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Introduction

The Bureau of Indian Standards (BIS) certification under IS 3055 (Part 2) is mandatory for manufacturers of enclosed scale clinical thermometers to ensure they meet national quality standards. The ISI mark signifies compliance with essential safety and performance criteria, guaranteeing reliable use for healthcare professionals and patients.

Why is BIS Certification Necessary for Clinical Thermometers?

Accurate temperature measurement is crucial in medical diagnostics. The BIS certification verifies that clinical thermometers meet the standards of IS 3055 (Part 2), ensuring they are safe, accurate, and dependable. This certification enhances consumer trust in the thermometer’s reliability and safety.

Overview of Indian Standard IS 3055 (Part 2)

IS 3055 (Part 2) specifies essential requirements for enclosed scale clinical thermometers, focusing on accuracy, safety, and durability. The standard ensures that the thermometers provide precise temperature measurements, which are critical for effective medical assessment. It mandates a clear, easily interpretable enclosed scale to enhance the accuracy of readings. The thermometers must be made from durable materials to ensure long-lasting performance and reliability. Additionally, the standard includes safety provisions to minimize risks during use, ensuring the thermometers are safe and reliable for clinical applications.

Process for BIS Certification

The BIS certification process for enclosed scale clinical thermometers under IS 3055 (Part 2) includes the following steps:

1. Application Submission: The manufacturer submits an application form along with product specifications and technical details.
2. Document Review: BIS reviews the provided documentation to verify compliance with IS 3055 (Part 2).
3. Factory Inspection: BIS conducts an inspection of the manufacturing site to assess quality control processes.
4. Sample Testing: Product samples are tested in BIS-approved labs to check adherence to required safety and accuracy standards.
5. Certification Grant: Upon successful inspection and testing, BIS grants certification, allowing the ISI mark to be displayed on the thermometers.

Documents Required for BIS Certification

To apply for BIS certification for enclosed scale clinical thermometers, manufacturers must provide:

• Application form
• Technical specifications and product details
• Quality control process documentation
• Test reports from BIS-approved laboratories
• Business registration proof
• Declaration of conformity to IS 3055 (Part 2) standards

BIS Documents For Domenstic and Foreign Manufacturer Check

To Know The Process in Detail, Please Visit:

Conclusion

BIS certification for enclosed scale clinical thermometers under IS 3055 (Part 2) ensures strict adherence to quality and safety standards, making these thermometers dependable and safe for healthcare use. EVTL India offers expert consultancy to guide manufacturers through the BIS certification process, helping them achieve compliance with IS 3055 (Part 2) for a successful product launch in the medical market.