chapter  4
28 Pages

- Assessing Biocompatibility: A Guide for Medical Device Manufacturers

Executive Summary .................................................................................................66 Purpose of Biocompatibility Testing ...................................................................66 Biocompatibility Test Planning ...........................................................................66 Conducting Tests ................................................................................................. 67 Evaluating the Data ............................................................................................. 67

Introduction to Biocompatibility Testing ................................................................. 67 What Is Device Biocompatibility? ...................................................................... 67 What Are the Food and Drug Administration and European Union/ International Organization for Standardization Requirements for Biocompatibility Testing? ...................................................................................68 Do I Need Biocompatibility Data? ......................................................................69 How Do I Determine Which Tests I Need? ......................................................... 70 Should I Test Device Materials, or Only a Composite of the Finished Device? ............................................................................................................ 70 Is GLP Treatment Required for Biocompatibility Testing? ................................ 73

Planning Biocompatibility Testing ........................................................................... 74 Choosing Extraction Media................................................................................. 74 Sample Preparation ............................................................................................. 76

Noncontact Devices ........................................................................................ 79 Biological Test Methods .......................................................................................... 79

Cytotoxicity (Tissue Culture) .............................................................................. 79 Sensitization Assays ............................................................................................ 81 Irritation Tests ..................................................................................................... 81

Biocompatibility is, by denition, a measurement of how compatible a device is with a biological system. The purpose of performing biocompatibility testing is to determine the tness of a device for human use, and to see whether use of the device can have any potentially harmful physiological effects. As stated by the International Organization of Standards, “The primary aim of this part of ISO 10993 is the protection of humans from potential biological risks arising from the use of medical devices” (ISO 10993-1, 2009).