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Biological evaluation of medical devices - Tests for genotoxicity, carcinogenicity and reproductive toxicity

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Biological evaluation of medical devices - Tests for genotoxicity, carcinogenicity and reproductive toxicityBS EN ISO 10993 3 specifies strategies for hazard identification and tests on medical devices for the biological aspects of genotoxicity, carcinogenicity, and reproductive and developmental toxicity. It is applicable for evaluation of a medical device whose potential for genotoxicity, carcinogenicity or reproductive toxicity has been identified. Guidance on selection of tests is provided in BS EN ISO 10993 1.

intended to be used in industrial and non-industrial locations

and giving guidance on their realization

With obedience and compliance to ISO 20769‑1

It’s paramount that audio-visual (AV) and information technology equipment (ITE) is safe for users and technicians alike

This standard includes aerospace requirements applied to

This may be considered equivalent to eIDAS Annex II items 1 and 2

this document supersedes BS EN 62366:2008+A1:2015

BS EN 60974-11 is applicable to electrode holders for manual metal arc welding with electrodes up to 10 mm in diameter

nightclubs

It gives the most important characteristics and associated test methods for assessing PET recyclates intended to be used for the production of semi-finished/finished products

BS EN 806-3:2006 Specifications for installations inside buildings conveying water for human consumption

by materials or by material family which:

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