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

SS-EN-ISO-19001 - 2013 EDITION - CURRENT


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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.

To find similar documents by classification:

11.040.55 (Diagnostic equipment Including medical monitoring equipment, medical thermometers and related materials)

11.100.01 (Laboratory medicine in general)

11.100.10 (In vitro diagnostic test systems)

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Designation Name

SS-EN ISO 19001:2013

Revision Level

2013 EDITION

Status

Current

Publication Date

March 27, 2013

Language(s)

English

Page Count

28

International Equivalent

EN ISO 19001:2013(IDT); ISO 19001:2013(IDT)