India Revises Rules for Clinical Thermometers
The Ministry of Consumer Affairs has introduced an important amendment to the Legal Metrology (General) Rules, 2011, focusing on clinical electrical thermometers for continuous measurement. Key Highlights ▪️ New Standards Introduced A new Part D has been added under the Eighth Schedule, defining metrological and technical requirements for clinical electrical thermometers used in medical settings (e.g.,
The Ministry of Consumer Affairs has introduced an important amendment to the Legal Metrology (General) Rules, 2011, focusing on clinical electrical thermometers for continuous measurement.
Key Highlights
▪️ New Standards Introduced
A new Part D has been added under the Eighth Schedule, defining metrological and technical requirements for clinical electrical thermometers used in medical settings (e.g., ICUs, surgeries).
▪️ Scope & Application
Applies to thermometers used for continuous monitoring of human or animal body temperature, including battery- and mains-powered devices.
▪️ Accuracy & Performance
- Defined measuring range: minimum 35.5°C to 42.0°C
- Strict maximum permissible error limits introduced
- Requirements for stability, reliability, and environmental performance
▪️ Design & Safety Requirements
Covers detailed specifications for:
- Temperature probes & indicating units
- Alarm and self-checking features
- Resistance to environmental factors (temperature, humidity, electromagnetic interference)
▪️ Testing & Certification
Comprehensive testing procedures, pattern approval, and verification requirements have been prescribed to ensure compliance.
Effective Date
Comes into force from the date of publication in the Official Gazette.
For more information, you can refer to the official notification from here: LM (General) Second Amendment Rules, 2026.pdf
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