These devices are classified as Class I medical devices within the European Union and
have been approved to be sold as medical devices according to the European Union's
regulatory requirements listed below:
EN 60601-1: 1988 + A1: 1991 + A2: 1995 – Medical Electrical Equipment Part 1:
General Requirements for Safety
EN 60601-1-2:2007, inc. C:2010 – Medical Electrical Equipment Part 1-2: General
Requirements for Basic Safety and Essential Performance – Collateral Standard:
Electromagnetic Compatibility – Requirements and tests IEC 60601-1-2 (Modified)
EN 61000-4-2:2009 – Electromagnetic Compatibility – Part 4: Testing and
measurement techniques – Section 2: Electrostatic discharge immunity test
EN 61000-4-3:2006, inc. A2:2010 – Electromagnetic Compatibility – Part 4: Testing
and measurement techniques – Section 3: Radiated, radio-frequency,
electromagnetic field immunity test
EN 55011:2009, inc. A1:2010 – Limits and methods of measurement of radio
disturbance, characteristics of industrial, scientific and medical radio frequency
equipment
EN 300 440-2 V1.4.1 – Electromagnetic compatibility and Radio spectrum Matters
(ERM); Short range devices; Radio equipment to be used in the 1 GHz to 40 GHz
frequency range; Part 2: Harmonized EN covering the essential requirements of
article 3.2 of the R&TTE Directive (wGT3X+ device only)
EN 301 489-3 V1.4.1 – Electromagnetic compatibility and Radio spectrum Matters
(ERM); Electromagnetic Compatibility (EMC) standard for radio equipment; Part
3: Specific conditions for Short-Range Devices (SRD) operating on frequencies
between 9kHz and 40GHz
These devices comply with Industry Canada license-exempt RSS standard(s). Operation is
subject to the following two conditions: (1) this device may not cause interference, and
(2) this device must accept any interference, including interference that may cause
undesired operation of the device.
Le présent appareil est conforme aux CNR d'Industrie Canada applicables aux appareils
radio exempts de licence. L'exploitation est autorisée aux deux conditions suivantes : (1)
l'appareil ne doit pas produire de brouillage, et (2) l'utilisateur de l'appareil doit accepter
tout brouillage radioélectrique subi, même si le brouillage est susceptible d'en
compromettre le fonctionnement.
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