BS EN 862-2005 pdf download.Packaging Child- resistant packaging Requirements and testing procedures for non-reclosable packages for non-pharmaceutical products.
Type approval for non-reclosable child-resistant packaging is obtained by a sequential test method for children. 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 a child fails to gain access within 5 mm, the method of opening is demonstrated by the supervisor and the child is given a further 5 mm 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 into the acceptance zone or if at least 80 % of the children are unable to access one or more units within 10 mm and at least 85 % of the children are unable to access one or more units within the first 5 mm. The packages accessibility may also be assessed by an optional full panel test for adults using a test group of 100 adults. Each adult Is given a non-reclosable package, any associated opening tools and written instructions, and is allowed 5 mm to familianse themselves with the packaging. The number of adults opening the package within a 1 mm test period Is recorded. The package is deemed to comply with the requirements of this standard if at least 90 % of the adults are able to access at least 1 unit in 1 mm.
4.2 Samples and sample preparation
Sufficient packages shall 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 used. The material and design of the test samples shall conform to the technical specification and they shall be representative of an average batch of original packages.
Packages for the child panel test shall be unprinted
In every test, a new package shall be provided for each member of the test group.
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.
4.3.2.1 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 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 that might affect manual dexterity. They shall not have taken part in more than one previous test and, in that test, 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 reported poisoning accident shall be excluded from the test.
NOTE ChEldren should be selected to represent, as closely as is reasonably possible, the different social. ethnic and cultural origins of the population as a whole, arid not just of the immediate district in which the test Is carried out
4.3.2.2 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 1 Test 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 (4.4.1.1 to 4.4.1.3). The number of children
tested will therefore depend on the results obtained, however, the age and sex constraints specified in 4.3.2.1 shall be adhered to.
Pairs of children shall be involved in the test, each pair being monitored by one supervisor. Should a child wander off during the test, action by the supervisor shall be limited to leading the child back to its place and requesting that he or she continue the test, without any additional instruction being given
concerning the opening of the package this fact shall be included in the report (clause 5).BS EN 862-2005 pdf download.