ISO 10993-1

Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process

Body

ISO

Number

ISO 10993-1

Editions

2018、2025

FDA recognition no.

2-258

FDA recognition no.

2-313

Scope

Partial recognition. The following part(s) of the standard is (are) not recognized: Table A.1 in Annex A.

Scope source: FDA 认可共识标准库

Laboratories covering this standard