Instructions for use for in vitro diagnostic instruments for self-testing

Le présent document spécifie le contenu des notices d'utilisation des instruments de diagnostic in vitro pour auto-test.

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Main informations

Collections

National standards and national normative documents

Publication date

June 2002

Number of pages

12 p.

Reference

NF EN 592

ICS Codes

11.100.10 In vitro diagnostic test systems

Classification index

S92-017

Print number

1 - 07/12/2002

European kinship

EN 592:2002

Sumary

Instructions for use for in vitro diagnostic instruments for self-testing

Le présent document spécifie le contenu des notices d'utilisation des instruments de diagnostic in vitro pour auto-test.

Replaced standards (1)

NF EN 592

January 1995

Standard Cancelled

In vitro diagnostic systems. Requirements for user manuals for in vitro diagnostic instruments for home use.

Le présent document spécifie le contenu des manuels d'utilisation pour les instruments de diagnostic in vitro pour usage à domicile.

Standard replaced by (1)

NF EN ISO 18113-5

March 2010

Standard Cancelled

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5 : in vitro diagnostic instruments for self-testing

ISO 18113-5:2009 specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) instruments for self-testing. ISO 18113-5:2009 also applies to apparatus and equipment intended to be used with IVD instruments for self-testing. ISO 18113-5:2009 can also be applied to accessories.

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