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Requirements for medical vinyl compounds
Author(s) -
Rakus Julius P.
Publication year - 1996
Publication title -
journal of vinyl and additive technology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.295
H-Index - 35
eISSN - 1548-0585
pISSN - 1083-5601
DOI - 10.1002/vnl.10124
Subject(s) - viewpoints , medical device , risk analysis (engineering) , position (finance) , construction engineering , forensic engineering , business , engineering , biomedical engineering , art , finance , visual arts
What makes a material suitable for applications in the medical device industry? It is a question often asked, but seldom answered in a definitive way. This paper examines vinyl compounds from various viewpoints and attempts to define the requirements for their medical use with respect to formulation, chemical and mechanical purity, and performance characteristics such as viscoelastic properties, appearance, sterilizability, shelf life, and biological safety. Primary consideration is given to the situation in the United States, with a brief review of the position of some other countries' regulatory agencies. An outline is presented of how material suppliers can assure their customers and the regulators about the suitability of the compounds in question for various applications.