AIM User Manual
07608
Issue A
Copyright Vitalograph 2011 DT_0006-8
18
D
ECLARATION OF
C
ONFORMITY
Product
:
Vitalograph Model 4500 AIM
Vitalograph hereby ensures and declares that the above product
associated with this user manual, is designed and manufactured in
accordance with the following QMS regulations and standards:
•
European
Medical
Devices
Directive
{MDD}
93/42/EEC, as amended.
This device is classified as 1 with a measuring function
per Annex IX of the MDD also meets the provisions of
the Essential Requirements, Annex I, via compliance
with Annex II of the Medical Devices Directive as per
Article 11, section 3a, excluding point 4 of Annex II.
•
Canadian Medical Device Regulation {CMDR SOR/98-282}
•
FDA Quality System Regulation {QSR} 21 CFR 820.
•
EN ISO 13485: 2003. Medical devices. Quality management
systems. Requirements for regulatory purposes.
Certifying Body: British Standards Institute {BSI}.
{For 93/42/EEC and CMDR}.
BSI Notified Body #: 0086
Certificate Nos. CE 00772, CE 85553, MD 82182, FM 83550
Signed on behalf of Vitalograph (Ireland) Ltd.
B. R. Garbe.
Group Managing Director
