With the widespread use of diagnostic X-ray imaging in medical practices, protecting healthcare professionals and patients from harmful radiation exposure is of critical importance. Devices such as lead aprons, thyroid collars, protective eyewear, and patient shields play a vital role in minimizing the effects of ionizing radiation during diagnostic procedures.
To ensure these radiation protection products meet stringent safety and performance standards, the Bureau of Indian Standards (BIS) has adopted IS/IEC 61331 (Part 3) — a harmonized Indian and international standard for protective devices against diagnostic medical X-radiation. Let’s explore what this standard entails, why BIS certification is essential, and how manufacturers can obtain it to ensure compliance and safety.
IS/IEC 61331 (Part 3) is the Indian adoption of the International Electrotechnical Commission (IEC) standard, titled Protective devices against diagnostic medical X-radiation — Part 3: Protective clothing, eyewear and protective patient shields.
This standard provides specifications for materials and construction of protective devices intended to reduce exposure to X-radiation during diagnostic procedures such as Fluoroscopy, Radiography, CT scans, and Interventional procedures.
The Indian Standard IS/IEC 61331 (Part 3) outlines comprehensive requirements and test methods for:
Must provide radiation attenuation within specified limits across different kVp (kilovolt peak) energy ranges.
Medical-grade radiation protection equipment must adhere to high standards of safety and effectiveness. BIS certification ensures that products:
With the implementation of quality control orders (QCOs) across medical device categories, obtaining BIS certification under IS/IEC 61331 (Part 3) is now becoming mandatory for manufacturers of Protective Devices Against Diagnostic Medical X-Radiation.
To obtain BIS certification for protective X-ray shielding devices, manufacturers must follow these steps:
Additionally, manufacturers may be required to provide proof of compliance with environmental and safety regulations, depending on the specific type of product being certified.
As diagnostic imaging continues to expand across India, ensuring high-quality radiation protection for healthcare workers and patients is essential. Adhering to IS/IEC 61331 (Part 3) and obtaining BIS certification for protective X-ray devices is no longer optional; it's a vital step toward compliance, safety, and professionalism in the healthcare ecosystem.
By securing the ISI mark for protective clothing, eyewear, and patient shields, manufacturers can offer not only compliance but also peace of mind to users across the medical industry. Need help with the BIS certification process for radiation protection gear? Our team can guide you through testing, documentation, audits, and licensing with expert precision.