BIS QUALITY CONTROL ORDER (QCO) FOR Diagnostic X-ray Machines

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.

Adherence to these regulations is crucial for ensuring the safety of users and workers, as well as maintaining high standards in the production and operation of diagnostic X-ray machines in India.