ISO 19001:2013

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

Publication date: Mar 7, 2013

General information

Current stage: 90.93 Effective date: Jul 13, 2018

Originator: ISO

Owner: ISO/TC 212

Type: International Standard

ICS: 11.100.10 11.040.55

Languages: English French

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Status: Published

PDF - EC$276.92

Paper - EC$276.92

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Scope

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.

Life cycle

PREVIOUSLY

Revises
ISO 19001:2002

NOW

PUBLISHED
ISO 19001:2013
90.93 Standard confirmed
Jul 13, 2018

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