IAPMO IGC 317
Open Colonic Irrigation Systems
|Publication Date:||1 May 2015|
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).
The requirements of this Standard are not intended to prevent the use of alternative materials or methods of construction provided such alternatives meet the intent and requirements of this Standard.
In this Standard,
(a) "shall" is used to express a requirement, i.e., a provision that the user is obliged to satisfy to comply with the Standard;
(b) "should" is used to express a recommendation, but not a requirement;
(c) "may" is used to express an option or something permissible within the scope of the Standard; and
(d) "can" is used to express a possibility or a capability.
Notes accompanying sections of the Standard do not specify requirements or alternative requirements; their purpose is to separate explanatory or informative material from the text. Notes to tables and figures are considered part of the table or figure and can be written as requirements.
Units of Measurement
SI units are the primary units of record in global commerce. In this Standard, the inch/pound units are shown in parentheses. The values stated in each measurement system are equivalent in application, but each unit system is to be used independently. All references to gallons are to U.S. gallons.
Proposals for amendments to this Standard will be processed in accordance with the standardswriting procedures of IAPMO.
The user's attention is called to the possibility that compliance with this Standard might require use of an invention covered by patent rights. By publication of this Standard, no position is taken with respect to the validity of any such claim(s) or of any patent rights in connection therewith. If a patent holder has filed a statement of willingness to grant a license under these rights on reasonable and nondiscriminatory terms and conditions to applicants desiring to obtain such a license, then details can be obtained from IAPMO.