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ISO 18113-5E In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 5: In vitro diagnostic instruments for self-testing

ISO 18113-5:2009

ISO 18113-5E In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 5: In vitro diagnostic instruments for self-testing

This international standard specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) instruments for self-testing.

This document is available in electronic format only. 

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Publication Details

Date of Publication: December 1, 2009

Order Code PDF: ISO181135E

Order Code Print: print not available

Edition: First

Pages: 8

ISO 18113-5:2009 Additional Details

The document also applies to apparatus and equipment intended to be used with IVD instruments for self-testing.

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