The Fedegari Autoklaven AG Quality System has been certified on 2005 in compliance with the requirements
of following standards:

 EN ISO 9001:2000   | Quality Management Systems-Requirements
 EN ISO 13485:2003 | Medical Devices-Quality Management Systems-Requirements for regulatory purposes

The Fedegari Autoklaven AG Quality System has been also approved according to the requirements on Attachment V
(CE Mark declaration - Quality guarance of production) of the European Medical Devis Directive.

In addition to the above mentioned certification, are also available the product quality certificates applicable to all the sterilizer models manufactured by Fedegari Autoklaven AG.

The certificates are available at the section "Products" of our site and they are mainly referring to the application of the European Directive PED 97/23/CE "Pressure Equipment Directive".

In the same domain of pressure vessels certification, can be available also other type of certification in compliance with
the Statutory regulation of extra EU countries.
For such cases, it is recommended to directly contact Fedegari Autoklaven AG for further information.

Telephone +41 (0)91 935 20 90  |  info@fedegariautoklaven.ch




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