biocompatibility of medical devices iso 10993 - Hermon Labs

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STANDARD OPERATING PROCEDURES A test facility should have written Standard Operating Procedures approved by Test Facility Management and Quality Assurance that are intended to ensure the quality and integrity of the data generated by that test facility Deviations from Standard Operating Procedures related to the study should be documented Harlan Laboratories 28
CHARACTERIZATION Test Item/Test Device is any product that has to be evaluated and is the reason for the conduct of the Study Each Test and Reference Items should be appropriately identified ‣Mean of Identification / composition / purity ‣Expiry date ‣Storage conditions ‣Safety data ‣Disposal Harlan Laboratories 29
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 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: RESOURCES Management commitment Eac
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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