Schicht H H
Med Device Technol. 1994 May;5(4):18-9, 22.
Part 1 of this two-part article outlined the contamination-control requirements for medical device manufacturing, and the basic technical concepts for effectively and economically achieving them. Part II provides four case studies that illustrate how the basic principles of clean-room technology can be translated into industrial practice. It features examples of controlled clean-air manufacturing environments used in the production of injection cannulae, orthopaedic endoprostheses, heart pacemakers, and porcine aortic bioprostheses.
这篇分为两部分的文章的第一部分概述了医疗器械制造的污染控制要求，以及有效且经济地实现这些要求的基本技术概念。第二部分提供了四个案例研究，阐述了洁净室技术的基本原理如何转化为工业实践。文中列举了用于生产注射套管、骨科植入物、心脏起搏器和猪主动脉生物假体的受控洁净空气制造环境的实例。
