length. Do not use Teflon-coated1)stirrers in order to reduce wear and to prevent the washed-out adhesive from sticking to the bar.4.3.2.4 Plastic container/cup, translucent, 365 ml in capacity, 95 mm in diameter.4.3.2.5 Lid to cup, transl
37、ucent, 95 mm in diameter, with an 8 mm diameter centre hole and a 2 mm diameter air vent.1) Teflon is an example of a suitable product available commercially. This information is given for the convenience of users of this document and does not constitute an endorsement by ISO of this product.2 ISO 2
38、016 All rights reservedBS ISO 12505-2:2016ISO 12505-2:2016(E)4.3.2.6 Punching tools, cutting two holes in lid (4.3.2.5); 8 mm and 2 mm in diameter, and cutting out a 65 mm diameter plate (4.3.2.9) with an 8 mm diameter centre hole, a 65 mm outer diameter and 45 mm inner diameter ring of foam (4.3.2.
39、11), and a 55 mm outer diameter and 25 mm inner diameter ring-formed specimen of skin barrier.4.3.2.7 Distance tube, fixing tube with a distance between the lid (4.3.2.5) and the plate (4.3.2.9). For example, Quick Star push-in fittings QSH-10-50 1307262)by Festo Co.4.3.2.8 Fasteners, auto cover cli
40、ps, plastic (7 22) mm axis and 18 mm diameter head. The head shall not exceed 18 mm diameter. For example, Art.nr. 050094053)by Wrth-Danmark A/S.4.3.2.9 Mounting disc plate, APET (Amorphous Polyethylene Terephthalate) disk of 0,8 mm thickness, 65 mm diameter with an 8 mm diameter centre hole (for ex
41、ample, Axpet4)by Bayer Material Science AG).4.3.2.10 Insulating material, used between the bottom of the plastic container (4.3.2.4) and the magnetic stirrer (4.3.2.3) to maintain the specified temperature constant and to keep the stirring function intact. The material, thickness and shape are up to
42、 the test person (for example, fabric or expanded polystyrene disk).4.3.2.11 Waterproof ring-shaped foam, backed with adhesive, 65 mm diameter with a centre hole of 45 mm diameter, and used to prevent the outer rim of the skin barrier specimen from getting washed out by the salt water. It can be any
43、 tape that is good enough to stay on the specimen during the testing period.4.3.2.12 Measuring template, circles with diameters between 15 mm and 45 mm at 1 mm increments printed on a transparent film, for measuring the inner and outer diameters after test. The diameters of the circles on the templa
44、te shall be measured using a calibrated measuring tool before the template is used.4.3.2.13 Oven or incubator, having a circulating fan and capable of maintaining the temperature of the test solution within an accuracy of 0,75 C and designed to distribute the air evenly throughout the oven or incuba
45、tor.4.3.3 ProceduresSee Figure 1.a) Prepare the required mounting disc plate of 65 mm diameter with an 8 mm diameter centre hole, the lid with an 8 mm diameter centre hole and a 2 mm diameter air vent hole, the adhesive foam ring of 65 mm outer diameter/45 mm inner diameter, and the required skin ba
46、rrier ring specimen of 25 mm inner diameter/55 mm outer diameter, by punching out each hole.b) Remove the release liner from the skin barrier specimen but not the backing; the removed side is adhesive, and the adhesive side shall be attached to the disc plate.c) Place the specimen on the mounting di
47、sc plate centred around the 8 mm diameter hole in an upside-down position to avoid stretching of the adhesive, which could lead to non-circular centre holes after testing.d) Place the punched foam on top of the specimen centred around the outer edge.2) Quick Star push-in fittings QSH-10-50 130726 is
48、 an example of a suitable product available commercially. This information is given for the convenience of users of this document and does not constitute an endorsement by ISO of this product.3) Art.nr. 05009405 is an example of a suitable product available commercially. This information is given fo
49、r the convenience of users of this document and does not constitute an endorsement by ISO of this product.4) Axpetis an example of a suitable product available commercially. This information is given for the convenience of users of this document and does not constitute an endorsement by ISO of this product. ISO 2016 All rights reserved 3BS ISO 12505-2:2016ISO 12505-2:2016(E)e) Assemble the lid and the disc plate of the specimen by using a distance tube and two auto clips at each edge.f) Place the magneti
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