摘要
麻醉设备和呼吸设备的产品质量与人民医疗保健息息相关,完善的麻醉和呼吸设备的标准体系对促进行业规范、服务政府监管具有重要的作用。文章调研国际、欧盟、等标准化组织及其标准,与我国麻醉和呼吸设备的标准进行比较分析。目前,我国麻醉和呼吸设备标准体系在标准数量和标准内容方面和国际有所不同,具有自身特点,并且较符合我国现阶段产业特点和监管需求。我国麻醉和呼吸设备标准化体系建设仍然要进一步完善,为加强服务和监管提供有力依据。
The quality of anesthesia equipment and breathing equipment is closely related to people’s medical care.A sound standard system of anesthesia and breathing equipment plays an important role in promoting industry norms and serving government supervision.Investigate international,European Union,and other standardization organizations and their standards,and compare and analyze with my country’s standards for anesthesia and respiratory equipment.At present,our anesthesia and respiratory equipment standard system has its own characteristics,and it is different from international standards in terms of the number and content of standards.It’s In line with the characteristics of Chinese current industry,meet the requirements of supervision and management.The construction of our anesthesia and respiratory equipment standardization system still needs to be further improved to provide a strong basis for strengthening services and supervision.
作者
刘靓
LIU Jing(Shanghai Medical Device Inspection and Research Institute,Shanghai 200233)
出处
《中国医疗器械信息》
2021年第19期17-19,58,共4页
China Medical Device Information
关键词
麻醉呼吸设备
标准体系
国际标准化组织
international standardization organization
anaesthetic and respiratory equipment
standard system