翻译——AAMI_PB70-2003.docx

American National StandardANSI/AAMI PB70:2003Liquid barrier performance and classification of protective apparel and drapes intended for use inhealth care facilities（医疗保健设施中使用的防护服和防护布的防液性能和分类）The Objectives and Uses of AAMI Standards and Recommended Practices（AAMI标准的目的和应用以及推荐做法）It is most important that the objectives and potential uses ofanAAMIproduct standard or recommended practice areclearlyunderstood. The objectives of AAMIs technical developmentprogramderive from AAMIs overall mission: the advancementofmedicalinstrumentation. Essential to such advancementare (1) acontinued increase in the safe and effective application ofcurrenttechnologiesto patient care, and (2) the encouragement of new technologies.ItisAAMIs view that standards and recommendedpracticescancontributesignificantlytotheadvancementofmedical instrumentation, provided that they are drafted with attentiontothese objectives and provided that arbitrary and restrictive usesareavoided. A voluntary standard for a medical device recommendstothe manufacturer the information that should be provided with oronthe product, basic safety and performance criteria that shouldbecon-sidered in qualifying the device for clinical use, andthemeasurement techniques that can be used to determine whether thedeviceconformswiththesafetyandperformancecriteriaand/ortocomparetheper-formance characteristics of different products. Somestandardsem- phasize the information that should be provided withthedevice, including performance characteristics, instructions foruse,warningsand precautions, and other data considered important inensuringthe safe and effective use of the device in theclinicalenvironment. Recommending the disclosure of performancecharacteristicsoften necessitates the development of specialized test methodstofacilitate uniformity in reporting; reaching consensus on thesetestscanrepresent a considerable part of committee work. Whenadrafting committee determines that clinical concerns warranttheestablishment of mini