ISO 10993-18

Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process [Including Amendment 1 (2022)].

Body

ISO

Number

ISO 10993-18

Editions

2020

FDA recognition no.

2-298

Scope

Partial recognition. The following part(s) of the standard is (are) not recognized: Clause 5.5 second and third sentences. Clause 7, second paragraph, phrase "to assist in any toxicological risk assessment" Table D.3 in Clause D.5 of Annex D Clause E3 of Annex E, 5th paragraph, 4th sentence, "For example, a UF value of 2 has been proposed[39][45] as being appropriate, in certain situations, to the screening of extracts for semi-volatile extractables via GC-FID or GC-MS, as analytical FID or MS response factors for extractables are somewhat consistent, extractable to extractable" Clause E3 of Annex E, paragraph before the last paragraph, the last two sentences "The use of multiple analytical methods can reduce response factor variation and can be considered in the determination of the necessary UF that is then applied to all the complementary methods. See References [56] and [57]."

Scope source: FDA 认可共识标准库

Laboratories covering this standard