TSE - TS EN ISO 13485
Medical devices - Quality management systems - Requirements for regulatory purposes
inactive
| Organization: | TSE |
| Publication Date: | 29 April 2004 |
| Status: | inactive |
| ICS Code (Quality management and quality assurance): | 03.120.10 |
| ICS Code (Medical equipment in general): | 11.040.01 |
scope:
BU STANDARD, TIBBI CIHAZ VE ILGILI SERVISLERI SAGLAMAK, TUTARLIBIR BICIMDE TIBBI CIHAZLARA UYGULANABILIR OLAN MUSTERI VE MEVZUATSARTLARINI KARSILAYABILME KABILIYETINI KANITLAMAK ISTEYENKURULUSLARIN UYMALARININ GEREKTIGI ISO 9001?DEN DAHA KAPSAMLI VEOZEL KALITE SISTEM SARTLARINI KAPSAR.
Document History
April 18, 2016
Medical devices - Quality management systems - Requirements for regulatory purposes
Bu standard, bir kurulusun musteri sartlarini ve tibbi cihazlarave ilgili hizmetlere uygulanabilir mevzuat sartlarini tutarli birsekilde karsilayan tibbi cihazlari ve ilgili hizmetleri duzenliolarak...
June 25, 2014
Medical devices - Quality management systems - Requirements for regulatory purposes
Bu standard, bir kurulusun musteri sartlarini ve tibbi cihazlarave ilgili hizmetlere uygulanabilir mevzuat sartlarini tutarli birsekilde karsilayan tibbi cihazlari ve ilgili hizmetleri duzenliolarak...
June 12, 2013
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003)
A description is not available for this item.
June 5, 2012
Medical devices - Quality management systems - Requirements for regulatory purposes
A description is not available for this item.
April 12, 2012
Medical devices - Quality management systems - Requirements for regulatory purposes
Bu standard, tibb? cihazlar saglama ve tutarli olarak musteriihtiyaclarini ve tibb? cihazlar ile ilgili hizmetlere uygulanabilirmevzuat sartlarini karsilama kabiliyetini kanitlamasi gereken...
November 9, 2010
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003/Cor 1:2009)
A description is not available for this item.
December 6, 2007
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003)
A description is not available for this item.
TS EN ISO 13485
April 29, 2004
Medical devices - Quality management systems - Requirements for regulatory purposes
BU STANDARD, TIBBI CIHAZ VE ILGILI SERVISLERI SAGLAMAK, TUTARLIBIR BICIMDE TIBBI CIHAZLARA UYGULANABILIR OLAN MUSTERI VE MEVZUATSARTLARINI KARSILAYABILME KABILIYETINI KANITLAMAK ISTEYENKURULUSLARIN...
April 25, 2002
Quality systems - Medical devices - Particular requirements for the application of EN ISO 9001
Bu standard, ISO 9001 standardinin tibbi cihazlara uygulanmasiicin ozel sartlari kapsar.