Varex Imaging XRpad2 4343, Руководство пользователя

Страница: 25 / 74

www.vareximaging.com 7
XRpad2 4343
U
SER
M
ANUAL
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 Table 8 ) 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.
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 60601-1:2006/A1:2013 General Requirements for Basic Safety for Medical Electrical
Equipment
EN 60601-1-2:2015 Medical Electrical Equipment, Part 1-2: General Requirements for
Safety and Essential Performance – Collateral Standard:
Electromagnetic Compatibility
EN 60601
EN 60601-1-6:2010
IEC 6601-1-6:2010
EN 62366
EN 62366:2008
IEC 62366:2007
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
CAN CSA C22.2 No 60601-1 08
(Adopted IEC 60601-1:2005,
third edition, 2005-12) 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 V2.1.1 (2017) Broadband Radio Access Networks (BRAN); 5 GHz high
performance RLAN
DRAFT ETSI EN 301 489-1 V2.2.0
(2017-03) 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
DRAFT ETSI EN 301 489-17
V3.2.0 (2017-03) 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.
EN ISO 10993-5:2009 Biological evaluation of medical devices – Part 5: Tests for in vitro
cytotoxicity
EN ISO 10993-10-2010-2013 Biological evaluation of medical devices – Part 10: Tests for irritation
and skin sensitization
Version
01
2017-11-03