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Importance of Compliance with Quality Standards

Compliance with quality standards is crucial for diagnostic X-ray units to ensure patient safety, accurate diagnostics, and the protection of healthcare workers. High-quality standards prevent the malfunction of equipment, which can lead to incorrect diagnoses or excessive radiation exposure. Adherence to these Indian standards as per IS 7620 (Part 1) guarantees that the machines operate safely and effectively, thereby maintaining trust in medical diagnostics.

Regulatory Compliance Requirements

According to the Atomic Energy Regulatory Board (AERB) and the Radiological Protection Division, Government of India, manufacturers of diagnostic X-ray machines must meet several regulatory requirements:

1. BIS Certification: Manufacturers must obtain certification from the Bureau of Indian Standards (BIS) for their X-ray machines, confirming conformance with Indian Standard IS 7620 (Part 1). This standard covers the electrical, mechanical, and non-radiological safety of X-ray units. Machines without BIS certification will not receive type approval from the competent authority and cannot be supplied to users or used for radiological examinations.

2. Quality Assurance Testing: Manufacturers must provide a certificate stating the results of a Quality Assurance (QA) test conducted on the diagnostic units after installation at the user’s premises. These QA tests must also be performed whenever the equipment is serviced or repaired to ensure continuous compliance and safety.

3. Radiation Protection: Manufacturers are responsible for protecting their workers against radiation exposure during the manufacturing, installation, commissioning, servicing, and repair of diagnostic X-ray units. Radiation protection must be overseen by suitably qualified and trained personnel approved by the competent authority, in accordance with the Radiation Protection Rules, 1971.

BIS Documents For Domestic and Foreign Manufacturer Check

BIS ISI Mark Certification Costing And Timeline

To Know The Process in Detail, Please Visit:

• BIS ISI Mark Certification for Domestic Manufactures
• BIS ISI Mark Certification for Foreign Manufactures

Under BIS Registration Products ISI and CRS

• BIS CRS Registration For IT Products List
• BIS ISI Mark Certification For ISI Products List

How EVTL India Can Help

EVTL India, a leading regulatory compliance expert, provides comprehensive assistance to manufacturers of diagnostic X-ray machines in securing BIS certification. EVTL India offers expert advice on understanding and fulfilling the regulatory requirements set by the AERB and the Bureau of Indian Standards. The team at EVTL India helps manufacturers navigate the BIS certification process, ensuring all necessary documentation and testing procedures are completed accurately and efficiently. EVTL India assists in setting up robust QA testing protocols to ensure compliance with Indian Standard IS 7620 (Part 1) and maintaining high-quality standards throughout the lifecycle of the diagnostic X-ray machines.

By partnering with EVTL India, manufacturers can ensure their diagnostic X-ray machines meet all regulatory standards, enhancing safety, reliability, and marketability in the healthcare sector.

In conclusion, the compliance with quality standards and obtaining the necessary certifications are pivotal for the safety and effectiveness of diagnostic X-ray machines. EVTL India stands ready to assist manufacturers in navigating these regulatory landscapes, ensuring their products meet the highest standards of quality and safety.