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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| IEC 60601-
2-47:2012: Medical electrical equipment - Basic safety and essential
performance of ambulatory electrocardiograph systems| IEC 57:2012:
Testing and reporting performance results of cardia rhythm and ST-
segment measurement algorithms
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