Abstract： AS 5014:2010 pdf download.Child-resistant packaging— Requirements and testing procedures for non-reclosable packages for pharmaceutical products (EN 14375:2003, MOD). 4.2.1 Child test An individual child test shall be considered a failure...

AS 5014:2010 pdf download.Child-resistant packaging— Requirements and testing procedures for non-reclosable packages for

pharmaceutical products (EN 14375:2003, MOD).

4.2.1 Child test

An individual child test shall be considered a failure in relation to unit, strip or blister packages if within 10 mm the child accesses more than 8 unit doses from the packaging provided.

When tested in accordance with 5.3.2 and evaluated in accordance with 5.4.1.3, the packaging shall be deemed to be child-resistant.

NOTE The figure of eight units is based on existing national standards published by certain CEN members and does not address the issue of toxicity. Some pharmaceutical products on the market can cause harm to children by the ingestion of fewer than eight units. However, reliable data on child toxicity exists for few pharmaceutical pi-oducts. A harmful dose can be established for sonie

existing pharmaceutical products and a maximum sale dose can be established for all pharmaceutical products by one means or

another. Such information is not currently available for all products and there is no central register where this information could be held. In the absence of European legislation on this topic the drafters of this European Standard acknowledge these concerns and believe that research and collection of data should continue with a view to considering the substitution of a toxicity based pass/

fail criterion fom the child panel test in a later revision.

Recommended：