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NF EN 375 : 2001

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

INFORMATION SUPPLIED BY THE MANUFACTURER WITH IN VITRO DIAGNOSTIC REAGENTS FOR PROFESSIONAL USE

Superseded date

03-05-2013

Published date

12-01-2013

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Avant-propos
1 Domaine d'application
2 Références normatives
3 Termes et définitions
4 Exigences relatives aux étiquettes
  4.1 Emballage externe
  4.2 Contenant primaire
5 Exigences relatives aux instructions d'utilisation
Annexe ZA (informative) Relation entre le présent document
                        et les Directives CE
Bibliographie

Defines the requirements for the information supplied by the manufacturer of in vitro diagnostic reagents that includes reagent products, calibrators, control materials and kits for professional use, hereafter called IVD reagents. Also applicable to accessories.

DevelopmentNote
Indice de classement: S92-010. (09/2002)
DocumentType
Standard
PublisherName
Association Francaise de Normalisation
Status
Superseded

Standards Relationship
I.S. EN 375:2001 Identical
UNE-EN 375:2001 Identical
BS EN 375:2001 Identical
EN 375 : 2001 Identical
DIN EN 375:2001-06 Identical
UNI EN 375 : 2002 Identical

NF EN ISO 17511 : 2004 IN VITRO DIAGNOSTIC MEDICAL DEVICES - MEASUREMENT OF QUANTITIES IN BIOLOGICAL SAMPLES - METROLOGICAL TRACEABILITY OF VALUES ASSIGNED TO CALIBRATORS AND CONTROL MATERIALS
XP ENV 13607 : 2003 XP HEALTH INFORMATICS - MESSAGES FOR THE EXCHANGE OF INFORMATION ON MEDICINE PRESCRIPTIONS

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