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,
25、 style or size, and do not recommend medical affairs such as treatment, nursing, 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 references, only the edition cited applies. For un
26、dated references, the latest edition of the referenced document (including any amendments) applies.ISO 554:1976, Standard atmospheres for conditioning and/or testing SpecificationsISO 7886-1:1993, Sterile hypodermic syringes for single use Part 1: Syringes for manual useISO 10523:2008, Water quality
27、 Determination of pHISO 24214:2006, Skin barrier for ostomy aids Vocabulary3 Terms and definitionsFor the purposes of this document, the terms and definitions in ISO 24214 and the following apply.3.1surface pHvalue obtained with a glass electrode pH meter in the skin-contacting part of skin barrier
28、in moisturized condition3.2water absorbencypossibility which allows water in the skin barrier3.3samplesmall trial sheet representing a whole product of skin barrier, including test specimen that is a single typical part or example taken from the trial sheet as test piece3.4linear dimensionstraight s
29、hortest distance between any two points selected on the sampleINTERNATIONAL STANDARD ISO 12505-1:2014(E) ISO 2014 All rights reserved 1BS ISO 12505-1:2014ISO 12505-1:2014(E)4 Evaluation of skin barriers4.1 GeneralThis part contains the following tests/measurements:a) measurement of sizes;b) measurem
30、ent of surface pH;c) water absorbency test.4.2 General conditions of test4.2.1 Standard conditions of test place: Follow ISO 554:1976; preferred standard test conditions shall be temperature (23 2) C and relative humidity (50 5) %. If not available, state conditions used in the test report.4.2.2 Pre
31、treatment 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 method of test resultsTest items Test results obtainedSize
32、: Length, width, and diameter (mm)Thickness (mm)Integer number position in allOne digit after decimal pointSurface pH One digit after decimal pointWater absorbency (mg/cm2) Integer number position4.3 Measurement of size4.3.1 PrincipleFollowing description of shape, length and width or diameter of th
33、e skin barrier is measured using a scale ruler. The area of the skin barrier can be calculated, if necessary. The diameter of the precut or starter hole and the flange can be measured and also the maximum diameter to which the hole can be cut if applicable. The thickness of the skin barrier is measu
34、red using a thickness gauge. Measurements shall always be performed in 3 samples to take the average.4.3.2 Apparatus4.3.2.1 Scale ruler, capable of measuring to the nearest 1 mm.Alternatively, a caliper can be used. For diameter measurements, a diameter gage can also be used.4.3.2.2 Thickness gage,
35、dial indicator capable of measuring to the nearest 0,1 mm having a flat surface of 8 mm diameter and capable of exerting a pressure of 12 kPa (0,6 N) on the object measured.It is recommended to have a flat surface of (8 1) mm, but the actual diameter shall be measured with a precision of 0.1 mm.To o
36、btain 12 kPa pressures on the measured object, an 8,0 mm flat surface with a total weight of 61,2 g can be used. If other dimensions are used within 1 mm, the weight shall be recalculated.2 ISO 2014 All rights reservedBS ISO 12505-1:2014ISO 12505-1:2014(E)4.3.3 Procedures4.3.3.1 Description of shape
37、4.3.3.1.1 Skin barrier faceplateDescribe the shape of the skin barrier faceplate according to the following list:a) square;b) rectangle;c) diamond;d) triangle;e) circle;f) oval;g) others.4.3.3.1.2 Skin barrier cross sectionDescribe the shape of the skin barrier cross section according to the followi
38、ng list:a) flat;b) convex;c) other.4.3.3.1.3 Skin barrier edgeDescribe the shape of the skin barrier edge according to the following list:a) flat edge;b) tapered edge;c) others.4.3.3.1.4 Fringe of the skin barrierDescribe the fringe of the skin barrier according to the following list:a) no tape;b) t
39、ape border.4.3.3.2 Length, width, and diameterMeasure dimensions according to the list below in at least three samples, and take the average value. See Figure 1. rectangle/square: measure the length and width of the skin barrier; diamond: measure the longest and shortest diagonal dimensions of the s
40、kin barrier; circle: measure the diameter of the skin barrier; oval: measure the longest and shortest diameter dimensions of the skin barrier; ISO 2014 All rights reserved 3BS ISO 12505-1:2014ISO 12505-1:2014(E) triangle: measure base and height of the skin barrier; others: measure the diameter or t
41、he longest and shortest linear dimensions of the skin barrier.Measure the diameter of the starter hole or stoma hole if necessary. See Figure 2.As skin barriers come in different shapes, it is sometimes necessary to measure other dimensions in order to be able to describe the product and to calculat
42、e the surface area. These calculations and measurements shall then be reported in the test report.NOTE The flange is a plastic coupling ring used for coupling together the skin barrier with the ostomy bag. Manufacturers have their own coupling system which is named according to the size. However, it
43、 is not possible to couple together products from different manufacturers, the couplings are manufacturer specific.4 ISO 2014 All rights reservedBS ISO 12505-1:2014ISO 12505-1:2014(E)Figure 1 Measurement map of sizes ISO 2014 All rights reserved 5BS ISO 12505-1:2014ISO 12505-1:2014(E)HVKeyV vertical
44、 lengthH horizontal lengthNOTE Arrows show the length (mm) and direction to be measuredFigure 2 Measurement map of stoma hole or starter holeNOTE Arrows show the length (mm) and direction to be measured4.3.3.3 ThicknessThe thickness shall be measured with the release liner in place, which thickness
45、is then subtracted. See Figure 3.The thickness shall be measured at centre or around the stoma hole and 5 mm from the outer edge.NOTE This is only a measurement of the skin barrier thickness and not the height of the convexity.Measure the thickness by placing the skin barrier test between the jaws o
46、f the thickness gage. Lower the moving pressure foot gently on to the surface of the sample and take the reading on the gage within 2 s. Record this as the total thickness.Remove the release liner and measure it in the same way. Record this as the thickness of the release liner.Report the thickness
47、of the skin barrier by subtracting the thickness of the release liner from the total thickness to the nearest 0,1 mm.As skin barriers come in different shapes, like for example, convex plates, it might be necessary to measure several thicknesses in order to describe the product. These measurements s
48、hall then be reported in the test report.Measure thickness including the backing or any cover if united by heat-seal or too tight to separate, but its inclusion shall be described in the measurement report.6 ISO 2014 All rights reservedBS ISO 12505-1:2014ISO 12505-1:2014(E)Repeat the procedure in at
49、 least three samples, and take the average value.A C B5 mm 5 mmA C1 C25 mm 5 mm 5 mm 5 mmBA C1 C2 B5 mm 5 mm 5 mm 5 mmA C1 C2 B5 mm 5 mm 5 mm 5 mmA C1 C2 B5 mm 5 mm 5 mm 5 mmA C1 C2 B5 mm 5 mm 5 mm 5 mmKeyA and B Site to be measured for bilateral peripheral thicknessC, C1, and C2 Site to be measured for central thicknessFigure 3 Measurement map of thickness4.4 Measurement of surface pH4.4.1 PrincipleThe pH of the saline immersion surface of skin barrier is determined after 4 h immersion by usi
