AS 3655-1989

1 - AS 3655-1989 SPHYGMOMANOMETERS
4 - PREFACE
5 - CONTENTS
6 - FOREWORD
7 - 1 SCOPE.
7 - 2 APPLICATION.
7 - 3 REFERENCED DOCUMENTS.
7 - 4 DEFINITIONS.
7 - 4.1 Sphygmomanometer
7 - 4.2 Cuff
7 - 4.3 Manual device
7 - 4.4 Semi-automated device
7 - 4.5 Fully automated device
7 - 4.6 Audible alarm
7 - 5 DESCRIPTIONOF SPHYGMOMANOMETER.
7 - 6 GENERAL REQUIREMENTS.
7 - 6.1 Environmental performance and stability.
7 - 6.1.1 Operating conditions.
8 - 6.1.2 Durability and resistance to shock.
8 - 6.2 Pressure sensing device.
8 - 6.2.1 Markings.
8 - 6.2.2 Range.
8 - 6.2.3 Resolution.
8 - 6.2.4 Accuracy.
8 - 6.2.5 Repeatability.
8 - 6.3 Requirements for the inflation system.
8 - 6.3.1 Air leakage.
8 - 6.3.2 Overpressure.
8 - 6.3.3 Pressure release valve.
8 - 6.4 Requirements for the cuff.
8 - 6.4.1 Inflatable bladder.
9 - 6.4.2 Cuff sleeves.
9 - 6.4.3 Cuff closures and construction.
9 - 7 SPECIFIC REQUIREMENTS.
9 - 7.1 Manometers.
9 - 7.1.1 Aneroid.
9 - 7.1.2 Mercury gravity.
9 - 7.2 Inflating device.
9 - 8 ELECTRICALLY POWERED DEVICES.
9 - 8.1 General requirements.
10 - 8.2 Display for digital read-out devices.
10 - 8.3 Front panel controls.
10 - 8.4 Data communication.
10 - 9 REQUIREMENTS FOR DEVICES WITH AUTOMATED SYSTOLIC AND DIASTOLIC PRESSURE DETECTION.
10 - 9.1 Electrical safety.
10 - 9.2 Functions.
10 - 9.3 Overall system efficacy.
10 - 9.4 Switch-on behaviour.
10 - 9.5 Power failure.
10 - 9.6 Pressure cycling.
11 - 9.7 Alarms.
11 - 10 REQUIREMENTS FOR SEMI-AUTOMATIC DEVICES.
11 - 11 REQUIREMENTS FOR SPECIFIC TYPES OF DEVICES.
11 - 11.1 Ultrasonic devices.
11 - 11.2 Oscillometric devices.
11 - 11.3 Commercial ‘vending machine’ or ‘coin-in-the-slot’ devices.
11 - 11.4 Korotkoff sound processing devices.
11 - 12 PRODUCT LITERATURE.
12 - 13 MARKING.
12 - 13.1 Device.
12 - 13.2 Cuff marking.
13 - APPENDIX A - TEST FOR DURABILITY OF INFLATION SYSTEM
13 - A1 SCOPE.
13 - A2 PRINCIPLE.
13 - A3 APPARATUS.
13 - A4 PROCEDURE.
13 - A5 REPORT.
14 - APPENDIX B - TEST FOR STATIC AND DYNAMIC ACCURACY OF PRESSURE SENSING DEVICE
14 - B1 SCOPE.
14 - B2 PRINCIPLE.
14 - B3 APPARATUS.
14 - B4 PROCEDURE.
14 - B4.1 Static testing of mercury and anaeroid devices.
14 - B4.2 Dynamic testing of mercury and anaeroid devices.
14 - B4.3 Static testing of devices with a di gital pressure display.
14 - B4.4 Dynamic testing of semi-automated devices with a digital pressure di splay.
15 - B5 CRITERIA FOR PASSING OR FAILING SEMI-AUTOMATED DIGITAL DISPLAY DEVICES
15 - B6 CALCULATION.
15 - B6.1 Static testing of mercury, anaeroid and digital di splay devices.
15 - B6.2 Dynamic testing of mercury, anaeroid and digital display devices.
15 - B7 REPORT.
15 - B7.1 Static testing.
15 - B7.2 Dynamic testing.
16 - APPENDIX C - TEST FOR AIR LEAKAGE
16 - C1 SCOPE.
16 - C2 PRINCIPLE.
16 - C3 APPARATUS.
16 - C4 PROCEDURE
16 - C4.1 Non-automated devices (including self-bleed devices).
16 - C4.2 Devices with electronic displays.
16 - C5 REPORT.
17 - APPENDIX D - TEST FOR EFFECTS OF OVERPRESSURE
17 - D1 SCOPE.
17 - D2 PRINCIPLE.
17 - D3 APPARATUS.
17 - D4 PROCEDURE.
17 - D4.1 Non-automated devices.
17 - D4.2 Devices with electronic displays.
17 - D5 REPORT.
18 - APPENDIX E - TEST FOR PRESSURE RELEASE RATE OF MANUALLY OPERATED VALVES
18 - E1 SCOPE.
18 - E2 PRINCIPLE.
18 - E3 APPARATUS.
18 - E4 PROCEDURE.
18 - E5 REPORT.
19 - APPENDIX F - TEST FOR VENTING
19 - F1 SCOPE.
19 - F2 PRINCIPLE.
19 - F3 APPARATUS.
19 - F4 PROCEDURE.
19 - F5 REPORT.
20 - APPENDIX G - TEST FOR PRESSURE RELEASE RATE OF SELF-BLEEDING VALVES
20 - G1 SCOPE.
20 - G2 PRINCIPLE.
20 - G3 APPARATUS.
20 - G4 PROCEDURE.
20 - G5 REPORT.
21 - APPENDIX H - CYCLIC TESTING OF PRESSURE RELEASE VALVE
21 - H1 SCOPE.
21 - H2 PRINCIPLE.
21 - H3 APPARATUS.
21 - H3.1 Manually operated rotating pressure release valve.
21 - H3.2 All other pressure release valves.
21 - H4 PROCEDURE.
21 - H4.1 Manually operated rotating pressure release valve.
21 - H4.2 All other pressure release valves.
21 - H5 REPORT.
22 - APPENDIX I - INTEGRITY OF INFLATABLE BLADDER AND CUFF
22 - I1 SCOPE.
22 - I2 PRINCIPLE.
22 - I3 APPARATUS.
22 - I4 PROCEDURE.
22 - I5 REPORT.
22 - APPENDIX J - TEST FOR MERCURY SPILLAGE
22 - J1 SCOPE.
22 - J2 PRINCIPLE.
22 - J3 APPARATUS.
22 - J4 PROCEDURE.
22 - J5 REPORT.
23 - APPENDIX K - TEST FOR TUBE DIAMETER
23 - K1 SCOPE.
23 - K2 PRINCIPLE.
23 - K3 APPARATUS.
23 - K4 PROCEDURE.
23 - K5 REPORT.
23 - APPENDIX L - TEST FOR INFLATION SOURCE
23 - L1 SCOPE.
23 - L2 PRINCIPLE.
23 - L3 APPARATUS.
23 - L4 PROCEDURE.
23 - L5 REPORT.
24 - APPENDIX M - METHOD FOR TESTING SPHYGMOMANOMETER (SYSTEM) ACCURACY BY THE INTRA-ARTERIAL COMPARISON METHOD
24 - M1 SCOPE.
24 - M2 PRINCIPLE.
24 - M3 APPARATUS AND SUBJECTS.
24 - M3.1 Apparatus.
24 - M3.2 Subjects.
24 - M4 PROCEDURE.
26 - M5 DATA ANALYSIS.
26 - M6 REPORT.
29 - APPENDIX N - METHOD FOR TESTING SPHYGMOMANOMETER (SYSTEM) ACCURACY BY THE INDIRECT COMPARISON METHOD.
29 - N1 SCOPE.
29 - N2 PRINCIPLE.
29 - N3 APPARATUS AND SUBJECTS.
29 - N3.1 Apparatus.
29 - N3.2 Subjects.
29 - N4 PROCEDURE.
29 - N5 DATA ANALYSIS.
30 - N6 REPORT.
31 - APPENDIX O - BLOOD PRESSURE UNITS
31 - O1 SCOPE.
31 - O2 GENERAL.
33 - COMMENTARY - RATIONALE FOR SPHYGMOMANOMETER ACCURACY/PERFORMANCE TESTING REQUIREMENTS
33 - Intra-arterial pressure measurement.
34 - Indirect pressure measurement.
34 - Cuff dimensions.
35 - Testing procedure.
35 - Accuracy requirements.
36 - Sample size.
36 - Hypothesis testing.
36 - Data reporting and statistical analysis.

Specifies requirements for manual, semi-automated and automated devices for indirect measurement of arterial blood pressure. Definitions, general and specific requirements for the various types of devices, and labelling requirements are specified.

This Standard specifies requirements for manual, semi-automated and automated devices for indirect measurement of arterial blood pressure. The Standard applies to liquid manometer, mechanical gauge, oscillotonometer or electro-manometer sphygmomanometers used in conjunction with a stethoscope or other methods for the detection and display of pulsations, flow or sounds in connection with the measurement, display or recording of blood pressure by electronic means, regardless of whether they have an automatic inflation system. Safety aspects of the instruments and their servicing and maintenance are also dealt with.The Standard does not apply to invasive devices such as those used for the direct measurement of blood pressure, nor does it apply to the non-invasive determination of blood pressure during exercise.NOTE: Specialized instruments, such as the population of new ambulatory blood pressure recorders, the London School of Hygiene (LSH), or the random zero machines (RZM) and devices based on the vascular unloading principle combined with plethysmography may require additional consideration, as these research-based instruments are not completely covered by this Standard.