ISO TR 10993-33

Biological evaluation of medical devices - Part 33: Guidance on tests to evaluate genotoxicity - Supplement to ISO 10993-3

Body

ISO

Number

ISO TR 10993-33

Editions

2015

FDA recognition no.

2-243

Scope

Partial recognition. The following part(s) of the standard is (are) not recognized: Clause 6.3.2, Sentence, "A DRF study may be conducted prior to the main study if cytotoxicity of the test sample is expected to be significant, e.g. cytotoxicity or growth inhibition greater than 50%," Clause 6.5.3, Paragraph 2, First bullet, "reduction greater than 50% with dose-dependency in the mean number of revertants per plate as compared to the mean corresponding solvent control." Clause 7.3.2., Paragraph 4, Phrase, "degree of confluency" Clause 9.5.2.2, Paragraph 2, Second Sentence, "Low spontaneous mutant frequencies, i.e. 20 to 34 mutants per 106 surviving cells, are considered acceptable if small colony recovery is demonstrated, see Reference" Clause 9.5.2.2, Paragraph 3, First bullet "4 h: >=100 mutants over the negative control". Annex A

Scope source: FDA 认可共识标准库

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