Name | Date modified | File size |
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|---|---|---|---|
BS EN ISO 15378_2015 Primary packaging materials for medicinal products. Particular requirements for the application of ISO 9001 - libgen.li.pdf Shared | Nov 14, 2024 | 1.8 MB | |
IEC 60601-1-10_2013 Medical electrical equipment - Part 1-10_ General requirements for basic safety and essential performance - - libgen.li.pdf Shared | Nov 14, 2024 | 2.4 MB | |
ISO - ISO 13485_2016 Medical devices -- Quality management systems -- Requirements for regulatory purposes (2016, International Organization for Standardization) - libgen.li.pdf Shared | Aug 12, 2024 | 966 KB | |
ISO - ISO 13485_2016 Medical devices – Quality management systems – Requirements for regulatory purposes (2016) - libgen.li.pdf Shared | Aug 12, 2024 | 3.7 MB | |
ISO - ISO_TR 24971 Medical devices - Guidance on the application of ISO 14971 (2020, ISO) - libgen.li.pdf Shared | Nov 14, 2024 | 2.2 MB | |
ISO TR 10993-33_2015 Biological evaluation of medical devices. Guidance on tests to evaluate genotoxicity. Supplement to ISO.pdf Shared | Nov 14, 2024 | 1.4 MB | |
Medical Devices Rules, 2017.pdf Shared | Aug 12, 2024 | 3.3 MB |