BIS Certification of Clinical Thermometers IS 3055

Diagnostic instruments known as clinical thermometers serve essential roles across households, clinics, and hospitals for body temperature monitoring and fever detection. The importance of these devices in safeguarding patient safety and public health demands their accuracy and reliability. The Bureau of Indian Standards requires certification under IS 3055 to control clinical thermometer quality which details safety design and performance standards particularly for mercury-in-glass types. The Indian market allows only thermometers with BIS certification which ensures standardization and compliance for both locally manufactured and imported products.

In this blog, we are going to read about what is BIS Certification of Clinical Thermometers IS 3055 means, why BIS certification is mandatory, the step-by-step certification process, required documents, costs, and how ELT corporate can assist you in getting certified quickly and smoothly.

What Is BIS Certification 

BIS Certification is a quality management system operated by the Bureau of Indian Standards, which is the national standards body of India. The system guarantees that the product conforms to Indian Standards with regard to safety, quality, and performance.

Whether BIS certification is voluntary or mandatory is determined by whether the product falls under a Quality Control Order (QCO). BIS certification is compulsory for car rims based on government notifications.

Read More: Introduction To Bureau Of Indian Standards

What is IS 3055?

IS 3055 is the Indian Standerds Specification that governs the quality and design of clinical thermometers. It is divide into two parts:

• IS 3055 (Part 1): Mercury-in-glass thermometers – Scale down to 35°C
• IS 3055 (Part 2): Mercury-in-glass thermometers – Scale up to 42°C

However, with the growing environmental concern regarding mercury, digital thermometers are now wedely used, and BIS includes these under quality orders for broader regulatory control. 

Why is BIS Certification Mandatory for Clinical Thermometers?

Under the Compulsory Registration Scheme (CRS) or ISI Mark Scheme, BIS ensures that thermometers manufactured or imported into India meet minimum standards related to:

• Accuracy of temperature measurement
• Safe material composition
• Clear and legible temperature scales
• Resistance to breakage and leakage
• Compliance with health and hygiene requirements

The Ministry of Consumer Affairs has notified clinical thermometers as a mandatory product under the Quality Control Order (QCO). Hence, manufacturers (domestic or foreign) must obtain BIS certification before selling or distributing these products in the Indian market.

Documents Required for Documents Required for BIS Certification of Clinical Thermometers

To obtain Documents Required for BIS Certificate of Clinical Thermometers under IS 3055, applicants need to submit the following:

For Indian Manufacturers:

• Manufacturing License or MSME Certificate
• Factory Layout and Process Flow Chart
• In-house/outsourced lab test facilities details
• Test Reports as per IS 3055
• ISO 9001 Certificate (if applicable)
• Sample product and labeling details
• Packaging material and markings
• Authorized signatory ID proof

For Foreign Manufacturers (FMCS Route):

Business License of the company

• Nomination of Authorized Indian Representative (AIR)
• Product samples for testing in BIS-approved labs
• Technical specifications and product catalog
• Factory Inspection report
• Legal Agreement with BIS
• Labeling and user manual details

Read More: Documents Required For BIS Registration

Step-By-Step Process BIS Certification for Clinical Thermometers

Below we mentioned steps to obtain BIS Certificate for Clinical Thermometers:

For Indian Manufacturers (ISI Mark Scheme):

• Application Submission on BIS Portal
• Payment of Fees
• Product Testing in BIS Recognized Lab
• Inspection Visit by BIS Officer
• Compliance Check with IS 3055
• Grant of BIS License and Allotment of ISI Mark

 For Foreign Manufacturers (FMCS Scheme):

• Nominate Indian Representative (AIR)
• Apply Online at BIS Portal
• Submit Documents + Product Samples
• BIS Testing in India
• Factory Audit by BIS Officials (Overseas)
• Grant of License under FMCS

Read More: Process for getting BIS for Certification

Timeframe for BIS Certification of Clinical Thermometers

• Indian Manufacturers: Approx. 30–45 working days
• Foreign Manufacturers: Approx. 90–120 working days (due to overseas factory audit and logistics)

BIS Certification of Clinical Thermometers Cost

Labelling Requirements under IS 3055

Each certified thermometer must carry the following markings:

• ISI Mark with License Number (e.g., CM/L-xxxxxxxx)
• Manufacturer’s Name or Trademark
• Model Number/Type
• Range of Temperature (e.g., 35°C–42°C)
• “Made in India” or country of origin
• Mercury warning (if applicable)

How ELT Corporate Can Help

At ELT Corporate, we specialize in BIS Certification services for electronic products, including power banks. We offer:

• End-to-end application support
• Testing coordination with BIS labs
• Documentation & portal filing
• Post-certification compliance advisory

Conclusion 

The intricate healthcare environment demands precision cleanliness and regulatory follow making BIS Certification of Clinical Thermometers under IS 3055 essential as it represents both legal compliance and a standard of trust and excellence. Manufacturers and importers of clinical thermometers achieve essential safety, performance, and reliability standards for the Indian market through BIS certification.

The process of navigating BIS requirements presents significant challenges which become more intricate with shifting regulatory standards. That is the point where ELT Corporate becomes involved. Our comprehensive support system which includes documentation services combined with lab coordination and extends to audit preparation and post-approval guidance delivers a smooth certification process for your business without interruptions.