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IAPMO IGC 317-2015 Open Colonic Irrigation Systems

IAPMO IGC 317-2015 Open Colonic Irrigation Systems
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1.1 Scope

This Standard covers plumbing and electrical aspects of open colonic irrigation systems and specifies general requirements, materials, physical characteristics, performance test methods, and markings.
Note: As stated in CFR Title 21, Chapter I, Part 876, Section 876.5220, open or closed colonic irrigation systems are
(a) FDA Class II prescription-use medical devices when intended for colon cleansing when medically indicated (e.g., before radiological or endoscopic examinations); and
(b) FDA Class III when intended for other uses (e.g., colon cleansing routinely for general well-being).


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