ISO 5910

Cardiovascular implants and extracorporeal systems - Cardiac valve repair devices

Body: ISO
Number: ISO 5910
Editions: 2018、2024
FDA recognition no.: 3-159
FDA recognition no.: 3-195

Scope

Partial recognition. The following part(s) of the standard is (are) not recognized: Section 7.2.5.2 Structural component fatigue assessment Section 7.2.5.3 Device durability assessment Section 7.4.6 Statistical considerations including sample size and duration Annex N.3 Test parameters

Scope source: FDA 认可共识标准库

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