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)].

Recognized editions of ISO 10993-18

FDA recognitions of ISO 10993-18, newest first (FDA database snapshot of 2026-09-01)

Recognition	Edition	Entered	Extent	Transition ends
2-298	ISO 10993-18 Second edition 2020-01 Amendment 1 2022-05	2022-12-19	Partial	—

What FDA does not recognize in ISO 10993-18 Second edition 2020-01 Amendment 1 2022-05

Recognition 2-298 is partial. FDA's statement of the extent, verbatim:

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]. " Example C2 in Clause E.4 of Annex E

Product codes that cite ISO 10993-18

No product code cites ISO 10993-18: it is a horizontal standard, applied across device types rather than tied to particular codes.

Source: FDA Recognized Consensus Standards database, snapshot of 2026-09-01. Search every recognition in the Consensus Standards Lookup, or browse all standards with a page.