biocompatibility of medical devices iso 10993 - Hermon Labs

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ASTM / ASTM International NATIONAL STANDARDS American Society for Testing and Materials ANSI American National Standards Institute AAMI American National Standards Institute BSI British Standards DIN German Institute for Standardization A joint effort by standards development organizations AAMI, ANSI, ASTM, and DIN created a single, centralized database for medical device standards. Harlan Laboratories 6
ISO 10993 GUIDELINE The ISO 10993 Guideline covers only the testing of materials and devices that come into direct or indirect contact with the patient's body With the exception of Products which might be considered to be medical devices but for which there is not yet a harmonized approach, are: 1. aids for disabled/handicapped people; 2. devices for the treatment/diagnosis of diseases and injuries in animals; 3. accessories for medical devices; 4. devices incorporating animal and human tissues, which might meet the requirements of the above definition but are subject to different controls. Harlan Laboratories 7
Page 1 and 2: Harlan Laboratories BIOCOMPATIBILIT
Page 3 and 4: DEFINITION Biological evaluation of
Page 5: INTERNATIONAL STANDARDS ISO 10993 B
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 and 32: CONTROL SYSTEM The testing facility
Page 33 and 34: USE ONLY CERTIFIED LABORATORY GLP l

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