Legal Compliance


At ZONOSISTEM, INGENIERÍA DEL OZONO SLU, all our ozone generators are designed, manufactured, and documented in accordance with the main European regulations that ensure their safety, quality, and effectiveness. These include:


  1. Machinery Regulation (CE) – We comply with Directive 2006/42/EC, ensuring that our equipment is designed to operate with maximum mechanical and functional safety.                                                                                                                                     

  2. Pressure Equipment Directiven (PED) – Our generators with pressurized components are certified under Directive 2014/68/EU, ensuring strength, reliability, and safety under demanding conditions.                                                                     

  3. Biocidal Products Regulation (BPR – EU Regulation 528/2012) – As manufacturers of ozone generators intended for biocidal uses (disinfection of air, surfaces, or water), we comply with the obligations established by European regulation.

We ensure:

📄 A complete dossier of the active substance “ozone” submitted to ECHA (European Chemicals Agency).

         Click here to download the certificate.


📄 A complete product dossier submitted to BAuA (German Federal Institute for Occupational Safety and Health).

         Click here to download the certificate.


This ensures that our equipment is authorized for the in situ generation of ozone as a biocide, complying with the transitional provisions of Article 95 of the BPR Regulation.
Thanks to this strict compliance, our generators are suitable for applications in sectors such as:

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