EN ISO 19001:2013
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 (ISO 19001:2013)
20-03-2013
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
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 |
| 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 |
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