NF EN ISO 19001
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.
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.
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.
- Avant-proposiv
- Introductionv
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1 Domaine d'application1
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2 Références normatives1
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3 Termes et définitions1
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4 Exigences relatives aux informations fournies par le fabricant3
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4.1 Exigences générales3
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4.2 Exigences supplémentaires relatives à certains types de réactifs5
- Annexe A (informative) Exemples d'informations fournies par le fabricant avec les colorants utilisés en biologie7
- Bibliographie13
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