BIS CERTIFICATION FOR SAFETY REQUIREMENTS FOR DIAGNOSTIC MEDICAL X-RAY EQUIPMENT: PART 1 IS 7620 (Part 1)

Published Date: January 22, 2025 4 min Read

BIS certification is essential for diagnostic medical X-ray equipment as per IS 7620 (Part 1): 1986. This standard establishes comprehensive safety requirements to ensure the safe design, construction, and performance of diagnostic X-ray equipment, which is critical for minimizing radiation risks to patients and healthcare professionals. Compliance with IS 7620 (Part 1): 1986 demonstrates a manufacturer's commitment to safety and reliability in medical imaging technology.

IS 7620 (Part 1): Safety Requirements for Diagnostic Medical X-ray Equipment

The IS 7620 (Part 1): 1986 standard specifies safety guidelines for diagnostic X-ray equipment used in medical imaging. It outlines requirements for radiation protection, electrical safety, mechanical stability, and operational reliability. The standard ensures that the equipment is designed to reduce radiation exposure, provide accurate diagnostic results, and operate safely in clinical environments. It also specifies performance evaluation methods to verify compliance with safety norms.

Benefits of BIS Certification for Diagnostic Medical X-ray Equipment

Mandatory BIS certification under IS 7620 (Part 1): 1986 ensures that X-ray equipment adheres to the highest safety standards, reducing potential risks associated with radiation exposure and electrical hazards. For healthcare providers, this certification guarantees safer diagnostic practices, enhancing patient trust and care quality. For manufacturers, BIS certification confirms adherence to Indian regulatory standards, improves market credibility, and ensures product acceptance across healthcare facilities. Certified equipment symbolizes a commitment to safety, precision, and compliance with national standards.

Key highlights

Product Name	Safety requirements for diagnostic medical X-ray equipment: Part 1
Applicable Indian Standard	IS 7620 (Part 1) : 1986
Applicable Certification Scheme	Product Certification Scheme (ISI Mark Scheme) Scheme 1 - Schedule 2
Compliance Requirement	Mandatory
Quality Control Order	Click here
Scope as per Standard	This standard (Part 1) specifies the general and safety requirements for all types of diagnostic medical X-ray equipment and their components. It covers equipment with a capacity of up to 500 mA and 150 kV, designed to operate directly on a single-phase power supply or through a phase converter.

Note

For Detailed Information about the Procedure for BIS ISI Certification, Visit :

Visit :

Procedure for Domestic Manufacturer
Procedure for Foreign Manufacturer

Timeline for BIS Certification

The estimated timeline for obtaining BIS certification under IS 7620 (Part 1): 1986 is as follows:

For Indian Manufacturers (Standard Timeframe – 30 days)
For Foreign Manufacturers (Standard Timeframe – 180 days)

Conclusion

BIS certification under IS 7620 (Part 1): 1986 is crucial for ensuring the safety and reliability of diagnostic medical X-ray equipment. By complying with this standard, manufacturers contribute to safer medical imaging practices and uphold stringent quality norms in healthcare technology.

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