ISO 19001 2013 Edition has just been released. The document, titled “In vitro diagnostic medical devices — Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology,” specifies requirements for information supplied by the manufacturer with reagents used in staining in biology. It’s the 2nd Edition and is a technical revision of the 1st Edition which is now obsolete.
The standard 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 are a prerequisite for achieving comparable and reproducible results in all fields of staining in biology.
The standard may be used with ISO 18113-1, “In Vitro Diagnostic Medical Devices – Information Supplied by the Manufacturer (Labelling) – Part 1: Terms, Definitions and General Requirements” and ISO 18113-2, “In Vitro Diagnostic Medical Devices – Information Supplied by the Manufacturer (Labelling) – Part 2: in Vitro Diagnostic Reagents for Professional Use.”
All ISO standards are available from Document Center Inc. You can order on our website, www.document-center.com, or by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com). We appreciate your business!