NF EN 556-1

NF EN 556-1

February 2002
Standard Current

Sterilization of medical devices - Requirements for medical devices to be designated STERILE - Part 1 : requirements for terminally sterilized medical devices

Le présent document spécifie les exigences pour qu'un dispositif médical qui a subi une stérilisation terminale puisse être étiqueté "STÉRILE".

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Main informations

Collections

National standards and national normative documents

Publication date

February 2002

Number of pages

9 p.

Reference

NF EN 556-1

ICS Codes

11.080.01   Sterilization and disinfection in general

Classification index

S98-107-1

Print number

2 - 01/10/2006

European kinship

EN 556-1:2001
Sumary
Sterilization of medical devices - Requirements for medical devices to be designated STERILE - Part 1 : requirements for terminally sterilized medical devices

Le présent document spécifie les exigences pour qu'un dispositif médical qui a subi une stérilisation terminale puisse être étiqueté "STÉRILE".
Replaced standards (1)
NF EN 556 + A1
November 1998
Standard Cancelled
Sterilization of medical devices. Requirements for terminally-sterilized medical devices to be labelled "Sterile".

Le présent document spécifie les conditions que doivent remplir les dispositifs médi caux ayant subi une stérilisation terminale pour être étiquetés "Stérile" (à l'exception des dispositifs destinés au diagnostic in vitro.

Table of contents
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  • Avant-propos
  • 1 Domaine d'application
  • 2 Références normatives
  • 3 Termes et définitions
  • 4 Exigences
  • Annexe ZA (informative) Articles de la présente norme européenne concernant les exigences essentielles ou d'autres dispositions des Directives UE
  • Bibliographie
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