NF EN ISO 14607
NF EN ISO 14607

NF EN ISO 14607

November 2009
Standard Cancelled

Non-active surgical implants - Mammary implants - Particular requirements

Main informations

Collections

National standards and national normative documents

Publication date

November 2009

Release date

mai 2018

Number of pages

39 p.

Reference

NF EN ISO 14607

ICS Codes

11.040.40   Implants for surgery, prosthetics and orthotics

Print number

1 - novembre 2009

International kinship

ISO 14607:2007

European kinship

EN ISO 14607:2009
Replaced standards (1)
NF EN ISO 14607
NF EN ISO 14607
January 2007
Standard Cancelled
Non-active surgical implants - Mammary implants - Particular requirements

Le présent document a pour objectif essentiel : - de spécifier les exigences particulières relatives aux implants mammaires destinés à des fins cliniques ; et - en matière de sécurité, de spécifier des exigences relatives aux performances prévues, aux caractéristiques de conception, aux matériaux, à l''évaluation de la conception, à la fabrication, à la stérilisation, à l''emballage et aux informations fournies par le fabricant. Le présent document introduit des nouvelles annexes. Deux d''entre elles concernent les informations destinées au patient et à l''utilisateur, une autre concernant l''évaluation du relargage de silicone des implants mammaires selon une méthode in vitro.

Standard replaced by (1)
NF EN ISO 14607
NF EN ISO 14607
May 2018
Standard Cancelled
Non-active surgical implants — Mammary implants — Particular requirements

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