IAPMO IGC 317-2015 (R2020) Open Colonic Irrigation Systems

1 Scope
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).