ISI Certification (BIS) for
Clinical Thermometers :Part 2 Enclosed Scale Type IS 3055 PART 2 : 2004 in India

BIS CERTIFICATION OF CLINICAL THERMOMETERS :PART 2 ENCLOSED SCALE TYPE IS 3055 Part 2 : 2004

It is a long narrow glass tube with a bulb containing mercury at the end. The normal human body temperature is 37˚C, which can fluctuate between the ranges 35˚C to 42˚C. Hence, the clinical thermometers range from 35˚C to 42˚C.

Clinical thermometers are used in the following areas –

• It is developed for measuring the human body temperature.

Introduction to Indian Standard IS 3055 (Part 2); Clinical thermometers :Part 2 Enclosed scale type

• IS 3055 (Part 2) cover Clinical thermometers :Part 2 Enclosed scale typeThis standard (Part 2) specifies requirements and methods of sampling and tests for enclosed scale type, mercury-in-glass clinical thermometers having a maximum indicating device.
• IS 3055 (Part 2) specifies the quality parameters or characteristics of the Clinical thermometers :Part 2 Enclosed scale type as follows

Material

Glass Tubing

Bulb

Glass

Thermometric Liquid

Construction

Dimension

Graduation and Numbering

Appearance

Ageing and Accuracy

Influence of Immersion Time

For more info on the product standardization click here

Mandate for ISI Mark Certification of Clinical thermometers :Part 2 Enclosed scale type (IS 3055 (Part 2)) :

• Under section 14 of Bureau of Indian Standards Act, 1986 (63 of 1986), the Ministry of Consumer Affairs, Food and Public Distribution, Department for Consumer Affairs after consulting the Bureau of Indian Standards has issued Clinical Thermometers  (Quality control) order, 2001.
• As per this Quality control order, allthe manufacturers of Clinical thermometers :Part 2 Enclosed scale type are obligated to obtain ISI Mark Certification.

Types of Clinical Thermometer covered under IS 3055 (Part 2)

Procedure to obtain BIS Certification of Clinical thermometers :Part 2 Enclosed scale type to use ISI mark as per IS 3055 (Part 2)

For Indian Manufacturers (Standard Timeframe – 30 days) click here

For Foreign Manufacturers (Standard Timeframe – 180 days)click here

Requisites to get the BIS license for Clinical thermometers :Part 2 Enclosed scale type

Conformity of Raw Material as per IS 3055 (Part 2)

In-house testing laboratory for mandatory tests

Competent Quality Control Personnel

Adherence to the BIS guidelines for Clinical thermometers as per Indian standard IS 3055 (Part 2)

There are 3 major categories of document required to get the BIS license:

Administrative Details

Technical Details

Quality Control Personnel Details 

Commercial Details

Expenses involved in obtaining BIS certificate for Clinical thermometers :Part 2 Enclosed scale type as per IS 3055 (Part 2) under the Product Certification (Scheme-I) of BIS :

• In the certification process, product testing is the most important stage as it determines whether the quality of the product meets Indian standards.
• For the same purpose, investments in testing facilities are required to install test equipment for internal factory test laboratories.
• Apart from charges mentioned above in the table, we may ask you to pay/reimbursement for a Pre-Visit at your Factory Premises to ensure the conformity of your product as per the relevant Indian Standard & BIS guidelines for its BIS certification.

Role of ERCS Private Limited in getting your product certified :

• To get BIS certification and produce a standard quality product, the manufacturer must ensure that their product must follow the specified Indian Standard Specifications (ISS) which we directly interpret to you from the BIS officials as per the Indian Standards.
• ECRS Private Limited will be your friend, philosopher and guide in the whole process of getting your product certified by the concerned authorities/ departments.

• Scope of work by ECRS Private Limited:

Ensuring the conformity of your product as per IS 3055 (Part 2):

ERCS Pvt. Ltd. has developed a vast network within the Medical Equipment Industry & various BIS departments to assist for ensuring conformity of the product Clinical thermometers :Part 2 Enclosed scale type according to according to IS 3055 (Part 2).

Effective documentation with the awareness of the BIS guidelines:

In order to facilitate the manufacturing industry in obtaining BIS certifications, guidelines have been developed. Our team has the experience of completing over 150 projects and technically competent acquaintances in various Industries.

We are familiar with the Indian Standard Specifications & BIS guidelines and deliver the most suitable interpretation to the Quality Control Personnel so we can do a reliable and effective documentation of your product in accordance with the BIS guidelines.

A pre-visit can be paid at your factory premises:

In the process of getting BIS certification, the officer from BIS authority visits the factory for inspection. In order to get good results, the BIS inspection should go smoothly without any Non-Conformity. By keeping this goal in mind, our team will organize a pre-visit to your factory premises so that required changes can be adapted so as to remove the elements of fallibility.

Assistance for BIS audits:

We will explain the whole procedure of conducting a BIS inspection and make you aware of the things which need to be prepared and readily available at the time of inspection.

Benefits of getting ISI Mark for Clinical thermometers :Part 2 Enclosed scale type to sell in Indian Market with our help

• The term “ISI mark" means, that a certain product conforms to the quality standards set up by the government.
• It is compulsory for Clinical thermometers :Part 2 Enclosed scale type to obtain the ISI Mark and the violators are penalized with the material seize and a significant sum as fine.
• Getting certification improves the probability of your product to survive and compete in the market.
• Customers have the tendency of buying ISI certified products as it ensured safety and standard quality. Hence, with the certified products you can win the confidence and trust of the buyer.
• With the word of mouth of such client list, you can establish your credibility in the market.
• Hence with the renowned brand, you can raise the standard and benchmark the market value of the product.