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Verfügbare Sprachen
Verfügbare Sprachen
Regulatory Information
Regulatory Information
Regulatory Information
The device complies with the following regulations:
MDR: (EU) 2017/745 Medical Device Regulation, Cass I following the Rule 5.
FDA Center for Devices & Radiological Health CDRH - Title 21 CFR 872.3661 (USA).
Medical Devices Regulations (Canada).
RoHS: Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic
Equipment, 2011/65/EU Annex II and its amendment Directive (EU) 2015/863
RED: Directive 2014/53/EU The Radio Equipment Directive
FCC: Part 15 of The Federal Communications Commission Rules
ISED: Innovation, Science and Economic Development Canada
Compliance with European and International Standards
EN / IEC 60601-1: Medical Electrical Equipment, Part 1: General Requirements for Basic Safety
and Essential Performance
ANSI/AAMI ES 60601-1: Medical Electrical Equipment - Part 1: General requirements for basic
safety and essential performance
CAN/CSA-C22.2 No. 60601-1: Medical Electrical Equipment - Part 1: General requirements for
basic safety and essential performance
EN / IEC 60601-1-2: Medical Electrical Equipment, Part 1-2: General requirements for basic
safety and essential performance – Collateral Standard: Electromagnetic disturbances –
Requirements and tests
EN / IEC 80601-2-60: Medical electrical equipment — Part 2-60: Particular requirements for
the basic safety and essential performance of dental equipment
EN / IEC 62471: Photobiological safety of lamps and lamp systems
EN / ISO 17664: Processing of health care products – Information to be provided by the
medical device manufacturer for the processing of medical devices
EN / ISO 17665-1: Sterilization of health care products — Moist heat — Part 1: Requirements
for the development, validation and routine control of a sterilization process for medical
devices
EN / IEC 60601-1-6: Medical Electrical Equipment, Part 1-6: General requirements for basic
safety and essential performance - Collateral Standard: Usability
EN / IEC 62366-1: Medical devices - Part 1: Application of usability engineering to medical
devices
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