F. H. Silver
Biomaterials, Medical Devices and Tissue Engineering: An Integrated Approach
- Springer Netherlands
- 2012
- Taschenbuch
- 312 Seiten
- ISBN 9789401043168
are then selected and must meet the general 'biocompatibility' require ments. Prototypes are built and tested to include biocompatibility evalua tions based on ASTM standard procedures. The device is validated for sterility and freedom from pyrogens before it can be tested on animals or humans. Medical devices are classified as class I, II or III depending on their invasiveness. Class I devices can be marketed by submitting notification to the FDA. Class II and III devices require either that they show equivalence to a device marketed prior to 1976 or that they receive pre-marketing approval. The time from device conception to FDA approval can range from
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