BIS ISI Certification For Medical X-ray Diagnostic Equipment

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BIS ISI Certification For Medical X-ray Diagnostic Equipment

Product Description

The main purpose of diagnostic medical X-ray equipment is to obtain images of inside body parts. It directs a little quantity of radiation at the specific bodily component that has to be examined. The X-ray travel through the body and produce an image on a thin film or computer monitor. 

BIS ISI Certification For Medical X-ray Diagnostic Equipment IS 7620 (Part 1)

The main purpose of diagnostic medical X-ray equipment is to obtain images of inside body parts. It directs a little quantity of radiation at the specific bodily component that has to be examined. The X-ray travel through the body and produce an image on a thin film or computer monitor. 

It is mandatory for all Indian manufacturers of diagnostic medical X-ray equipment to adhere to the product certification is required by BIS under IS 7620 Part-1. Only after receiving BIS ISI Certification for Diagnostic Medical X-ray equipment from the Bureau of Indian Standards BIS are all manufacturers and importers of this type of equipment eligible to sell their goods in the Indian market. 

The product's ISI Mark guarantees both the consumer's safety and the product's quality. Thus, following appropriate testing under BIS, makers of x-ray equipment are required to have the BIS ISI Certification for Diagnostic Medical X-ray Equipment.  

General Requirements for Diagnostic Medical X-Ray Equipment BIS ISI Certification

The general requirements for BIS ISI Certification of Diagnostic Medical X-ray Equipment are as follows:

Physical and mechanical requirements:

X-ray equipment must be built to withstand abuse without becoming flammable due to collapse, changes in looseness, spacing, or displacement of parts, or other defects.

Sheet metal used to surround x-ray equipment must be thick enough or reinforced to match or exceed the rigidity and strength of 0.6 mm flat steel sheets.

Position or encapsulate the equipment's electrical components to prevent accidental contact with uninsulated live-metal elements.

Moveable equipment must be protected from touch to protect the operator.

In usage, equipment is on tables or floors. It must be stable enough to avoid toppling over and endangering users or others.

Use protective sleaving only on insulated wires as an additional layer of insulation and fasten it properly.

The suitability and compliance with Indian Standards must be considered while selecting cables, fuses, receptacles, attachment plugs, light holders, circuit breakers, motor-operated components, etc. for X-ray equipment. 

Oil-containing high-voltage equipment cannot be stored in wood.

All high-voltage equipment, including the X-ray tube, must be placed in a metallic enclosure with earthing if not in an insulating material enclosure.

Tools are needed to remove moisture-protecting parts.

A device must disconnect the equipment from the mains on all poles.

Radiation Protection: 

In order to safeguard patients and staff from ionizing radiation, X-ray equipment must meet all applicable standards outlined in IS: 7061.

Temperature Rise: 

Under typical operating and idling conditions, materials used in the construction of X-ray equipment should not be adversely impacted by the temperature reached (12 hours). The rise in temperature of various components and materials must not beyond the specified limits. 

Earthing: 

Earth all metal components on X-ray apparatus.

All portions of the earthing conductor and termination must be corrosion-free.

Connecting components to the earth conductor and earthing conductor terminals/earthing contact requires low resistance.

Tests Carried Out 

The tests needed to get BIS ISI certification for diagnostic medical X-ray equipment may be roughly divided into the two groups listed below: 

Type Tests: The type tests (for safety standards) that follow should be included in this list:

  • Testing the x-ray control's recycling time;

  • Test for interlocks; Milliampere (mA) stabilisation test for the x-ray control;

  • Grid pattern test (for Potter Bucky and X-ray grids); 

  • Grid cleanup (for Potter Bucky and X-ray grids);

  • Test of stator voltage and current;

  • Test of installation;

  • test using a tube stand

  • Test for body section devices using magnification;

  • the body section devices' exposure angle and the position of the target plane test;

  • Examine on an x-ray table; 

  • Measure section thickness  

Regular Examinations: The following will make up the regular examinations:

visual assessment and inspection;

  • Check for interlocks;

  • x-ray table test;

  • Time trial for the x-ray con artist;

  • stator and current tests;

  • Test the installation.

BIS Documents For Domestic and Foreign Manufacturer Checklist

BIS ISI Registration for Normal Process

BIS ISI Mark Certification Costing And Timeline

BIS ISI Mark Certification Timeline and costing
Note: foreign applications will be submitted through an offline process only. we can only check the grant of CML no. on the BIS portal for foreign applications

In summary

The BIS ISI mark is mandatory for manufacturers in India and overseas to sell X-ray equipment in the Indian market. This certification also eases the import and export process. Through getting their medical X-ray equipment certified, manufacturers can enter the huge and growing Indian healthcare market. It promotes confidence among the healthcare professionals that the equipment is safe and reliable as well.

Getting BIS ISI certification is a long and complicated process. This is where EVTL India can help. With years of experience in testing and certification services, EVTL India will guide you through the entire ISI/BIS certification process quickly and efficiently. Their experts will ensure your diagnostic X-ray equipment meets all the required quality standards. Contact EVTL India now to get your BIS ISI certification and unlock the Indian market potential.

FAQS

1. How can EVTL India help with certification?

With years of experience in testing and certification, EVTL India can guide you through the entire BIS ISI certification process efficiently. Their experts will ensure your X-ray equipment passes all required tests.

2. Does BIS evaluate the manufacturing facility too?

Yes, BIS officers inspect the production processes, quality control procedures, testing methods, and documentation practices. Compliance with quality management standards is verified through rigorous audits.

3. What are the benefits of BIS ISI Certification for Diagnostic Medical X-ray Equipment?

Many benefits come with BIS ISI Certification:

  • Guarantees product safety, uniformity, dependability, and quality.

  • Ensures certified items operate better and last longer.

  • Provides a replacement guarantee for ISI-marked products that disappoint.

  • Less company losses and product rejections.

  • Shows the quality of approved products.

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