DS DS/EN ISO 18113-5
DS DSEN SO 18113-5 2011-DEC-09 n vtro dagnostc medcal devces - nformaton suppled by the manufacturer labellng - Part 5 n vtro dagnostc nstruments for self-testng
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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.