医疗器械辐射灭菌的现状及进展

本文叙述了医疗器械辐射灭菌的特点和在国内外的发展概况。论述了医疗器械辐射灭菌的几个关键问题：建立现代化的工业辐射灭菌工厂；建立完善的剂量监测系统；灭菌剂量的设定与验证；灭菌工艺的确认；日常加工的过程控制；网络管理和防伪标识；质量体系的认证和建设；辐射防护和安全等。同时提出了我国的医疗器械辐射灭菌事业在当前和今后一个时期内应关注的几个关键问题：机遇与发展；质量体系建设与国际水平接轨；现代企业制度的建设等。

Status and progress in radiation sterilization of medical devices(A review)

This paper describes the features and status of radiation sterilization of medical devices in the world. The key points include establishment of modern commercial radiation company; establishment of dosimetry system; dose setting and auditing; validation of process; routine control; intranet management and product identification system; establishment of quality system; and radiation protection and safety. It is emphasized that the following should be paid great attention to in the near future: seizing opportunities for development; following the international level in construction of quality system; and establishing modern enterprise system.