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麻醉和呼吸设备标准体系研究

Research on Standard System of Anesthesia and Respiratory Equipment
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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
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  • 1Council directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices [EB/OL]. [2007-10-28]. http ://eur-lex. europa. eu/LexUriServ/site/en/consleg/1990 /L/01990L0385-20031120-en. pdf.
  • 2Council Directive 93/42/EEC of 14 June 1993 concerning medical devices [EB/OL]. [ 2007-10-28 ]. http://eur-lex. europa. eu/LexUriServ/site/en/consleg/1993/L/01993L00 42-20031120-en. pdf.
  • 3The European Parliament and the Council of the European Union. Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices [ EB/OL ]. [ 2007-10-30 ]. http.//eur-lex. europa. eu/LexUriServ/site/en/oj/1998/1_331/1_33119981 207en00010037. pdf.
  • 4Guidelines relating to medical devices Directives[EB/OL]. [ 2007-11-01 ]. http ://ec. europa. eu/enterprise/medical _ devices/meddev/index, htm.
  • 5Directive 2007/47/EC of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market [EB/OL]. [2007-11-02]. http://eur-lex. europa, eu/LexUriServ/site/en/oj/2007/1_24 7/1_24720070921en00210055. pdf.
  • 6Guide to the implementation of directives based on new approach and global approach part 6 notified bodies[EB/OL]. [ 2007-11-04 ]. http://ec. europa. eu/enterprise/newapproa ch/legislation/guide/document/chap06, pdf.
  • 7Co-ordination of notified bodies medical devices (NB-MED) on Council Directives 90/385/EEC, 93/42/EEC and 98/ 79/EC. Technical Documentation[EB/OL]. [ 2007-11-05 ]. http://www. team-nb. org/Documents/R2_5_1-5_rev4. pdf.
  • 8Enterprise and industry. Harmonized standards [EB/OL]. [ 2007-11-06 ]. http ://ec. europa. eu/enterprise/newappro ach/standardization/harmstds/index_en, html.
  • 9European Standards Organizations/ Name of the Organization: European Committee for Electrotechnical Standardization (CENELEC) [EB/OL]. Standards Setting in the European Union Standards Organizations and Officials in EU Standards Activities. [ 2007-11-06 ]. http ://ts. nist. gov/Standards/Global/upload/staneu, pdf.
  • 10The European Parliament and the Council of the European Union. A procedure for the provision of information in the field of technical standards and regulations [ EB/OL].[2007-11-06 ]. http://eur-lex. europa. eu/LexUriServ/ site/en/oj/1998/1_204/1_20419980721 en00370048, pdf.

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