BIS Certification for Clinical thermometers Part 2-Enclosed scale type IS 3055 (Part-2): 2004

In today's competitive landscape, maintaining market presence without a certified, high-quality product can be challenging. Obtaining a BIS license may also be essential for selling products in the Indian market. To achieve BIS certification and ensure product quality, manufacturers must adhere to the specified Indian standards.

Let's delve deeper into at IS 3055 (Part-2): 2004 For Clinical thermometers.

Clinical thermometers are essential medical tools for accurately measuring body temperature. They provide critical data for diagnosing medical issues, enabling timely interventions and ensuring patient safety and comfort.

Clinical thermometers, including those with enclosed scale designs, are crucial for accurately and consistently measuring a patient’s temperature. The term "enclosed scale type" typically describes traditional mercury-in-glass thermometers, which have been widely used in both home and medical settings.

Proper use, calibration, and disposal of enclosed scale thermometers are essential to ensure the safety of both patients and healthcare providers while maintaining accurate readings. In this blog, we will explore the key requirements outlined in IS 3055 Part 2 for enclosed scale clinical thermometers.

Tests

Required Tests for Clinical Thermometer:

Material
Glass Tubing
Bulb
Glass
Thermometric Liquid
Construction
Dimension
Graduation and Numbering
Appearance
Ageing and Accuracy
Influence of Immersion Time

Under IS standard IS 3055 (Part-2):

Under IS standard IS 3055 (Part-2), established in 2004, all enclosed scale clinical thermometers must be included in the ISI Certification Scheme. These thermometers cannot be sold, imported, or exported in the Indian market without the ISI Mark. IS 3055 is divided into two parts: Part 1 addresses mercury-in-glass clinical thermometers, while Part 2 focuses on enclosed scale type clinical thermometers.

Part 2 of IS 3055 outlines the requirements and testing methods for enclosed scale clinical thermometers, which typically include mercury-in-glass and alcohol-in-glass thermometers with temperature markings within the glass tube. Adherence to this standard is essential for thermometer manufacturers in India to secure ISI certification and the ISI Mark.

PROCESS FOR BIS ISI MARK CERTIFICATION

BIS CERTIFICATION PROCESS

Acquiring a BIS license requires a comprehensive review of manufacturing infrastructure, quality control abilities, testing resources, and production procedures. This thorough assessment guarantees that products not only adhere to regulations but also prioritize consumer safety and reliability.

NOTE:

For comprehensive guidance on the BIS ISI Certification process, please explore:

WHY USE ABSOLUTE VERITAS?

Absolute Veritas is a prominent organisation from the private sector of India primarily dealing with the Inspection, Testing, Audits, Certification of products& consulting services to various industries in India and worldwide, ensuring compliance with regulatory standards and industry requirements. Offering a comprehensive range of services including product certification, testing, training, auditing, and compliance services, Absolute Veritas helps manufacturers and importers achieve higher production efficiency and quality standards.

Absolute Veritas (AV) will handle end to end pre-registration request, sample preparation, documentation, testing and application process for ISI Mark Certification

For any questions regarding the most recent update on ISI Mark registration licenses, please reach out to us via email at cs@absoluteveritas.com