FDA-recognized standard · Biocompatibility
ISO 10993-17: Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents
Yes. FDA recognizes ISO 10993-17 Second edition 2023-09 as recognition 2-303, in part, entered 2023-12-18. FDA also lists ISO 10993-17 First edition 2002-12-01 (recognition 2-237, transition period ending 2026-12-20).
Recognized editions of ISO 10993-17
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 2-303 | ISO 10993-17 Second edition 2023-09 | 2023-12-18 | Partial | — |
| 2-237 | ISO 10993-17 First edition 2002-12-01 also ANSI AAMI ISO 10993-17:2002/(R)2012 | 2016-07-26 | Partial | 2026-12-20 |
What FDA does not recognize in ISO 10993-17 Second edition 2023-09
Recognition 2-303 is partial. FDA's statement of the extent, verbatim:
Partial recognition. The following part(s) of the standard is (are) not recognized: - Table B1 in Annex B, second column, unit "g/d" - Example 6 in Clause B3 of Annex B, phrase "10 is the SF where 50 cm2 is the maximum device surface area, in cm2" - Table E.2 in Clause E2 of Annex E - Phrase "e.g. the largest surface area of device which can be in contact with the body is not the same as the surface area of the device which is in contact with the solution during extraction" in the paragraph before formula E.2 of Clause E2 and in the paragraph before formula E.4 of Clause E3.1
What FDA does not recognize in ISO 10993-17 First edition 2002-12-01
Recognition 2-237 is partial. FDA's statement of the extent, verbatim:
Partial recognition. The following part(s) of the standard is (are) not recognized: Clause 6.2.1 Clause 6.3.2 b) 2) and Equation 6 Clause 6.3.3 and Equation 7 Clause 7.1 b) Paragraph 2, Sentences: "Economic feasibility refers to the ability to meet the tolerable exposure without making provision of the device an unsound economic proposition. Cost and availability implications should be considered in the selection of allowable limits to the extent that these impact upon the preservation, promotion or improvement of human health." Clause 7.2, Words, either and or economically Annex C, Clause C.2.1
Product codes that cite ISO 10993-17
No product code cites ISO 10993-17: 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.