The Legal Metrology (General) Rules, 2011 prescribe metrological and technical requirements for specified measuring instruments. The Eighth Schedule to the said Rules contains instrument-specific standards. The present amendment inserts additional provisions relating to clinical thermometers.

In the Legal Metrology (General) Rules, 2011, in the Eighth Schedule, in Part VI, under the heading “Clinical Thermometer”, after Part D, the following Part shall be inserted, namely:

“Part E

Part 1: Metrological and Technical Requirements

Clinical electrical thermometers for continuous measurement

This Part specifies the metrological and technical requirements for clinical electrical thermometers used for continuous measurement of human or animal body temperature.

The provisions include, inter alia:

• Measurement unit: Degree Celsius (°C)
• Measurement range: Minimum 35.5°C to 42.0°C
• Maximum permissible errors within 32.0°C to 42.0°C:
  • Complete thermometer: ±0.2°C
  • Indicating unit: ±0.1°C
  • Interchangeable probe: ±0.1°C
• Prescribed reference conditions (ambient temperature, humidity, supply conditions)
• Technical requirements relating to probes, indicating units, power supply, display, alarm, and self-check functions
• Performance tests including environmental, electrical, electromagnetic interference, and humidity tests
• Marking, labelling, approval, and verification requirements
• Annexure A: Establishment of reference temperature and determination of maximum permissible errors
• Annexure B: Description of instrument performance tests

These provisions shall apply to battery-operated and mains-operated clinical electrical thermometers intended for continuous temperature monitoring, excluding skin temperature measuring devices.