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TSE - TS EN 13612

Performance evaluation of in vitro diagnostic medical devices

active, Most Current
Organization: TSE
Publication Date: 12 February 2009
Status: active
ICS Code (In vitro diagnostic test systems): 11.100.10
scope:

Bu standard, kisisel kullanima yonelik vucut disi tanisal tibbicihazlar da d?hil olmak uzere Vucut Disi Tanisal Tibbi Cihazlarin(VDT TC) performans degerlendirmesini kapsar. Bu standard, imalatcitarafindan yapilacak performans degerlendirme calismasininplanlama, uygulama, degerlendirme ve belgelendirmeye yoneliksorumluluklarini ve genel ozelliklerini kapsar.

Document History

TS EN 13612
February 12, 2009
Performance evaluation of in vitro diagnostic medical devices
Bu standard, kisisel kullanima yonelik vucut disi tanisal tibbicihazlar da d?hil olmak uzere Vucut Disi Tanisal Tibbi Cihazlarin(VDT TC) performans degerlendirmesini kapsar. Bu standard,...
February 12, 2009
Performance evaluation of in vitro diagnostic medical devices
Bu standard vucut disi kullanilan tibbi tani cihazlarininperfomans degerlendirilmesini belirtir.
April 25, 2006
Performance evaluation of in vitro diagnostic medical devices; Amendment AC
Bu standard, öngerme çeliklerine (çubuk, tel veya halat). uygulanacak deney metotlarını kapsar
November 11, 2002
Performance evaluation of in vitro diagnostic medical devices
Bu standard, sertmetaller için Rockwell sertlik deneyini (Skala A) kapsar.
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