Reference To Standards - Withings BPM Connect Betriebsanleitung

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 : IRECTIVE 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:
ICHTLINIE 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: Electromagnetic compatibility and
Radio spectrum Matters (ERM); ElectroMagnetic Compatibility
(EMC) standard for radio equipment and services; Part 1: Common
technical requirements. | EN 301 489-17: Electromagnetic
compatibility and Radio spectrum Matters (ERM); ElectroMagnetic
Compatibility (EMC) standard for radio equipment and services;
Part 1: Common technical requirements | IEC/EN60601-1-2: Medical
electrical equipment: Part 1-2: General requirements for basic safety
and essential performance-collateral standard electromagnetic
compatibility | EN 55011: Industrial, scientific and medical equipment
– Radio-frequency disturbance characteristics – Limits and methods
of measurement. | FCC part B 15B: Electromagnetic Compatibility.
| FCC Rule Part: 15.247 Cat: DSS (Bluetooth) FCC Rule Part: 15.247
Cat: DTS (BT4.0). | EN ISO 10993-1: Biological evaluation of medical
devices -- Part 1: Evaluation and testing within a risk management
process. | EN ISO 10993-5: Biological evaluation of medical
devices -- Part 5: Tests for in vitro cytotoxicity | EN ISO 10993-
10: Biological evaluation of medical devices. Tests for irritation
and skin sensitization | IEC/EN 60601-1-6: Medical electrical
equipment - Part 1-6: General requirements for basic safety and
essential performance - Collateral standard: Usability | ANSI/AAMI/
ISO 81060-2 Non-invasive sphygmomanometers Part 2: Clinical
validation of automated measurement type | EN ISO 15223-1: Medical
devices – Symbols to be used with medical device labels, labelling
and information to be supplied – Part 1: General requirements
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