1. Scope

1.1

General This Standard applies to nonreclosable packages for drugs and any other substances, in either liquid or solid form, that incorporate child-resistant features whereby children are restricted in their ability to access the contents of the package.

1.2

Requirements This Standard provides a standardized method to determine the number of units or cells of a nonreclosable package that may be opened by children and establishes a limit above which packages are considered as having failed to comply with its requirements. This Standard also provides a method to determine the number of units or cells that may be opened by senior adults.

1.3

Testing This Standard describes the minimum level of physical tests used to ensure that subsequent production lots conform to this Standard.

1.4

Reclosable Child-Resistant Packages This Standard does not apply to reclosable packages or features for which requirements are provided by CSA Standard Z76.1.

1.5

Toxicity This Standard does not assess the toxicity or other hazards associated with the product contained within a package. It is the packager's responsibility to satisfy the regulatory authorities that the package design chosen is appropriate for a product.

1.6

Terminology In this Standard, the word ""shall"" indicates a mandatory requirement; ""should"" indicates a recommendation or that which is advised but not mandatory; and ""may"" indicates an advisory or optional statement. Notes accompanying clauses do not include mandatory or alternative requirements. The purpose of a note accompanying a clause is to separate from the text explanatory or informative material that is not properly a part of the Standard. Notes to figures and tables are considered part of the figure or table and may be written as mandatory requirements.