System identification
80028681_002_C – 774259 – 2021-09-01
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Legislation and rules applicable to European Union (EU) countries:
1.3
Warranty
The complete warranty clauses are provided in the sales contract.
VIDEOMED S.r.l. assures system safety and functional reliability
provided that:
–
the system is used, managed and repaired solely as described
in these instructions for use;
–
installation, modification and repair are carried out exclusively
by VIDEOMED S.r.l. assistance services
–
only spare parts and accessories authorised by the
Manufacturer are used;
–
no structural changes are made to the devices.
The system status following system testing must be recorded in an
installation protocol. Commissioning is used as proof of the start
of the warranty period.
Further details may be provided in the commercial contract.
The conditions required by the commercial contract (should they
differ) take priority over what is stated in this section.
Standard
Description
Regulation (EU) 2017/745
The regulation on medical devices amending Directive 93/42/
EEC will enter into force on 26 May 2021
93/42/EEC
Medical Devices Directive (MDD) and f.m. 2007/47/EC
EN 1041:2008
Information supplied by the manufacturer of medical devices
EN ISO 13485:2016
Medical devices — Quality management systems
EN ISO 14971:2012
Application of risk management to medical devices
EN ISO 15223-1:2016
Symbols to be used with medical device labels, labelling and
information to be supplied — Part 1: General requirements
EN 60601-1:2006/A1:2013
General requirements for basic safety and essential performance
EN 60601-1-2:2015
General requirements for basic safety and essential performance
- Collateral standard: Electromagnetic compatibility
EN 60601-1-6:2010
General safety standards — Collateral standard: Usability
EN 62304:2006 + A1:2015
Medical Device Software — Software Life-cycle Processes
EN 62366-1:2015
Application of usability engineering to medical devices
WEEE 2012/19/EU
Waste electrical and electronic equipment
RoHS 2011/65/EU
Restriction of the use of certain hazardous substances in
electrical and electronic equipment
