biocompatibility of medical devices iso 10993 - Hermon Labs

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CHECKLIST 1. GLP accreditation 2. Management commitment 3. Qualified Personnel – Training Records 4. Quality Assurance Department 5. Adequate Facility 6. Availability of Calibrated equipment 7. Controlled and certified reagents 8. known and controlled source of Test System (in-vivo / in-vitro) 9. Formulation Department 10. Archiving Harlan Laboratories 32
USE ONLY CERTIFIED LABORATORY GLP like Based on GLP According to GLP In the spirit of GLP Etc…… Harlan Laboratories 33
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 and 28: RESOURCES Management commitment Eac
Page 29 and 30: CHARACTERIZATION Test Item/Test Dev
Page 31: CONTROL SYSTEM The testing facility

biocompatibility of medical devices iso 10993 - Hermon Labs

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