Draft Rules for Clinical Electrical Thermometer for comments from stakeholders- India

 The Indian Government invited comments on the draft.

https://consumeraffairs.nic.in/sites/default/files/file-uploads/latestnews/Draft%20Rules%20for%20Clinical%20Electrical%20Thermometer%20with%20Maximum%20Device.pdf

This specification applies to battery-powered instruments which provide a digital indication of temperature. 

(4) Clinical electrical thermometers designed to measure skin temperature are not covered by this specification. 

(5) This specification does not exclude the use of any contract device based on other measurement principles that meets equivalent performance standards in determining maximum body temperature at specified time intervals. 

2. Terminology.- 

(1) A clinical electrical thermometer, as covered by this specification is a contact thermometer comprising a temperature probe and an indicating unit, and that is designed to measure human or animal body temperature. 

(2) A temperature probe is the component of a thermometer of which part is applied to a body cavity or tissue with which it establishes thermal equilibrium. It comprises a temperature sensor with associated parts including coverage, seals, inner leads, and connecting plug, where appropriate. 

Notes: 

1. A body or tissue may be the mouth (sublingual), rectum, or armpit. 2. The part of the probe in contact with a body cavity or tissue is called the ‘applied part’. 

3. An indicating unit is the component of a thermometer that process the output signal of the temperature sensor and displays the measured temperature.