BIS Certification for DIAGNOSTIC MEDICAL X-RAY EQUIPMENT IS 7620 PART 1

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 7620 PART 1 For Diagnostic Medical X-Ray Equipment.

Diagnostic medical X-ray equipment is designed to capture internal images by directing a small amount of radiation at specific body parts. This radiation passes through the body, creating an image on a film or computer monitor.

For Indian manufacturers and importers, obtaining BIS ISI Certification under IS 7620 Part-1 is mandatory. This certification from the Bureau of Indian Standards (BIS) ensures that the X-ray equipment meets required safety and quality standards before it can be sold in the Indian market.

The ISI Mark ensures consumer safety and product quality for diagnostic medical X-ray equipment. To achieve this, manufacturers must undergo rigorous testing and obtain BIS ISI Certification from the Bureau of Indian Standards (BIS).

General Standards for BIS ISI Certification of Diagnostic Medical X-Ray Equipment

The key requirements for BIS ISI Certification of Diagnostic Medical X-ray Equipment are:

Physical and Mechanical Requirements:

X-ray equipment must be designed to endure rough handling without becoming flammable due to issues like collapse, loosening, displacement of parts, or other defects.
The sheet metal enclosing the X-ray equipment must be sufficiently thick or reinforced to match or exceed the rigidity and strength of 0.6 mm flat steel sheets.
Electrical components of the equipment should be positioned or encapsulated to prevent accidental contact with uninsulated live metal parts.
Moveable equipment must be safeguarded to prevent accidental contact and protect operators.
When in use on tables or floors, the equipment must be stable to prevent tipping and ensure user safety.
Protective sleeving should be used only on insulated wires as an additional layer of insulation and must be properly secured.
Components such as cables, fuses, receptacles, plugs, light holders, circuit breakers, and motor-operated parts must comply with Indian Standards.
High-voltage equipment containing oil must not be stored in wooden enclosures.
All high-voltage equipment, including the X-ray tube, must be housed in a metallic enclosure with proper earthing, unless it is enclosed in insulating material.
Tools must be available for removing moisture-protective parts.
A device must be installed to disconnect the equipment from the mains on all poles.

Radiation Protection:

To protect patients and staff from ionizing radiation, X-ray equipment must comply with the radiation safety standards specified in IS: 7061.

Temperature Rise:

X-ray equipment materials should withstand temperature increases during typical operation and idling conditions (over 12 hours) without adverse effects. The temperature rise of components and materials must remain within specified limits to ensure optimal performance and safety.

Earthing Requirements:

All metal components of X-ray equipment must be properly earthed.
All parts of the earthing conductor and its terminations must be free from corrosion.
Connections between components and the earth conductor, as well as the earthing terminals or contacts, must ensure low resistance.

Tests

Required Tests for Diagnostic Medical X-Ray Equipment:

Marking
Insulation Resistance
High Voltage Test
Leakage Current
Earth Resistance Test
Temperature rise test
Over-Current Protective Device Testing for X-Ray Control

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