• There are no items in your cart

EN 12376:1999

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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Superseded date

04-01-2013

Published date

01-20-1999

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.

Committee
CEN/TC 140
DocumentType
Standard
PublisherName
Comite Europeen de Normalisation
Status
Superseded
SupersededBy

Standards Relationship
BS EN 12376:1999 Identical
SN EN 12376 : 1999 Identical
NF EN 12376 : 1999 Identical
NBN EN 12376 : 1999 Identical
NS EN 12376 : 1ED 1999 Identical
UNE-EN 12376:1999 Identical
DIN EN 12376:1999-04 Identical
PN EN 12376 : 2006 Identical
NEN EN 12376 : 1999 Identical
I.S. EN 12376:1999 Identical
UNI EN 12376 : 2001 Identical

EN 376 : 2002 INFORMATION SUPPLIED BY THE MANUFACTURER WITH IN VITRO DIAGNOSTIC REAGENTS FOR SELF-TESTING
EN 375 : 2001 INFORMATION SUPPLIED BY THE MANUFACTURER WITH IN VITRO DIAGNOSTIC REAGENTS FOR PROFESSIONAL USE

View more information
Sorry this product is not available in your region.

Access your standards online with a subscription

Features

  • Simple online access to standards, technical information and regulations.

  • Critical updates of standards and customisable alerts and notifications.

  • Multi-user online standards collection: secure, flexible and cost effective.