AGFA 5366/400, User Manual

Page: 38 / 148

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.
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
which case the user will be required to correct the interference at its own
expense.
If required, contact your local service organization.
38 | Drystar 5301 XL, Drystar 5302 XL | Introduction
3731D EN 20210601 1655