【正文】 Medical electrical equipment Part 11: General requirements for safety Collateral standard: Safety requirements for medical electrical systems EN 6060112:2020 Medical electrical equipment – Part 11:General requirements for safety – Collateral standard: Electromagic patibility – Requirements and tests EN 6060114: Medical electrical equipment – Part 16: General requirements for safety – Collateral standard: Programmable electrical medical systems EN 6060116 Medical electrical equipment – Part 16: General requirements for safety – collateral standard: Usability EN 6060118 Medical electrical equipment – Part 21: Particular requirements for the safety – Collateral standard: General requirements, tests and guidance for 14 alarm systems in medical electrical equipment and medical electrical systems EN 60601227 Medical electrical equipment – Part 227:Partcular requirements for the safety, including essential performance, of electrocardiographic monitoring equipment EN 60601230 Medical electrical equipment – Part 230:Particular requirements for the safety, including essential performance, of automatic cycling noninvasive blood pressure monitoring equipment EN60601249 Particular requirements for the safety of multifunction patient monitoring equipment EN ISO 9919:2020 Medical electrical equipment – Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use(ISO 9919:2020) EN 124704 ： 2020 Clinical thermometers – Part 5: Performance of electrical thermometers for continuous measurement SP10 Manual, electronic, or automated sphygmomanometers 15 YY06702020《無創(chuàng)自動血壓計》 16 附件 1: “多參數(shù)監(jiān)護(hù)儀血氧、血壓測量模塊” 臨 床 試 驗（草案） 依據(jù) 2020 年 12月 22日國家食品藥品監(jiān)督管理局發(fā)布，自2020 年 4 月 1 日起施行的國家食品藥品監(jiān)督管理局令第 5 號令《醫(yī)療器械臨床試驗規(guī)定》實施“多參數(shù)監(jiān)護(hù)儀血氧，血壓測量模塊”技術(shù)審評的