Information Essential to a Food and Drug Administration Evaluation of Medical Plastics
- 1 January 1974
- journal article
- research article
- Published by Taylor & Francis in Biomaterials, Medical Devices, and Artificial Organs
- Vol. 2 (4) , 397-406
- https://doi.org/10.3109/10731197409118609
Abstract
The FDA has established no standard for safety and efficacy of plastics used with medical devices. The term “medical grade plastic” is an industrial term with no defined values. New legislation is needed to assure the patient of the lack of toxicity, acute and chronic, from device materials.Keywords
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