ISO 18113-5:2009 specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) instruments for self-testing.ISO 18113-5:2009 also applies to apparatus and equipment intended to be used with IVD instruments for self-testing.ISO 18113-5:2009 can also be applied to accessories.
Document identifier
ISO 18113-5:2009
Title
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing
ISO Category
TC 212: Clinical laboratory testing and in vitro diagnostic test systems
Publication date
2009-12-15
International Relationship
BS EN ISO 18113-5:2011 * DIN EN ISO 18113-5 * DIN EN ISO 18113-5
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