ISO 14607

Non-active surgical implants - Mammary implants - Specific requirements

Body: ISO
Number: ISO 14607
Editions: 2024
FDA recognition no.: 6-513

Scope

Partial recognition. The following part(s) of the standard is (are) not recognized: * Note in Subclause 11.8.2 Patient Information Brochure * Subclause 7.2.1 General * Subclause 7.2.5 Biological Evaluation

Scope source: FDA 认可共识标准库

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