American National ANSVAAMLEC38:2007 Standard Medical electrical eguipment - Part 2-47: Particular reguirements for the safety, including essential performance, of ambulatory electrocardiographic systems AAMI Association for the Advancement of Medical Instrumentation Objectives and uses of AAMI standards and recommended practices It is most important that the objectives and potential uses of an Each AAMI standard or recommended practice reflects the AAMI product standard or recommended practice are clearly collectiveexpertiseof acommittee of health careprofessionals and understood. The objectives of AAMI's technical development representatives, whose work has been reviewed industrial program derive from AAMI's overall mission: the advancement of nationally (and sometimes internationally).As such, the consensus medical instrumentation. Essential to such advancement are (1) a recommendations embodied in a standard or recommended practice continued increase in the safe and effective application of current are intended to respond to clinical needs and, ultimately, to help technologiestopatient care,and (2)the encouragement of new ensurepatient safety.Astandard orrecommendedpracticeis technologies. It is AAMI's view that standards and recommended limited, however, in the sense that it responds generally to practices can contribute significantly to the advancement of perceived risks and conditions that may not always be relevant to medical instrumentation, provided that they are drafted with specific situations. A standard or recommended practice is an attention to these objectives and provided that arbitrary and important reference in responsible decision-making, but it should restrictive uses are avoided. never replace responsible decision-making. A voluntary standard for a medical device recommends to the Despite periodic review and revision (at least once every five manufacturer the information that should be provided with or on years),a standard or recommended practice is necessarily a static the product, basic safety and performance criteria that should be document applied to a dynamic technology. Therefore, a standards considered in qualifying the device for clinical use, and the usermust carefullyreviewthereasonswhythedocumentwas measurement techniques that can be used to determine whether the initially developed and the specific rationale for each of its device conforms with the safety and performance criteria and/or to provisions. This review will reveal whether the document remains compare the performance characteristics of different products. relevant to the specific needs of the user. Some standards emphasize the information that should be provided Particular care should be taken in applying a product standard with the device, including performance characteristics, instructions to existing devices and equipment, and in applying a recommended for use, warnings and precautions, and other data considered practice to current procedures and practices. While observed or important in ensuring the safe and effective use of the device in the potential risks with existing equipment typically form the basis for clinical environment. Recommending the disclosure the safety and performance criteria defined in a standard, of performance characteristics often necessitates the development of professional judgment must be used in applying these criteria to specialized test methods to facilitate uniformity in reporting; existing equipment. No single source of information will serve to reaching consensus on these tests can represent a considerable part identify a particular product as "unsafe". A voluntary standard can of committee work. When a drafting committee determines that be used as one resource,but theultimate decisionastoproduct clinical concerns warrantthe establishment of minimum safetyand safety and efficacy must take into account the specifics of its performance criteria, referee tests must be provided and the reasons utilizati