In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) Part 2: In vitro diagnostic reagents for professional use
This international standard specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) reagents for professional use.
The standard also applies to information supplied by the manufacturer with calibrators and control materials intended for use with IVD medical devices for professional use.
This document is available in electronic format only.
Date of Publication: December 1, 2009
Order Code PDF: ISO181132E
Order Code Print: print not available
ISO 18113-2:2009 Additional Details
Membership discounts cannot be applied to ISO documents because they are not published by CLSI. CLSI is able to offer ISO Technical Committee 212 approved and draft standards through an agreement with the American National Standards Institute.
Technical Committee: ISO/TC 212 Clinical laboratory testing and in vitro diagnostic test systems