20
REF0315 March-2015
5 Appendix
5
5.3
EC Declaration of conformity
We:
United Care Products BV
Bremenweg 5
9723 TC Groningen
Nederland
Declare under their own responsibility that the:
‘OpeMax Lite’ hoist and associated tilting cradle
spreader bar
to which this declaration refers 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/ECC
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, 31 March 2014
Name and position : Jan Stevenson, director
Signature:
Содержание OpeMed OpeMax Lite
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