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Standards and Regulations
8.0
Standards and Regulations
The X-ray detector is designed to be compliant with the standards and/or regulations detailed in
Table
3. 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 alteration to the product is made and any
instruction, warning, or caution is not followed.
Table 3
Standards and Regulations
Standards and Regulations
ANSI/AAMI ES60601-1
CAN CSA C22.2 No. 60601-1
EN 60601-1
IEC 60601-1
EN 60601-1-2
IEC 60601-1-2
EN 60601-1-6
IEC 60601-1-6
EN 62366
IEC 62366
FCC Part 15 subpart B/E
ETSI EN 301 893
DRAFT ETSI EN 301 489-1
DRAFT ETSI EN 301 489-17
EN ISO 10993-5
EN ISO 10993-10
EN ISO 4090
EN 60529
24
Table
10) are used according to prescribed instructions. Product
Medical electrical equipment Part 1: General Requirements for Basic
Safety and Essential Performance
Medical Electrical Equipment Part 1: General Requirements for Basic
Safety and Essential Performance
Medical electrical equipment - Part 1: General Requirements for Basic
Safety and Essential Performance
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 - Collateral Standard:
Usability
Medical devices - Application of usability engineering to medical
devices
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; Harmonized
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; Harmonize 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
Photography – Medical Radiographic Cassettes/Screens/Films and
Hard-Copy Imaging Films – Dimensions and Specifications
Degrees of Protection Provided by Enclosures (IP-code)
www.vareximaging.com
XRpad2 HWC-M Detectors User Manual
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