DD+DIS031.07E
Installation Planning
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Printed copies of this document are not controlled.
The reader should always refer to MedNet to ensure that they are working with the latest copy of the document.
Edition 1, Revision 1
DRYSTAR AXYS
Chapter 11 / 27
12-2007 5367/100
Agfa Company Confidential
10
Safety Standards and Regulations
The printer has been tested and found to comply with the following international
standards and regulations:
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Medical Devices Directive 93/42/EEC
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CFR Part 21
Safety standards:
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IEC 60601-1 + A1 + A2
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EN 60601-1 + A1 + A2
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UL
60601-1:2003
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CSA 22.2 No. 601.1-M90
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GB4943-2001
Radio-interference regulations (interference suppression):
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FCC Rules 47 CFR part 15 subpart B, class A
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FCC rules 47 CFT part 15 subpart C, class B
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IEC
60601-1-2
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CISPR 11, class A
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CISPR 22, class A
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IEC
61000-4-3
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IEC
61000-4-4
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IEC
61000-4-5
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IEC
61000-4-6
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IEC
61000-3-2
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IEC
61000-3-3
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IEC
61000-4-11
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ETSI
300330
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GB9254-1998 (Class A)
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GB17625.1-2003
The DRYSTAR AXYS carries the FCC ID: HPL5367, CE, TUV, cULus and CCC label.
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