Reference To Standards - Withings BPM Connect Bedienungsanleitung

Reference to standards

Référence aux normes | Verweis auf Normen
This device complies with the following normative
documents: COUNCIL DIRECTIVE 93/42/EEC of 14
June 1993 concerning medical devices as amended
by Directive 2007/47/EC
FR Cet appareil est conforme aux normes suivantes :
DIRECTIVE 93/42/ CEE DU CONSEIL du 14 juin 1993
concernant les dispositifs médicaux, telle que modifiée
par la directive 2007/47/CE
DE Dieses Gerät entspricht folgenden normativen
Dokumenten: RICHTLINIE 93/42/EWG DES RATES
vom 14. Juni 1993 über Medizinprodukte, geändert
durch die Richtlinie 2007/47/EG
EN ISO 13485: Medical devices – Quality management
systems – Requirements for regulatory purposes.
Reference to standards contd. | EN ISO 14971:
Medical devices – Application of risk management
to medical devices. | IEC/EN 60601-1: Medical
electrical equipment - Part 1: General requirements
for basic safety and essential performance. | EN
1060-3: Non-invasive sphygmomanometers, Part 3:
Supplementary requirements for electromechanical
blood pressure measuring systems. | EN 1060-4: Non-
invasive sphygmomanometers. Test procedures to
determine the overall system accuracy of automated
non-invasive sphygmomanometers. | IEC/EN 60601-1-
11: General requirements for basic safety and essential
performance – Collateral Standard: Requirements for
medical electrical equipment and medical electrical
systems used in the home healthcare environment. |
IEC 80601-2-30: Medical electrical equipment - Part
2-30: Particular requirements for the basic safety and
essential performance of automated non-invasive
sphygmomanometers. | EN 300 328: Electromagnetic
compatibility and Radio spectrum Matters (ERM);
Wideband transmission systems; Data transmission
equipment operating in the 2,4 GHz ISM band and
using wide band modulation techniques; Harmonized
EN covering the essential requirements of article
3.2 of the Directive (2014/53/EU). | EN 301 489-1: