Standards And Regulations; Table 4 Standards And Regulations - Varex Imaging XRpad2 4343 User Manual

XRpad2 4343
9.0

Standards and Regulations

The X-ray detector is designed to be compliant with the standards and/or regulations detailed in
Table 4. The manufacturer's certifications to standards and regulations are valid only if the
original accessories (as listed in
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.
Table 4 Standards and Regulations
Standards and Regulations
ANSI/AAMI Std ES60601-1:2005 Medical electrical equipment Part 1: General Requirements for Basic
EN 60601-1:2006/A1:2013
EN 60601-1-2:2015
EN 60601
EN 60601-1-6:2010
IEC 6601-1-6:2010
EN 62366
EN 62366:2008
IEC 62366:2007
CAN CSA C22.2 No 60601-1 08
(Adopted IEC 60601-1:2005,
third edition, 2005-12)
FCC Part 15 subpart B/E
ETSI EN 301 893 V2.1.1 (2017)
DRAFT ETSI EN 301 489-1 V2.2.0
(2017-03)
DRAFT ETSI EN 301 489-17
V3.2.0 (2017-03)
EN ISO 10993-5:2009
EN ISO 10993-10-2010-2013
Table 8) are used according to prescribed instructions. Product
Safety and Essential Performance
General Requirements for Basic Safety for Medical Electrical
Equipment
Medical Electrical Equipment, Part 1-2: General Requirements for
Safety and Essential Performance – Collateral Standard:
Electromagnetic Compatibility
Medical electrical equipment - Part 1-6: General requirements for
basic safety and essential performance - Usability
Medical devices - Part 1: Application of usability engineering to
medical devices
Medical Electrical Equipment Part 1: General Requirements for Basic
Safety and Essential Performance
Radio Frequency Exposure
Broadband Radio Access Networks (BRAN); 5 GHz high
performance RLAN
Electromagnetic Compatibility (EMC) standard for radio equipment
and services; Part 1: Common technical requirements; Harmonised
Standard covering essential requirements Article 3.1(b) 2014/53/EU
and Article 6 2014/30/EU
Electromagnetic Compatibility (EMC) standard for radio equipment
and services; Part 17: Specific conditions for Broadband Data
Transmission Systems; Harmonise standard covering essential
requirements Article 3.1(b) 2014/53/EU.
Biological evaluation of medical devices – Part 5: Tests for in vitro
cytotoxicity
Biological evaluation of medical devices – Part 10: Tests for irritation
and skin sensitization
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