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安規認證 >> 新聞及活動 >> Eurofins為台灣首家具有ISO14708-1和 ISO14708-3植入式醫療器材資質

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

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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)

Test Technology:

Test Method(s) 1, 2:

Implants for surgery — Active implantable medical devices —Part 1: General requirements for safety, marking and for information to be provided by the manufacturer

ISO 14708-1:2014;

ANSI/AAMI/ISO 14708-1:2014

Implants for surgery — Active implantable medical devices — Part 3: Implantable neurostimulators

ISO 14708-3:2017;

ANSI/AAMI/ISO 14708-3:2017

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