ISO 20696

Sterile urethral catheters for single use

Body

ISO

Number

ISO 20696

Editions

2018

FDA recognition no.

9-143

Scope

Partial recognition. The following part(s) of the standard is (are) not recognized: Clause 6.3 and Annex C, Balloon Volume Maintenance Clause 6.4 and Annex D and I, Deflation Reliability (Failure to Deflate) Clause 6.5 and Annex E, Flow Rate Clause 6.6 and Annex F, Balloon Integrity (Resistance to Rupture)

Scope source: FDA 认可共识标准库

Laboratories covering this standard