Comparison of Domestic And International Production Standards for X-ray Protective Equipment

X-ray protective equipment is widely used in medical diagnosis, industrial flaw detection, scientific research, and other fields, and its quality is directly related to the health and safety of users. To ensure effective protection, different countries and regions have established strict production standards. However, due to different regulatory systems, testing methods, and industry backgrounds, there are certain differences in the formulation and implementation of standards at home and abroad. This article compares and analyzes the production standards of major domestic and international X-ray protective equipment to provide a reference for manufacturers, purchasers, and users.

Major Production Standards for Domestic X-ray Protective Equipment

In China, the production and testing of X-ray protective equipment generally comply with the following standards and regulations:

• "GB 18871-2002 Basic Standard for Ionizing Radiation Protection and Radiation Source Safety"

This is the foundational standard for radiation protection in China, specifying dose limits, control principles, and personal protection requirements for radiation workplaces.

• "GBZ 130-2013 X-ray Diagnostic Radiation Protection Requirements"

This standard sets specific technical specifications for medical diagnostic X-ray equipment and its protective facilities, including the lead equivalent, thickness, and shielding design requirements for protective materials.

• "YY/T 0605 Series Medical Diagnostic X-ray Protective Equipment"

This is a recommended industry standard covering the structural design, material properties, manufacturing processes, and testing methods for products such as lead vests, lead helmets, and lead screens.

Testing and Certification Requirements

Domestic protective products must undergo lead equivalent testing by provincial or national metrology and testing institutions. Some medical products also require a medical device registration certificate.

Major International Production Standards for X-ray Protective Equipment

Internationally, different regions have their own standards for X-ray protective equipment:

• IEC 61331 Series (International Electrotechnical Commission)

This is a widely used global testing standard for X-ray protective equipment. It includes lead equivalent measurement methods and labeling requirements for protective clothing, shielding panels, gloves, etc. Its test conditions, X-ray tube voltage range, and accuracy requirements are relatively strict.

• ASTM F2547 (American Society for Testing and Materials)

This is primarily used to evaluate the shielding performance and physical durability of medical radiation protective clothing, with additional testing for abrasion resistance and flexibility.

• EN 61331 (European Standard)

Developed with reference to IEC standards, it also adds provisions for product labeling, instructions for use, and recycling, emphasizing environmental protection and lifecycle management.

• FDA & CE Certification

In the United States, some X-ray protection products must comply with FDA medical device registration requirements; in the EU market, products must obtain CE certification and comply with the Medical Device Regulation (MDR).

Major Differences between Domestic and International Standards

Different Testing Methods and Parameters

IEC and EN standards provide more detailed requirements for testing conditions (such as tube voltage, focus-detector distance, and half-value layer measurement method), while domestic standards allow for some flexibility in some testing conditions.

Different Labeling and Instructions

International standards emphasize clear product labeling of lead equivalent, production batch, expiration date, and precautions, while domestic labeling requirements are relatively simplified.

Environmental Protection and Recycling Requirements

European standards focus more on the environmental performance and recycling of protective materials, requiring manufacturers to provide disposal instructions in their instructions; domestic standards currently have fewer relevant provisions.

Coverage of Applicable Fields

International standards often cover multiple fields, including medical, industrial, and scientific research. Domestic standards, however, focus on medical diagnostic protection, with more fragmented standards for industrial and scientific research applications.

Recommendations for Manufacturers and Buyers

• Export-oriented companies should prioritize IEC 61331 and EN 61331 standards for production, while meeting domestic standards, to facilitate access to European, American, and international markets.

• Domestic buyers should consider whether products have undergone authoritative testing and select appropriate lead equivalents and structural designs based on actual usage scenarios.

• In the R&D phase, it is recommended to incorporate environmentally friendly protective materials to meet future trends in green manufacturing, both domestically and internationally.

Conclusion

While domestic and international production standards for X-ray protective equipment share similarities, there are differences in testing details, environmental requirements, and information labeling. Understanding and comparing these standards can help manufacturers optimize product design and production processes, and assist buyers in selecting high-quality, safe, and reliable protective products worldwide. With international exchange and technological advancement, the convergence of standards will further promote quality improvement and market integration within the industry.