1、ANSI/AAMIBP22:1994/(R)2016Blood pressure transducersAmerican National StandardAssociation for the Advancementof Medical Instrumentation4301 N. Fairfax Drive, Suite 301Arlington, VA 22203-1633 2000 b y the Association for the Advancement of Medical InstrumentationAll Rights ReservedCopyright and Perm
2、issionsPublication, reproduction, photocopying, storage, or transmission, electronically or otherwise, of all or any part of these documents without the prior written permission of the Association for the Advancement of Medical Instrumentation or the copyright holder (if not AAMI) is prohibited by l
3、aw. It is illegal under federal law (17 U.S.C. 101, et seq.) to make copies of all or any part of these documents (whether internally or externally) without the prior written permission of the copyright holder. Violators risk legal action, including civil and criminal penalties, and damages of $100,
4、000 per offense. For permission regarding the use of all or any part of these documents, contact AAMI, 1110 N. Glebe Road, Suite 220, Arlington, VA 22201-4795. Phone: (703) 525-4890; Fax: (703) 525-1067.Violators of this copyright policy should be reported to AAMIs legal counsel:McKenna however, man
5、y of the electricalrequirements for ensuring interchangeability were retained. The sensitivity and nonlinearity/hysteresisrequirements were replaced by an accuracy error band requirement. A test method using alternating currentexcitation was added along with a synchronous demodulator circuit for per
6、forming the test. Catheter tiptransducers were included in this standard. A labeling provision was added to allow transducers that cannotwithstand defibrillation discharges to be included. The volume displacement requirement, which was toensure adequate reproduction of pressure waveforms, was replac
7、ed by a frequency response requirement.This standard reflects the conscientious efforts of concerned health care professionals, device manufacturers,and government representatives to develop a standard for those performance levels that could be reasonablyachieved at this time.The concepts incorporat
8、ed in this document should not be considered inflexible or static. This standard, likeany other, must be modified as advances are made in technology and as new data become available. AAMIstandards development procedures require that all standards are reviewed and, if necessary, updated at leastonce
9、every five years.As used within the context of this document, “shall“ indicates requirements strictly to be followed in orderto conform to the standard; “should“ indicates that among several possibilities one is recommended asparticularly suitable, without mentioning or excluding others, or that a c
10、ertain course of action is preferredbut not necessarily required, or that (in the negative form) a certain possibility or course of action should beavoided but is not prohibited; “may“ is used to indicate a course of action is permissible within the limits ofthe recommended practice; and “can“ is us
11、ed as a statement of possibility and capability. “Must“ is used onlyto describe “unavoidable“ situations, including those mandated by government regulation.Recommendations for improving this standard are invited. Comments and suggested revisions should besent to: AAMI, 3330 Washington Boulevard, Sui
12、te 400, Arlington, VA 22201-4598. 2000 Association for the Advancement of Medical InstrumentationNOTEThis foreword is not a part of the American National Standard, Blood pressure transducers(ANSI/AAMI BP221994).Blood pressure transducers1 Scope1.1 GeneralThis standard applies to pressure transducers
13、, including cables, used to measure blood pressure throughcatheters or direct vascular puncture. Physiological measurements other than blood pressure may be takenwith this transducer, although the requirements and tests of this standard were developed and designed withblood pressure measurement as t
14、he intended application of the device. Even though this standard addressesthe safety and efficacy of the transducer for measurement of blood pressure, care should be exercised toensure the compatibility of the particular transducer and blood pressure monitor.1.2 InclusionsIncluded within the scope o
15、f this standard are safety and performance requirements for transducers,including cables, designed for blood pressure measurements through an indwelling catheter or directpuncture and disclosure requirements to permit the user to determine compatibility between the transducerand blood pressure monit
16、or.1.3 ExclusionsExcluded from the scope of this standard are transducers designed specifically for the measurement of otherphysiological parameters. This standard does not address operating procedures for the transducer or monitor.Therefore, it is necessary to consult appropriate instruction manual
17、s to set up, balance, and calibrate thesystem properly.NOTEFor an explanation of the rationale for the provisions of this standard as well as a statement of theneed for the standard, see annex A.2 Normative referencesThe following standards contain provisions which, through reference in this text, c
18、onstitute provisions of theAmerican National Standard. At the time of publication, the editions indicated were valid. All standards aresubject to revision and parties to agreements based on this standard are encouraged to investigate thepossibility of applying the most recent editions of the standar
19、ds indicated below.2.1 ASSOCIATION FOR THE ADVANCEMENT OF MEDICAL INSTRUMENTATION. Cardiacdefibrillator devices. ANSI/AAMI DF21989. Arlington (Vir.): AAMI, 1989.2.2 ASSOCIATION FOR THE ADVANCEMENT OF MEDICAL INSTRUMENTATION. Evaluation ofclinical systems for invasive blood pressure monitoring. AAMI
20、TIR9. Arlington (Vir.): AAMI, 1992.2.3 ASSOCIATION FOR THE ADVANCEMENT OF MEDICAL INSTRUMENTATION. Safe current limitsfor electromedical apparatus. ANSI/AAMI ES11993. Arlington (Vir.): AAMI, 1993.2.4 AMERICAN NATIONAL STANDARDS INSTITUTE. Medical materielLuer taperfittingsPerformance. ANSI/HIMA MD 7
21、0.11983. New York, NY: ANSI, 1983. (Withdrawn.)NOTEThe following international standards are equivalent to the above-mentioned American NationalStandard:INTERNATIONAL ORGANIZATION FOR STANDARDIZATION. Conical fittings with a 6% (Luer)taper for syringes, needles, and certain other medical equipmentPa
22、rt 1: General requirements. ISO594/11986. Geneva, Switzerland: ISO, 1986; and 2000 Association for the Advancement of Medical InstrumentationINTERNATIONAL ORGANIZATION FOR STANDARDIZATION. Conical fittings with a 6% (Luer)taper for syringes, needles, and certain other medical equipmentPart 2: Lock f
23、ittings. ISO 594/21991.Geneva, Switzerland: ISO, 1991.2.5 INSTRUMENT SOCIETY OF AMERICA. Electrical transducer nomenclature and terminology.ANSI/ISA-S37.11975 R1982. Research Triangle Park (NC): ISA, 1982.3 DefinitionsFor the purposes of this American National Standard, the following definitions app
24、ly:3.1 accuracy: Ratio of the error (measured minus true) to the true or theoretical value expressed as apercentage.3.2 balance: Either a condition of symmetry in a Wheatstone bridge or the condition of zero output from thebridge when properly energized.3.3 critical damping: Value of damping which y
25、ields the minimum settling time to a step input withoutovershoot.3.4 damping: Energy-dissipating characteristics which together with natural frequency determine the upperlimits of frequency response and the response time characteristics of the transducer.3.5 damping coefficient: Ratio of the actual
26、damping to the damping required for critical damping.3.6 diaphragm: Sensing element consisting of a membrane placed between two volumes. The membrane isdeformed by the pressure differential applied across it.3.7 electrical calibration: Calibration of accessory equipment during which the transducer i
27、s deliberatelyunbalanced electrically by means of a calibration resistor placed across one leg of the bridge or a ratiodivider across the excitation to simulate a known pressure.3.8 excitation: External electrical voltage or current applied to a transducer for its proper operation.3.9 excitation imp
28、edance: Impedance presented to the excitation source and measured across the excitationterminal of the transducer. Sometimes called “input impedance.“3.10 frequency response: Change in output amplitude ratio for a sinusoidal varying pressure, which for asecond order system is defined by the undamped
29、 natural frequency and damping coefficient.3.11 15% bandwidth: The bandwidth over which the frequency response amplitude is within 15% of the flatlow-frequency amplitude.3.12 hysteresis: Maximum difference in output of a pressure-measuring device at a given pressure value withina range when the valu
30、e is approached first with increasing and then with decreasing pressure.3.13 point-based linearity: Nonlinearity expressed as deviation from a straight line passing through a givenpoint or points.3.14 resistive bridge transducer: Transducer capable of excitation from alternating or direct currents a
31、ndwhose output is directly proportional to the product of the applied pressure and excitation.3.15 resonant frequency: Frequency at which an electrical or mechanical system (second order) will oscillatewhen the damping coefficient is zero. Also called the “undamped natural frequency.“3.16 sensitivit
32、y: Ratio of the change in transducer output to a change of the value of the pressure at a givenexcitation voltage.3.17 signal impedance: Effective impedance across the output terminals of the transducer presented by the 2000 Association for the Advancement of Medical Instrumentationtransducer to the
33、 associated external circuitry. Sometimes called “output impedance.“3.18 symmetry: Centering of the transducer common mode signal output between the excitation voltages.4 Requirements4.1 Labeling requirementsThe term “labeling“ refers to any printed matter or markings that appear on the device, its
34、accessory items,or its container, and to all documentation that accompanies the device. In addition to federal regulationsapplicable to the labeling of all medical devices, the requirements contained in the section shall apply todevices within the scope of this standard.4.1.1 Device markingsThe devi
35、ce (or package, in the case of disposable devices) shall be permanently and visibly marked with thefollowing information:a) the model number;b) the name of the manufacturer;c) the serial number or other manufacturing control identification;d) the reusable electrical components should be marked with
36、the serial number or other controllingidentification.4.1.2 Instruction manualInstructions shall be provided with each transducer or reusable cable or, in the case of multiple units, asstipulated in the purchase order. At a minimum, the following information shall be included in theinstruction manual
37、:a) the excitation voltage (or voltage range);b) the excitation frequency (or frequency range);c) the excitation impedance or component characteristics for the excitation voltage and frequency specifiedin (a) and (b);d) the transducer signal impedance, with a specified tolerance;e) the maximum phase
38、 shift or phase characteristic over the excitation frequency range specified in (b),where applicable;f) the nominal transducer sensitivity for the ideal transducer output;g) the transducer cable to monitor connector and corresponding monitor manufacturer, including a wiringtable to enable connection
39、 to the blood pressure monitor for proper operation and safety;h) cautions and warnings about storage, use, handling, and sterilization of the transducer assembly;i) a list of recommended accessories to be used with the transducer, including domes, mounting clips, andother devices;j) the recommended
40、 procedure for connecting the transducer to the hydraulic system;k) detailed instructions for cleaning and sterilizing the transducer, dome, and other related parts, ifapplicable;l) instructions for use, care, storage, handling, and maintenance of the transducer to ensure functionalintegrity of the
41、device; 2000 Association for the Advancement of Medical Instrumentationm) the names and addresses of acceptable customer service facilities;n) the magnitude of half-sine shock acceleration that the transducer can be subjected to on each axis and stillmeet the requirements of section 4.2, given that
42、the unbalance limits of 4.2.3.7 may increase to 150 mmHg;o) the maximum deviation from the initial transducer zero at 25 1C over 4 hours in mmHg after therecommended warm-up time;p) the error band of zero shift in mmHg for a temperature change of 25C to 15C and 25C to 40C inmmHg after the recommende
43、d warm-up time;q) the error band of sensitivity from 25C to 15C and from 25C to 40C expressed as a percentage changefrom 25C;r) the light sensitivity of the transducer at 3,000 foot-candles from a 3,400 Kelvin (K) tungsten light sourceat zero pressure in mmHg. The maximum error should be stated over
44、 the stated excitation voltage range.4.2 Performance requirements for the transducer4.2.1 Environmental performanceUnless stated otherwise, the transducer shall meet the requirements of 4.2 after storage at temperatures in therange of -25C to + 70C (-13F to 158F) and when operated under the followin
45、g conditions:a) operating temperatures: 15C to 40C (59F104F);b) humidity: 10% to 90%, noncondensing;c) atmospheric pressure: 425 to 850 torr.4.2.2 Mechanical requirementsThe following requirements cover all configurations of pressure transducers when used with domes orfittings recommended by the tra
46、nsducer manufacturer and when the domes or fittings are applied accordingto the manufacturers recommended procedures.4.2.2.1 Pressure rangeThe transducer shall perform over an operating range of -30 to 300 mmHg, and it shall not be damaged byan overpressure of -400 to 4,000 mmHg.4.2.2.2 Mounting req
47、uirementThe transducer shall meet the performance requirements of 4.2 when mounted on any axis.4.2.2.3 Requirements for the fittingsLuer-lock or Linden fittings meeting the requirements of the American National Standard, Performancestandard for medical luer taper fittings (normative reference 2.4),
48、shall be used for transducers capable ofconnecting to needles or catheters.4.2.2.4 Frequency responseThe frequency response in Hertz (Hz) based on 15% bandwidth established in AAMI TIR9, Evaluation ofclinical systems for invasive blood pressure monitoring (see normative reference 2.2), with all inte
49、gral,reusable, or disposable domes recommended by the transducer manufacturer when the domes are appliedaccording to the manufacturerss recommended procedures shall be a minimum of 200 Hz.4.2.3 Electrical performanceThis section describes electrical requirements that ensure a functional monitoring system when the 2000 Association for the Advancement of Medical Instrumentationtransducer or interface is coupled to a blood pressure monitor.4.2.3.1 Transducer excitationThe transducer shall meet the requirements of 4.2 when excited from direct current
