Standard Swedish standard · SS-EN ISO 19001:2013

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

Status: Valid

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Standard Swedish standard · SS-EN ISO 19001:2013

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

Subjects

Diagnostic equipment (11.040.55) General (11.100.01) In vitro diagnostic test systems (11.100.10)


Buy this standard

Standard Swedish standard · SS-EN ISO 19001:2013

In vitro diagnostic medical devices - Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology (ISO 19001:2013)
Subscribe on standards - Read more Dölj
Price: 875 SEK
standard ikon pdf

PDF

Price: 875 SEK
standard ikon

Paper

Price: 1 400 SEK
standard ikon pdf + standard ikon

PDF + paper

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Product information

Language: English

Written by: Svenska institutet för standarder

International title:

Article no: STD-89560

Edition: 1

Approved: 3/27/2013

No of pages: 28

Replaces: SS-EN 12376