Transcription of Medical Device Testing Guide - Toxikon
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Medical Device Testing Guide - Toxikon
Rev. May 2011 15 Wiggins Avenue, Bedford, MA 01730 Medical Device Testing Guide A resource for sample submissions, test descriptions, sample requirements , and turnaround times for biocompatibility Testing according to: FDA/ISO 10993 MHLW-Japan USP Microbiology Rev. May 2011 15 Wiggins Avenue, Bedford, MA 01730 TABLE OF CONTENTS Contact Information .. 3 Instructions for Test Requests & Sample 3 Instructions to Complete Requisition Forms .. 4 Biocompatibility Testing Matrix .. 5 Sample requirements .. ERROR! BOOKMARK NOT DEFINED. Cytotoxicity Tests ISO 10993-5 .. 7 Sensitization Tests ISO 10993-10 .. 7 Irritation Tests ISO 10993-10 .. 8 Systemic Toxicity Testing ISO 10993-11 .. 11 Acute Systemic Toxicity Tests .. 12 Subacute Systemic Toxicity Testing .
Rev. May 2011 15 Wiggins Avenue, Bedford, MA 01730 781.275.3330 www.toxikon.com Medical Device Testing Guide A resource for sample submissions, test descriptions, sample requirements, and turnaround times
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