Eurofins為台灣首家具有ISO14708-1, ISO14708-3植入式醫療器材資質

恭喜歐陸Eurofins E&E取得A2LA的認證資格,其中ISO14708-1和 ISO14708-3植入式醫療器材,Eurofins為台灣首家有此資質的實驗室。

(A2LA Cert. No. 6326.01)

ISO 14708-1:2014;ANSI/AAMI/ISO 14708-1:2014
Implants for surgery — Active implantable medical devices —Part 1: General requirements for safety, marking and for information to be provided by the manufacturer

ISO 14708-3:2017;ANSI/AAMI/ISO 14708-3:2017
Implants for surgery — Active implantable medical devices — Part 3: Implantable neurostimulators