ISO 10993-3

Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity

Body

ISO

Number

ISO 10993-3

Editions

2014

FDA recognition no.

2-228

Scope

Partial recognition. The following part(s) of the standard is (are) not recognized: Clause 4.1. Clause 5.2.3 Clause 5.3. Clause 6.2, Sentence, "One animal species is typically sufficient for testing medical devices." Clause 7.2, Phrase, "or test material" Annexes A and B

Scope source: FDA 认可共识标准库

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