SANS 16037-2003 Rubber condoms for clinical trials - Measurement of physical properties《临床试验用橡胶避孕套 物理性能测试》.pdf

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1、 Collection of SANS standards in electronic format (PDF) 1. Copyright This standard is available to staff members of companies that have subscribed to the complete collection of SANS standards in accordance with a formal copyright agreement. This document may reside on a CENTRAL FILE SERVER or INTRA

2、NET SYSTEM only. Unless specific permission has been granted, this document MAY NOT be sent or given to staff members from other companies or organizations. Doing so would constitute a VIOLATION of SABS copyright rules. 2. Indemnity The South African Bureau of Standards accepts no liability for any

3、damage whatsoever than may result from the use of this material or the information contain therein, irrespective of the cause and quantum thereof. ICS 11.200 ISBN 0-626-14473-6 SANS 16037:2003 Edition 1 ISO 16037:2002 Edition 1 SOUTH AFRICAN NATIONAL STANDARD Rubber condoms for clinical trials Measu

4、rement of physical properties This national standard is the identical implementation of ISO 16037:2002 and is adopted with the permission of the International Organization for Standardization Published by Standards South Africa 1 dr lategan road groenkloof private bag x191 pretoria 0001 tel: 012 428

5、 7911 fax: 012 344 1568 international code + 27 12 www.stansa.co.za Standards South Africa 2003 SANS 16037:2003 Edition 1 ISO 16037:2002 Edition 1 Table of changes Change No. Date Scope National foreword This South African standard was approved by National Committee STANSA SC 5140.17G, Mechanical co

6、ntraceptives, in accordance with procedures of Standards South Africa, in compliance with annex 3 of the WTO/TBT agreement. INTERNATIONALSTANDARDISO16037First edition2002-05-15Reference numberISO 16037:2002(E) ISO 2002Rubber condoms for clinical trials Measurement of physical propertiesPrservatifs m

7、asculins en caoutchouc destins aux essais cliniques Mesurage des proprits physiquesISO 16037:2002(E)ii ISO 2002 All rights reservedPDF disclaimerThis PDF file may contain embedded typefaces. In accordance with Adobes licensing policy, this file may be printed or viewed but shall not beedited unless

8、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 Adobes licensing policy. The ISO Central Secretariat accepts no liability in this area.Adobe is a trademark of A

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10、likely eventthat a problem relating to it is found, please inform the Central Secretariat at the address given below. ISO 2002All 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 pho

11、tocopying and microfilm, without permission in writing from either ISO at the address below or ISOsmember body in the country of the requester.ISO copyright officeCase postale 56 CH-1211 Geneva 20Tel. + 41 22 749 01 11Fax + 41 22 749 09 47E-mail copyrightiso.chWeb www.iso.chPrinted in SwitzerlandISO

12、 16037:2002(E) ISO 2002 All rights reserved iiiForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISOmember bodies). The work of preparing International Standards is normally carried out through ISO technicalcommittees. Each membe

13、r body interested in a subject for which a technical committee has been established hasthe right to be represented on that committee. International organizations, governmental and non-governmental, inliaison with ISO, also take part in the work. ISO collaborates closely with the International Electr

14、otechnicalCommission (IEC) on all matters of electrotechnical standardization.International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 3.Draft International Standards adopted by the technical committees are circulated to the member bodies for voting.Publ

15、ication 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 International Standard may be the subject ofpatent rights. ISO shall not be held responsible for identifying any or all

16、such patent rights.International Standard ISO 16037 was prepared by Technical Committee ISO/TC 157, Mechanical contraceptives.ISO 16037:2002(E)iv ISO 2002 All rights reservedIntroductionClinical investigations of condoms involve many aspects, notably condom acceptability and failure. Useful studiesr

17、equire many condoms and subjects, which are expensive. Clinical studies often underestimate the potentialinfluence of condom physical properties, whose laboratory testing is far less expensive. As physical properties mayvary over time and from product to product, a lack of brand- and lot-specific da

18、ta may well reduce the usefulness ofa clinical investigation for improving condom quality and efficacy.While some investigations may best be conducted using condoms of the participants choice, it is usually appropriateto ensure that all participants use condoms having the same physical characteristi

19、cs. In most cases, each clinicalinvestigation will evaluate condoms of one or more types. Study condoms of each type should generally be from thesame lot, in order to ensure that they are characterized by the same physical properties. If special properties aredesired, independent test laboratories m

20、ay be able to advise as to which laboratories or manufacturers should becontacted for assistance.In most situations determination of these characteristics should be part of the study design. Assistance in this regardis available from a number of independent testing laboratories, and from some condom

21、 manufacturers. Laboratoriesshould be experienced in, and accredited for, condom testing, in accordance with recognized standards.It is believed that gathering as much physical information as possible about the condoms used is a sensibleprecaution. In principle, tests on physical properties should a

22、ll be done at the beginning of the investigation, andsome should be repeated at the end. In investigations running over more than six months, additional tests may beconsidered during the investigation to give a profile of the change in physical properties over the duration of the study.While there h

23、ave been several clinical investigations on condom failure, relatively few of these fully identify thephysical characteristics of the condoms used. Thus, it is difficult to compare meaningfully the results of differentinvestigations, or to build hypotheses about design or manufacturing factors that

24、may affect condom efficacy.Having developed an International Standard on the requirements and test methods for natural latex rubber condoms,(ISO 4074), ISO/TC 157 remains interested in further clinical validation of the physical requirements given, and inany data that may suggest a need for amendmen

25、ts to them. This document offers guidance on the measurement ofphysical properties characterizing condoms used in clinical investigations. Recommended sample sizes forlaboratory testing in this document are in some cases intentionally larger than those in ISO 4074.This document is written primarily

26、for investigations on natural rubber condoms, but the principles apply to condomsof other materials also. It should not be expected that elongation properties of synthetic materials will be similar tothose of natural rubber.INTERNATIONAL STANDARD ISO 16037:2002(E) ISO 2002 All rights reserved 1Rubbe

27、r condoms for clinical trials Measurement of physical properties1 ScopeThis International Standard is intended as a guideline for clinical researchers working with condoms. It suggests aseries of laboratory tests to be conducted on the products to be used in any clinical investigation, so that it wi

28、ll beeasier to relate the clinical results to the design and quality of the condoms used.This International Standard is not applicable to the design of clinical investigations.2 Normative referencesThe following normative documents contain provisions which, through reference in this text, constitute

29、 provisions ofthis International Standard. For dated references, subsequent amendments to, or revisions of, any of thesepublications do not apply. However, parties to agreements based on this International Standard are encouraged toinvestigate the possibility of applying the most recent editions of

30、the normative documents indicated below. Forundated references, the latest edition of the normative document referred to applies. Members of ISO and IECmaintain registers of currently valid International Standards.ISO 37, Rubber, vulcanized or thermoplastic Determination of tensile stress-strain pro

31、pertiesISO 4074, Natural latex rubber condoms Requirements and test methods3 Terms and definitionsFor the purposes of this International Standard, the terms and definitions given in ISO 4074 apply.4 Length4.1 Measure and record the length of 13 condoms per lot, as described in ISO 4074. Calculate lo

32、t mean length andstandard deviation (or confidence interval).4.2 The length and width of any teat (reservoir) should also be measured (see also 5.2 below).5Width5.1 Measure and record the flat width of 13 condoms per lot, as described in ISO 4074, at sections every between from the closed end and fr

33、om the open end (rim). For each section, calculate the lot meanwidth and standard deviation (or confidence interval).5.2 Alternatively, a profile of the condom may be constructed by photocopying cleaned, dusted and flattenedspecimens alongside a transparent ruler.10 mm30 mm 30 mmISO 16037:2002(E)2 I

34、SO 2002 All rights reserved6 Thickness6.1 Determine the thickness of the condom in the transition area between the shaft of the condom and the reservoir(or closed end if there is no reservoir). Make this measurement as close as possible to the closed end, consistentwith being able to flatten the rub

35、ber film on the micrometer anvil without excessive stretching.6.2 Measure at least 13 condoms, using a micrometer dial gauge with a resolution of at least , a footdiameter of and foot pressure of . At each section, measure and record at least fourevenly spaced single wall thicknesses.6.3 Thickness m

36、ay also be determined using the weighing method outlined in ISO 4074, on parallel-sided parts ofthe condom. This may be useful if any comparisons are made with condoms tested for compliance using ISO 4074,and a relationship between the two types of measurement is required.Cut the test piece centred

37、on the section concerned. Measure and record each test piece flat width to the nearestand mass to the nearest . Calculate the test piece thickness from the formula:whereis the thickness, expressed in millimetres;is the mass, expressed in milligrams;is the width, expressed in millimetres.NOTE There i

38、s a systematic difference between the direct measurement and weighing methods, the latter giving higher valuesthan the former.7BeadFrom 13 condoms per lot, remove the bead (rim) by scissors or tearing, and cut it open. Measure and record eachbead length (to the nearest ) and thickness at three secti

39、ons (to the nearest ). Calculate the lot meanlength and thickness, with standard deviation (or confidence interval).8 Air inflation propertiesInflate at least 315 condoms per lot (but preferably 500), as described in ISO 4074. Measure and record eachbursting pressure and volume. Data should be recor

40、ded to the maximum precision available from the equipment,rather than using the rounding specified in ISO 4074. Calculate lot mean bursting pressure and volume, withstandard deviations (or confidence intervals); and report the number of defectives (specimens visibly leaking air, orbursting under ISO

41、 4074 minimum pressure and/or volume).Data may be summarized as histograms (or stem-and-leaf diagrams). The aim of the test is not only to determinewhether the lot(s) of products being used in the investigation comply with ISO 4074, but also to reliably estimate themean, range, standard deviation, a

42、nd number of non-compliers. For a more reliable estimate of lot defectiveness, atleast 2 000 condoms should be tested.9 Tensile properties9.1 Cut mid-body test pieces as specified in ISO 4074 from 20 condoms per lot. Measure and record for each testpiece either:a) length (to the nearest ), and thick

43、ness at four points (to the nearest ), or b) flat width (to the nearest ) and mass (to the nearest ).0,010 mm(5 2) mm (22 4) kPa0,5 mm 1 mgt = 0,026 8 m/wtmw1 mm 0,01 mm0,5 mm 0,001 mm0,5 mm 1 mgISO 16037:2002(E) ISO 2002 All rights reserved 3Test the test-pieces on a tensile tester as specified in

44、ISO 4074. Measure and record each test-piece force (to thenearest ) at , and elongation and at break, and the elongation at break (as percentage oforiginal length).9.2 Calculate lot mean elastic modulus at , and elongation, breaking force and elongation(strain), and tensile strength, with standard d

45、eviation (or confidence interval).In case 9.1 b), stresses and tensile strength may be calculated from:whereis the stress, expressed in megapascals;is the tensile force at break, expressed in newtons;is the width, expressed in millimetres;is the mass, expressed in milligrams.9.3 For non-isotropic ma

46、terials, the tensile properties shall also be determined along the long axis of the condom.These tests shall be carried out using a dumbbell sample cut with an ISO Type I or Type II cutter as specified inISO 37. The width of the test piece (nominally ) may be taken to be the width of the throat of t

47、he cutter.Measure and record the thickness of each test piece (to the nearest ) at four points.10 LubricantOn 32 specimens per lot, measure and record the mass of lubricant (to the nearest ) in each individualcontainer, and that on each condom as removed from its individual container, using the meth

48、od described inISO 4074. Calculate the lot mean mass of lubricant on the condom and in the individual container, with the standarddeviations (or confidence intervals).11 Freedom from holes and visible defects11.1 Test at least 315 condoms per lot for aqueous leakage, as described in ISO 4074 (specif

49、ying the method).Record the number of specimens with holes (over from the rim), and the distance from the closed end of anyhole detected, measured to the nearest .11.2 In the same sample, inspect each condom for visible defects (including holes). Record the number of visiblydefective specimens, and the location and nature of any visible defect.11.3 For a more reliable estimate of lot defectiveness, at least 2 000 condoms per lot should be tested for holesand visible defects.12 Information from manufacturerThe manufacturer should be informed o