BSI 21/30384564 DC:2021 Edition
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BS ISO 23417. General specifications and validation methods for non-sterile medical device packages in good distribution practice principles
Published By | Publication Date | Number of Pages |
BSI | 2021 | 19 |
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.