IS 7620 (Part 1)
Medical - Diagnostic Medical X-Ray Equipment
Summry
Diagnostic Medical X-Ray Equipment is a medical imaging device used to view internal body structures such as bones, lungs, and organs. It works by emitting controlled X-ray radiation to create images that help doctors diagnose fractures, infections, tumors, and other medical conditions accurately.
Why BIS Certificate is Mandatory for Diagnostic Medical X-Ray Equipment ?
BIS certification is mandatory to ensure patient and operator safety from harmful radiation exposure. It confirms that the equipment meets Indian safety, performance, and radiation control standards. Mandatory BIS certification prevents the use of unsafe or substandard X-ray machines in hospitals and diagnostic centers.
What is BIS Certified for Diagnostic Medical X-Ray Equipment ?
BIS certification for Diagnostic Medical X-Ray Equipment confirms compliance with Indian Standards related to electrical safety, radiation protection, mechanical strength, and performance accuracy. It is issued under the Compulsory Registration Scheme (CRS), ensuring the equipment is safe, reliable, and legally approved for use in India.
Test required for Diagnostic Medical X-Ray Equipment
| Title | Mandatory/Optional |
|---|---|
| General requirements | -- |
| Marking | -- |
| nsulation resistance | Required |
| High Voltage test | Required |
| Leakage current | Required |
| Earth resistance test | Required |
| Testing of over-current protective device for X-Ray control | Required |
| Temperature rise test | Required |
Benefits of BIS Certification for Diagnostic Medical X-Ray Equipment
1. Radiation Safety Assurance BIS-certified X-ray equipment follows strict radiation limits, reducing health risks to patients, technicians, and doctors during diagnostic procedures.
2. Compliance with Indian Regulations BIS certification is legally required in India. Certified equipment can be sold, imported, and installed without regulatory issues or penalties.
3. Reliable Diagnostic Accuracy BIS standards ensure consistent image quality and equipment performance, helping doctors make accurate diagnoses.
4. Enhanced Trust and Credibility Hospitals and diagnostic centers prefer BIS-certified machines as they reflect safety, quality, and regulatory compliance.
5. Market Acceptance and Long-Term Use BIS certification improves product acceptance in government hospitals, tenders, and private healthcare facilities while ensuring long-term operational reliability.