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1、INTERNATIONAL STANDARD ISO 16038 First edition 2005-11-01 Reference number ISO 16038:2005(E) ISO 2005 Rubber condoms Guidance on the use of ISO 4074 in the quality management of natural rubber latex condoms Prservatifs en caoutchouc Directives sur lutilisation de lISO 4074 dans le management de la q
2、ualit des prservatifs en latex de caoutchouc naturel Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/20/2007 03:29:50 MDTNo reproduction or networking permitted without license from IHS
3、-,-,- ISO 16038:2005(E) ii ISO 2005 All rights reserved 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 are embedded are licensed to and installed on the com
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6、e Central Secretariat at the address given below. ISO 2005 All 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 photocopying and microfilm, without permission in writing from either
7、 ISO at the address below or ISOs member body in the country of the requester. ISO copyright office Case postale 56 CH-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax + 41 22 749 09 47 E-mail copyrightiso.org Web www.iso.org Published in Switzerland Copyright International Organization for Standardization
8、 Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/20/2007 03:29:50 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 16038:2005(E) ISO 2005 All rights reserved iii Contents Page 1Scope 1 2Normative references 1 3Term
9、s and definitions 1 4Quality of design 1 4.1General . 1 4.2Clinical investigation . 2 4.3Risk management 2 5Quality of manufacture 3 5.1Quality management . 3 5.2Lot testing (finished-product testing) 3 5.3Rounding-off values 3 6Quality in procurement 3 7Quality in testing 4 8Important parameters to
10、 be considered when using ISO 4074 . 4 8.1Size . 4 8.2Resistance to breakage 5 8.3Compatibility of materials 5 8.4Shelf-life and resistance to degradation . 5 8.5Packaging and labelling 9 8.6Type testing . 9 8.7Lubricants 10 9Sampling . 10 Bibliography . 11 Copyright International Organization for S
11、tandardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/20/2007 03:29:50 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 16038:2005(E) iv ISO 2005 All rights reserved Foreword ISO (the International Organiz
12、ation 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 which a technical committee has been established
13、 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 all matters of electrotechnical standardization. I
14、nternational 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 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 document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent
16、rights. ISO 16038 was prepared by Technical Committee ISO/TC 157, Mechanical contraceptives. Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/20/2007 03:29:50 MDTNo reproduction or networ
17、king permitted without license from IHS -,-,- ISO 16038:2005(E) ISO 2005 All rights reserved v Introduction Condoms are medical devices used for contraception and for prevention of sexually transmitted infections. ISO 4074 is a quality standard for natural rubber latex condoms. It is a reference doc
18、ument for standardised end-product quality test protocols and a baseline specification for critical attributes that affect condom safety and effectiveness. It is applied by manufacturers, procurement agencies, regulatory bodies and testing laboratories. The use of ISO 4074 does not by itself ensure
19、consistency in quality; consistent high quality at the lowest possible cost is attained ONLY through a regime termed quality management, through which, quality is built into the product and assured at every point in the design, planning, production and procurement processes. This International Stand
20、ard should lead to continuous improvement in manufacturing, procurement and testing processes. The special requirements of buyers and consumers should also be given due consideration when applying ISO 4074, as ISO 4074 is general by design, and will not cover completely all circumstances. This Inter
21、national Standard is a guidance document providing manufacturers, buyers, and third-party test laboratories guidance to implement and apply ISO 4074 in the manufacture of condoms and for purchasers to apply ISO 4074 as a technical specification and to verify that condoms delivered, comply with the s
22、pecification. In order to be acceptable, condoms need to meet or exceed the minimum requirements specified in ISO 4074. It is not possible, nor is it required, to subject condoms to user trials on a batch-by-batch basis. For this reason, certain evaluations are carried out only in the case of a pre-
23、market validation; for example for new or significantly modified designs. Design validation requirements normally include all the GMP validation requirements and the validation requirements of ISO 9001; these are not currently covered by ISO 4074, but are generally included by regulatory authorities
24、 as prerequisites for registering new designs of medical devices. Design considerations such as stability testing, etc. are however covered in ISO 4074. ISO 4074 is mainly concerned with finished product testing carried out to monitor or to verify that the condoms have been manufactured with adequat
25、e level of consistency in quality. For this purpose, tests have been designed that can be carried out rapidly and economically. The requirements in ISO 4074 are based on those properties which, based upon current knowledge, are believed to be relevant to the performance of condoms in normal use. Som
26、e important properties of condoms are nevertheless difficult to define in quantitative terms because of lack of controlled studies, the absence of practical and economical tests, and the need for different specifications to suit different users. ISO 4074 is therefore focused on the essential propert
27、ies where limits can be clearly defined. Other properties are addressed only in general terms and are meant to be augmented through appropriate manufacturing records, certification by the manufacturer or by buyers specifications. This International Standard also addresses how to deal with other impo
28、rtant issues not covered by ISO 4074. It is meant to help the user of ISO 4074 to understand any risks that may be associated with the use of condoms. It also helps in deciding whether such risks are acceptable when weighed against the benefits to the user. ISO 4074 also helps in assessing whether t
29、he products are demonstrably safe and offer protection to health. Good communication between the buyer and the manufacturer will result in the delivery of satisfactory and safe products, thus avoiding unnecessary testing or inappropriate specifications, thereby minimizing compliance testing costs. I
30、t should also be noted that in many countries condoms being medical devices are subject to appropriate regulations. Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/20/2007 03:29:50 MDTNo
31、 reproduction or networking permitted without license from IHS -,-,- ISO 16038:2005(E) vi ISO 2005 All rights reserved Information about standards can be obtained through catalogues issued by ISO, IEC, national standards bodies and regulatory agencies. List of projects under development by various I
32、SO technical committees can be found in the ISO technical programme of each committee. Additional useful information can also be found by searching in the work program documents for a specific technical committee or its working groups. The catalogues and abstracts are issued yearly to the member bod
33、ies. Modern technology opens up the opportunity for new ways to disseminate information about standards. Many national member bodies issue information on CD-ROM. Information also can be found on the World Wide Web by searching for quality-related subjects or under ISO. It is possible to search for i
34、nformation by committees, by published standards, and in a standards catalogue. It is also possible to obtain information on the revision status of a standard and the expected time of publication. This information is updated regularly, and it is therefore an extremely useful tool to search for stand
35、ards in a given field and the stage of development. ISO on-line has the address http:/www.iso.org; IEC on-line has the address http:/www.iec.ch. On both of these servers, links to member bodies which also have additional services are available, sometimes by subscription. Other useful documents are g
36、iven in the Bibliography. Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/20/2007 03:29:50 MDTNo reproduction or networking permitted without license from IHS -,-,- INTERNATIONAL STANDAR
37、DISO 16038:2005(E) ISO 2005 All rights reserved 1 Rubber condoms Guidance on the use of ISO 4074 in the quality management of natural rubber latex condoms 1Scope This International Standard provides guidance on using ISO 4074 and addresses quality issues to be considered during the development, manu
38、facture, quality verification and procurement of condoms. It encompasses the aspects of quality management systems in design, manufacture and delivery of condoms with emphasis on performance, safety and reliability of condoms. 2Normative references The following referenced documents are indispensabl
39、e for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 31-0:1992, Quantities and units Part 0: General principles ISO 2859-1, Sampling procedures for i
40、nspection by attributes Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection ISO 4074:2002, Natural latex rubber condoms Requirements and test methods ISO 9000, Quality management systems Fundamentals and vocabulary ISO 14155-1, Clinical investigation of medic
41、al devices for human subjects Part 1: General requirements ISO 14155-2, Clinical investigation of medical devices for human subjects Part 2: Clinical investigation plans 3Terms and definitions For the purposes of this document, the terms and definitions given in ISO 4074 and ISO 9000 apply. 4Quality
42、 of design 4.1General The condom is a single-use medical device, the performance and safety of which depends upon the design and the manufacturing process. New designs of condoms may require clinical testing, several other tests and analysis on a limited basis for validation purposes such as shelf-l
43、ife determination (type testing) and risk assessment. These requirements are generally prescribed by licensing authorities and the data generated become part of the master file for the product. Guidelines are available in ISO 9000 and the GMP requirements. When new products are developed, their desi
44、gn should conform to the requirements of design control as laid down in ISO 9001 and GMP requirements. Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/20/2007 03:29:50 MDTNo reproduction
45、 or networking permitted without license from IHS -,-,- ISO 16038:2005(E) 2 ISO 2005 All rights reserved The design control principles should be applied to parameters such as shape of condoms; dimensions; critical components in formulation such as antioxidants, vulcanizers, stabilizers, colorants, e
46、tc.; lubricants and additives such as flavour, additional lubricants etc; and packaging materials. Design control activities should be documented as part of the quality management system documentation, reviewed and updated, when regulatory agency and/or customer needs warrant changes. Whenever signi
47、ficant changes are made to the formulation or process that may substantially affect the performance and/or safety of the condoms, these changes should be evaluated, validated and documented (e.g. changes in lubricant, changes in primary (individual) packaging material, changes in leaching process).
48、Design validation should be used as the basis for ensuring that design parameters such as dimensions, formulation, components, stability and shelf-life claims, packaging and dressing materials, etc., are appropriate. When appropriate or necessary, such as when there has been a significant change in the formulation, skin irritation studies and safety evaluation should be performed and documented as part of design control activities. Purchasers including procurement agencies, in addition to assuring that cond