Name: EN ISO 19001:2013
Brand: CEN

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

Published date

20-03-2013

Publisher

Comite Europeen de Normalisation

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

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.

Committee	CEN/TC 140
DevelopmentNote	Supersedes PREN ISO 19001. (04/2013) Supersedes EN 12376. (05/2013)
DocumentType	Standard
PublisherName	Comite Europeen de Normalisation
Status	Current
Supersedes	EN 12376:1999

Standards	Relationship
NEN EN ISO 19001 : 2013	Identical
I.S. EN ISO 19001:2013	Identical
NS EN ISO 19001 : 2013	Identical
DIN EN ISO 19001:2013-07	Identical
UNE-EN ISO 19001:2013	Identical
PN EN ISO 19001 : 2013	Identical
SN EN ISO 19001:2013	Identical
BS EN ISO 19001:2013	Identical
NBN EN ISO 19001 : 2013	Identical
NF EN ISO 19001 : 2013	Identical
UNI 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