General
• The product has been designed in accordance with the MEDDEV
Guidelines relating to the application of Medical Devices and have been
tested as part of the conformity assessment procedures required by
93/42/EEC Medical Device Directive (European Council Directive
93/42/EEC on Medical Devices).
• ISO 13485
• ISO 14971
Safety
• IEC 60601-1
• AAMI ES 60601-1
• CSA C 22.2 No.60601-1
Electromagnetic Compatibility
• IEC 60601-1-2
Radio Frequency
Declaration of conformity
U.S.A.
FCC Part 15.107(b) / Part 15.109(b)
FCC Part 15 Subpart E 15.407
FCC Part 15 Subpart C 15.247
European Un-
ion (and EEA)
ETSI EN 301 489-1 V2.1.1
ETSI EN 301 489-17 V3.1.1
EN 300 328 V2.1.1
EN 301 893 V2.1.1
South Korea
KN 301 489-1
KN 301 489-17
Brazil ANATEL This product contains the module WLE900VX
7AA000S-VW, ANATEL ID: 05379-20-05431
Related Links
Remarks for HF-emission and immunity on page 131
Topics:
XD 14, XD⁺14 | Introduction to the DR Detector | 33
0430A EN 20210426 1355
To Next Page
Loading...
