TASK 3: DIGITAL THERMOMETER GROUP MEMBER: NAZATHUL HASHIMA BINTI HASHIM NURUL HAMIZAH BINTI MUZAMIL TEOH SOO YEE WAN NORHIDAYAH BINTI WAN AZMI

Reference To Standard Document

Clinical thermometers Part 3: Performance of compact electrical thermometers (non-predictive and predictive) with maximum device. ISO EN12470-3:2000+A1:2009 Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature. ASTM E1112-00:2006 Medical electrical equipment. Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement. ISO 80601-2-56:2009 Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature ASTM E1965-98:2009 ISO – international organization for standardization IEC -  International Electrotechnical Commission ASTM - American Society for Testing and Materials ISO/IEC 17025 - General requirements for the competence of testing and calibration laboratories Intermittent - occurring at irregular intervals; not continuous or steady

EN 12470-3:2000. Clinical thermometers EN 12470-3:2000 Clinical thermometers. Part 3: Performance of compact electrical thermometers (non-predictive and predictive) with maximum device Applies to devices that, when taking temperature, are powered by an internal power supply temperature and provide a digital indication of the temperature. The test apparatus : 5 liters of water bath and the reference thermometer. Test must be performed on at least 10 thermometers. EN standard requires that thermometer provides a visual or auditory warning when the measured temperature is outside the measuring range – in range 35.5°C to 40.2°C. Other than that : Visual inspection of the digital increment and size of numerical values Time response, long term stability, ambient operating range Effect of energy dissipation in the probe, effect of storage, effect of thermal shock, effect of humidity, effect of mechanical shock Electromagnetic compatibility, water resistance The test should be carried out in a room with an ambient temperature of 23⁰C ± 5⁰C. with a relative humidity of 50% ± 20%. measuring range that specified by manufacturer Test must be performed on at least 10 thermometers - to determine if there are any inhomogeneities that could result in exceeding the maximum permissible error in small sub‐ranges

ASTM E1112-00:2006 Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature This specification covers electronic instruments intended for intermittent monitoring of patient temperatures. Well stirred water bath must have volume greater than 1 liter and its must be accurately calibrated within 0.03%. Tests are conducted - to compare measurements of the test thermometer against the reference thermometer. Other than that : The full set of validation tests also includes tests of accuracy under different environmental conditions Effects of storage conditions, battery indication, cleaning tests Inspection of labeling, inspection of the graduated intervals in the display, inspection of resolution and readability Inspection of instructions provided by the manufacturer and recalibration instructions.

ISO 80601-2-56:2009 Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement Applies to the basic safety and essential performance of a clinical thermometer. Applies to all electrical thermometers that are used for measuring body temperature of patients. The temperature of the bath should be measured by a reference thermometer with a total uncertainty not greater than 0.07⁰C. The tests are repeated at 1⁰C of the upper limit and 1⁰C of the lower limit of the rated output temperature range. Other than that : The standard describes a test for time response; clinical accuracy validation tests; inspections and functional testing related to markings, units of measure, instructions for use, basic safety of medical electrical equipment basic safety of medical electrical equipment according to IEC 60601‐1.

ASTM E1965-98:2009 Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature Specification covers electronic instruments intended for intermittent measuring and monitoring of patient temperatures by detecting the intensity of thermal radiation between the subject of measurement and the sensor. Describe testing for clinical accuracy for tympanic IR thermometers. ASTM E1965 requires that the clinical accuracy must be disclosed upon request for each device model, each adjustable display mode, and for every age group intended for use. Other than that : This standard provides performance requirements for non-contact temperature measurement of skin Performance and storage limits under various environmental conditions Requirements for labeling and test procedures

Setup of Testing -Audible Testing -Button Testing -Display Testing -Battery Testing -Accuracy Testing

Apply the probe to the measurement site Buzzer will beep after a while Audible testing Procedure Apply the probe to the measurement site Buzzer will beep after a while

Button testing Button on/off change Celsius & Fahrenheit

-Apply to measurement site -Observe the LCD display Display testing Procedure -Apply to measurement site -Observe the LCD display

Battery testing Check the battery indicator in the display or test the battery with a battery tester. Coin battery 3.0V DC Coin battery 2 method measurement Without resistance With resistance Battery tester resistors adjustable to a value that will simulate the load conditions to which the battery is to be applied, to simulate the current drain for that usage. Variable resistance +/- Probe

Accuracy testing ISO EN12470-3:2000 & ASTM E1112-00 1 4 7 Prepare a container filled with at least 5 litres of distilled or de-ionized water. Monitor the temperature for several minutes to ensure the thermal equilibrium Compare all the results with approved standard 2 5 Heat the bath gradually to the lowest temperature of measuring range Immerse the digital thermometer into the bath 3 *Note: if the thermometer use disposable probe or sheath, place a probe cover on the test thermometer before insert into water bath 6 Verify the temperature of the bath with a reference thermometer (±0.03°C on the International Temperature Scale) Conduct the test at three points within the practical temperature range of the device ISO EN12470-3:2000 & ASTM E1112-00

Minimum Testing Requirements

VERIFICATION METHODS Narrow temperature range (-50 °C to 100 °C) A single-check point at the ice melting point (0 °C) or at an ambient temperature Temperature above 100 °C A single-check point at the ice melting point (0 °C) Check on the steam point (~100 °C) Broader temperature range (-196 °C to 500 °C) Inspection on historical calibration records & periodic calibration records.

Measurement at the Ice Melting Point (0 °C) Use distilled water or purified by reverse osmosis for both water and ice Size of ice pieces should be around 1 cm or 0.5 in. Pack the container by using insulated flask or styrofoam cup to make sure there is an ice-water mixture from top to bottom Insert the thermometer, immerse it at least 10 cm to 15 cm, and the probe tip is at least 2 cm from the container and about 5 cm from the bottom of the container The test thermometer should read 0 °C

Measurement at the Steam Point (100 °C) Cover the top of beaker with a loose-fitting cover to ensure the steam fill the space below the cover Fill the beaker with at least 4 cm of water Use a clamp to hold the thermometer probe above the water, in the steam. The probe should not contact with the boiling water Heat the water to a rolling, but not violent, boil . If a glass beaker is used, wrapping the outside cylinder with aluminium foil to prevent an error due to radiative cooling of the thermometer. Immerse the thermometer probe at least 10 cm to 15 cm into the space where steam collects Wait for 5 mins and record the thermometer reading The thermometer should not necessarily read 100 °C. The boiling point temperature can be calculated by using steam-point calculator.

Reports & Acceptable Performance Rates/ Passing Measurement Values

1 Digital (electronic) thermometer ACCURACY TEST EN12470-3:2000+A1:2009 Parameter Summary of the Specification Test Procedure Maximum permissible error over the specified temperature range 0.1°C Measuring temperature range: 35.5°C-42.0°C Ambient temperature range: 18°C to 28 °C Method in 7.3 of EN 12470-3:2000 0.2°C Outside the above measuring range or ambient temperature range

Continue… ASTM E1112-00 (reapproved 2006) Parameter Summary of the Specification Test Procedure Maximum permissible error over the specified temperature range ±0.3°C Measuring temperature range: <35.8°C Ambient temperature range: See below Method in 5.4 of ASTM E1112-00 ±0.2°C Measuring temperature range: 35.8°C to <37°C Ambient temperature range: See below ±0.1°C Measuring temperature range: 37°C to 39°C Measuring temperature range: >39°C to 41°C Measuring temperature range: >41°C

Temporal, Tympanic or combined infrared (IR) Thermometer ASTM e1865-98 (reproved 2009) Parameter Summary of the Specification Section Maximum permissible laboratory error for given blackbody temperature range 0.3°C Method in 5.4 of ASTM E1112-00 Minimum measuring range 22°C-40.0°C

EN 12470-5:2003 for tympanic IR thermometer Parameter Summary of the Specification Section Maximum permissible error over the specified temperature range ±0.2°C Measuring temperature range:35.5°C-42.0°C Ambient temperature range: 18°C to 28°C Method in 7.4 and 7.5 of EN 12470-5:2003 Outside the above measuring range or ambient temperature range Minimum measuring range 35.5°C – 40.0°C Method in 7.3 of EN 12470‐5:2003 Maximum permissible clinical repeatability ±0.3°C for every patient age group (new born, children, adults) for which the infrared ear thermometer is intended for use Method in 7.7 of EN 12470‐5:2003

ASTM E1965-98 (reapproved 2009) Parameter Summary of the Specification Section Maximum permissible laboratory error for given blackbody temperature range 0.3°C <36°C 5.3 (see test method in 6.1.4) 0.2°C 36°C-39°C >39°C Minimum measuring range 34.4°C to 42.2°C unless otherwise labelled 5.2 Clinical accuracy To be determined and disclosed upon request for each device model, each adjustable display mode, and for every age group intended for use 5.5.1 (see also 6.2)

References https://www.iso.org/standard/39883.html https://www.unido.org/sites/default/files/2010- 08/Complying_with_ISO_17025_A_practical_guidebook_0.pdf https://reference.globalspec.com/standard/3836811/astm-e1965-98-2009 https://www.astm.org/Standards/temperature-measurement-standards.html

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