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