ANSI/AAMI SP10:2002 pdf download.Manual, electronic, or automated sphygmomanometers.
1 Scope
1.1 General This standard establishes safety and performance requirements for all sphygmomanometers, whether nonautomated, automated, or electronic, that are used with an occluding cuff for the indirect determination of arterial blood pressure.
1.2 Inclusions Included within the scope of this standard are aneroid, mercury gravity, and electronic sphygmomanometers used in conjunction with a stethoscope or other manual methods for detecting Korotkoff sounds and with any other type of display. Also included within the scope of this standard are all devices that sense or display pulsations, flow, or sounds in connection with the measurement, display, or recording of blood pressure. These devices may or may not employ electrical means for measurement and display. These devices might or might not have an automatic cuff inflation. This standard covers neonatal or newborn through adult categories. Ambulatory blood pressure monitors, which are portable, lightweight, automated devices worn or carried by the patient that are able to obtain and store the results of repeated determinations of blood pressure and heart rate during activities of ordinary daily living, are included in this standard. NOTE—For an explanation of the need for this standard and the rationale for its provisions, see annex A.
1.3 Exclusions Excluded from the scope of this standard are devices for direct, intra-arterial measurement of blood pressure. The use of automated monitors that measure blood pressure on the finger are not covered in this standard.
2 Normative references The following documents contain provisions which, through reference in this text, constitute provisions of this American National Standard. At the time of publication, the editions indicated were valid. All standards are subject to revision and parties to agreements based on this American National Standard are encouraged to investigate the possibility of applying the most recent editions of the documents indicated below.
2.1 AMERICAN HEART ASSOCIATION. Recommendations for human blood pressure determination by sphygmomanometers. Dallas: American Heart Association, 1 994.
2.2 AMERICAN NATIONAL STANDARDS INSTITUTE. Voltage ratings for electric power systems and equipment (60 Hz). ANSI C84.1 -1 982, 1 982. American National Standard.
2.3 ASSOCIATION FOR THE ADVANCEMENT OF MEDICAL INSTRUMENTATION. Developing safe, effective, and reliable medical software. AAMI MDS, 1 991 .
2.4 INTERNATIONAL ELECTROTECHNICAL COMMISSION. Medical electrical equipment—Part 1–2: General requirements for safety—Collateral standard: Electromagnetic compatibility: Requirements and tests, second edition. IEC 60601 -1 -2, 2001 .
2.5 INTERNATIONAL ELECTROTECHNICAL COMMISSION. Medical electrical equipment—Part 2: Collateral standard: Particular requirements for safety, including essential performance of automatic cycling non-invasive blood pressure monitoring equipment. IEC 60601 -2-30, 1 999.
2.6 INTERNATIONAL ELECTROTECHNICAL COMMISSION. Medical electrical equipment—Part 1: General requirements for safety. IEC 60601 -1 , 1 988; Amendment 1 , 1 991 ; and Amendment 2, 1 995.
2.7 INTERNATIONAL SAFE TRANSIT ASSOCIATION. ISTA 2 Series, Integrity—Plus test procedures. 1 999 rev.ANSI/AAMI SP10 pdf download.