21/30383734 DC

This standard 21/30383734 DC BS ISO 23416. General specifications and testing methods for temperature-sensitive pharmaceutical packages in good distribution practice principles is classified in these ICS categories:

• 11.120.99 Other standards related to pharmaceutics
• 55.020 Packaging and distribution of goods in general

This International Standard specifies the test methods of the validation and the performance of the distribution packaging for medical devices that do not need sterilization. This document is intended to facilitate harmonized regulatory requirements for transport packaging of medical devices in good distribution practice principles.

This document does not cover any sterilization for medical device packaging, equipment and processing and quality assurance system in all stages of manufacture and does not guarantee the safety of medical devices.