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Your Guide to
New EU 2016/425
Regulations

What You Need to Know

Beginning April 21, 2019, compliance with the new EU PPE Regulation (EU) 2016/425-EC will become mandatory for CE marking and sale in the EU. In response, the three PPE notified bodies accredited for CE marking of PPE for Class III Ionizing Radiation Products, SGS, BTTG and TuV-Sud, have collectively modified their use of un-harmonized sub-standards (IEC 61331:2014, Parts 1 and 3). This ensures improved protection testing (mm Pb/LEV) over a wider range of kV beam qualities in broad beam and required weight testing of the same samples, with improved garment labeling and manufacturer documentation.

The IEC 61331-3:2014 standard (Section 3.1) requires the declaration of area-weight, called “area density” or “Ws” value (kg/sq m), to be
clearly stated on the product label.
The Ws value corresponds to the area-weights of samples in the same lab lead-equivalency test. Field
auditors of notified bodies will become increasingly diligent in ensuring manufacturing weights meet these real Ws values.

How to Find Compliant Radiation Protection

For compliance with (EU) 2016/425 regulations, all radiation protection aprons must adhere to a specific set of guidelines and must be tested using the new IEC 61331-1:2014 *BBG (modified broad beam) test at 60/70/90/110 kV (and 150 kV for CT/eyewear). Previous IEC 61331-1:2014 *IBG (inverse broad beam) testing is no longer valid. Here’s how to find compliant radiation protection:

Ask the Manufacturer For:

  • Certification to (EU) 2016/425 regulations
  • PPE certificates (both Modules B or D & Modules C or C2)
  • Lab test reports confirming pass test results

Search Garment Labels For:

  • The CE mark
  • Statement confirming protection at required energy levels in accordance with IEC 61331-3:2014 (60-110 kV or 60-150 kV)
  • The area-weight in kg/sq m (this will vary for 0.25 mm, 0.35 mm and 0.5 mm lead equivalence)

Xenolite STRATA+ Bi-Layer Protection

COMPLIANT WITH IEC 61331:2014 and (EU) 2016/425 Regulations

Lite Tech offers compliant radiation protection apparel certified using the new (EU) 2016/425 BBG broad-beam test. Xenolite’s Lead-Free Strata+ (300 Series) and EVAL (900 Series) attenuation materials are fully compliant and offer lightweight and eco-friendly protection for
you and your team.

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