General
• The product has been designed in accordance with Regulation (EU)
2017/745 on medical devices (MDR).
• ISO 14971:2012
• IEC 60601-1-2 (ed. 4)
• The Quality Control test procedure for general radiography applications
complies with the grayscale reproduction constancy test, according to the
international standard IEC 1223-2-4.
• The Quality Control test procedure for the optional mammography
application complies with the NEMA Standards Publication XR 23-2006.
Related Links
Quality control for general radiography applications on page 88
Quality control for mammography application on page 99
Safety
• IEC 60601-1
• IEC 60601-1-6
• IEC 62366
• ANSI/AAMI ES60601-1:2005/(R2012)
• CAN/CSA C22.2 No60601-1:14
• GB4943
Electromagnetic Compatibility
• FCC Rules 47 CFR part 15 subpart B
• FCC Rules 47 CFR part 15 subpart C
• IEC 60601-1-2
• ETSI 300330
• ETSI 301489-1
• GB9254-1998 (Class A)
• GB17625.1-2003
EMC issues
• USA:
This equipment has been tested and found to comply with the limits for a
class A digital device, pursuant to part 15 of the FCC rules. These limits are
designed to provide reasonable protection against harmful interference
when the equipment is operated in a commercial environment. This
equipment generates, uses, and can radiate radio frequency energy and, if
not installed and used in accordance with the Reference manual, may
cause harmful interference to radio communications. Operation of this
equipment in a residential area is likely to cause harmful interference in
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| Drystar 5500, Drystar 5503 | Introduction
2901J EN 20191018 0826
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