The Handbook of Medical Device Design provides a review of regulatory and standards issues in medical device design, including FDA regulations, types of 510 (k), the ISO 9000 series, and medical device directives. It identifies how to determine and document customer needs and device requirements. It also establishes reliability and quality metrics for the duration of the product development cycle. Topics includeof the Canadian Electrical Code, Part I. Rationale for Section 52 is that x-ray or computerized tomography equipment in operation generates very high voltages and dangerous radiation. Special Rules are required to ensure that the electrical anbsp;...
|Title||:||Handbook of Medical Device Design|
|Author||:||Richard C. Fries|
|Publisher||:||CRC Press - 2000-09-14|