BIS ISI CERTIFICATION FOR CLINICAL THERMOMETERS PART 1-SOLID STEM TYPE IS 3055(PART 1)

Introduction

A thermometer is one instrument used to measure temperature. In several fields, including business, science, health, meteorology, and daily life, it is a vital tool. Animal and human body temperatures are measured using specialised thermometers known as clinical thermometers. 

They are essential to healthcare and are commonly found in residences, clinics, and hospitals. These thermometers come in a few different variants, one of which having a solid stem. Solid-stemmed clinical thermometers are vital for healthcare, public health, and sickness prevention. 

They give accurate temperature readings, diagnose illnesses, and provide patient care and monitoring. Solid-stemmed clinical thermometers are versatile, user-friendly, and enhance patient comfort and safety. These thermometers are essential to maintaining and improving overall health and wellness, whether at work or at home. 

All clinical thermometers with member 1-Solid stem types must now be a member of the ISI Certification Scheme in accordance with IS standard IS 3055 (Part-1): 1994.

This product cannot be sold, imported, or exported into the Indian consumer market without the ISI Mark.

What is ISI/BIS Certification?

In 1987, the Indian Standards Institute (ISI) changed its name to the Bureau of Indian Standards (BIS). The ISI Mark is the official mark that the Bureau of Indian Standards issues to producers of different kinds of goods. It has been used as a conformity marking for industrial items and to denote compliance with Indian standards (IS) established by the Bureau of Indian Standards (BIS). Through the product certification programme, manufacturers have been granted authorization by BIS to use the ISI Mark on products that meet applicable Indian standards.

The only manufacturers (local or international) who receive ISI Certification are those who create the final product. No product importers, traders, dealers, or distributors will get this.

Testing Carried Out For Clinical Thermometers

Here are the key tests conducted for ISI/BIS certification of clinical thermometers (solid stem type) as per IS 5482-1:

- Temperature Range - Measured at ice point and steam point to verify range of 35°C to 42°C.

- Accuracy - Tested at 4 points in range (35°C, 36°C, 38°C, 42°C) and must be within 0.1°C of the standard thermometer.

- Time of Reading - Time taken to reach final reading should be within 3 minutes. 

- Residual Heat Effect - Thermometer checked for residual heating by rapid cooling after heating, reading must not exceed specified limits.

- Thermal Aftereffect - Verified by heating to 42°C and cooling to 36°C, subsequent reheating, reading must be within limits.

- Effect of Immersion - Tested by immersing to different depths, reading must be within accuracy limits.

- External Pressure Effect - Reading is checked under compressed air at 150kPa, no visible damage should occur.

- Supply Voltage Variation - For electronic thermometers, measured at different voltages, accuracy must be maintained.

- Rigidity of Stem - Bending tests conducted to ensure integrity.

Along with testing, manufacturer's quality control process is evaluated through factory audits before granting certification.

BIS Documents For Domestic and Foreign Manufacturer Checklist

BIS ISI Mark Certification Costing And Timeline

Final Words

The manufacturer has to achieve BIS certification and should make its product matching the ISS standard which we directly quiz you from the BIS officials themselves as per the Indian Standards. It is compulsory for Clinical thermometers :Type1 Solid stem to get the ISI Mark and the offenders are punished with the material seize and a substantial amount as fine.

Getting certified makes your product to have a higher chance of staying alive and competing in the market. Customers are more likely to buy ISI certified products as it would ensure safety and standard quality. Thus, using the certified products you can make a buyer believe and trust your product.

From the very beginning of this process, EVTL India will be your friend, philosopher and guide in getting your product certified by the relevant authorities/ departments. The Indian quality specifications & BIS guidelines are familiar to us and we present the best interpretation to the Quality Control Personnel so we can better document your product under the BIS guidelines directly. Got ISI/BIS Certification now!

FAQs

Who needs to obtain ISI/BIS certification for thermometers?

Any manufacturer, exporter, or importer dealing with clinical thermometers intended for sale in India needs BIS certification. It is mandatory for solid stem thermometers sold in the country.

Does the certification have an expiry period?

Yes, ISI/BIS certification for clinical thermometers is valid for 2 years. Manufacturers need to promptly renew it to continue using the ISI mark after the expiry date.

Can I get certification for electronic clinical thermometers also?

Yes, BIS has a separate specification for electronic clinical thermometers which involves some additional tests like supply voltage variation. ISI mark can be obtained for both electronic and solid stem types.

What makes EVTL India the best option?

A valuable resource for obtaining ISI Mark Certification is EVTL India. Among the products we provide are:

• professional advice

• Simplify the procedure

• All-encompassing assistance

• Affordable options

• Time-saving