EN 13486 Temperature Recorders and Thermometers for the Transport, Storage and Distribution of Temperature-Sensitive Goods

A European standard "EN 13486 Temperature recorders and thermometers for measuring the ambient or internal temperature for the transport, storage and distribution of temperature-sensitive goods - Periodic verification" describes the verification procedure for temperature recorders and thermometers for measuring the ambient or internal temperature of products between minus 80 degrees and plus 85 degrees, designed to equip vehicles used for the transport, storage and distribution of temperature-sensitive goods and complying with the standards EN 12830 and EN 13485 (classes and ranges of measurement) as well as others used for the transport, distribution and storage of temperature-sensitive goods.

This standard provides test methods that allow verification of the conformity of equipment according to the class requirements defined in the EN 12830 and EN 13485 standards.

Examples of goods sensitive to temperatures between -80°C and +85°C include chilled, frozen, deep-frozen and quick-frozen foods, ice cream, fresh and hot foods, pharmaceuticals, blood and organs, chemicals, biological products, electronic and mechanical devices, flowers, plants and bulbs, raw materials and liquids, animals, art and furniture.

For the purposes of this standard, the following definitions apply in addition to the terms and definitions given in EN 12830 and EN 13485:

• Verification is confirmation that specified requirements have been met through the provision of objective evidence. The objective evidence required for verification may be the result of an examination or other forms of determination, such as performing alternative calculations or reviewing documentation. The activities performed for verification are sometimes referred to as the qualification process.
• The measurement error is the value of the measured quantity minus the value of a reference quantity.
• A thermometer is any device for measuring and displaying temperature.
• A temperature sensor is a measuring device or element of a measuring chain that is directly affected by temperature.
• The recorder is the part of a measuring device that records an indication.

Verification is done for:

• All new thermometers and recorders
• In case of any change in the measurement chain
• In case of any issues or problems mentioned
• In case of repairs to the measuring system.

The frequency and type of checks vary depending on the requirements of the contracting parties, namely the recorder owner and customer, the manufacturer and user, as well as any mandatory regulations and operational impacts such as storage/transport, fresh/frozen, frequently changing temperatures, vibration, or usage. Data collected during recorder operation can be used as supporting evidence to assess or adjust the frequency period. Systematic verification is recommended after a period of non-use exceeding the user's agreed-upon period, or when an operational event or deterioration is noticed or suspected, or during an intervention such as the installation of a new sensor, except for calibrated digital sensors where permitted by the manufacturer. For accuracy classes below 0,5, particular attention should be paid to ensuring that standard equipment and uncertainty requirements are met when verifications are performed on-site. The verification should ensure traceability of the measurement made before the verifications and that the equipment is within specifications for the next period.

The method for verifying temperature measurements is by direct comparison of the device under test with a working standard thermometer. It must be ensured that the environmental conditions for the tests are compatible with the device being verified and the measuring devices used (e.g., disturbances caused by the source unit, inverters, high-voltage cables). The table titled "Maximum uncertainty of the working standard" provided in the standard provides the maximum calibration uncertainty for the verification measurement range.

The detailed procedure of the operating method must be prepared, specifying the operating sequence and in accordance with the verification procedures according to the EN ISO 10012 standard.

Preliminary procedures to be performed when necessary are as follows:

• Cleaning the thermometer or temperature recorder and sensors
• Verification of display or recorder (self-test) and connectors
• Possible replacement or charging of the battery
• Verification of electrical connections

Then the following operations are performed:

• Temperature stabilization of sensors (attention should be paid to response time, temperature lag, heat radiation)
• For recording devices, the clock or chart recording system must be verified to be functioning properly according to the manufacturer's specifications.

Verification should be conducted for the lowest and highest temperature of the range most frequently occurring among those specified by:

• Manufacturer's declaration of intended classification
• Statement of the use of recording devices or thermometers to confirm that each class is within the intended uses and to confirm that each class is within this range.

If the total range is greater than 10 K, an additional average temperature value must be added. For example, if the intended use is the storage or transport of fresh and deep-frozen perishable food, the class 0,5 will be between minus 25°C and plus 7°C, and for pharmaceutical products, the class 0,5 will be between plus 3°C and plus 25°C.

For temperature logging devices that do not have direct cloud storage access by laboratories, the validation process is initiated by verifying the local time and clock logging along with a specific temperature shock greater than 10 K to specify the starting point of the validation.

If verification is done in the field:

• An appropriate measurement method must be applied to comply with the following requirements:
  • Maximum thermal coupling between sensors
  • Maximum stability of the measured temperature
  • Sufficient time for the reading to stabilize (at least longer than the probe response time).

If suitable equipment that meets these requirements is recommended by the manufacturer, it may be used if available.

• If class 0,2 is recommended, the thermostatic bath specified in this standard should be used. If the thermostatic bath is not applicable, a climate chamber for class 0,5, 1, or 2 may be used. Validation should be limited to these classes only. This may include declassifying sensors if the installation presents practical limitations.

Our organization, which has been supporting businesses across all sectors for years through a wide range of testing, measurement, analysis, and evaluation activities, boasts a strong team of employees who closely follow global developments in science and technology and are constantly improving themselves. In this context, we also provide testing services in accordance with the EN 13486 standard for "Temperature recorders and thermometers for measuring ambient or internal temperatures for the transportation, storage, and distribution of temperature-sensitive goods - Periodic verification."