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| | Regulatory Guidelines for Biocompatibility Safety Testing (MPB archive, May 97) |
 | | Since adverse health effects could result from exposure to the materials from which a device is made, preclinical assessment of the toxic potential of such materials or components is needed to minimize the potential hazard to the patient. |
 | | Tests that may be used in an evaluation of medical device biocompatibility include procedures for cytotoxicity, skin sensitization, dermal irritation and intracutaneous reactivity, acute systemic toxicity, subchronic toxicity, mutagenicity, implantation, hemocompatibility, chronic toxicity, and carcinogenicity. |
 | | The biocompatibility of a device depends on several factors, especially the type of patient tissue that will be exposed to device materials and the duration of the exposure. |
| www.devicelink.com /mpb/archive/97/05/001.html (0 words) |
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