| Product | Diagnostic Medical X-Ray Equipment |
| Certification Body | Bureau of Indian Standards |
| Indian Standard | IS 7620 (Part 1): 1986 |
| Scope | This standard (Part 1) specifies the general and safety requirements for all types of diagnostic medical X-ray equipment (and parts thereof)
up to and including a capacity of 500 mA, 150 kV operated directly on a single-phase supply or through a phase converter. |
| Voluntary/Mandatory | Mandatory |
| Implementation date | 10th October 1994 |
| End-use application | Diagnostic medical X-ray equipment is used to image internal body structures to detect conditions like fractures and infections. It aids in accurate diagnosis and treatment planning, and it is essential in hospitals and diagnostic centres. |
| Gazette Notification released by | Department of Atomic Energy |
| Download Notification | Medical X-Ray QCO order.pdf |
The Department of Atomic Energy, Government of India, regularly issues Quality Control Orders (QCOs) under the aspect of Environment, Health & Safety (EHS) to regulate various types of goods imported into or manufactured locally within the country. The objective is to foster a safe and quality-centric environment nationwide.
In line with this objective, a recent QCO has been issued to regulate “Diagnostic Medical X-Ray Equipment “. This product falls under the mandatory BIS-ISI Mark certification scheme (Scheme-I of Schedule II), requiring manufacturers and importers to obtain a valid license by a specified deadline. Failure to comply will prohibit importing, manufacturing or selling these goods in the Indian market.
Certification plays a crucial role in ensuring that products meet specific quality and safety standards mandated by the government. Its implementation aims to safeguard consumers, promote standardization, uphold public health and safety, facilitate international trade, and stimulate economic development.
To achieve BIS certification, products must fully comply with all parameters outlined in the corresponding Indian Standard. This ensures that products meet stringent quality and safety requirements, bolstering consumer confidence and advancing industry standards.
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