54
D
ECLARATION OF
C
ONFORMITY
(To the requirements of 93/42 EEC 169, volume 36)
Product:
VITALOGRAPH COMPACT
Vitalograph hereby ensures and declares that the above
product associated with this user manual, bearing the CE
Mark, which is classified as 2a, meet the following
provisions of Annex II of the Medical Devices Directive as
per Article 11, section 3a, excluding point 4 of Annex II.
Vitalograph design and manufacture in accordance with the following
standards:
•
European Medical Devices Directive 93/42/EEC L169 Vol. 36
•
BS EN ISO 9001:1994 : Quality Systems - Model for Quality
Assurance in Design, Development, Production, Installation and
Servicing.
•
EN 46001:1996 : Specification for application of EN ISO 9001 to
the manufacture of medical devices.
Certifying Body: British Standards Institute - Certificate Nos. Q5460 &
CE 00772
FDA Quality System Regulation: 21 CFR Sections 820 & 803.
Signed on behalf of Vitalograph (Ireland) Ltd. / Vitalograph Ltd.
B. R. Garbe.
Group Managing Director.
