Medizintechnik EasyOne-CS 2001 Manual Del Usuario página 309

2030434-002 Rev. B
ndd Medizintechnik AG
Technoparkstrasse 1, CH-8005 Zürich, Schweiz
Tel +41 (44) 445 25 30, Fax +41 (44) 445 25 31, E-Mail info@ndd.ch
Manufacturer:
Address:
declares under its sole responsibility, that the product
Product designation: Spirometer
Product name:
EasyOne has been classified as Class IIa and is in conformity with the essential requirements and
provisions of Council Directive 93/42 EEC,
is in conformity with the following standards transposing harmonized standards:
EN 1041:1998
EN ISO 14971:2000 and A1 : 2003
EN 50103:1995
EN 60601-1: 1990 and A1 :1993 and A2 : 1995
EN 60601-1-1: 2001
EN 60601-1-2: 2001
EN 60601-1-4: 1996 and A1: 1999
is subject to the procedure set out in ISO 9001, ISO 13485, EN 46001 and in Annex 2 of Directive
93/42/EEC under the supervision of Notified Body Number 0120, SGS Yarsley International
Certification Services Ltd., 217-221 London Road, Camberley, Surrey, GU15 3EY.
Zurich, March 4 th , 2005
Declaration of Conformity
ndd Medizintechnik AG
Technoparkstrasse 1
CH-8005 Zurich, Switzerland
EasyOne-CS
Página 50