3 System description
3.10 Certification and standards
Dentsply Sirona
Operating Instructions Xios AE Sensor USB interface and sensors
26
67 29 433 D3780
D3780.201.01.01.02 09.2019
Operating conditions:
Temperature: 10 °C (50 °F) to 35 °C
(95°F)
Relative humidity: 20 % to 85 %
Air pressure: 700 to 1060 hPa
Operating altitude:
≤ 2000 m
3.10
Certification and standards
The Xios AE sensor and the AE Sensor USB Interface comply with the
following standards, among others. They comply with the requirements
of these regulations.
EMC / safety
● IEC 60601-1 (Standard for Safety Medical Electrical Equipment -
Part 1: General Requirements for Safety)
● IEC 60601-1-1 (Medical electrical equipment - Part 1-1: General
requirements for safety; 1. Collateral standard: Safety requirements
for medical electrical systems)
● IEC 60601-1-2 (Medical electrical equipment - Part 1: General
requirements for safety; 2. Collateral standard: Electromagnetic
compatibility - Requirements and tests)
Quality
● AAMI TIR12:2004 (Designing, testing and labeling reusable medical
devices for reprocessing in health care facilities: A guide for device
manufacturers)
● CAN/CSA C22.2 No.601.1-M90 (Medical Electrical Equipment -
Part 1: General Requirements for Safety)
0413
This product bears the CE mark in accordance with the provisions of the
Council Directive 93/42/EEC of June 14, 1993 concerning medical
devices.
Original language of the present document: English
