GENDEX GXS-700 Benutzerhandbuch Seite 43

•
ISO 14971:2007, 2nd Edition 'Application of risk management to medical
devices'
•
ISO 13485:2003, 2nd Edition 'Quality management systems —
Requirements for regulatory purposes'
D. The following national technical standards and specifications are used to
demonstrate conformity:
•
ANSI/AAMI ES60601-1:2005, 3rd Edition 'General requirements for basic
safety and essential performance'
•
CAN/CSA-C22.2 No. 60601-1:2008, 3rd Edition 'General requirements for
basic safety and essential performance'
•
SWITZERLAND NATIONAL DIFFERENCES to SN EN 60601-1:2006
E. GENDEX Dental Systems declares that the products described herein meet all the
relevant requirements of the following EU Directives:
•
Medical Device Directive 93/42/EEC
•
Electromagnetic Compatibility Directive 2004/108/EC
F. Authorized signatory of manufacturer:
Charles Ravetto
Vice President of Product Development
English
Specifications and Standards
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