BIS Certification for Protective Devices Against Diagnostic Medical X-Radiation – IS/IEC 61331 (Part 3)

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.

What is IS/IEC 61331 (Part 3)?

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:

1. Protective Clothing: Includes Lead aprons, Thyroid collars, Gonad shields, Wraparound vests, and skirts.

Must provide radiation attenuation within specified limits across different kVp (kilovolt peak) energy ranges.

2. Protective Eyewear: Radiation-attenuating glasses used by radiologists and technicians. Must reduce eye lens exposure to ionizing radiation. Includes side shielding and optical clarity requirements

3. Patient Shields: Used to protect sensitive organs (e.g., gonads, breasts, thyroid) during exposure. Must offer defined levels of attenuation while ensuring comfort and ease of use.

4. Material Testing: All protective devices must undergo lead equivalence testing at multiple energy levels, durability assessment (e.g., after bending or repeated use), and visual and mechanical inspection for defects.

5. Labeling and Marking: Products certified under IS/IEC 61331 (Part 3) must carry the manufacturer’s name and address, lead equivalence value (e.g., 0.25 mmPb, 0.50 mmPb), date of manufacture, and batch number, ISI mark once certified.

Why BIS Certification is Critical

Medical-grade radiation protection equipment must adhere to high standards of safety and effectiveness. BIS certification ensures that products:

● Perform reliably under radiation exposure

● Protect users and patients as per defined international norms

● Meet regulatory and hospital procurement standards in India

● Carry the credibility of the ISI mark, boosting trust in healthcare settings

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.

BIS Certification Process for IS/IEC 61331 (Part 3)

To obtain BIS certification for protective X-ray shielding devices, manufacturers must follow these steps:

  1. Application Submission: Submit the completed application form with necessary documentation to BIS.
  2. Document Review: BIS evaluates the submitted documents to verify accuracy and completeness.
  3. Factory Inspection: BIS officials conduct on-site inspections to assess manufacturing processes and quality control systems.
  4. Sample Testing: Product samples are collected and tested at BIS-approved laboratories to verify compliance with Indian standards.
  5. Certification Grant: Upon successful inspection and testing, the BIS issues the certification, allowing the use of the ISI Mark. 

Documents Required for BIS Certification 

To apply for ISI Certification for Fire Doors and Assembly, manufacturers must provide the following documents:

● Completed application form

● Detailed manufacturing process information

● Quality control plans and test reports

● Factory layout and equipment details

● Product specifications and technical details

● Business registration proof

● Declaration of conformity to Indian standards

Additional documentation may be required based on product specifications and environmental regulations.

BIS ISI Mark Certification Costing And TimelineBIS ISI Mark Certification Costing And Timeline

To Know The Process in Detail, Please Visit:

Under BIS Registration Products ISI and CRS

Conclusion

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.