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International Standards EO Sterilisation


International Standards

STEREtO manufacturing is in compliance with International Standards International Standards EO Sterilisation

(ISO, FDA, GOST Standards in Russia and SFDA in China). Full documentation and relevant certificates are provided.

  • EN 1422:1997 + A1:2009: Sterilizers for medical purposes. Ethylene oxide sterilizers. Requirements and test methods
  • ISO 11135-1:2007: Sterilization of health care products. Ethylene oxide Requirements for development, validation and routine control of a sterilization process for medical devices
  • Machines Directive: European Directive 2006/42/CE
  • Directives ATEX: European Directives 94/9/CE and 1999/92/CE
  • EN 60079-0:2010 (IEC 60079-0): Explosive atmospheres – Part 0: Equipment –
  • EN 60079-14:2008 (IEC 60079-14): Explosive atmospheres Partie 14 : Electrical installations design, selection and erection
  • 21 CFR Part 11: Electronic records and electronic signatures
  • PED: Pressure Equipment Directive.
  • CE Marking

International Standards EO Sterilisation

Conception, manufacturing for sterilization