MICA Freeform - Microfabrica

M A T E R I A L S D O S S I E R 1 MICA Freeform BIOCOMPATIBILITY REPORT M A T E R I A L S D O S S I E R 2 Biocompatibility 3 Palladium Valloy-120 Sterility 17 Palladium Valloy-120 Corrosion 19 Palladium Valloy-120 MATERIALS DOSSIER B I O C O M PAT I B I L I T Y M A T E R I A L S D O S S I E R 3 Introduction The primary standard for biological evaluation of medical devices is International Standard ISO 10993. An overview of test requirements is provided in ISO 10993-1:2003(E) [Reference 1]. For both ISO and FDA, the chart shown in Appendix 1 [Reference 2] applies. For the Japanese Ministry of Health and Welfare, the chart shown in Appendix 2 [Reference 2] applies.

M A T E R I A L S D O S S I E R Rev.B 3 Introduction The primary standard for biological evaluation of medical devices is International Standard ISO 10993.

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  Devices, Medical, Of medical device

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