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BS EN ISO 19001:2013

Current
Current

The latest, up-to-date edition.

In vitro diagnostic medical devices. Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

08-31-2013

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements for information supplied by the
  manufacturer
Annex A (informative) - Examples of information
        supplied by the manufacturer with reagents
        commonly used in biological staining
        procedures
Bibliography

Defines requirements for information supplied by the manufacturer with reagents used in staining in biology.

This International 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 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 this International Standard are a prerequisite for achieving comparable and reproducible results in all fields of staining in biology.

Committee
CH/212
DevelopmentNote
Supersedes 10/30228700 DC. (04/2013) Supersedes BS EN 12376. (09/2013)
DocumentType
Standard
Pages
26
PublisherName
British Standards Institution
Status
Current
Supersedes

Standards Relationship
EN ISO 19001:2013 Identical
ISO 19001:2013 Identical

ISO 80000-9:2009 Quantities and units Part 9: Physical chemistry and molecular physics
ISO 18113-1:2009 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions and general requirements
ISO 80000-1:2009 Quantities and units — Part 1: General
ISO 18113-2:2009 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 2: In vitro diagnostic reagents for professional use

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