DIN EN ISO 10993-2:2020 Edition

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Biological evaluation of medical devices – Part 2: Animal welfare requirements (Draft)

Published By	Publication Date	Number of Pages
DIN	2020-04	51

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Categories: 11.100.20 - Biological evaluation of medical devices, DIN

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Description

This document is aimed at those who commission, design, perform or evaluate data from animal tests undertaken to assess the biocompatibility of materials or medical devices intended for use in medical devices. It specifies the minimum requirements to be satisfied to ensure and demonstrate that proper provision has been made for the welfare of animals used in animal tests to assess the biocompatibility of materials used in medical devices. It also makes recommendations and offers guidance intended to facilitate future further reductions in the overall number of animals used, refinement of test methods to reduce or eliminate pain or distress in animals, and the replacement of animal tests by other scientifically valid means not requiring animal tests.

Additional information

Published Code	DIN
Published By	Deutsches Institut für Normung
Publication Date	2020-04
Pages Count	51
Language	Germany
Descriptors	Animal husbandry, Animal protection, Bioassay, Biological tests, Compatibility tests, Definitions, Documentation, Experimental animals, Fine mechanics, Human medicine, Implants (surgical), Laboratory animals, Medical devices, Medical equipment, Medical products, Medical sciences, Personnel, Pharmacy, Product tests, Research, Specification (approval), Surgical equipment, Surgical implants, Validation
File Size	2.3 MB
ICS Codes	11.100.20 - Biological evaluation of medical devices

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DIN EN ISO 10993-2:2020 Edition

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