DS/EN ISO 19001:2013

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


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 68.08

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.


Number of pages: 32

Published: 2013-05-03

Date of approval: 2013-04-23

International relationships : EN ISO 19001:2013 IDT ISO 19001:2013 IDT

ICS: 11.100.10 - In vitro diagnostic test systems 11.040.55 - Diagnostic equipment

Item number: M250077


Committees

Committee

  • CEN/TC 140
  • ISO/TC 212

Danish committee

DS/S-260