ISO 10993-1《醫療器械的生物學評估》

ISO 10993-1: Risk Management Process for Evaluation and Testing

無菌屏障系統測試 Sterile Barrier System - ISO 11607 & EN 868 series

Sterile Barrier System - ISO 11607 & EN 868 series

無菌測試 Sterility Testing - ISO 11737 series

Sterility Testing - ISO 11737 series

毒理風險評估 Toxicological Risk Assessment - ISO 10993-17

Toxicological Risk Assessment - ISO 10993-17

Chemical Characterisation - ISO 10993-18

Chemical Characterisation - ISO 10993-18

Implantation - ISO 10993-6

Implantation - ISO 10993-6

全身毒性及熱原測試 Systemic Effects of Systemic Toxicity and Pyrogenicity - ISO 10993-11 and ASTM

Systemic Effects of Systemic Toxicity and Pyrogenicity - ISO 10993-11 and ASTM

Sensitisation - ISO 10993-10

Sensitisation - ISO 10993-10

Irritation - ISO 10993-10

Irritation - ISO 10993-10

Hemocompatibility - ISO 10993-4 & ASTM

Hemocompatibility - ISO 10993-4 & ASTM

Genotoxicity (基因毒性測試) - ISO 10993-3

Genotoxicity - ISO 10993-3

Cytotoxicity (細胞毒性測試) - ISO 10993-5

Cytotoxicity - ISO 10993-5

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委託檢驗流程

Commissioned inspection process