1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS ISO 23409:2011Male condoms Requirementsand test methods for condomsmade from synthetic materialsBS ISO 23409:2011 BRITISH STANDARDNational forewordThis British Standard is the
2、 UK implementation of ISO 23409:2011.The UK participation in its preparation was entrusted to TechnicalCommittee CH/157, Mechanical contraceptives.A list of organizations represented on this committee can beobtained on request to its secretary.This publication does not purport to include all the nec
3、essaryprovisions of a contract. Users are responsible for its correctapplication. BSI 2011ISBN 978 0 580 55401 8ICS 11.200Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStandards Policy and Strategy Commit
4、tee on 31 March 2011.Amendments issued since publicationDate Text affectedBS ISO 23409:2011Reference numberISO 23409:2011(E)ISO 2011INTERNATIONAL STANDARD ISO23409First edition2011-02-15Male condoms Requirements and test methods for condoms made from synthetic materials Prservatifs masculins Exigenc
5、es et mthodes dessai pour les prservatifs fabriqus en matires synthtiques BS ISO 23409:2011ISO 23409:2011(E) PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobes licensing policy, this file may be printed or viewed but shall not be edited unless the typefaces which
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10、 Published in Switzerland ii ISO 2011 All rights reservedBS ISO 23409:2011ISO 23409:2011(E) ISO 2011 All rights reserved iiiContents Page Foreword iv Introduction.v 1 Scope1 2 Normative references1 3 Terms and definitions .1 4 Quality verification 3 5 Lot size .4 6 Biocompatibility.4 7 Product claim
11、s.4 8 Design.4 9 Preclinical evaluation5 10 Clinical (human use) investigations6 11 Bursting volume and pressure 6 12 Freedom from holes7 13 Stability and shelf-life .7 14 Visible defects .8 15 Package integrity for individual container8 16 Packaging and labelling8 17 Data sheet and test report 11 A
12、nnex A (normative) Sampling plans intended for assessing compliance of a continuing series of lots with sufficient number to allow the switching rules to be applied .12 Annex B (informative) Sampling plans that are intended for assessing the compliance of isolated lots 13 Annex C (normative) Determi
13、nation of total lubricant for condoms in individual containers14 Annex D (normative) Determination of length .16 Annex E (normative) Determination of width.18 Annex F (normative) Determination of thickness19 Annex G (informative) Determination of barrier properties using the bacteriophage method.20
14、Annex H (normative) Determination of the bursting volume and pressure24 Annex I (informative) Calibration of air inflation equipment for determination of burst volume and pressure .27 Annex J (normative) Testing for holes .31 Annex K (normative) Determination of shelf-life by real-time stability tes
15、ts36 Annex L (informative) Guidance on conducting and analysing ageing studies 38 Annex M (normative) Tests for individual container integrity40 Annex N (informative) Oven treatment for condoms made from synthetic materials .42 Bibliography43 BS ISO 23409:2011ISO 23409:2011(E) iv ISO 2011 All rights
16、 reservedForeword ISO (the International Organization for Standardization) 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
17、which a technical committee has been established has the right 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 al
18、l matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are
19、circulated to the member bodies for voting. Publication 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 document may be the subject of patent rights. ISO shall not be held res
20、ponsible for identifying any or all such patent rights. ISO 23409 was prepared by Technical Committee ISO/TC 157, Non-systemic contraceptives and STI barrier prophylactics. BS ISO 23409:2011ISO 23409:2011(E) ISO 2011 All rights reserved vIntroduction Synthetic condoms can be made from 100 % syntheti
21、c materials or a blend of synthetic materials and natural rubber latex. The material(s) used in synthetic condoms should be validated as constituting a barrier to human immunodeficiency virus (HIV), to other infectious agents responsible for the transmission of sexually transmitted infections (STIs)
22、, and to spermatozoa. It is essential that the condoms fit the penis properly, remain on the penis during use, are free from holes and have adequate physical strength so as not to break or tear during use so that the condoms can be deemed to be effective for contraceptive purposes and in order to he
23、lp prevent the transmission of STIs. It is also important that they be correctly packaged so that they are protected during storage and suitably labelled. All of these issues are addressed in this International Standard. To be safe, it is essential that the condom and any lubricant, additive, markin
24、g materials, dressing, individual packaging material or powder applied to it neither contain nor liberate substances in amounts that are toxic, likely to produce allergies (sensitization), locally irritating or otherwise harmful under normal conditions of storage and use. Condoms are medical devices
25、. To ensure high quality product, it is essential that condoms be produced under a quality management system using design controls. Reference can be made, for example, to ISO 90014, to ISO 14971, and to ISO 134858. Additional guidance can be found in ISO 160389. Condoms are non-sterile medical devic
26、es; however, a clean environment is essential to minimize microbiological contamination of the product during manufacturing and packaging. Condoms can be of the designs given in the following terms, which are not intended to be exhaustive: smooth, textured, parallel-sided, non-parallel-sided, plain-
27、ended, reservoir-ended, dry, lubricated, transparent, translucent, opaque, coloured, preshaped, welded or non-welded. This International Standard specifies preclinical, clinical, and lot-by-lot physical requirement testing for condoms made from synthetic materials, including condoms made from a blen
28、d of synthetic materials and natural rubber latex. Application of lot-by-lot testing requirements becomes relevant only after the preclinical and clinical requirements of this International Standard have been met. BS ISO 23409:2011BS ISO 23409:2011INTERNATIONAL STANDARD ISO 23409:2011(E) ISO 2011 Al
29、l rights reserved 1Male condoms Requirements and test methods for condoms made from synthetic materials 1 Scope This International Standard specifies the minimum requirements and the test methods applicable to male condoms produced from synthetic materials or blends of synthetic materials and natura
30、l rubber latex which are used for contraceptive purposes and to aid in the prevention of sexually transmitted infections. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undate
31、d references, the latest edition of the referenced document (including any amendments) applies. ISO 2859-1, Sampling procedures for inspection by attributes Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection ISO 4074, Natural latex rubber condoms Requirement
32、s and test methods ISO/TR 8550 (all parts), Guidance on the selection and usage of acceptance sampling systems for inspection of discrete items in lots ISO 10993-1, Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process ISO 10993-5, Biological evalua
33、tion of medical devices Part 5: Tests for in vitro cytotoxicity ISO 10993-10, Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization ISO 14155, Clinical investigation of medical devices for human subjects Good clinical practice ISO 14971, Medical devices Applic
34、ation of risk management to medical devices ISO 15223 (all parts), Medical devices Symbols to be used with medical device labels, labelling, and information to be supplied ISO 16037, Rubber condoms for clinical trials Measurement of physical properties 3 Terms and definitions For the purposes of thi
35、s document, the terms and definitions given in ISO 2859-1 and the following apply. 3.1 acceptance quality limit AQL quality level that is the worst tolerable process average when a continuing series of lots is submitted for acceptance sampling ISO 2859-1:1999, 3.1.26 BS ISO 23409:2011ISO 23409:2011(
36、E) 2 ISO 2011 All rights reserved3.2 male condom medical device, intended to cover and to be retained on the penis during sexual activity, used by consumers for purposes of contraception and prevention of sexually transmitted infections NOTE If a consumer can responsibly consider a device to be a ma
37、le condom (due to its shape, packaging, etc.) it is considered to be a male condom for the purposes of this International Standard. 3.3 consumer package package, intended for distribution to a consumer, containing one or more individual containers of condoms 3.4 expiry date date after which a condom
38、 is not suitable for use 3.5 identification number number, or combination of numerals, symbols or letters, used by a manufacturer on consumer packages to identify uniquely the lot numbers of individual condoms contained in that package, and from which it is possible to trace those lots through all s
39、tages of manufacturing, packaging and distribution NOTE When the consumer package contains only one type of condom, then the identification number can be the same as the lot number. However, if the consumer package contains several different types of condoms, e.g. condoms of different shapes or colo
40、urs, then the identification number is different from the lot numbers. 3.6 individual container primary package containing a single condom 3.7 inspection level relationship between lot size and sample size NOTE For a description, see ISO 2859-1:1999, 10.1. 3.8 lot collection of condoms of the same d
41、esign, colour, shape, size and formulation, manufactured at essentially the same time, using the same process, raw materials of the same specifications and common equipment, and packed with the same lubricant and any other additive or dressing in the same type of individual container 3.9 lot number
42、number, or combination of numerals, symbols or letters, used by the manufacturer to identify a lot of individually packaged condoms, and from which it is possible to trace that lot through all the stages of manufacture up to packaging 3.10 lot test test to assess the conformity of a lot NOTE A lot t
43、est may be limited to include only those parameters that can change from lot to lot. 3.11 non-visible hole hole in a condom that is not visible under normal or corrected vision, but is detected by a suitable water leak test or electrical test NOTE Suitable tests are specified in this International S
44、tandard. BS ISO 23409:2011ISO 23409:2011(E) ISO 2011 All rights reserved 33.12 sampling plan specific plan which indicates the number of units of product from each lot which are to be inspected (sample size or series of sample sizes) and the associated criteria for determining the acceptability of t
45、he lot (acceptance and rejection numbers) 3.13 shelf-life period from date of manufacture, during which condoms are required to conform to specified requirements for burst pressure, burst volume, freedom from holes, and pack integrity NOTE Suitable requirements are specified in this International St
46、andard. 3.14 synthetic material any base material other than 100 % natural rubber latex that is used to make condoms NOTE This term applies to both condoms made from all synthetic materials and to condoms made from synthetic and latex blends. 3.15 visible hole hole in the condom that is visible unde
47、r normal or corrected vision before the condom is filled with water or electrolyte during testing for freedom from holes 3.16 date of manufacture date of sheath formation or the date the condoms are packed in their individual containers provided that, in the latter case, a maximum period of bulk sto
48、rage is specified and shelf-life studies have been conducted on condoms that have been subjected to the maximum bulk storage period 3.17 visible defect (other than hole or tear) broken, missing or severely distorted rim, and permanent creases with adhesion of the film 4 Quality verification Condoms
49、are mass produced articles manufactured in very large quantities. Inevitably, there is some variation between individual condoms, and a small portion of condoms in each production run that might not meet the requirements of this International Standard. Further, the majority of the test methods described in this International Standard are destructive. For these reasons, the only practicable method of assessing conformity with this International Standard is by testing a representative sample from a lot or series of l
