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Replacement of mercury thermometers and sphygmomanometers in health care: technical guidance Ȁ
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ͻͺͻʹͶͳͷͶͺͳͺʹ ȋ ǣʹͻ͵Ȍ
©WorldHealthOrganization2011
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C o n t e n ts
Foreword...........................................................................................................v
Acknowledgements.....................................................................................vii
I. WHOpolicy........................................................................................1
II. Purposeofthisguide......................................................................3
III. Background.......................................................................................5
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Ǥ ǤǤǤǤǤǤǤǤǤǤǤǤǤǤǤǤǤǤǤǤǤǤǤǤǤǤǤǤǤǤǤǤǤǤǤǤǤǤǤǤǤǤǤǤǤǤǤǤǤǤǤǤǤǤǤǤǤǤǤǤǤǤǤǤǤǤǤǤǤǤǤǤǤǤǤ
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IV. Thermometers.................................................................................9
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V. Sphygmomanometers..................................................................17
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iii
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VI. Conclusion.......................................................................................25
Annex1............................................................................................................27
Annex2............................................................................................................39
References......................................................................................................45
Tables
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v
A c k n o w l e d g e m e n ts
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vii
I. WHO policy
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1
II. Purpose of this guide
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ȋ4ȌǤ
ǡǦ
ȋ5ȌǤ
3
III. Background
a. Chemistry
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Ȃ͵ͻιǡ͵ͷιǡ
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ȋ6ȌǤ
b. Exposure
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c. Human exposure
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ȋ11ȌǤ
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ǤʹͲͲͲǡ
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Background 7
I V. T h e r m o m e t e r s
a. History
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ȋ14ȌǤ
ͳʹͶ
ȋ͵ʹȂʹͳʹι ȌǤ
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ȋȌͳͲͲȋ
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Ǧȋ10ȌǤ
ͳͺ
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ͳͺͲ ͳͺͲͷǡ
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ȋ15ȌǤ
9
c. Accuracy of mercury thermometers
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ȋȌ
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άͲǤʹι ͻͺǤͲι
ͳͲʹǤͲι ǡ άͲǤͶι δͻǤͶι εͳͲι ȋ16ȌǤ
ǡ ǡ
ȋ12ȌǤ
d. Mercury-free thermometers
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ȋǦȌ
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ȋ17ȌǤ
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ȌȋȌ
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ǯǡ
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f. Cost considerations
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ʹͲͲͷǡ Ǥ ȋ20Ȍ
ʹʹͲͷ ͳͲǦ
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Thermometers 11
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ͳͲΨ
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ȋȌʹͳʹ
ʹʹͲͷǦǡ
ʹͲͲΨǤ
Step1
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Step2
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Thermometers 13
Guide to alternatives for healthcare personnelǡ
ǡǡʹͲͲǣ
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Ȁ
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̴̴Ǥ
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ǯǡ
ͷͳͲȋ
ȌǤ
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ǤǤȀ
Ȁ
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ȀǤ
Step7
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Ȍǡǡ
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1
These product listings are examples. Other listings are also available.
Step11 Ǧ Ǥ
Step12
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Step13
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Step14
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Thermometers 15
Step15 Ǧ
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a. History
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ͳͺͺͲǤ
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ͳͺͻǤǡͳͺͻǡ
ȋ35ȌǤ
ͳͻͲͷǡ
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ȋ27ȌǤ
17
c. Accuracy of mercury sphygmomanometers
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ǡǯǤ
d. Mercury-free sphygmomanometers
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ȋ37ȌǤ
f. Calibration
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ȋȌ Ǧǡ
ǦǤ
both
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Ͷ
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Sphygmomanometers 19
ȋ41ȌǤ
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g. Validation
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ȋ ͷǤͳȌ
ȋ43ȌǤ
ͷǡ ͳͲ
ͳͷ
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ͳͳ͵ ʹʹ
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ǡͳͻͻ͵Ǣ
ǡʹͲͲʹǢ
ȋǦȌǡ
ʹͲͲʹǤ
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ȋͺͳΨȌ
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Ͷͳ
ȋͻͲΨȌǢǦ
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͵ͷ
ȋͻΨȌǤ
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͵͵
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ͺͷ
ȋ32ȌǤ
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h. Cost considerations
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ȋ45ȌǤ
i. Replacement of mercury-containing
sphygmomanometers
Step1 ͳ ͵
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Step3
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Sphygmomanometers 21
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ǤȀ̴̴ǤǤ
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Step5
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Step9 Ǧ Ǥ
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Sphygmomanometers 23
VI. Conclusion
25
Annex 1
27
Table A1.1 Requirements for digital thermometers continued
ͳͳͳʹǦͲͲȋʹͲͲȌǣ
Summary of the
Summary of the specification in specification in
Parameter EN 12470-3:2000 ASTM E1112-00
Warning when The device should give a visual or n/a
out of range auditory warning when the measured
temperature is not within the specified
measuring range [see sections 6.2.1 and
7.2]
Time response 60 seconds under specified conditions n/a
[see sections 6.2.4 and 7.4]
Effect of storage The device should meet the EN accuracy The device should meet the
requirement after being stored in its ASTM accuracy requirement
unopened primary package at five after being stored and/or
different temperatures for 24 hours each transported in an environment
in sequence [see sections 6.3.2 and 7.8] of –20 °C to 50 °C and a
relative humidity of 15–95%
non-condensing for one
month [see test method in
section 5.5.2]
Long-term The device should meet the EN accuracy n/a
stability requirement after exposure to either
55 °C or 80 °C for a specified number of
days [see section 6.2.6]
Readability Numerals should appear at least 4 mm Numerals should appear at
high [see section 6.4.1.2] least 2.5 mm high and
1.5 mm wide, with at least
0.7 mm in between [see
section 4.4.2.2]
Ability to The device should meet the EN accuracy n/a
withstand thermal requirement after being exposed to five
shock cycles of 0 °C and 55 °C for an hour
each [see sections 6.3.3 and 7.9]
Effect of humidity The device should meet the EN accuracy The device should meet the
requirement after being exposed to a ASTM accuracy requirement
temperature of 45 °C and a relative after being exposed to at
humidity of 85% for 48 hours [see least four test conditions
sections 6.3.4 and 7.10] involving two temperatures
and four relative humidities
[see section 5.5.1]
Annex 1 29
Table A1.1 Requirements for digital thermometers continued
Summary of the
Summary of the specification in specification in ASTM
Parameter EN 12470-3:2000 E1112-00
Resistance to The device should meet the EN accuracy The instruction manual
mechanical shock requirement after being dropped onto a should inform the user if
hard surface from a height of 1 metre [see the performance is
sections 6.3.6 and 7.11] degraded by
mechanical shock such
as from a drop test; the
device should withstand
dropping without
presenting an electrical
hazard [see sections
4.3.3.3 and 4.6.2.1]
Water resistance The device should meet the EN accuracy n/a
requirement after being immersed in water
for 30 minutes [see sections 6.3.7 and 7.12]
Maximum energy The energy dissipated by the probe should n/a
dissipation not cause a temperature rise in the
indicated temperature of more than 0.01 °C
[see sections 6.2.5 and 7.5]
n/a, not available,
Note: See the list of available features of digital thermometers, below.
Annex 1 31
Table A1.1 Requirements for digital thermometers continued
Ǣ
ȏȐǣ
Summary of the
Summary of the specification in specification in
Parameter EN 12470-3:2000 ASTM E1112-00
Marking Information from the manufacturer should Identification markings
comply with EN 1041 (30); marking should should not deteriorate
include the symbol “C” adjacent to the when the device is
numerals, the body site (if applicable), etc. cleaned [see cleaning
[see sections 8.1 and 8.2] test in section 5.2];
markings should include
model, serial or lot
number, temperature
scale, etc. [see
section 4.7]
Instructions for use The information in the instructions should Instructions should
include environmental conditions of use, include operation, care
storage and transport; cleaning and and use, biological and
disinfection; selection, replacement and physical cleaning,
disposal of batteries, if applicable; probe service and repair if
cover use, if applicable; measuring time; permitted, determination
maintenance and calibration; etc. [see of accuracy,
section 8.3] recalibration, detailed
specifications, etc. [see
sections 4.3.3, 4.7 and
4.8]
Identification Compliance with EN 1041 and EN 980 (31) “Conforms to ASTM
[see section 8.1] E1112 (name and
address of producer or
distributor)” [see section
4.7.6.1 for the full
statement of
identification]
ͳʹͶͲǦ͵ǣʹͲͲͲ
ǡ
ǤͳǤͳ
ʹͺͷͻǦʹǣͳͻͺͷ ȋ32ȌǤ
ǡ ͳͳͲͶǦͻͺ ȋ33Ȍǡ
Ǥ
Annex 1 33
Ȉ
ǡ
ͳʹͶͲǦ͵ǣʹͲͲͲ ͳͳͳʹǢ Ȁ ͲͲͳ ͲͲͳǢ
ͳͲͶͳͻͺͲǢͳͳͲͶǡ
Ǣ
Ȉ ͻͲͲͳ ȋ Ȍ
Ǣ
Ȉ ͳ͵Ͷͺͷ ͳ͵Ͷͺͺ ȋ
Ȍ
Ǣ
Ȉ ͳͶͲͲͲ ȋ Ȍ
Ǥ
Annex 1 35
Table A1.3 Requirements for tympanic infrared thermometers
ͳʹͶͲǦͷǣʹͲͲ͵ȋ25Ȍǣ
Annex 1 37
Table A1.4 Requirements for temporal artery infrared thermometers
ͳͺͷǦͻͺȋʹͲͲͻȌȋ26Ȍǣ
39
Table A2.1 Requirements for aneroid sphygmomanometers continued
Parameter Summary of the specification Section
Accuracy and other key requirements
Maximum error for ±3 mmHg (±0.4 kPa) for the following conditions: 7.1.1
the cuff pressure temperature range of 15–25 °C, relative humidity range of
measurement over 15–85% (non-condensing) and decreasing pressure; see
the nominal range compliance test
±3 mmHg (±0.4 kPa) or 2%, whichever is greater, for the
following conditions: temperature range of 10–40 °C, relative
humidity range of 15–85% (non-condensing) and decreasing
pressure; see compliance test
Nominal range and 0 mmHg (0 kPa) to at least 260 mmHg (35 kPa) 7.1.2
measuring range
Air leakage Should not cause a pressure drop that exceeds 4 mmHg/min 7.2.1
(0.5 kPa/min); see compliance test
Pressure reduction Should be adjustable to a deflation rate of 2 mmHg/s 7.2.2
rate (0.3 kPa/s) to 3 mmHg/s (0.4 kPa/s); see compliance test
Rapid exhaust Should not exceed 10 seconds from 260 mmHg (35 kPa) to 7.2.3
15 mmHg (2 kPa); see compliance test
Dimensions of cuff Dimensions based on the limb circumference at the midpoint 7.2.4
of the intended range of the cuff
Cuff, bladder and Should be able to withstand the maximum pressure; should 7.2.5
tubing connectors have a means to prevent accidental disconnection; see and
compliance tests 7.2.6
Tamper proofing or Should prevent tampering with, or unauthorized access to, 7.3
unauthorized adjustments and functions that affect accuracy
access
Dynamic response <1.5 seconds in cuff pressure indication for a specified drop 7.4
in pressure; see compliance test
Additional requirements
Scale mark and Requirements for a tolerance zone and movement of the 9.1 and 9.2
zero elastic sensing element
Hysteresis error <4 mmHg (0.5 kPa) throughout the pressure range; see 9.3
compliance test
Construction and Not more than 3 mmHg (0.4 kPa) difference in pressure 9.4
materials indication after 10 000 full-scale cycles; see compliance
test
Cleaning, Reusable parts that come in contact with the patient 10
sterilization, should be capable of being cleaned, and disinfected or
disinfection sterilized
Annex 2 41
Table A2.2 Requirements for automated sphygmomanometers
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Ȍ
ȀȀ ͺͳͲͲǦʹǣʹͲͲͻ ȋ47Ȍ
ȀȀͺͲͲͳǦʹǦ͵ͲǣʹͲͲͻȋ48ȌǤ
Annex 2 43
Table A2.3 Summary of requirements in ANSI/AAMI/ISO 81060-2:2009 (47)
Parameter Summary of the specification Section
Validation studies
General requirements Automated sphygmomanometers should be clinically 4
validated using either a non-invasive (auscultatory)
reference sphygmomanometer or a reference
invasive blood pressure monitoring equipment in
each mode of operation
Validation with an Minimum of 85 subjects with three valid blood 5
auscultatory reference pressure determinations for each (see details about
sphygmomanometer the study procedure and data analysis in section 5)
Validation with See study procedure and data analysis in section 6; 6
reference invasive clinical validation studies should comply with ISO
blood pressure 14155 (49); validation with reference invasive blood
monitoring equipment pressure monitoring equipment should not be used
for patients or subjects solely for the purpose of
validating sphygmomanometer performance
Validation for pregnant A sphygmomanometer for use in pregnant, including 7
patients pre-eclamptic, patients should be clinically evaluated
in that patient population
45
ͳͳǤ
ȋǣȀȀǤǤ
ǤȀȀͶǦ
ʹǤǡ
ʹͲͳͲȌǤ
ͳʹǤ
Ǥ Toxicological effects of
methylmercuryǡ ǡ
ǡ ʹͲͲͲǣͶ
ȋǣȀȀǤǤȀ
Ǥǫ
̴αͻͺͻͻ͓
ȌǤ
ͳ͵Ǥ ǡ ǡ
Ǥ
Ǥ
EnvironmentalHealthPerspectivesǡʹͲͲͷǡͳͳ͵ǣͷͻͲȂͷͻǤ
ͳͶǤ
ȋǣȀȀǤ
ǤȀȀǡ
ʹͲͳͲȌǤ
ͳͷǤ Ǥ
ȋͳͷȂͳͺͲͷȌǣ
ǡ
ǡ
Ǥ Journal of Medical Biographyǡ ʹͲͲǡ
ͳͶȋͳȌǣ͵Ǥ
ͳǤ Selecting nonmercury thermometersǤ
ȋǣȀȀǤǤȀ
Ȁ̴
̴
Ǥ
ǡ
ͳͶ
ʹͲͳͲȌǤ
ͳǤ
Ǥ Guidance on technical specifications for nonmercury medical
devicesǤ
ǡ
ǡʹͲͳͲǤ
ͳͺǤ ǡǡǤ
Ǥ Australian Family PhysicianǡʹͲͳͲǡ͵ͻȋͶȌǣʹ͵Ȃ
ʹ͵ͻǤ
References 47
ʹͶǤ Standard specification for phase changetype disposable fever thermometer
for intermittent determination of human temperatureǤ ͺʹͷǦͻͺ
ȋʹͲͲͻȌǤ
ʹͷǤ Clinical thermometers—Part 5: Performance of infrared ear thermometers
(withmaximumdevice)ǤͳʹͶͲǦͷǣʹͲͲ͵Ǥ
ʹǤ Standard specification for infrared thermometers for intermittent
determinationofpatienttemperatureǤͳͻͷǦͻͺȋʹͲͲͻȌǤ
ʹǤ Medical electrical equipment—Part 12: General requirements for basic
safety and essential performance; Collateral standard: Electromagnetic
compatibility—requirementsandtestsǤͲͲͳǦͳǤ
ʹͺǤ Medicalelectricalequipment—Part1:Generalrequirementsforbasicsafety
and essential performanceǤ Ȁ ͲͲͳǦͳǣʹͲͲͷǡ ʹͲͲǢ
ͲͲͳǦͳǣʹͲͲͷǤ
ʹͻǤ Standardsforsafety,medicalanddentalequipmentǡͷͶͶǤǡǡ
Ǥ
Medical electrical equipment—Part 1: General requirements for safetyǡ
ͲͲͳǦͳǡǡǡʹͷ
ʹͲͲ͵Ǥ
͵ͲǤ Information supplied by the manufacturer of medical devicesǤ
ͳͲͶͳǡʹͲͲͺǤ
͵ͳǤ SymbolsforuseinthelabellingofmedicaldevicesǤͻͺͲǡ
ʹͲͲͺǤ
͵ʹǤ Sampling procedures for inspection by attributes—Part 2: Sampling plans
indexedbylimitingquality(LQ)forisolatedlotinspectionǤʹͺͷͻǦʹǣͳͻͺͷǤ
͵͵Ǥ Standard specification for clinical thermometer probe covers and sheathsǤ
ͳͳͲͶǦͻͺȋʹͲͲͻȌǤ
͵ͶǤ ȋǡ
Ǧ
Ǧ
Ȍ Ǥ
Ǥ ǡ
ʹǤͷǡͺǤͷͳͲǤͺ
ǡ
Ǥ
Ǧ
Ǥ Ǧ
ȋǡ ǡ
Ǣ ǡ Ͳ͵ ͳ Ȍ
Ǥ
ȋ
ǣ
ǡ
Ǥ An investigation of alternatives to
miniature batteries containing mercuryǤ
ǡ
ͳǡʹͲͲͶǤȌ
͵ͷǤ ǡǤBloodpressuremeasurement:anillustratedhistoryǡ
ǤͷȂǤǡǡͳͻͻͺǤ
References 49
ͶǤ Noninvasivesphygmomanometers—Part1:Requirementsandtestmethods
fornonautomatedmeasurementtypeǤȀȀͺͳͲͲǦͳǣʹͲͲǤ
ͶǤ Noninvasivesphygmomanometers—Part2:Clinicalvalidationofautomated
measurement typeǤ ȀȀ ͺͳͲͲǦʹǣʹͲͲͻ ȋ ͳͲǣʹͲͲʹ
ͳǣʹͲͲ͵ʹǣʹͲͲȌǡʹͲͲͻǤ
ͶͺǤ Medical electrical equipment—Part 230: Particular requirements for the
basicsafetyandessentialperformanceofautomatednoninvasivesphygmo
manometersǤȀȀͺͲͲͳǦʹǦ͵ͲǣʹͲͲͻǤ
ͶͻǤ Clinicalinvestigationofmedicaldevicesforhumansubjects—Part1:General
requirementsǤͳͶͳͷͷǦͳǣʹͲͲ͵Ǥ