Each component of a device that contacts the patient should be tested according to the ISO standard. In addition, you should definitely conduct testing on the finished device as specified by ISO 10993-1. Generally, the best approach is to:
1. Assemble vendor data on candidate materials.
2. Conduct analytical and in vitro screening of materials.
3. Conduct confirmatory testing on a weighted composite sample from the finished device.
There is a risk in testing the finished device without developing data on component materials. If an adverse result occurs, it can be difficult to track down the component that is causing the problem. You may end delaying your regulatory submission while you repeat testing on the individual components.
Screening device materials minimizes this risk. The initial chemical characterization should detect leachable materials that could compromise device safety. Inexpensive nonanimal studies (such as cytotoxicity and hemocompatibility tests) provide an additional screen for material safety. Material screening tests also help ensure that you will not be forced to redesign your device due to biocompatibility test failures. Many manufacturers assemble data on a library of qualified materials used in their products.
Some test procedures do not lend themselves to testing of composite samples. Due to physical limitations, agar overlay or direct contact cyto-toxicity tests and implant studies require separate testing of each device component. For all biocompatibility studies, test samples should be sterilized using the same method as will be used for the finished device.
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