Declaration of Conformity
Product:
Vitalograph copd-6/Bedfont LungLife
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. This device, classified
as a as per Annex IX of MDD 93/4/EEC, meets the following provisions of
Annex II of the Medical Devices Directive as per Article , section 3a,
excluding point 4 of Annex II.
This device complies with the EMC Directive 89/336/EC, conformance
demonstrated by following standard EN60601-1-2:2001. Equipment
classification: Residential.
Canadian Medical Device Regulation {CMDR}
FDA Quality System Regulation {QSR} 21 CFR 820.
EN ISO 13485: 2003. Medical devices. Quality management systems. Requirements for regulatory
purposes.
Certifying Body {for 93/4/EEC and CMDR}: British Standards Institute {BSI}
Certificate Nos. CE 00772, MD 82 182, FM 83550
