NF EN ISO 19001

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

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.

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Main informations

Collections

National standards and national normative documents

Publication date

June 2013

Number of pages

24 p.

Reference

NF EN ISO 19001

ICS Codes

11.040.55   Diagnostic equipment
11.100.10   In vitro diagnostic test systems

Classification index

S92-040

Print number

1 - 04/06/2013

International kinship

ISO 19001:2013

European kinship

EN ISO 19001:2013
Sumary
In vitro diagnostic medical devices - Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology

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.

Replaced standards (1)
NF EN 12376
April 1999
Standard Cancelled
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.

Table of contents
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  • Avant-propos
    iv
  • Introduction
    v
  • 1 Domaine d'application
    1
  • 2 Références normatives
    1
  • 3 Termes et définitions
    1
  • 4 Exigences relatives aux informations fournies par le fabricant
    3
  • 4.1 Exigences générales
    3
  • 4.2 Exigences supplémentaires relatives à certains types de réactifs
    5
  • Annexe A (informative) Exemples d'informations fournies par le fabricant avec les colorants utilisés en biologie
    7
  • Bibliographie
    13
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