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11.3 Declaration of conformity
SANO Transportgeraete GmbH takes sole responsibility in declaring that
LIFTKAR stairclimbers comply with:
-
the essential requirements of the EU directive for medical products 93/42/EWG,
Appendix I
-
the guidelines 2014/35/EG relating to electromagnetic compatibility
-
the applicable basic safety and health requirements of the EU guidelines for
machines 2006/42/EG, appendix IIA
Any changes made to the product without our prior consent render this declaration
void.
Relevant standards:
ISO 7176-23
Requirements and test methods for attendant-operated
stair-climbing devices
DIN EN 12182
Technical aids for disabled persons - General
requirements and test methods
DIN EN ISO 14971
Risk analysis
DIN EN 1041
Information supplied by the manufacturer of medical
+ Attachment 1 devices
ISO 7176-28
Wheelchairs -- Part 28: Requirements and test methods
for stair-climbing devices
ÖNORM EN 12100
Plastics piping systems - Polyethylene (PE) valves -
Test method for resistance to bending between
supports
DIN EN ISO 13485
Medical devices - Quality management systems -
Requirements for regulatory purposes
DIN EN ISO 60601-1-11
Medical electrical equipment - Part 1-11: General
requirements
for
basic
safety
and
essential
performance
Collateral standard: Requirements for medical electrical
equipment and medical electrical systems used in the
home healthcare environment.
DIN EN 62366
Medical devices - Application of usability engineering to
medical devices
DIN EN 980
Medical devices - Symbols to be used with medical
device labels
Jochum Bierma (Ing.), Managing Director
