Professional Documents
Culture Documents
RECOMMENDATION
OIML R 16-1
Edition 2002 (E)
ORGANISATION INTERNATIONALE
DE MTROLOGIE LGALE
INTERNATIONAL ORGANIZATION
OF LEGAL METROLOGY
Contents
Foreword ........................................................................................................................................................................... 3
1 Scope ........................................................................................................................................................................... 4
2 Terminology ................................................................................................................................................................ 4
3 Description of the category of instrument ................................................................................................................ 5
4 Units of measurement ................................................................................................................................................ 5
5 Metrological requirements ......................................................................................................................................... 5
6 Technical requirements .............................................................................................................................................. 6
7 Metrological controls ................................................................................................................................................. 8
Annex A: Test procedures (Mandatory) ....................................................................................................................... 10
Annex B: Test report format (Mandatory for application within the
OIML Certificate System for Measuring Instruments) ................................................................................. 15
Annex C: Advice to be included in the instructions accompanying a
sphygmomanometer using a mercury manometer (Informative) ............................................................. 31
Foreword
International Recommendations and International Documents are published in French (F) and English (E) and are
subject to periodic revision.
Scope
2.5
2.6
2.1
2.7
Pneumatic system
Terminology
Bladder
System that includes all pressurized and pressurecontrolling parts such as cuff, tubing, connectors,
valves, transducer and pump.
Sleeve
2.3
2.9
Cuff
Sphygmomanometer
2.4
Units of measurement
The blood pressure shall be indicated either in kilopascals (kPa) or in millimeters of mercury (mmHg).
Metrological requirements
5.1
6.3
Technical requirements
6.1
6.2
140
160
120
180
100
200
80
220
60
240
40
260
20
280
0
300
mmHg
Figure 1 Example of an aneroid manometer scale (division in mmHg without a tolerance zone at zero)
6.4
6.5
6.6
Safety requirements
It shall be possible to abort the blood pressure measurement at any time by activating the manual rapid
exhaust valve, which shall be easily accessible.
Metrological controls
7.1
Type approval
7.2
Verification
7.3
Sealing
7.4
7.5
Manufacturers information
Annex A
Test procedures
(Mandatory)
A.1.2 Procedure
Replace the cuff with the vessel. Connect the calibrated
reference manometer by means of a T-piece connector
and hoses to the pneumatic system (see Figure 2). After
disabling the electromechanical pump (if fitted),
connect the pressure generator into the pressure
system by means of another T-piece connector. Carry
out the test in pressure steps of not more than 7 kPa
(50 mmHg) between 0 kPa (0 mmHg) and the maximum pressure of the scale range.*
A.2.2 Procedure
Replace the cuff with the vessel. Connect the calibrated
reference manometer by means of a T-piece connector
to the pneumatic system (see Figure 3). After disabling
the electro-mechanical pump (if fitted), connect the
additional pressure generator into the pneumatic
system by means of another T-piece connector.
1234
1234
500 ml
10
1 - Reference manometer
2 - Manometer of the device to be tested
3 - Metal vessel
4 - Pressure generator
Figure 2 Measurement system for determining the limits of error
of the cuff pressure indication
1234
1234
500 ml
4
5
1 - Reference manometer
3 - Manometer of the device to be tested
5 - Pressure generator
2 - Climatic chamber
4 - Metal vessel
A.3.1 Apparatus
A.3.2 Procedure
11
Store the instrument under test for 24 h at a temperature of 20 C and subsequently for 24 h at a temperature of 70 C and a relative humidity of 85 % (noncondensing).
A.5.1 Apparatus
T-piece connector;
calibrated reference manometer with signal output
and an uncertainty less than 0.1 kPa (0.8 mmHg);
artificial limbs (see Notes under A.5.2);
recording unit.
A.5.2 Procedure
A.4.1 Apparatus
rigid metal cylinder of an appropriate size (see 6.1);
pressure generator, e.g. ball pump (hand pump) with
a deflation valve;
time measuring device.
A.4.2 Procedure
Wrap the cuff around the cylinder.
Note: Electro-mechanical pumps which are part of the
device may be used for the test.
Carry out the test over the whole measuring range at at
least five equally spaced pressure steps (e.g. 7 kPa
(50 mmHg), 13 kPa (100 mmHg), 20 kPa (150 mmHg),
27 kPa (200 mmHg) and 34 kPa (250 mmHg)). Test the
air leakage over a period of 5 min and determine the
measured value from this.
12
A.8.2 Procedure
Test the nominal internal diameter of the tube at each
end by using the limit plug gauge.
A.6.2 Procedure
A.9.2 Procedure
Carry out the test with the vessel in place of the cuff.
A.7.2 Procedure
Determine the thickness of the scale marks and the
scale spacing using the scaled magnifying lens.
A.8.1 Apparatus
A.10.2 Procedure
13
A.12.2 Procedure
Carry out the procedure specified in A.1.
A.11.2 Procedure
Replace the cuff with the vessel. Connect the calibrated
reference manometer by means of a T-piece connector
to the pneumatic system. After disabling the electromechanical pump (if fitted) connect the additional
pressure generator into the pneumatic system by
means of another T-piece connector.
Test the device with increasing pressure steps of not
more than 7 kPa (50 mmHg) to the scale maximum, at
which point hold the pressure for 5 min and then
decrease it by the same steps. Disconnect the calibrated
reference manometer during the 5 min at maximum
pressure.
14
Annex B
Test Report Format
(Mandatory for application within the
OIML Certificate System for Measuring Instruments)
15
EXAMPLES
a) at a given location, the value assigned to the quantity realized by a reference standard may be taken as a conventional true value;
b) the CODATA (1986) recommended value for the Avogadro constant NA: 6,022 136 7 1023 mol1.
NOTES
1 Conventional true value is sometimes called assigned value, best estimate of the value, conventional value or reference value.
Reference value, in this sense, should not be confused with reference value in the sense used in the note to VIM 5.7.
2 Frequently, a number of results of measurements of a quantity is used to establish a conventional true value.
n
s=
(xi x)2
i=1
n1
xi being the result of the ith measurement and x being the arithmetic mean of the n results considered.
NOTES
1 Considering the series of n values as a sample of a distribution, x is an unbiased estimate of the mean , and s2 is an unbiased
estimate of the variance 2, of that distribution.
2 The expression s / n is an estimate of the standard deviation of the distribution of x and is called the experimental standard
deviation of the mean.
3 Experimental standard deviation of the mean is sometimes incorrectly called standard error of the mean.
16
17
TEST REPORT
TYPE APPROVAL TEST REPORT
VERIFICATION TEST REPORT
(For verification purposes tick those fields which are appropriate for verification
according to your national regulations or which are listed in B.1.2
under the heading: Summary of test results for verification.)
Number of report: ....................................................
Object: ...................................................................................................................................................................................
Type: ......................................................................................................................................................................................
Serial number: ......................................................................................................................................................................
Manufacturers name and address: .....................................................................................................................................
................................................................................................................................................................................................
................................................................................................................................................................................................
Customers name and address: ............................................................................................................................................
................................................................................................................................................................................................
................................................................................................................................................................................................
Date of receipt: .....................................................................................................................................................................
Date/period of measurement: ..............................................................................................................................................
Date of report: .................................................................. Number of pages: ...................................................................
Issuing Institutes name and address: .................................................................................................................................
................................................................................................................................................................................................
................................................................................................................................................................................................
Characteristic values (principle of measurement, measuring unit,
measuring range, range of display): ...................................................................................................................................
................................................................................................................................................................................................
Additional devices (printer, interface etc.): ........................................................................................................................
................................................................................................................................................................................................
Reference manometer (serial number, uncertainty, calibration certificate): ...................................................................
................................................................................................................................................................................................
Stamp/signature:
18
Clause
Subject
B.2
B.3
B.4
B.5
B.6
B.7
B.8
B.9
Electrical safety
B.10
B.10.1
B.10.2
B.10.3
B.10.4
B.10.5
B.11
B.11.1
B.11.2
Portable devices
B.11.3
B.11.4
B.11.5
B.11.6
B.12
B.12.1
B.12.2
Zero
B.12.3.1
Pointer length
B.12.3.2
Pointer thickness
B.12.4
Hysteresis error
B.12.5
B.13
Tamper proofing
Maximum
deviation
Maximum
permissible error
Passed
Failed
19
Subject
Maximum
deviation
B.2
B.5
B.7
B.9
Electrical safety
B.11.4
B.11.5
B.12.4
Hysteresis error
B.13
Tamper proofing
Maximum
permissible error
Passed
Failed
Note 1: The sequence of the different tests is arbitrary; it follows the sequence of the different clauses in the text.
The sequence of testing is at the discretion of the person conducting the tests.
Note 2: To be considered as approved or verified, an instrument must have successfully passed all the applicable
tests.
3
1st
5
2nd
reading
reading
mean
9
deviation
reading
2nd
reading
mmHg
up
down
up
down
up
down
up
down
50
52
54
54
54
53
54
100
106
100
104
104
105
102
200
250
20
11
hysteresis
pressure
150
10
1st
3
1st
5
2nd
reading
reading
mean
9
deviation
pressure
mmHg
up
down
up
down
up
10
down
up
down
11
hysteresis
1st
reading
2nd
reading
0
50
100
150
200
250
300 or max
Note 1: The hysteresis error is the difference between the indications of the instrument when the same pressure is
reached by increasing or decreasing the pressure.
Note 2: The time between up and down run should not be less than 5 minutes at the maximum pressure (see
A.11.2). A time difference from the first run to the second run of one hour is recommended.
Is the maximum deviation of all of the readings of the instrument under test and of the reference manometer less
than or equal to 0.4 kPa ( 3 mmHg) for type approval test and first verification and less than or equal to 0.5 kPa
( 4 mmHg) for subsequent verification, respectively (see 5.1.1)?
yes
passed
no
failed
21
down
up
down
mean
up
down
up
down
0
50
100
150
200
250
300 or max
22
yes
passed
no
failed
pressure
mmHg
up
2nd reading
down
up
mean
down
up
up
down
0
50
100
150
200
250
300 or max
pressure
mmHg
up
2nd reading
down
up
mean
down
up
up
down
0
50
100
150
200
250
300 or max
passed
no
failed
23
pressure
first reading
difference
between the readings
50 mmHg
100 mmHg
150 mmHg
200 mmHg
250 mmHg
Does the air leakage rate over a period of 5 minutes correspond to a pressure drop less than or equal to 0.5 kPa/min
(4 mmHg/min)?
yes
passed
no
failed
passed
no
failed
24
yes
passed
no
failed
tRe = .........s
passed
no
failed
B.9 Electrical safety (This test is optional within the OIML Certificate System)
If the instrument is equipped with electrical devices, do these devices comply with regional and national safety
regulations?
yes
passed
no
failed
passed
no
failed
yes
passed
no
failed
25
passed
no
failed
passed
no
failed
passed
no
failed
yes
passed
no
failed
26
yes
passed
no
failed
passed
no
failed
B.11.3 Device to prevent mercury from being spilled during use and transport
Does the tube have a device to prevent the mercury from being spilled during transport and use and is this device
efficient?
yes
passed
no
failed
B.11.4 Influence of the device to prevent mercury from being spilled during use and transport
Does the delay in the setting of the mercury column due to this device exceed 1.5 s for the flow of the mercury from
27 kPa to 5 kPa (from 200 mmHg to 40 mmHg ) when the pressure in the system drops rapidly from 27 kPa to 0 kPa
(from 200 mmHg to 0 mmHg)?
yes
failed
no
passed
passed
no
failed
27
passed
no
failed
passed
no
failed
passed
no
failed
B.12.2 Zero
Is the movement of the elastic sensing element including the pointer obstructed within 0.8 kPa (6 mmHg) below
zero?
yes
failed
no
passed
28
B.12.3 Pointer
For reference see 6.5.3.
All the tests can be carried out by visual inspection.
passed
no
failed
failed
no
passed
passed
no
failed
Note: The purpose of this test is to determine if the elastic sensing element has been exposed to a tension within
the elastic range (i.e. the Hookes range) or not throughout the whole pressure range.
For reference see 6.5.4. The test should be carried out according to A.11.
29
failed
no
passed
For reference see 6.5.5. The test should be carried out according to A.12. The pressure test has to be performed
according to B.2.
Note: The construction of the aneroid manometer and the material for the elastic sensing elements shall ensure an
adequate stability of the measurement. The elastic sensing elements shall be aged with respect to pressure
and temperature.
passed
no
failed
30
Annex C
Advice to be included in the instructions accompanying
a sphygmomanometer using a mercury manometer
(Informative)
C.1 Guidelines and precautions
A mercury-type sphygmomanometer should be handled with care. In particular, care should be taken to avoid
dropping the instrument or treating it in any way that could result in damage to the manometer. Regular checks
should be made to ensure that there are no leaks from the inflation system and to ensure that the manometer has
not been damaged so as to cause a loss of mercury.
31
Printed in France