Standard Svensk standard · SS-EN ISO 19001:2013

In vitro diagnostik - Information som ska tillhandahållas av tillverkaren av in vitro-diagnostiska reagens för färgning av biologiska material (ISO 19001:2013)

Status: Gällande

Omfattning
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.

Ämnesområden

Utrustning för diagnostik (11.040.55) Allmänt Laboratoriemedicin (11.100.01) (11.100.10)


Produktinformation

Språk: Engelska

Framtagen av: Laboratoriemedicin, SIS/TK 331

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

Artikelnummer: STD-89560

Utgåva: 1

Fastställd: 2013-03-27

Antal sidor: 28

Ersätter: SS-EN 12376