EN 12376:1999

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
    3.1 Information supplied by the manufacturer
    3.2 Label
    3.3 In vitro diagnostic
    3.4 Staining
    3.5 Dye
    3.6 Stain
         3.6.1 Stock solution of stain
    3.7 Chromogenic reagent
    3.8 Fluorochrome
    3.9 Antibody
         3.9.1 Polyclonal antibody
         3.9.2 Monoclonal antibody
    3.10 Nucleic acid probe
    3.11 Lectin
4 Requirements for information supplied by the manufacturer
    4.1 General requirements
         4.1.1 Information supplied by the manufacturer
                 with reagents used for staining in biology
         4.1.2 Product name
         4.1.3 Description of reagent
         4.1.4 Intended use
    4.2 Additional requirements for specific kinds of
         reagents
         4.2.1 Fluorochromes
         4.2.2 Metal salts
         4.2.3 Antibodies
         4.2.4 Nucleic acid probes
Annex A (informative) Examples of information supplied by
                      the manufacturer with reagents commonly
                      used in biological staining procedures
    A.1 Methyl Green-Pyronin Y stain
    A.2 Feulgen-Schiff reaction
    A.3 Immunohistochemical demonstration of oestrogen
         receptors
    A.4 Flow cytometric demonstration of T-cells
Annex B (informative) Bibliography

This European standard 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 biology. The requirements for information supplied by the manufacturer specified in this European standard are a prerequisite for achieving comparable and reproducible results in all fields of staining in biology.