Reference To Standards - Withings BPM Core Instruction Manual

Reference to standards

Verwijzing naar 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
NL Dit apparaat voldoet aan de volgende normatieve documenten
: RICHTLIJN 93/42/EEG van de RAAD van 14 juni 1993 betreffende
medische hulpmiddelen, zoals gewijzigd door Richtlijn 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
NL EN ISO 13485: Medische hulpmiddelen -
Kwaliteitsmanagementsystemen – Eisen voor reguleringsdoeleinden.
Verwijzing naar normen vervolg | EN ISO 14971: Medische hulpmiddelen
- Toepassing van risicomagement voor medische hulpmiddelen. | IEC/
54