Diagnostic Medical X-Ray Equipment IS 7620 PART 1

BIS CERTIFICATION OF DIAGNOSTIC MEDICAL X-RAY EQUIPMENT IS 7620 Part 1

Diagnostic X-ray, or radiography, is a special method for taking pictures of areas inside the body. A machine focuses a small amount of radiation on the area of the body to be examined. The X-rays pass through the body, creating an image on film or a computer display.

Diagnostic Medical X-Ray Equipment is used in the following areas –

• Healthcare providers and dentists both use x-rays for your care. A healthcare provider may recommend x-rays to look for bone fractures, some types of tumors, injuries or abnormal masses, and signs of pneumonia in the lungs. Dentists take x-rays to check for cavities or other dental problems.

Introduction to Indian Standard IS 7620 (Part 1); Diagnostic Medical X-Ray Equipment

• IS 7620 (Part 1) cover Diagnostic Medical X-Ray Equipment. This standard (Part 1) specifies the general and safety requirements for all types of diagnostic medical X-ray equipment (and parts thereof) up to and including a capacity of 500kV operated directly on a single-phase supply or through a phase convertor.
• IS 7620 (Part 1) specifies the quality parameters or characteristics of the Diagnostic Medical X-Ray Equipment as follows

General Requirements

Marking

Insulation Resistance

High Voltage Test

Leakage Current

Earth Resistance Test

Testing of over-current protective device for X-Ray control

Temperature rise test

For more info on the product standardization click here

Mandate for ISI Mark Certification of Diagnostic Medical X-Ray Equipment (IS 7620 (Part 1)) :

• Atomic Energy Board, Radiological Protection Division, Government of India has mandated to allthe manufacturers of Diagnostic Medical X-Ray Equipment to obtain ISI Mark Certification of Bureau of Indian Standards.

Types of Diagnostic Medical X-Ray Equipment covered under IS 7620 (Part 1)

Licence is granted to use Standard Mark as per IS 7620 (Part 1): 1986 with the following scope:

“Sationary/ Mobile Medical electrical equipment- Diagnostic X-ray machine ________type, ___________ frequency generator, for rated line voltage _____V, frequency ______Hz, ____ phase, current ______ A, Rated Peak Output Voltage _______kVp, output power _____ W” Other relevant aspects may also be mentioned in the scope.

Procedure to obtain BIS Certification of Diagnostic Medical X-Ray Equipment to use ISI mark as per IS 7620 (Part 1)

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 Diagnostic Medical X-Ray Equipment

Conformity of Raw Material as per IS 7620 (Part 1)

In-house testing laboratory for mandatory tests

Competent Quality Control Personnel

Adherence to the BIS guidelines for Diagnostic Medical X-Ray Equipment as per Indian standard IS 7620 (Part 1)

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 Diagnostic Medical X-Ray Equipment as per IS 7620 (Part 1) under the Product Certification (Scheme-I) of BIS :

 

For Indian Manufacturers
No.	Major Charges		Amount	Remark
1.	BIS Fee	Application Fees	INR 1000	To be paid in BIS A/c directly. 20% rebate on Marking Fee for MSME units.
		Audit Charges	INR 7000
		License Fee	INR 1000
		Marking Fee	INR 58,000
2.	Testing Charges	Sample Test Fee	As Applicable	To be paid into BIS approved Lab A/c
3.	ERCS Service Fee	Consultancy & others	As per actual, (Depending upon the product and the region of factory)

For the Foreign Manufacturers
No.	Major Charges	Particulars	Amount	Remark
1.	BIS Fee	Application Fees	USD 30	To be paid into BIS A/c directly in USD (SWIFT). SAARC countries can pay in INR with GST@18%
		Audit Charges (consolidated)	USD 3200 to USD 5900
		License Fee	USD 30
		Marking Fee	USD 710
2.	Testing Charges	Sample Test Fee	As applicable	To be paid into BIS approved Lab A/c
3.	ERCS Service Fee	Consultancy & other charges	As per actual, (Depending upon the product and the location of mfg.)

• 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 7620 (Part 1):

ERCS Pvt. Ltd. has developed a vast network within the Medical Equipment Industry & various BIS departments to assist for ensuring conformity of the product Diagnostic Medical X-Ray Equipment according to according to IS 7620 (Part 1).

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 Diagnostic Medical X-Ray Equipment 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 Diagnostic Medical X-Ray Equipment 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.