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

ISO-19001 - 2ND EDITION - CURRENT -- See the following: EN-375 EN-376
Show Complete Document History

Document Center Inc. is an authorized dealer of ISO standards.
The following bibliographic material is provided to assist you with your purchasing decision:

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.




Want this as a site license?

To find similar documents by classification:

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

11.100.10 (In vitro diagnostic test systems)

This document comes with our free Notification Service, good for the life of the document.

This document is available in either Paper or PDF format.


Customers who bought this document also bought:

Standards Express Standing Order Service - Must Also Order Standards Alert Service as Well

Medical devices. Quality management systems. Requirements for regulatory purposes

Electrical equipment for measurement, control and laboratory use. EMC requirements

Document Number

ISO 19001:2013

Revision Level




Publication Date

March 15, 2013

Committee Number

ISO/TC 212