Declaration Of Conformity - DeVilbiss Healthcare VacuAide 7310 Serie Manual De Instrucciones

deCLArAtiOn

DEClARATIon of ConfoRmITy

Manufacturer: Sunrise Medical dba DeVilbiss Healthcare
Address: Respiratory Products Division
100 DeVilbiss Drive
Somerset, PA 15501-2125 USA
Product Designation:
Type/Model:
We herewith declare that the above-mentioned product complies with the requirements of EC Directive
93/42/EEC and the following:
Class:
Quality System Standards Applied:
Notified Body:
MDD:
Safety Standards Applied:
EMC Compliance to:
For Battery Operation Only:
Authorized Representative:
0044
DeVilbiss VacuAide Compact Suction Unit
7310 Series
IIa, Rule 2
ISO13485:2003
TUV NORD
Annex II Applied
UL 2601-1
EN 60601-1
CAN/CSA 22.2 No. 601.1-M90
ISO 10079-1:1999
IEC 801-2 through 5
CISPR 11/Level B
EN 60601-1-2
RTCA DO-160E
RTCA/DO-160E,
Section 21 Category M
Commercial aircraft, airborne equipment
Sunrise Medical Ltd.
Sunrise Business Park
High Street
Wollaston, West Midlands DY8 4PS
ENGLAND
44-138-444-6688
EN
11
A-7310