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BOE-A-2026-2011 ·27 January 2026 ·Resolution Low impact
Tax

Instrumentación Analítica, SA: modification of type approval authorised for XOS brand X-ray equipment

The Directorate General for Energy Planning and Coordination has authorised the modification of the type approval (NHM-X313) to include the Sinde+Clora R-Series model from the brand XOS (X-Ray Optical Systems) (1st). These X-ray generator devices are intended for the analysis of chemical elements in petroleum products and aromatic compounds via fluorescence (2nd). The resolution is issued in accordance with Royal Decree 1217/2024 and Royal Decree 1029/2022 following a favourable report from the Nuclear Safety Council.

In 3 key points

  1. Equipment must bear indelible markings of the brand, model, serial number, the word "Radioactive", and maximum operating conditions (3rd). (3.ª)
  2. The radiation dose rate at any point outside 0.1 m from the surface must not exceed 1 μSv/h (4th, I, c). (4.ª)
  3. An administrative appeal (recurso de alzada) may be filed before the Secretary of State for Energy within one month (7th). (7.ª)

How it affects those involved

For the importer Instrumentación Analítica, SA, the resolution allows the inclusion of new models in its type approval, but conditions their use on strict compliance with indelible marking specifications and technical documentation (3rd and 4th). Users of this equipment must ensure that the radiation dose rate at 0.1 m from the surface does not exceed 1 μSv/h (4th, I, c). The resolution does not authorise manufacturing, marketing, or technical assistance, which require additional permissions (7th).

Lifecycle

2026-01-27PublishedPublished in the BOE
Official text Based on BOE data (boe.es). Information, not advice.

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This analysis is informational only and does not constitute legal advice or create a client-adviser relationship. BM Consulting.
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