prBAS EN ISO 14607:2026
Non-active surgical implants - Mammary implants - Specific requirements
General information
Status:Project
Number of pages:61
Adoption method:Proglašavanje
Language:engleski
Edition:4.
Realization date:28.11.2025
Forseen date for next stage code:20.02.2026
Technical committee:BAS/TC 25, Healthcare
ICS:
11.040.40, Implants for surgery, prosthetics and orthotics
Abstract
This document specifies specific requirements for mammary implants. With regard to safety, this document specifies requirements for intended performance, design attributes, materials, design evaluation, manufacturing, packaging, sterilization and information supplied by the manufacturer.
Lifecycle
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Original document and degree of correspondence
EN ISO 14607:2025, identical
ISO 14607:2024, identical
Relation to BAS standards
Work material
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