ANSI AAMI SP9:1994 (2000) pdf download.Non-automated sphygmomanometers.
1.1 General
ANSI AAMI SP9 establishes safety and performance requirements for pneumatic or other nonautomated sphygrnomanometers that are used with an occluding cuff for the indirect determination of blood pressure.
1.2 Inclusions
Included within the scope of this standard are aneroid and mercury gravity sphygmornanorneters used in conjunction with a stethoscope or other manual methods for detecting Koroikoff sounds and with any other type of display.
1.3 Exclusions
Excluded from the scope of this standard are devices that sense or display pulsations, flow, or sounds in connection with the electronic measurement, display, or recording of blood pressure, regardless of whether they have an automatic inflation system. Indirect measurement systems that do not have an occluding cuff are also excluded from the scope of this standard, as are invasive devices such as those used for direct blood pressure measurement.
NOTE—For an explanation of the need for this standard, as well as the rationale for its provisions, see annex A.
2 Normative references
2.1 NATIONAL FIRE PROTECTION AGENCY Standard for Health Facilities (Chapter 3, “Use of Inhalation Anesthetics”). ANSI/NFPA 99-1984. Boston: NFPA, 1984.
2.2 NATIONAL SAFE TRANSIT ASSOCIATIONPre-shipment Test Procedures. Chicago: NSTA, 1977.
3 Definitions
For the purposes of this standard, the following definitions apply.
3.1 aneroid manometer: Pressure-determining device using a mechanical indicating element or component.
3.2 calibration: Act or process of standardizing by determining the deviation of a measurement from an established standard of known accuracy (e.g., one traceable to the National Bureau of Standards).
3.3 Korotkoff sounds: Sounds heard over the artery when blood pressure is determined by the indirect (auscultatory) method.
3.4 manometer: Instrument for measuring the pressure of gases and vapors.
3.5 mercury gravity manometer: Pressure-determining device using a column of mercury as its indicating element.
3.6 outer container: Immediate/unit container (i.e., retail package) of a device intended for home or other unsupervised use.
3.7 sphygmomanometer: Instrument used for the indirect (noninvasive) measurement of arterial blood pressure.
3.8 stethoscope: Instrument for detecting and studying sound produced by the body: in the case of blood pressure measurement, for detecting Korotkoff sounds.
3.9 true zero: Position of the aneroid pointer or mercury column meniscus when a manometer is at zero differential pressure.
4 Requirements
4.1 Labeling requirements
4.1.1 General
In addition to federal regulations applicable to the labeling of all medical devices, the following requirements shall apply to devices within the scope of this standard.
4.1.2 Outer container
The outer container of the device shall display information needed by the end user, including cuff size, and shall also display the statement “limited range,” if the manometer range is less than the “standard range” specified in 4.4.1.1 and 4.4.2.1.ANSI AAMI SP9 pdf download.