SOLSTEO manufactures according to European standards and guarantees strict compliance with International ISO norms.

We have an in-depth expertise in ATEX related topics and compliance.

International Standards

SOLSTEO manufactures according to:

-EN 1422:1997 + A1:2009: Sterilizers for medical purposes. Ethylene oxide sterilizers. Requirements and test methods

-ISO 11135:2014: Sterilization of health care products. Ethylene oxideRequirements for development, validation and routine control of a sterilization process for medical devices

-Machines Directive: European Directive 2006/42/CE

-Directives ATEX: European Directives ATEX 2014/34/EU and 1999/92/CE

-ATEX standards (including but not limited to)

. EN 60079-0:2010 (IEC 60079-0): Explosive atmospheres - Part 0: Equipment - General requirements
. EN 60079-14:2008 (IEC 60079-14): Explosive atmospheres Partie 14 : Electrical installations design, selection and erection

-FDA 21 CFR Part 11: Electronic records and electronic signatures

Focus on ATEX

SOLSTEO has valuable experience and expertise in ATEX environments.

Our engineers in-depth knowledge guarantees strict compliance with ATEX requirements.

SOLSTEO EO sterilisers and gas treatment solutions (acid scrubbers or catalytic burners) are manufactured in compliance with the manufacturer’s Directive ATEX 94/9/EC.

Full documentation and relevant certificates are provided. SOLSTEO Customers have full access to ATEX training programs and benefit from SOLSTEO knowledge and guidance to integrate User’s Directive ATEX 1992/92/EC, right from the beginning of projects. At the end of installation & validation of equipment by SOLSTEO, an independent ATEX inspection can be organised. Such inspection is carried out by an INERIS-certified trainer. Whereas SOLSTEO certifies compliance with ATEX Directive 2014/34/EU, independent inspection evaluates compliance with ATEX Directive 1999/92/CE.

« Cristal-clear compliance! »

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