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Biocompatibility is a measurement of how compatible a device is with a biological system (not generating any local or systemic responses from a living system or tissue). In the simplest sense, a biocompatible material or device does not harm the patient. From a regulatory view, it is a series of tests that are used to determine the toxicity resulting from contact of the parts of medical devices or combination products with the body.
A medical device may consist of materials that are biocompatible, although the device itself requires biocompatibility testing and all testing is performed on the final product.
ISO Standard for Biocompatibility Testing:
Many of the biological screens that comprise the remaining parts of ISO 10993 are designed to estimate specific aspects of biocompatibility, and therefore are not required for all medical devices.
ISO was established to determine a uniform worldwide standards and it is a non-governmental network of national standards institutes and acting as a bridge between the private and public sectors. International Organization for Standardization is abbreviated ISO from the Greek word “isos” meaning equal.
ISO-10993 (Biological Evaluation of Medical Devices ) – a standard for evaluating the biocompatibility of a medical device or its components. Depending on the nature type and duration of body contact of a medical device, tests for some or all of the following effects may be recommended:
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