ISO 18113-2E In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) Part 2: In vitro diagnostic reagents for professional use

ISO 18113-2:2009

ISO 18113-2E 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.

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Publication Details

Date of Publication: December 1, 2009

Order Code PDF: ISO181132E

Order Code Print: print not available

Edition: First

Pages: 10

ISO 18113-2:2009 Additional Details

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.

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Technical Committee: ISO/TC 212 Clinical laboratory testing and in vitro diagnostic test systems