ISO 10993-17

Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances

Body

ISO

Number

ISO 10993-17

Editions

2002、2023

FDA recognition no.

2-237

FDA recognition no.

2-303

Scope

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

Scope source: FDA 认可共识标准库

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