ISO 5840-1

Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements

Body: ISO
Number: ISO 5840-1
Editions: 2021
FDA recognition no.: 3-205

Scope

Partial recognition. The following part(s) of the standard is (are) not recognized: Section 7.2.5.3 Device structural component fatigue assessment Annex J.3.1 General

Scope source: FDA 认可共识标准库

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