In vitro diagnostic medical devices. Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology.

Le présent document fixe des prescriptions d'étiquetage applicables à tous les réactifs de coloration utilisés en biologie. Il s'adresse aux fabricants, fournisseurs et vendeurs de teintures, colorants, réactifs chromogènes et autres réactifs de coloration utilisés en biologie.

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Main informations

Collections

National standards and national normative documents

Publication date

April 1999

Number of pages

19 p.

Reference

NF EN 12376

ICS Codes

11.100.10 In vitro diagnostic test systems

Classification index

S92-040

Print number

1 - 30/09/2004

European kinship

EN 12376:1999

Sumary

In vitro diagnostic medical devices. Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology.

Le présent document fixe des prescriptions d'étiquetage applicables à tous les réactifs de coloration utilisés en biologie. Il s'adresse aux fabricants, fournisseurs et vendeurs de teintures, colorants, réactifs chromogènes et autres réactifs de coloration utilisés en biologie.

Standard replaced by (1)

NF EN ISO 19001

June 2013

Standard Current

In vitro diagnostic medical devices - Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology

<p>ISO 19001:2013 specifies requirements for information supplied by the manufacturer with reagents used in staining in biology. It applies to producers, suppliers and vendors of dyes, stains, chromogenic reagents and other reagents used for staining in histology and cytology including bacteriology, haematology, histochemistry, as performed in medical laboratories, both routine and research bacteriology. The requirements for information supplied by the manufacturer specified in ISO 19001:2013 are a prerequisite for achieving comparable and reproducible results in all fields of staining in biology.</p>

Table of contents

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Avant-propos
3
Introduction
4
1 Domaine d'application
4
2 Références normatives
4
3 Termes et Définitions
4
3.1 informations fournies par le fabricant
4
3.2 étiquette
4
3.3 réactif de diagnostic in vitro
5
3.4 coloration
5
3.5 teinture
5
3.6 colorant
5
3.7 réactif chromogène
5
3.8 fluorochrome
5
3.9 anticorps
6
3.10 sonde nucléique
6
3.11 lectine
6
4 Exigences relatives aux informations fournies par le fabricant
6
4.1 Exigences générales
6
4.2 Exigences supplémentaires relatives à certains types de réactifs
7
Annexe A (informative) Exemples d'informations fournies par le fabricant avec les colorants utilisés en biologie
9
A.1 Coloration au vert de méthyl-pyronine Y
9
A.2 Réaction de Feulgen-Schiff
11
A.3 Révélation histochimique des récepteurs cestrogéniques
13
A.4 Identification des cellules T en cytométrie de flux
15
Annexe B (informative) Bibliographie
17

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