Important update regarding Indian Standard applicable to all existing license holders, new applicants, manufacturers, importers, and product sellers for Diagnostic X-ray Machines from the Atomic Energy Regulatory Board (AERB) and the Radiological Protection Division, Government of India.
As per the Atomic Energy Regulatory Board (AERB) and the Radiological Protection Division, Government of India, all manufacturers of diagnostic X-ray machines must comply with the following regulations to ensure safety and quality:
1. BIS Certification Requirement:
- Manufacturers
must obtain certification from the Bureau of Indian Standards (BIS) for their
diagnostic X-ray machines, demonstrating conformance with Indian Standard IS
7620 (Part 1). This standard covers electrical, mechanical, and
non-radiological safety aspects of X-ray units.
- Equipment without BIS certification will not receive type approval from the competent authority. Such equipment cannot be supplied to users or used for radiological examinations.
2. Quality Assurance Testing:
- After
installation at the user’s premises, manufacturers must provide a certificate
stating the results of a Quality Assurance (QA) test performed on the
diagnostic X-ray units.
- QA tests must also be conducted whenever the equipment is serviced or repaired to ensure ongoing compliance and safety.
3. Radiation Protection:
- Manufacturers are
required to protect 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.
Bureau of Indian Standards Manak Bhawan 9, B.S. Zafar Marg, New Delhi - 110002
Tel: +91-11-23231903
Email : med@bis.org.in
Implementation Dates : Implemented
At every stage of compliance, the knowledgeable consultants at EVTL INDIA are prepared to help, offering you the best services available in India. Obtain comprehensive details regarding the certification required for your product to join the Indian market and develop a strong customer base.