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Appendix 7 Declaration of conformity
WE:
MANUFACTURER:
Focal Meditech B.V.
ADDRESS:
Droogdokkeneiland 19
5026 SP Tilburg Netherlands
TEL:
+31 13 533 3103
FAX:
+31 13 533 5004
WEBSITE:
www.focalmeditech.nl
HEREBY DECLARE THAT THE DEVICE:
DEVICE (MODEL):
DESCRIPTION
872FOCSADWG**ABB817
Subassembly Dowing
872FOCSADWG**ABB819
Subassembly Table clamp
872FOCSADWG**ABB885
Subassembly Chair clamp
872FOCSAGWG**ABB122
Loadarm with arm swing right (Large)
872FOCSAGWG**ABB123
Loadarm with arm swing left (Large)
872FOCSAGWG**ABB212
Loadarm with arm swing left (X-Large)
872FOCSAGWG**ABB213
Loadarm with arm swing right (X-Large)
872FOCSAGWG**ABB144
Subassembly wrist support Right
872FOCSAGWG**ABB145
Subassembly wrist support (Left)
872FOCSAGWG**ABB140
Subassembly Elbow fitting Left (Large)
872FOCSAGWG**ABB141
Subassembly Elbow fitting Right (Large)
872FOCSAGWG**ABB214
Subassembly Elbow fitting Left (Small)
872FOCSAGWG**ABB215
Subassembly Elbow fitting Right (Small)
872FOCSAGWG**ABB130
Subassembly Armfitting size 1 Right
872FOCSAGWG**ABB131
Subassembly Armfitting size 1 Left
872FOCSAGWG**ABB132
Subassembly Armfitting size 2 Right
872FOCSAGWG**ABB159
Subassembly Armfitting size 2 Left
872FOCSAGWG**ABB133
Subassembly Armfitting size 3 Right
872FOCSAGWG**ABB134
Subassembly Armfitting size 3 Left
872FOCSAGWG**ABB135
Subassembly Armfitting size 4 Right
872FOCSAGWG**ABB136
Subassembly Armfitting size 4 Left
872FOCSAGWG**ABB631
Subassembly Armfitting size 5 Right
872FOCSAGWG**ABB630
Subassembly Armfitting size 5 Left
COMPLY WITH THE FOLLOWING STANDARDS:
NUMBER
TITLE
EN ISO 14971
Medical devices - Application of risk management to medical
ISO 10993-1
Biological evaluation of medical devices - evaluation and testing
EN12182
Assistive products for persons with disability - General requirements and test methods
IEC 60601-1
Medical electrical equipment : General requirements for basic safety and essential
performance
IEC 62079
Preparation of instructions
AND IF APPLICABLE, COMPLY WITH THE FOLLOWING DIRECTIVES:
NUMBER
TITLE
93/42/EEC
Medical Device Directive
89/336/EEC
Electromagnetic Compatibility Directive
73/23/EEC
Low Voltage Equipment Directive
93/68/EEC
CE Marking Directive
WITH LVFS 2001:6 TRANSPONDING THE EUROPEAN MEDICAL DEVICE DIRECTIVE 93/42/EEC.
SIGNED AT:
Tilburg, The Netherlands
P.C.M. Groenland
Directeur
DATE:
1-10-2014
SIGNATURE:
