Essential medical tools for determining body temperature are clinical thermometers. They offer useful data for evaluating medical problems, permitting prompt medical actions, and guaranteeing the security and comfort of patients.
Clinical thermometers, such as those with enclosed scale designs, are vital medical instruments for taking a patient's temperature precisely and consistently. The term "enclosed scale type" usually refers to the conventional mercury-in-glass thermometers that have been used extensively in households and medical environments.
Enclosed scale thermometers must be handled, calibrated, and disposed of properly to guarantee patient and healthcare provider safety and continuous accuracy.
Under IS standard IS 3055 (Part-2): 2004, all clinical thermometers of the Part 2-Enclosed scale type are now required to be part of the ISI Certification Scheme.
Without the ISI Mark, this product cannot be marketed, imported, or exported into the Indian consumer market.
Indian Standards Institute, or ISI was renamed the Bureau of Indian Standards (BIS) in 1987. The official mark that the Bureau of Indian Standards provides for manufacturers of various goods is the ISI Mark. It is used to indicate compliance with Indian standards (IS) set by the Bureau of Indian Standards (BIS) and has been used as a conformity marking for industrial products. Manufacturers received permission from BIS to use the ISI Mark on items that comply with relevant Indian requirements through the product certification program.
Only manufacturers (domestic or foreign) who produce the finished product will be awarded ISI Certification. This will not be given to any product importers, traders, dealers, or distributors.
The following documentation is required to get an ISI certification:
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There are two approaches for Indian manufacturers to become certified with the ISI Mark:
Regular Procedure
With the possible exception of cases deemed "All India first," which might take up to 180 days, the licensing procedure is expected to be finished in 120 days. This timeline starts on the day the application is received, assuming that at different points in time the documentation, unit assessment, and product conformance are all deemed acceptable.
Step 1: Manufacturing Unit Customization in Compliance with Applicable Indian Standards
Step 2: Submission of the Application Form
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Simplified Procedure
This is a much faster process than the standard procedure. After a factory inspection is deemed satisfactory and the initial evaluation establishes that the sample complies with the applicable Indian Standard(s), the license application process is expected to be finished in 30 days.
Step 1: Adapting the Manufacturing Unit to Comply with the Relevant Indian Standard
Step 2: Sample Testing
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The process of obtaining ISI Mark Certification for Foreign Manufacturers typically includes the following steps:
Step 1: Application
Step 2: Query Raised (If Any)
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Brand Liaison provides helpful support for achieving ISI Mark Certification. Among our offerings are:
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