Blog

Radiological protection is a key element of safety in every X‑ray room, dental practice, or medical facility. As of 2025, new regulations and updated standards have come into force across the European Union, precisely defining the requirements for materials used to protect against radiation. Increasing emphasis is placed on compliance with the EN 12588 standard and on having quality certificates such as 3.1, which confirm the technical parameters and safety of the products. Thanks to this, both patients and staff can rely on effective and well‑documented protection.

Why is updating the standards so important?

Radiological protection in medical facilities, dental offices, and industrial plants requires the use of materials that meet strict quality requirements. Since 2025, updated standards and guidelines have been in force throughout the European Union, aimed at increasing the safety of both staff and patients exposed to ionizing radiation.

An increase in inspections, new certification procedures, and clearly defined material standards make the selection of appropriate protective materials (such as lead foil, X‑ray shielding screens, or lead glass) more important than ever before.

EN 12588 – what does this standard mean?

The EN 12588 standard applies to cold‑rolled lead used, among other areas, in construction and in the medical industry. In the context of radiological protection, it is crucial because it precisely defines:

• the requirements for the chemical composition of lead,
• dimensional tolerances (for example, the thickness of foil or sheet),
• rules regarding surface finish and overall material quality.

Why is this important?

Lead material used for X‑ray shielding must have a uniform density and be free of internal defects. Only then will it provide proper radiation attenuation. Products that meet EN 12588 allow you to comply with the requirements of radiological protection inspectors and avoid costly modifications to installations.

Certificate 3.1 – a document confirming material quality

Another requirement increasingly appearing in tenders and inquiries is the 3.1 certificate according to EN 10204.

This is an official document issued by the manufacturer or supplier, confirming:

• compliance of the material with a specific standard (e.g., EN 12588),
• results of laboratory tests,
• identification of the batch and production process.

With a 3.1 certificate, you can be sure that the purchased material meets EU requirements and that, in the event of an inspection, you will be able to present full technical documentation.

New EU regulations from 2025 – what has changed?

Since the beginning of 2025, the European Union has introduced a number of improvements and clarifications in the regulations concerning protection against ionizing radiation. These apply to both manufacturers and end users.

Key changes:

• Mandatory use of materials compliant with EN 12588 in every new investment that requires X‑ray protection.
• Technical documentation – every protective product must be sold with the appropriate certificate (e.g., 3.1) and CE marking.
• Greater emphasis on environmental protection – encouragement to use lead‑free materials wherever possible, along with recycling programs for used shields and X‑ray aprons.

Regular inspections in medical facilities and dental offices to verify whether the implemented solutions truly meet the standards.

How to prepare for these changes?

For clinic owners, designers, and equipment suppliers, this means carefully verifying the market offer before making a purchase.

Before ordering a material or shield:

• Make sure the manufacturer provides a 3.1 certificate.
• Check if the product complies with EN 12588.
• Pay attention to the supplier’s experience and customer reviews.
• Compare technical parameters with the requirements of your radiation protection inspector.

Coradika – trusted products with certificates

In our offer, you will find a wide range of X‑ray protective materials and accessories that fully comply with current EU standards. Every product is supplied with complete documentation, including a 3.1 certificate, so you can present it with confidence during any inspection.

Examples of products:

• self‑adhesive lead foil in ECONOMIC and PREMIUM versions,
• lead glass for windows and shielding screens,
• ready‑made X‑ray screens and doors with certification.

Thanks to this, you can be certain that your investment meets all technical and legal requirements, ensuring the safety of both your staff and your patients.

Summary

The new EU regulations in 2025 are a step toward even greater safety in radiological protection. Implementing materials compliant with EN 12588 and having a 3.1 certificate is not only a formal requirement but also a guarantee of quality and durability for the solutions you use.

Ensure compliance with the standards today!

Contact us to select materials perfectly matched to your project and receive complete technical documentation.