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Biomaterials, Medical Devices, and Artificial Organs Volume 2, 1974 - Issue 4

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Original Article

Information Essential to a Food and Drug Administration Evaluation of Medical Plastics

Leon J. Demerre Division of Research & Classification, Bureau of Medical Devices (HFK-400) Food and Drug Administration, Rockville, Maryland, 20852

Carl W. Bruch Division of Research & Classification, Bureau of Medical Devices (HFK-400) Food and Drug Administration, Rockville, Maryland, 20852

Pages 397-406 | Received 03 Jul 1974, Published online: 11 Jul 2009

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https://doi.org/10.3109/10731197409118609

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Lee H., Neville K. Handbook of Biomedical Plastics. Pasadena Technology Press, Pasadena, California 1971
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Ives G. C., Mead J. A., Riley M. M. Handbook of Plastics Test Methods. CRC Press, The Plastics Institute, London 1971
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New Drug Application. (Title 21, Code of Federal Regulations, Paragraph 130.4). FD form 356 H.
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“Biological Tests-Plastic Drug Containers.”. United States Pharmacopeia, XVIII: 926
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