Performance evaluation of in vitro diagnostic medical devices (Corrigendum of English version)
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Разработчик:
Зарубежные/ON
ICS:
11.100.10 In vitro diagnostic test systems / Испытательные системы диагностики, проводимой в искусственных условиях
Описание
The European Corrigendum EN 13612:2002/AC:2002 modifies the English version of EN 13612:2002 and has the status of an Austrian Standard. The present corrigendum ÖNORM EN 13612/AC:2003 was issued without prior public enquiry, modifies the basic document ÖNORM EN 13612:2002 and is to be used in conjuction with said standard. 2.6 lay person 2.14 validation 4.5 Experimental design Annex ZA (informative) - Clauses of this European Standard addressing essential requirements or other provisions of EU Directives Bibliography