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Description of 21/30383734 DC 2021This 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.
About BSIBSI 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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