Regulatory Issues; Applied Standards; Declaration Of Conformity - vygon Plexygon Manuel De L'utilisateur

5. REGULATORY ISSUES

5.1

Applied standards

The following are the International regulations, European Union Directives and
International Technical Standards that were followed to design, build and test
Plexygon .
- Directive 93/42/EEC and following amendments (2007/47/EEC included)
- EN ISO 13485 Medical equipment - Quality system management
- EN ISO 15223-1 Symbols to be used with medical device labels, labelling
and information to be supplied
- EN ISO ISO 14971 - Medical devices - Application of risk management
- MED . D EV 2 . 1 2/1 Guidelines on a medical device vigilance system
- MED . D EV 2 . 7 /1 Guidelines on Clinical Evaluation
- IEC 60601-1:2005 + Ec1:2006; IEC 60601:2006 + EC:2010 Medical
electrical equipment – General safety standards
- IEC 60601-1-2 and EN 60601-1-2 Medical electrical equipment part 1:
general requirements for safety . Collateral standard: electromagnetic
compatibility - requirements and tests
- EN 60601-1-4 Medical electrical equipment part 1-4: general requirements
for collateral standard - Programmable electrical medical systems .
- EN 60601-2-10/A1 Medical electrical equipment part 2: particular
requirements for the safety of nerve
5.2

Declaration of conformity

VYGON ITALY S.R.L. declares that the device PLEXYGON complies with
93/42/EEC Directive and further ammendments included in 2007/47/EEC
concerning medical devices, according with the Essential Requirements of the
Annex I . Therefore the medical device PLEXYGON has the CE marking CE
0123 (see below) according with Annex XII of the 93/42/EEC Directive.
19
0123