应急救治装备可靠性评价技术标准探讨

Discussion on Technical Standards for Reliability Evaluation of Emergency Treatment Equipment

RONG Shankui1 SUN Hongru²ZHU Jiong1* （1.National Institutes forFoodand Drug Control（CenterforMedical Device StandardizationAdministration，NMPA）; 2. China Federation of Electronics and Information Industry）

Abstract：Emergencytreatmentequipmentiswidelyused，ndeliabilityisakeyndicatorthatneeds tobemeasuredtoesue its normal functioning in special scenarios. At present， theresearch onreliabilityrelated technical standards for emergency treatment equipment isstillintheexploratory stage.Thisstudy investigates thecurrent statusofreliabilityevaluation standardsforemergencytreatment equipment，analyzes therequirements forspecialusescenariosofsuchequipment，andthe technicalcharacteristicsofreliabilityevaluationbroughtaboutbythem.Combiningwiththestandardssituationofreliability evaluationforothermedicaldvices，itproposessuggestionsforrelevant technicalstandardsintheaspectsofgeneraltchical requirements，ommontechicalindicators，proutdevelopmentprocess，liicalevaluationndstadardssatedto emergencytreatmentequipmentreliabityevaluation，whichcanserveastechnicalreferences forresearchanddevelopment units and regulatory agencies.

Keywords： emergency treatment equipment; reliability evaluation; technical standards

0 引言

应急救治装备对高效救治伤员、避免和减少人员伤亡、保护公众生命安全至关重要，被广泛应用于突发灾害、重大疫情及野外战场等各类突发事件的紧急医学救援中[1-4]。（剩余4655字）