20
REF0518-2
5 Appendix
5.5
CE Declaration of Conformity
We:
United Care Products BV
Bremenweg 5
9723 TC Groningen
Nederland
Declare entirely under your own responsibility that the:
‘Tilly basic’ Hoist
and corresponding
spreader bar
to which this declaration relates and which falls under class I of the European Medical Devices Directive, is in accordance
with the provisions of the following directive:
Directive 93/42 / EEC
and is in accordance with the following standards or other normative documents:
NEN-EN-ISO 14971
ISO 10535
NEN-EN-60601-1
NEN-EN-60601-1-2 (EMC)
NEN-EN-ISO 15223: 2012
NEN-EN 12182: 2012
On behalf of: United Care Products BV,
Place and Date : Groningen, 19 april 2018
Name and Position: Jan Stevenson, directeur
Signature: