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XRpad2 4336
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Standards and Regulations
The X-ray detector is designed to be compliant with the standards and/or regulations detailed in
. The manufacturer’s certifications to standards and regulations are valid only if the
original accessories (as listed in
) are used according to prescribed instructions. Product
certification and warranty are rendered void if any modification or alteration to the product is
made, or any instruction, warning, or caution is not followed.
Symbol
Description
Keep away from children.
Maximum Load.
UL Recognized component mark for US and Canada.
European Conformity markings for the product.
Table 4
Standards and Regulations
Standards and Regulations
Description
ANSI/AAMI Std ES60601-1:2005
Medical electrical equipment Part 1: General Requirements for
Basic Safety and Essential Performance
EN IEC 60601-1:2006/AC:2010
General Requirements for Basic Safety for Medical Electrical
Equipment
EN IEC 60601-1-2:2007
Medical Electrical Equipment, Part 1-2: General Requirements for
Safety and Essential Performance – Collateral Standard:
Electromagnetic Compatibility
CAN CSA C22.2 No 60601-1 08
Medical Electrical Equipment Part 1: General Requirements for
Basic Safety and Essential Performance
FCC Part 15 subpart B/E
Radio Frequency Exposure
ETSI EN 301 893 V.1.7.1 (2012)
Broadband Radio Access Networks (BRAN); 5 GHz high
performance RLAN
ETSI EN 301 489-1 V1.9.2 (2011)
Electromagnetic Compatibility and Radio spectrum Matters
(ERM); Electromagnetic Compatibility (EMC) standard for radio
equipment and services; Part 1: Common technical requirements
ETSI EN 301 489-17 V2.2.1 (2012)
Electromagnetic Compatibility and Radio spectrum Matters
(ERM); Electromagnetic Compatibility (EMC) standard for radio
equipment and services; Part 17: Specific conditions for 2.4 GHz
wideband transmission systems and 5 GHz high performance
RLAN equipment”
EN ISO 10993-5:2009
Biological evaluation of medical devices – Part 5: Tests for
in vitro cytotoxicity
Table 3
Symbols (Continued)
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