ANSI-AAMI-SP10-2002
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ID： |
95C71DEDEA7742CDA1B600FCCF00D2A0 |
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文件大小(MB)： |
0.95 |
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页数： |
82 |
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文件格式： |
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日期： |
2024-6-22 |
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购买： |
文本摘录（文本识别可能有误，但文件阅览显示及打印正常，pdf文件可进行文字搜索定位）：
American,National,Standard,ANSI/AAMI SP10:2002,AAMI Association for the,Advancement of Medical,Instrumentation,Manual, electronic,or automated,sphygmomanometers,& ANSI/AAMI SP10:2002/A1:2003,List of Titles,The Objectives and Uses of AAMI Standards and,Recommended Practices,It is most important that the objectives and potential uses of an AAMI,product standard or recommended practice are clearly understood.,The objectives of AAMI's technical development program derive,from AAMI's overall mission: the advancement of medical,instrumentation. 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,AAMI's view that standards and recommended practices can,contribute significantly to the advancement of medical,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 safety and performance criteria that should be considered,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 performance,characteristics of different products. Some standards emphasize,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.,Recommending 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 concerns warrant the establishment,of minimum safety and performance criteria, referee tests must be,provided and the reasons for establishing the criteria must be,documented in the rationale.,A recommended practice provides guidelines for the use, care,and/or processing of a medical device or system. A recommended,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 manufacturer,it may also be of value 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 device 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 evaluation 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 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 recommended,practice is solely within the discretion and professional,judgment of the user of the document.,Each AAMI standard 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,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 recommended 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 practic……
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