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  • BSI
    21/30383734 DC BS ISO 23416. General specifications and testing methods for temperature-sensitive pharmaceutical packages in good distribution practice principles
    Edition: 2021
    $44.66
    / user per year

Description of 21/30383734 DC 2021

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.



Standard Number21/30383734 DC
TitleBS ISO 23416. General specifications and testing methods for temperature-sensitive pharmaceutical packages in good distribution practice principles
StatusDefinitive
Publication Date2021-02-01
Identical National Standard OfISO/DIS 23416
DescriptorsSpecification (approval), Standard specifications, Documents, Data media, Specifications, Pharmaceutical containers, Pharmaceutical technology, Pharmaceuticals, Capsules (packaging), Capsules (medicinal), Medicines, Temperature
ICS11.120.99 Other standards related to pharmaceutics, 55.020 Packaging and distribution of goods in general
CommitteePKW/0
PublisherBSI
Pages24

About BSI

BSI Group, also known as the British Standards Institution is the national standards body of the United Kingdom. BSI produces technical standards on a wide range of products and services and also supplies certification and standards-related services to businesses.
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