BIS Certification for Clinical thermometers: Solid stem type– IS 3055 (Part 1)

Clinical thermometers, especially the solid stem type, are essential medical instruments used for precise body temperature measurement. The IS 3055 (Part 1) standard sets quality and safety guidelines for these thermometers, ensuring they are accurate, durable, and suitable for healthcare settings. BIS certification under this standard confirms that clinical thermometers meet rigorous quality benchmarks for medical use.

Introduction

Bureau of Indian Standards (BIS) certification under IS 3055 (Part 1) is mandatory for manufacturers of clinical thermometers to ensure compliance with national standards. The ISI mark on these thermometers signifies adherence to essential safety and quality requirements, ensuring reliable performance for users.

Why is BIS Certification Necessary for Clinical Thermometers?

Given the critical nature of medical diagnosis, clinical thermometers must meet strict safety and accuracy standards to ensure reliability. BIS certification confirms that thermometers comply with IS 3055 (Part 1) standards, offering users peace of mind regarding the thermometer’s quality and performance.

Overview of Indian Standard IS 3055 (Part 1)

IS 3055 (Part 1) outlines key safety and performance standards for solid stem clinical thermometers, focusing on accuracy, durability, and safety. The standard ensures that the thermometer provides precise body temperature readings, critical for medical diagnosis. It specifies clear, easily readable display markings for quick interpretation. The thermometers must be made from durable materials, resistant to damage, ensuring long-term reliability. Additionally, the standard emphasizes safety features to minimize risks, ensuring safe operation and reducing hazards during regular use.

Process for BIS Certification

To achieve BIS certification under IS 3055 (Part 1), manufacturers must complete the following steps:

  1. Application Submission: Manufacturers submit an application form with technical specifications and safety details of the product.
  2. Document Review: BIS reviews submitted documents to verify adherence to IS 3055 (Part 1).
  3. Factory Inspection: BIS conducts an on-site inspection to check the manufacturing process and ensure product quality.
  4. Sample Testing: Product samples undergo testing at BIS-approved laboratories to confirm compliance with safety and accuracy standards.
  5. Certification Grant: Upon successful testing and inspection, BIS certification is granted, authorizing the use of the ISI mark.

Documents Required for BIS Certification

The following documents are required for BIS certification for solid stem clinical thermometers:

  • Completed application form
  • Product specifications and technical data
  • Quality control and manufacturing documentation
  • Test reports from BIS-approved laboratories
  • Proof of business registration
  • Declaration of conformity to IS 3055 (Part 1) standards
BIS Documents For Domestic and Foreign Manufacturer Check

BIS ISI Mark Certification Costing And Timeline


To Know The Process in Detail, Please Visit:

Conclusion

BIS certification under IS 3055 (Part 1) for solid stem clinical thermometers ensures compliance with essential quality standards, providing safe, accurate, and reliable tools for medical temperature measurement. EVTL India offers expert consultancy to streamline the certification process for manufacturers, ensuring their clinical thermometers comply with IS 3055 (Part 1) standards for safe, effective use in healthcare settings.