Significance and Use
5.1 Despite child-resistant packaging requirements for most potentially harmful liquid consumer products, each year tens of thousands of young children are evaluated in emergency departments for potential poisoning from liquid consumer products. Products that use reclosable safety packaging rely on users to resecure the child-resistant closure fully after each use. If the closure is not fully secured or a child opens the closure, the entirety of the product contents is immediately accessible. Restricted delivery systems are a type of packaging for medications and other liquid consumer products designed to limit the amount of product that is accessible even after the primary closure is removed.
5.2 This test method can be used to provide quantitative assessment of restricted delivery systems for liquid consumer products. This test method outlines three types of mechanical test procedures to simulate methods young children may use when attempting to access liquid contents from a container. To evaluate the efficacy of restricted delivery systems, tests are conducted with the primary closure removed and under conditions approximating intended use of the products. Instruction for use for the intended product should be used when preparing the samples for testing; for example, storage temperature, shaking of product, and use of associated dispensing devices when applicable.
1.1 This test method covers assessment of non-metered restricted delivery system characteristics so that they can be evaluated to a standard that signifies efficacy in limiting accessibility of liquid contents to young children.
1.2 This test method provides general test conditions for the determination of flow control of liquids by restricted delivery systems using mechanical testing to simulate methods that may be used to access liquid consumer products by young children.
1.3 The test parameters provided within this test method are estimates based on existing literature and experience. The estimated values are intended to allow comparison of performance characteristics across different restricted delivery systems.
1.4 This test method applies to liquids packaged in reclosable containers.
Note 1: Since there are many variables that may affect release of liquid (for example, rigidity of container, viscosity of liquid contents, or variation in test equipment), it is important that the entire restricted delivery system is tested together as intended for use while using the same or similar testing equipment. This test method does not address other product characteristics that might be affected by use of restricted delivery systems (for example, uniformity of active ingredient throughout duration of use).
1.5 Units—The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in nonconformance with the standard.
1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.