biocompatibility of medical devices iso 10993 - Hermon Labs

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SAMPLE SIZE Area includes the combined area of both sides of the sample Harlan Laboratories 18
BIOLOGICAL EVALUATION TESTS All tests shall be conducted according to recognized current/valid best laboratory/quality practices, for example Good Laboratory Practice (GLP) or ISO/IEC 17025 and the data shall be evaluated by competent, informed professionals. Harlan Laboratories 19
Page 1 and 2: Harlan Laboratories BIOCOMPATIBILIT
Page 3 and 4: DEFINITION Biological evaluation of
Page 5 and 6: INTERNATIONAL STANDARDS ISO 10993 B
Page 7 and 8: ISO 10993 GUIDELINE The ISO 10993 G
Page 9 and 10: IMPORTANT This part of ISO 10993 is
Page 11 and 12: BIOLOGICAL EVALUATION OF MEDICAL DE
Page 13 and 14: MATERIAL CHARACTERIZATION The exten
Page 15 and 16: BIOLOGICAL EVALUATION TESTS Testing
Page 17: EXTRACT PREPARATION The extraction
Page 21 and 22: QUALITY SYSTEMS General Quality sys
Page 23 and 24: Areas of Expertise OECD - GLP 1. Ph
Page 25 and 26: Good Laboratory Practice (GLP) is a
Page 27 and 28: RESOURCES Management commitment Eac
Page 29 and 30: CHARACTERIZATION Test Item/Test Dev
Page 31 and 32: CONTROL SYSTEM The testing facility
Page 33 and 34: USE ONLY CERTIFIED LABORATORY GLP l

biocompatibility of medical devices iso 10993 - Hermon Labs

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