IAPMO IGC 317-2015 Open Colonic Irrigation Systems
: Brown Technical Book Store
: Single Detail Page Misc
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).