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Biocompatibility: the latest developments
1Dutch Standardization Institute, Delft, The Netherlands.
Medical Device Technology
|November 3, 1997
Abstract:
The standards for biological evaluation of medical devices are currently being evaluated. This article presents the rationale behind the current ISO 10993 series and discusses the work in progress to revise elements of the standards and to incorporate new areas. Particular issues being addressed include a new definition of biocompatibility, and quality of health, which will include product risk assessment and surveillance in the market place.