ISO 17510

Medical devices - Sleep apnoea breathing therapy - Masks and application accessories

Body

ISO

Number

ISO 17510

Editions

2015、2025

FDA recognition no.

1-106

FDA recognition no.

1-197

Scope

Partial recognition. The following part(s) of the standard is (are) not recognized: Section 5.2 Biocompatibility, Note 1: For parts or materials not intended to be inserted into the nares or mouth (e.g. MASK elbows, tubing, cushions, and faceplates), the gas pathway materials shall be evaluated as skin contact.

Scope source: FDA 认可共识标准库

Laboratories covering this standard