Standard

DS/EN ISO 14607:2018

Ikke-aktive kirurgiske implantater – Brystimplantater – Særlige krav

Status
Gældende Checkmark
Type
Standard
Varenummer
M315894
Udgivelsesdato
2018-05-24
Komite

CEN/TC 285

ISO/TC 150

International arbejdsgruppe WG

CEN/TC 285

ISO/TC 150

Internationale relationer
Tooltip
ISO 14607:2018 IDT, EN ISO 14607:2018 IDT
Dansk udvalg
Antal sider
58
Under revision

Scope

ISO 14607:2018 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.