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1、BRITISH STANDARD BS 8404:2001 Packaging Child-resistant packaging Requirements and testing procedures for non-reclosable packages for pharmaceutical products ICS 11.120.99; 55.040 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW Licensed Copy: London South Bank University, Lond
2、on South Bank University, Fri Dec 08 00:58:31 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 8404:2001 This British Standard, having been prepared under the direction of the Consumer Products and Services Sector Policy and Strategy Committee, was published under the authority of the Standards Policy
3、and Strategy Committee on 21 December 2001 BSI 21 December 2001 The following BSI reference relates to the work on this British Standard: Committee reference PKW/5/27 ISBN 0 580 38700 3 Committees responsible for this British Standards The preparation of this British Standard was entrusted by Techni
4、cal Committee PKW/5, Primary and transport packaging, to Subcommittee PKW/5/27, Child-resistant packaging, upon which the following bodies were represented: Association of the British Pharmaceutical Industry British Association for Chemical Specialities British Glass Manufacturers Confederation Brit
5、ish Plastics Federation Child Accident Prevention Trust Consumer Policy Committee of BSI Department of Health Medicines Control Agency Department of Trade and Industry Consumer Safety Unit Flexible Packaging Association ICE Ergonomics National Pharmaceutical Association Proprietary Association of Gr
6、eat Britain Royal Pharmaceutical Society of Great Britain Amendments issued since publication Amd. No. DateComments Licensed Copy: London South Bank University, London South Bank University, Fri Dec 08 00:58:31 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 8404:2001 i Contents Committees responsible
7、. Inside front cover Foreword ii Introduction. 1 1Scope 2 2Normative references 2 3Terms and definitions 2 4Requirements 3 4.1General requirements. 3 4.2Performance requirements . 3 5Testing. 3 5.1Principle 3 5.2Samples and sample preparation. 4 5.3Procedure . 4 5.4Evaluation . 6 5.5Overall test res
8、ult 7 6Test report. 8 6.1General . 8 6.2Child test. 8 6.3Adult test. 8 6.4Additional (optional) information to be recorded. 9 6.5Overall test result 9 Annex A (informative) Guidance for persons supervising tests with children. 10 A.1Parental/guardian consent 10 A.2Surroundings and personnel. 10 A.3S
9、ocial circumstances of the children 10 A.4History of previous poisoning 10 A.5Avoidance of distractions 10 A.6Position of the children 10 A.7Behaviour of the supervisor during the test 11 Annex B (normative) Test charts. 12 Annex C (informative) Suitability of the test procedures chosen 15 Bibliogra
10、phy 16 Figure B.1 Chart of a sequential child test procedure (after 5 min of test before demonstration). 13 Figure B.2 Chart of a sequential child test procedure (total test period). 14 Table 1 Composition of the adult test group 6 Licensed Copy: London South Bank University, London South Bank Unive
11、rsity, Fri Dec 08 00:58:31 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 8404:2001 ii Foreword This British Standard has been prepared by Technical Subcommittee PKW/5/27, Child-resistant packaging. It is based on the draft of a proposed European Standard being prepared by CEN/TC 261, Packaging, by w
12、hich it may eventually be replaced. Product testing. Users of this British Standard are advised to consider the desirability of third-party testing of product conformity with this British Standard. Appropriate conformity attestation arrangements are described in the EN 45000 series of standards. Use
13、rs seeking assistance in identifying appropriate conformity assessment bodies or schemes may ask BSI to forward their enquiries to the relevant association. Annex A and annex C are informative. Annex B is normative. A British Standard does not purport to include all necessary provisions of a contrac
14、t. Users of British Standards are responsible for their correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. Summary of pages This document comprises a front cover, an inside front cover, pages i and ii, pages 1 to 16, an inside back cove
15、r and a back cover. The BSI copyright notice displayed in this document indicates when the document was last issued. Licensed Copy: London South Bank University, London South Bank University, Fri Dec 08 00:58:31 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 8404:2001 1 Introduction Child-resistant p
16、ackaging is used to create a physical barrier between a child and a potentially hazardous product. Various types of packaging are recognized as being child-resistant, based on performance testing against standards for specific product categories and packaging types. Since this type of packaging was
17、introduced, the incidence of accidental ingestion of potentially hazardous products by children under 5 years old has fallen. The degree to which this is due to the use of child-resistant packaging as opposed to other factors, such as greater public awareness of the hazards, is not easily assessed,
18、but there is little doubt that this packaging has made a positive contribution to the reduction. The use of child-resistant packaging needs to be confined to those products that are potentially hazardous, or for which any legislation makes its use mandatory, since, if used in other circumstances, th
19、ere could be confusion over the degree of hazard posed by the product. In any case, proper labelling and information by the manufacturer is important for the safe use of the product in the home. Child-resistant packaging acts as the last line of defence if other barriers separating the child and haz
20、ardous product have failed. However, it has to be recognized that it is unrealistic to expect that any functional packaging can be totally impossible for a child of 42 to 51 months, inclusive, to open and that child-resistant packaging cannot be a substitute for other safety precautions. There has b
21、een an increasing use of child-resistant packaging, therefore it is desirable to achieve agreement on testing procedures in order to avoid confusion and misunderstanding in an area of great importance to the safety of young children. This British Standard aims to reduce the number of children “expos
22、ed to training” during panel testing. Since the introduction of performance testing much has been learned about the use of children for testing child-resistant packaging and attention has been focused on how the number of children involved may be reduced. Future development of standards based on mec
23、hanical test methods is required to avoid unnecessary child panel testing and is essential in developing physical package attributes useable by manufacturers. Child-resistant packaging is only the last in a series of protective measures, and does not release parents or guardians from their duty to k
24、eep medicinal products out of the reach of children. Licensed Copy: London South Bank University, London South Bank University, Fri Dec 08 00:58:31 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 8404:2001 2 1 Scope This standard specifies performance requirements and methods of test for non-reclosabl
25、e packaging for pharmaceutical products that have been designated child-resistant. This standard is intended for type approval only (see 3.5) and is not intended for quality assurance purposes. 2 Normative references This standard incorporates, by dated or undated reference, provisions from other pu
26、blications. These normative references are cited at the appropriate places in the text, and the publications are listed hereafter. For dated references, subsequent amendments to or revisions of any of these publications apply to this standard only when incorporated in it by amendment or revision. Fo
27、r undated references, the latest edition of the publication referred to applies (including amendments). BS EN 862, Packaging Child-resistant packaging Requirements and testing procedures for non-reclosable packages for non-pharmaceutical products. 3 Terms and definitions For the purposes of this sta
28、ndard, the terms and definitions given in BS EN 862, some of which are repeated below for convenience, and the following apply. 3.1 child-resistant package package which is difficult for young children to open (or gain access to the contents), but which is not difficult for adults to use properly NO
29、TERequirements for the levels of accessibility to children and adults are contained within this standard and in BS EN 862. 3.2 non-reclosable child-resistant package child-resistant package or part of a child-resistant package which, when all or part of the contents have been removed, cannot be prop
30、erly closed again 3.3 substitute product inert substitute resembling the product it replaces, i.e. powder, tablets or liquids (uncoloured water) BS EN 862 NOTEThis is sometimes referred to as a placebo product. 3.4 unit dose discrete quantity of any product to be removed from its immediate packaging
31、 in its entirety BS EN 862 3.5 type approval procedure to certify as child-resistant a specific type of non-reclosable package, formed from a specified set of materials, which has met the requirements of this standard Licensed Copy: London South Bank University, London South Bank University, Fri Dec
32、 08 00:58:31 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 8404:2001 3 4 Requirements 4.1 General requirements A non-reclosable child-resistant package, when tested in accordance with the requirements of this standard, shall be capable of providing a satisfactory degree of resistance to opening by c
33、hildren (see 4.2.1) and a satisfactory level of accessibility to its contents by adults (see 4.2.2). A non-reclosable child-resistant package, in addition to conforming to the performance requirements specified in this standard (see 4.2), shall be appropriate for the contents, provide mechanical pro
34、tection and function properly for the life of the content and packaging. Manufacturers, fillers and packers of such packages shall initiate and operate procedures to control the quality of packaging materials so that they are in accordance with the requirements of this standard. NOTEBS EN ISO 9001:2
35、000 specifies requirements for quality management systems where organizations need to demonstrate their capability of supplying conforming products to customers. 4.2 Performance requirements 4.2.1 Child test When tested in accordance with 5.3.2 and evaluated in accordance with 5.4.1, the packaging s
36、hall be child-resistant. 4.2.2 Adult test When tested in accordance with 5.3.3, at least 90 % of the adults shall be able to access at least 1 unit dose, henceforth referred to as “unit”, within the 1 min test period, without a demonstration. 5 Testing 5.1 Principle Type approval for non-reclosable
37、child-resistant packaging is obtained by a sequential test method for children and a full panel test for adults. A test group of up to 200 children aged 42 to 51 months is divided into pairs. Each child is given a number of non-reclosable packages to be opened by whatever means they wish to use. If
38、a child fails to gain access within 5 min, the method of opening is demonstrated by the supervisor and the child is given a further 5 min to open the package. The results are recorded sequentially, as obtained. The package is deemed child-resistant if the trail of results on the test charts passes i
39、nto the acceptance zone or if at least 80 % of the children are unable to access more than 8 units within 10 min and at least 85 % of the children are unable to access more than 8 units within the first 5 min. The packages accessibility by a test group of 100 adults is also assessed. Each adult is g
40、iven a non-reclosable package, any associated opening tools and written instructions, and is allowed 5 min to familiarize themselves with the packaging. The number of adults opening the package within a subsequent 1 min test period is recorded. The package is deemed to conform to the requirements of
41、 this standard if at least 90 % of the adults are able to access at least 1 unit in 1 min. Licensed Copy: London South Bank University, London South Bank University, Fri Dec 08 00:58:31 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 8404:2001 4 5.2 Samples and sample preparation Sufficient packages s
42、hall be produced by the proposed manufacturing process to enable a representative sample to be selected by the supervisor for testing and to provide a reserve for reference purposes. Dangerous products shall not be used to fill the package to be tested; an appropriate substitute product shall be use
43、d. The material and design of the test samples shall be representative of an average batch of original packages. NOTEPackages for the child panel test should be unprinted. In every test, a new package shall be provided for each member of the test group. For both the child and adult tests, there shal
44、l be at least 10 units available for each participant. Each sample package shall be checked for integrity before the test is conducted. The packages shall be presented to the children without the outer retail packaging, giving them access to the individual units. 5.3 Procedure 5.3.1 General The test
45、 procedure is carried out in two stages: a) child test (see 5.3.2); b) adult test (see 5.3.3). 5.3.2 Child test 5.3.2.1 Composition of child test group The test group shall comprise no more than 200 children aged 42 to 51 months, inclusive, with approximately equal numbers of girls and boys. As far
46、as possible, there shall be an even distribution of ages and sexes within the panel. The children shall be selected at random and shall have no apparent physical or mental disability which might affect manual dexterity. They shall not have taken part in more than one previous test and, in that test,
47、 a packaging of a different type and design shall have been used. If a child is used for more than one test there shall be at least 4 weeks between tests. Parental or guardian consent shall be obtained before the child is used as a part of the test group. Any children having been involved in a repor
48、ted poisoning accident shall be excluded from the test. NOTEChildren should be selected to represent as closely, as is reasonably possible, the different social, ethnic and cultural origins or the population as a whole, and not just of the immediate district in which the test is carried out. 5.3.2.2
49、 Test procedure Testing shall be carried out in the presence of a test supervisor. The child test shall take place in an environment familiar to the children. NOTE 1Test personnel should visit the test location beforehand and become known by the children in order to gain their confidence. Only the supervisors should be present, parents being excluded from the test. The test shall be carried out by a sequential procedure (see 5.4.1.1 to 5.4.1.3). The number of children tested will therefore depend on the results obtained, however, the age and sex constraints specifie
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