300-002547-00 rev7 vii
Standard Number Standard Title
ISO 11607-2:2006 Packaging for terminally sterilized medical devices – Part
2: Validation requirements for forming, sealing and
assembly processes
ISO 10993-5:2009
Biological evaluation of medical devices -- Part 5: Tests for
in vitro cytotoxicity (Biocompatibility)
ISO 10993-10:2010 Biological evaluation of medical devices -- Part 10: Tests
for irritation and skin sensitization (Biocompatibility)
ISO 10993-11:2006 Biological evaluation of medical devices – Part 11: Tests
for systemic toxicity (Biocompatibility)
ISO 8600-1:2015
Endoscopes -- Medical endoscopes and endotherapy
devices -- Part 1: General requirements
ISO 8600-3:1997 Optics and optical instruments -- Medical endoscopes and
endoscopic accessories -- Part 3: Determination of field of
view and direction of view of endoscopes with optics
ISO 8600-4:2014
Endoscopes -- Medical endoscopes and endotherapy
devices -- Part 4: Determination of maximum width of
insertion portion
BS EN 1041:2008 Information supplied by a manufacturer of medical devices
BS EN 556-1:2001 Sterilization of medical devices - Requirements for medical
devices to be designated ""STERILE"" – Part 1:
Requirements for terminally sterilized medical devices"
ANSI/AAMI/ISO 14937:2009 Sterilization of health care products -- General
requirements for characterization of a sterilizing agent and
the development, validation and routine control of a
sterilization process for medical devices
CSA 22.2 NO 60601-1:14 Medical Electrical Equipment, Part 1: General
requirements for basic safety and essential performance
FCC ID: 2AOXMMonarch
NOTE: 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
instruction 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 his own expense.
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