| Popis: |
Determining what biological testing is required for the development and approval of a new medical device can be complex. Biological evaluation of medical devices is governed by standards such as ISO 10993, the Japanese Ministry of Health, Labor and Welfare Notifications and Ordinances, and China’s GB/T 16886 national standards. This chapter highlights the processes and steps involved in the evaluation of new medical devices and materials. It discusses how chemical characterization and toxicology data are used to evaluate risk and establish biocompatibility. A detailed overview of the development of biological evaluation plans and reports is described along with biological evaluations of combination products. In addition, information about new tools, special topics, and future trends are included. Plus, a list of sources for scientific, regulatory, and industry information is provided. |
