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.
Date of Publication: December 1, 2009
Order Code PDF: ISO181135E
Order Code Print: print not available
ISO 18113-5:2009 Additional Details
The document also applies to apparatus and equipment intended to be used with IVD instruments for self-testing.
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Technical Committee: ISO/TC 212 Clinical laboratory testing and in vitro diagnostic test systems