biocompatibility of medical devices iso 10993 - Hermon Labs

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MATERIAL CHARACTERIZATION The identity and quantity of novel materials and chemicals present should be established or measured For devices that have known leachable chemical mixtures, potential synergies of the leachable chemicals should be considered Where the potential for degradation exists under the conditions of manufacture, sterilization, transport, storage, and use of the device, the presence and nature of degradation products shall be characterized Harlan Laboratories 14
BIOLOGICAL EVALUATION TESTS Testing shall be performed on the sterile final product, or representative samples from the final product or materials processed in the same manner as the final product (including sterilization). Harlan Laboratories 15
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: MATERIAL CHARACTERIZATION The exten
Page 17 and 18: EXTRACT PREPARATION The extraction
Page 19 and 20: BIOLOGICAL EVALUATION TESTS All tes
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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