biocompatibility of medical devices iso 10993 - Hermon Labs

More documents

Recommendations

Info

OECD DEFINITIONS The purpose of the Principles of Good Laboratory Practice is to promote the development of quality test data. The Principles of GLP should be applied to the non-clinical safety testing of test items contained in pharmaceutical products, pesticide products, cosmetic products, veterinary drugs, food additives, feed additives, and industrial chemicals. The purpose of testing these test items is to obtain data on their properties and/or their safety with respect to human health and/or The environment. Harlan Laboratories 24
Good Laboratory Practice (GLP) is a quality system concerned with the organizational process and the conditions under which non-clinical health and environmental safety studies are: Planned Performed SCOPE Monitored Recorded Reported Archived Harlan Laboratories 25
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: Areas of Expertise OECD - GLP 1. Ph
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

Create successful ePaper yourself

Delete template?

Save as template?