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DIN Standards Committee Optics and Precision Mechanics

Abstract

This document specifies particular 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.

Begin

2020-11-09

WI

00285139

Planned document number

DIN EN ISO 14607

Project number

02703281

Responsible national committee

NA 027-05-07 AA - Mammary implants  

Responsible european committee

CEN/TC 285 - Non-active surgical implants  

Responsible international committee

ISO/TC 150/WG 8 - Breast implants  

draft standard

Non-active surgical implants - Mammary implants - Specific requirements (ISO/DIS 14607:2023); German and English version prEN ISO 14607:2023
2023-09
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previous edition(s)

Non-active surgical implants - Mammary implants - Particular requirements (ISO 14607:2018, Corrected version 2018-08); German version EN ISO 14607:2018
2018-10