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ÖNORM EN 13612/AC:2003-09

Действует
Performance evaluation of in vitro diagnostic medical devices (Corrigendum of English version)
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
ICS
11.100.10 In vitro diagnostic test systems / Испытательные системы диагностики, проводимой в искусственных условиях