The Legal Metrology (General) Second Amendment Rules, 2026: Ensuring Accuracy in Clinical Electrical Thermometers

The Ministry of Consumer Affairs, Food, and Public Distribution, through its Department of Consumer Affairs, has introduced the Legal Metrology (General) Second Amendment Rules, 2026, which focus on the metrological and technical requirements for clinical electrical thermometers used for continuous measurement. This amendment, notified on February 11, 2026, under the Legal Metrology Act, 2009, aims to ensure accuracy, safety, and reliability in the measurement of human or animal body temperature during critical medical procedures.

Key Highlights of the Amendment

Scope of the Amendment

The amendment specifically addresses clinical electrical thermometers designed for continuous temperature measurement during surgical procedures or intensive care. These thermometers are used to monitor body temperature at appropriate sites, such as the rectum, esophagus, or surgically created cavities. However, thermometers designed to measure skin temperature are excluded from this specification.

Metrological and Technical Requirements 

The amendment outlines detailed specifications for clinical electrical thermometers, including their components, performance standards, and testing procedures. Below are the key requirements:

Measuring Range and Scale Interval:
- The measuring range must be a minimum of 35.5°C to 42.0°C, with the option to extend the range.
- Scale intervals must not exceed 0.2°C for analog scales and 0.1°C for digital scales.
Maximum Permissible Errors:
- For the temperature range of 32.0°C to 42.0°C:
  - Complete thermometer: ±0.2°C
  - Indicating unit: ±0.1°C
  - Interchangeable probe: ±0.1°C
- Outside this range, permissible errors are doubled.
Reference Conditions:
- Ambient temperature: 23°C ± 5°C
- Relative humidity: 50% ± 20%
- Operating voltage: ±10% of nominal mains voltage or specified battery voltage.
Temperature Probe Requirements:
- Must be disinfectable, interchangeable, or permanently connected to the indicating unit.
- Thermal stability and electrical insulation must meet stringent standards.
- The probe must withstand mechanical stresses and meet cleaning and disinfecting requirements.
Indicating Unit Specifications:
- Must provide clear temperature readings with a display height of at least 4 mm for digital devices.
- Should include a self-checking device and alarm system for faulty operations or abnormal temperature readings.
Complete Thermometer Standards:
- Must maintain accuracy under varying power supply conditions, ambient temperatures, thermal shocks, storage conditions, humidity, electromagnetic interference, and electrical discharges.

Practical Instructions for Manufacturers 

Manufacturers are required to provide detailed operating manuals and instructions, including:

Component lists and circuit diagrams.
Installation and operation procedures.
Cleaning and disinfecting guidelines.
Safety precautions for operators and patients.
Environmental conditions for use, storage, and transport.

Metrological Controls

The amendment mandates rigorous testing and evaluation for pattern approval and verification. Manufacturers must provide detailed information about the thermometer’s components, principles of operation, and test results. Tests include:

Energy dissipation.
Electrical insulation resistance.
Cleaning and disinfecting procedures.
Performance under varying environmental conditions, electromagnetic interference, and electrical discharges.

Marks, Labels, and Certification 

Manufacturers must affix marks and labels on the thermometer and its components, including the name and address of the manufacturer, model designation, serial numbers, and other relevant information. Single-use probes must be sealed in packages with clear instructions for use. Thermometers that meet all requirements will receive a certificate of approval.

Annexures: Detailed Testing Procedures 

The amendment includes two annexures that provide mandatory guidelines for testing and evaluating clinical electrical thermometers:

Annexure A: Establishes reference temperatures and methods for determining maximum permissible errors using a reference water bath and reference thermometer.
Annexure B: Describes performance tests for energy dissipation, electrical insulation, cleaning and disinfecting, low battery indication, ambient temperature, thermal shock, humidity, electromagnetic radiation interference, electrical interference, and electrostatic discharge.

Impact of the Amendment

The Legal Metrology (General) Second Amendment Rules, 2026, are a significant step toward ensuring the accuracy and reliability of clinical electrical thermometers. By setting stringent standards for metrological and technical requirements, the amendment aims to enhance patient safety during critical medical procedures. It also provides clear guidelines for manufacturers, ensuring that their products meet international standards and are safe for use in healthcare settings.

Conclusion

The introduction of these rules reflects the government’s commitment to improving healthcare standards and ensuring the safety of medical devices. By adhering to these regulations, manufacturers can contribute to better healthcare outcomes and build trust among healthcare providers and patients. As technology continues to evolve, such amendments are crucial to keeping pace with advancements and ensuring the highest standards of quality and safety in medical devices.

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Source: Ministry of Consumer Affairs, Food and Public Distribution, Department of Consumer Affairs, Govt. of India

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