ISO 18562-1

Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1: Evaluation and testing within a risk management process

Body

ISO

Number

ISO 18562-1

Editions

2024

FDA recognition no.

1-173

Scope

Partial recognition. The following part(s) of the standard is (are) not recognized: Clause 7.2 b) 1) Parenteral toxicological information may be used in the absence of inhalational toxicological information without modification. Clause 7.3 b) 1) Parenteral toxicological information may be used in the absence of inhalational toxicological information without modification.

Scope source: FDA 认可共识标准库

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