EN 28317:1992

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Kindersichere Verpackung - Anforderungen und Prüfverfahren für wiederverschließbare Verpackungen (ISO 8317:1989)Emballages a l'épreuve des enfants - Exigences et méthodes d'essai pour emballages refermables (ISO 8317:1989)Child-resistant packaging - Requirements and testing procedure for reclosable packages (ISO 8317:1989)97.190Otroška opremaEquipment for children55.020Pakiranje in distribucija blaga na splošnoPackaging and distribution of goods in generalICS:Ta slovenski standard je istoveten z:EN 28317:1992SIST EN 28317:1996en,de01-avgust-1996SIST EN 28317:1996SLOVENSKI
STANDARD



SIST EN 28317:1996



SIST EN 28317:1996



SIST EN 28317:1996



INTERNATIONAL STANDARD IS0 8317 First edition 1989-07-01 Child-resistant packaging - Requirements and testing procedures for reclosable packages Emballages ;i Opreuve des enfants - Exigences et m6thodes d’essai pour emballages refermables Reference number IS0 8317 : 1989 (El SIST EN 28317:1996



ISO8317:1989(E) Foreword IS0 (the International Organization for Standardization) is a worldwide federation of national standards bodies (IS0 member bodies). The work of preparing International Standards is normally carried out through IS0 technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, govern- mental and non-governmental, in liaison with ISO, also take part in the work. IS0 collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. Draft International Standards adopted by the technical committees are circulated to the member bodies for approval before their acceptance as International Standards by the IS0 Council. They are approved in accordance with IS0 procedures requiring at least 75 % approval by the member bodies voting. International Packaging. Sta ndard IS0 8317 was prepared bY Technica Committee ISO/TC 122, Users should note that all International Standards undergo revision from time to time and that any reference made herein to any other International Standard implies its latest edition, unless otherwise stated. 0 IS0 1989 All rights reserved. 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 the publisher. International Organization for Standardization Case postale 56 l CH-1211 Geneve 20 l Switzerland Printed in Switzerland SIST EN 28317:1996



INTERNATIONAL STANDARD IS0 8317 : 1989 (El Child-resistant packaging - Requirements and testing procedures for reclosable packages 0 Introduction A significant number of suspected cases of ingestion by children of products used about the home is reported to the medical profession each year. Most are not serious and those that are associated with more serious side effects involve products known to be hazardous, e.g. certain drugs and medicines, liquid fuels and solvents, strongly acid or alkaline preparations and some garden products. Most commonly used household detergents, cleaning agents, and maintenance and care products do not appear on the list of products which have caused injury. However, whether ingestion (actual or suspected) causes injuries or not, such incidents can have traumatic effects on both the child and its parents. The use of potentially hazardous agents in certain products is necessary to achieve effectiveness; consequently steps have to be taken to limit the occurrence of accidents. One approach has been to try to increase general awareness of hazards associated with various products; this approach has been used but public education aimed to protect the child by educating the parent and other adults about correct storage practices, etc. has never been completely effective. Nevertheless, proper labelling and information by the manufacturer is important to the safe use of products in the home. Another approach has been the use of child-resistant packag- ing to put a physical barrier between the child and the haz- ardous product. Such packaging should only be used for products as mentioned above since, if used in other cir- cumstances, it could lead to confusion among consumers. It has to be recognized that it is unrealistic to expect that any functional packaging can be totally impossible for a child to open and this type of packaging cannot be a substitute for normal safety precautions. The packaging functions as a last defence if other barriers separating children and hazardous products have failed. Historically the United States of America was the first country to introduce a standard method of testing based on the inability of 200 children of a specific age and sex distribution to open the package and the ability of 100 adults of a particular age and sex distribution to open and, where applicable, reclose the package properly. Since then, a number of other countries have in- troduced standard test methods based on similar principles. There are now around the world various types of packagings which are recognized as child-resistant based on a test of the nature described. There is evidence that since these test methods were introduced the incidence of ingestion by children of hazardous products has fallen. The degree to which this is due to the use of child-resistant packaging as against other fac- tors, such as greater public awareness, is not easily assessed, but there is little doubt that child-resistant packaging has made a positive contribution. Over the last decade 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. So far it has not been possible to achieve an objective set of tests and criteria which would render the use of children in subjective testing unnecessary, but work should be directed towards achieving this aim as a matter of some urgency. Because of the increasing use of child-resistant packaging it is desirable to achieve international agreement on testing pro- cedures in order to avoid confusion and misunderstanding in an area of great importance to the safety of young children. An International Standard should also serve to reduce the number of children exposed to “training” during panel testing. However, it should not be supposed that the provision of a standard method for assessing child resistance is all that is needed either nationally or internationally. The test must be administered by some responsible authority in each country adopting the International Standard, as all must have con- fidence in the manner in which testing is carried out and thus common procedures should be adopted by all administering authorities covering such questions as - How needed ? is it decided that a child-resistant packaging is - How is the test to be authorized and carried out? - How recorded ? and by whom will the results be evaluated and - What minimum qualifications visors who carry out the procedure are required of super- - How is it ensured that no child takes part in more than two tests and then only on packagings that are significantly different ? Attention is drawn to the need to have adequate supervisory and accreditation bodies and reference should be made to ISO/IEC Guide 23, Methods of indicating conformity with standards for third-party certification systems, and ISOIIEC Guide 25, General requirements for the technical competence of testing laboratories, which provide useful guidance on these topics. SIST EN 28317:1996



IS0 8317 : 1989 (El This international Standard has been prepared to specify requirements and testing procedures for child-resistant packag- ing intended for potentially harmful products; it has been writ- ten as the best consensus which can be achieved at present and should be reviewed more frequently than other Inter- national Standards and revised in the light of experience. 1 This International Standard refers only to accessibility to the con- tents of the package. Attention is drawn to the need, when designing a child-resistant package, to give consideration to possible dangers linked to the risk of spillage which can happen unexpectedly when opening or trying to.open the package. 2 Studies are at present being carried out to determine whether it is feasible to develop an International Standard for non-reclosable packages and other International Standards may be published in future detailing mechanical methods which may be suitable for regulatory and quality assurance purposes. 1 Scope and field of application This International Standard specifies the requirements and test methods for reclosable packages designated as resistant to opening by children. Acceptance criteria are given for the package when tested by specified methods. These methods not only provide a measure of ‘the effectiveness of the package in restricting access by children but also cover the accessibility to the contents by adults. Reclosable packages for any product intended to be exposed or removed from the packaging in normal use are covered by the procedures. This International Standard is intended for type approval only (see 3.1) and is not intended for quality assurance purposes. Means of performing the test on a series of similar packages are given in annex A and guidance for persons carrying out the tests is given in annexes B and C. 2 Definitions For the purposes definitions apply. of this International Standard, the following 2.1 child-resistant package: A package which is difficult for young children under the age of five to open (or gain access to the contents), but which is not difficult for adults to use properly in accordance with the requirements of this Interna- tional Standard. 2.2 reclosable package: Any package which, after it has been initially opened, is capable of being reclosed with a similar degree of security and capable of being used a sufficient number of times to dispense the total contents without loss of security. NOTE - Solid substitute products for child-resistant packages should normally consist of powder, granules or units of any similar shape and size varying from 5 to 30 mm in any dimension, preferably of a neutral colour, and not harmful in any way. Liquid substitute product should always be uncoloured water. 3 General 3.1 Compliance with this International Standard A child-resistant package tested in accordance with the re- quirements of this International Standard is shown to be capable, when correctly made and used, of providing a satisfactory degree of resistance to opening by children while maintaining accessibility to its contents by adults; in other words, the test is designed for type approval. Manufacturers and fillers of such packages will be required to initiate and operate such procedures as are necessary to control production and use, and to ensure that all packages meet the required quality standards. 3.2 Packages for testing Sufficient packages shall be supplied to enable a representative sample to be selected for testing by the supervisor and to provide a reserve for reference purposes. In every test, a new package shall be provided for each member of the test group. Before child testing is carried out on reclosable child-resistant packages, both manufacturers and fillers shall satisfy themselves that the life expectancy of the child-resistant package will exceed the maximum expected number of open- ings and closings which are likely to occur in practice without unacceptable impairment of the child-resistant property. 3.3 Test panels Testing is carried out with two classes of people : a) a test with young children between 42 and 51 months of age, inclusive; 4 b) a test elusive. with adults between 18 and 65 years of age, in- Requirements 4.1 General safety requirements A child-resistant package, in addition to satisfying the re- quirements for child resistance specified in 4.2, shall meet the requirements for packaging, such as being appropriate for the contents, providing mechanical protection and functioning properly for the life of the package. 4.2 Performance requirements 4.2.1 Requirements concerning children 2.3 substitute product product it replaces. : An inert substitute resembling the When the packaging is tested in accordance followi ng requirements shall be met : with 5.3, the 2 SIST EN 28317:1996



IS0 8317 : 1989 (El a) at least 85 % of the children in the test panel shall be unable to open the package within 5 min without a demonstration, and b) at least 80 % of the children in the test panel shall be unable to open the package within 5 min without a demonstration and within another 5 min after a demonstra- tion has been given to those children unable to open the package in the first 5 min. 4.2.2 Requirements concerning adults When the packaging is tested in accordance with 5.4, at least 90 % of the adults shall be able to open and reclose the package properly within 5 min and without a demonstration. 5 Test procedures 5.1 Test supervision All procedures shall be carried out under the supervision of (an) impartial and appropriately qualified person(s). For the child test, the supervisor(s) shall also be skilled in handling children. Guidance B and C. for persons carrying out the tests is given in annexes 5.2 Preliminary checking and preparation Before packages are tested, and properly reclosed. each package should be opened Packages which incorporate a tamper-evident seal in addition to being child-resistant shall have the seal broken; they shall be opened and checked by the test supervisor(s) as specified in the previous paragraph prior to the child test. No hazardous product shall be used to fill any package submit- ted for test. A suitable substitute product shall be used for adult tests; a suitable substitute product shall also be used for child tests except in cases where this would conflict with national requirements. When a substitute product is used, packages up to a volume of 1 litre shall be filled to their nominal size capacity (i.e. as sold); packages greater than 1 litre volume shall be filled with 1 kg of solid or 1 litre of liquid substitute product as appropriate. 5.3 Child test 5.3.1 Composition of test group Enough children to ensure 200 valid participants between the ages of 42 and 51 months inclusive, with an even distribution of age and sex, shall be available. As far as possible they shall represent the social, ethnic and cultural origins of the country as a whole. They shall all be healthy with no evident physical or mental handicap associated with manual dexterity. They shall not have taken part in more than one previous test and, in that test, a packaging of a different type with opening arrangements based on a different principle shall have been involved. If a child is used on more than one test panel, it is desirable that there should be at least 1 week between the tests. 5.3.2 Location The children shall perform the test in any place with which they are familiar, e.g. in their usual school or kindergarten, but they shall be removed from the general school population and separated from extraneous distractions. Several venues should be selected from different demographic areas. The test series need not necessarily be completed at one venue at one time. 5.3.3 Procedure The test may be carried out on all 200 children or by a sequen- tial procedure. If the latter is used, the number of children tested will depend on the results obtained (see 6.1.2). When testing sequentially, the age and sex constraints specified in 5.3.1 shall be adhered to. The children shall be tested in pairs, each pair being monitored by one supervisor. If desired, a number of pairs (up to five) may be tested in the same room at the same time, provided that ar- rangements are such that they cannot distract other pairs. They may adopt any attitude or position they find convenient. Should a child wander off during the test, action by the super- visor(s) shall be limited to leading the child back to its place and requesting that he or she continue the test, without any addi- tional instru
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