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1、.；.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）AAMI InstrumentationAssociation for theAdvancement of MedicalThe Objectives and Uses of AAMI Standards a
2、nd 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 of an AAMI product standard or recommended practice are clearly understood. The objectives of AAMIs technical development program derive from AAMIs overall mission: the advancement of medical inst
3、rumentation. Essential to such advancement are (1) a continued increase in the safe and effective application of current technologies to patient care, and (2) the encouragement of new technologies. It is AAMIs view that standards and recommended practices can contributesignificantlytotheadvancemento
4、fmedical instrumentation, provided that they are drafted with attention to these objectives and provided that arbitrary and restrictive uses are avoided. A voluntary standard for a medical device recommends to the manufacturer the information that should be provided with or on the product, basic saf
5、ety and performance criteria that should be con- sidered in qualifying the device for clinical use, and the measurement techniques that can be used to determine whether the device conforms with the safety and performance criteria and/or to compare the per- formance characteristics of different produ
6、cts. Some standards em- phasize the information that should be provided with the device, including performance characteristics, instructions for use, warnings and precautions, and other data considered important in ensuring the safe and effective use of the device in the clinical environment. Recomm
7、ending the disclosure of performance characteristics often necessitates the development of specialized test methods to facilitate uniformity in reporting; reaching consensus on these tests can represent a considerable part of committee work. When a drafting committee determines that clinical concern
8、s warrant the establishment of minimum safety and performance criteria, referee tests must be provided and the reasons for establishing the criteria must bedocumented in the rationale.A recommended practice provides guidelines for the use, care, and/or processing of a medical device or system. A rec
9、ommended practice does not address device performance per se, but rather procedures and practices that will help ensure that a device is used safely and effectively and that its performance will be maintained.Although a device standard is primarily directed to the manufac- turer, it may also be of v
10、alue to the potential purchaser or user of the device as a fume of reference for device evaluation. Similarly, even though a recommended practice is usually oriented towards health care professionals, it may be useful to the manufacturer in better understanding the environment in which a medical dev
11、ice will be used. Also, some recommended practices, while not addressing device performance criteria, provide guidelines to industrial personnel on such subjects as sterilization processing, methods of collecting data to establish safety and efficacy, human engineering, and other processing or evalu
12、ation techniques; such guidelines may be useful to health care professionals in understanding industrial practices.In determining whether an AAMI standard or recommended practice is relevant to the specific needs of a potential user of the document, several important concepts must be recognized:All
13、AAMI standards and recommended practices are voluntary (unless, of course, they are adopted by government regulatory or procurement authorities). The application of a standard or recom- mended practice is solely within the discretion and professional judgment of the user of the document.Each AAMI st
14、andard or recommended practice reflects the collective expertise of a committee of health care professionals and industrial representatives, whose work has been reviewed nationally (and sometimes internationally). As such, the consensus recommendations embodied in a standard or recommended practice
15、are intended to respond to clinical needs and, ultimately, to help ensure patient safety. A standard or recommended practice is limited, however, in the sense that it responds generally to perceived risks and conditions that may not always be relevant to specific situations. A standard or recommende
16、d practice is an important reference in responsible decision-making, but it should never replace responsible decisionmaking.Despite periodic review and revision (at least once every five years), a standard or recommended practice is necessarily a static document applied to a dynamic technology. Therefore
