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CE-RICHTLINIEN | CE -DIRECTIVES | DIRECTIVES CE | DIRETTIVE CE | DIRECTRICES CE
Das Gerät ist funkentstört nach
EG-Richtlinie 87/308/EWG.
CE gemäß EG-Richtlinie
93/42/EWG, 2009/125/EWG,
87/308/EWG, 2006/95/EWG,
2004/108/EWG, 2002/95/EWG,
1907/2006/EWG und
2005/69/EWG.
Die Anforderungen der EG-Richtlinie
93/42/EWG für die Klasse II
medizinische Produkte wurden erfüllt.
Geräte-Einstufung: Klasse IIa
Angewandte Normen:
EN 55011:1998 +A1:1999 +A2:2002
EN 60601-1-:2002
EN 61000-3-2:2000 +A2:2005
EN 61000-3-3:1995 A1:2001
IEC 61000-4-2 Edition 1.2:2001-04
IEC 61000-4-3:2002 +A1:2002
IEC 61000-4-4:2002
IEC 61000-4-5 Edition 1.1:2001-04
IEC 61000-4-6 Edition 2.1:2004-11
IEC 61000-4-8 Edition 1.1:2001-03
IEC 61000-4-11
Second Edition:2004-03
09-2 03/2007 MDS-Hi
DIN EN ISO 9001
DIN EN ISO 13485
The unit is equipped with radio interfe-
rence suppression in accordance with
the EC Directive 87/308/EEC.
CE in accordance with EC Directive
93/42/EEC, 2009/125/EEC,
87/308/EEC, 2006/95/EEC,
2004/108/EEC, 2002/95/EEC,
1907/2006/EEC and
2005/69/EEC.
The requirements of the EC Directive
93/42/EEC for class II medical
products has been fulfilled.
Appliance classification: Class IIa
Standards applied:
EN 55011:1998 +A1:1999 +A2:2002
EN 60601-1-:2002
EN 61000-3-2:2000 +A2:2005
EN 61000-3-3:1995 A1:2001
IEC 61000-4-2 Edition 1.2:2001-04
IEC 61000-4-3:2002 +A1:2002
IEC 61000-4-4:2002
IEC 61000-4-5 Edition 1.1:2001-04
IEC 61000-4-6 Edition 2.1:2004-11
IEC 61000-4-8 Edition 1.1:2001-03
IEC 61000-4-11
Second Edition:2004-03
09-2 03/2007 MDS-Hi
DIN EN ISO 9001
DIN EN ISO 13485
Cet appareil est antiparasité con-
formément à la directive CE
87/308/EEC.
CE conformément à la directive CE
93/42/EEC, 2009/125/EEC,
87/308/EEC, 2006/95/EEC,
2004/108/EEC, 2002/95/EEC,
1907/2006/EEC et
2005/69/EEC.
Les spécifications de la directive CE
93/42/EEC pour la classe II Produits
médicaux ont été satisfaites.
Classement de l’appareil : Classe IIa
Normes appliquées :
EN 55011:1998 +A1:1999 +A2:2002
EN 60601-1-:2002
EN 61000-3-2:2000 +A2:2005
EN 61000-3-3:1995 A1:2001
IEC 61000-4-2 Edition 1.2:2001-04
IEC 61000-4-3:2002 +A1:2002
IEC 61000-4-4:2002
IEC 61000-4-5 Edition 1.1:2001-04
IEC 61000-4-6 Edition 2.1:2004-11
IEC 61000-4-8 Edition 1.1:2001-03
IEC 61000-4-11
Second Edition:2004-03
09-2 03/2007 MDS-Hi
DIN EN ISO 9001
DIN EN ISO 13485
L’apparecchio è schermato confor-
memente alla direttiva CE
87/308/EEC.
CE conformemente alla direttiva CE
93/42/EEC, 2009/125/EEC,
87/308/EEC, 2006/95/EEC,
2004/108/EEC, 2002/95/EWG,
1907/2006/EEC e 2005/69/EEC.
Sono stati soddisfatti i requisiti della
direttiva CE 93/42/EEC per la
classe II dispositivi medici.
Classificazione apparecchi: Classe IIa
Norme applicate:
EN 55011:1998 +A1:1999
+A2:2002
EN 60601-1-:2002
EN 61000-3-2:2000 +A2:2005
EN 61000-3-3:1995 A1:2001
IEC 61000-4-2 Edition 1.2:2001-04
IEC 61000-4-3:2002 +A1:2002
IEC 61000-4-4:2002
IEC 61000-4-5 Edition 1.1:2001-04
IEC 61000-4-6 Edition 2.1:2004-11
IEC 61000-4-8 Edition 1.1:2001-03
IEC 61000-4-11
Second Edition:2004-03
09-2 03/2007 MDS-Hi
DIN EN ISO 9001
DIN EN ISO 13485
El aparato es antiparásito según
la directiva CE 87/308/EEC.
CE según la directiva CE
93/42/EEC, 2009/125/EEC,
87/308/EEC, 2006/95/EEC,
2004/108/EEC, 2002/95/EEC,
1907/2006/EEC y 2005/69/EEC.
Este producto cumple las exigencias
de la directiva UE 93/42/EEC para
productos médicos de Clase II.
Clasificación del aparato: clase IIa
Normas aplicadas:
EN 55011:1998 +A1:1999 +A2:2002
EN 60601-1-:2002
EN 61000-3-2:2000 +A2:2005
EN 61000-3-3:1995 A1:2001
IEC 61000-4-2 Edition 1.2:2001-04
IEC 61000-4-3:2002 +A1:2002
IEC 61000-4-4:2002
IEC 61000-4-5 Edition 1.1:2001-04
IEC 61000-4-6 Edition 2.1:2004-11
IEC 61000-4-8 Edition 1.1:2001-03
IEC 61000-4-11
Second Edition:2004-03
09-2 03/2007 MDS-Hi
DIN EN ISO 9001
DIN EN ISO 13485
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