Checklist for the Product Review of Health Care Plumbing Appliances
Definitions
Health Care Plumbing Appliance
A plumbing appliance, the function of which is unique to health care activities.” [Wis. Adm. Code Section SPS 381.01 (117)]
Be prepared to attach the following to the application in the form of a PDF
The following information must be provided with each health care plumbing appliance application:
A $250.00 (US) fee for each application submitted.
A copy of sales brochures, web content or other promotional materials that will be used in Wisconsin.
A written detailed description of appliance function(s).
Detailed assembly drawings or exploded view of the appliance which clearly shows the water flow paths within the appliance.
Detailed information on the size, color, location, information shown and methods for labeling the appliance. Actual labels are acceptable.
Complete installation instructions including detailed installation drawings indicating all connections between the appliance and plumbing system.
A list and copy of all national standards that are not referenced in Wis. Admin. Code Section SPS 381.20, to which the appliance conforms.
Detailed information on the method(s) of cross connection control that are either integral to or provided along with the appliance.
For wetted (i.e., potable water contacting) materials of construction, documentation shall be provided to show that the construction material is accepted for contact with potable water by an ANSI accredited listing agency acceptable to the Department. See ch. 384 appendix, A-384.11.
The trade name, scientific name and chemical formula of any chemical used in the appliance that may be added to or leached into the water as part of the process or because of the process. Acceptable documentation must be provided showing that the chemical(s) is accepted for use with potable water by an ANSI accredited listing agency acceptable to the Department. See ch. 384 appendix, A-384.11.
Disposal requirements of any wastewater, backwash water, filters, membranes, or other expendable system components.
An operation and maintenance manual or instructions.
A signed report, by an ANSI accredited third party testing laboratory acceptable to the Department (see ch. 384 appendix, A-384.11) or the manufacturer, which concludes that the appliance performs in accordance with the assertions submitted to the Department. The test report must be complete enough to verify an acceptable testing protocol was used and to identify the laboratory that performed the testing.
Additional Information
Confidential Information:
Information may be identified as confidential by a submitter. Such identification must be made at the time of submittal by permanently marking “confidential business information” on each page containing information deemed a trade secret under Wis. Stat. Section 134.90 (1) (c) which reads:
(c) “Trade secret" means information, including a formula, pattern, compilation, program, device, method, technique or process to which all of the following apply:
1. The information derives independent economic value, actual or potential, from not being generally known to, and not being readily ascertainable by proper means by, other persons who can obtain economic value from its disclosure or use.
2. The information is the subject of efforts to maintain its secrecy that are reasonable under the circumstances.
Links:
Plumbing Code (i.e. Wis. Admin. Code chs. SPS 381-387): https://docs.legis.wisconsin.gov/code/admin_code/sps/safety_and_buildings_and_environment/380_387
Plumbing Product Listing Service (Search under the “Plumbing Products” tab): https://esla.force.com/publiclookup
General Information:
If granted, the term of approval is five years and effective statewide. All submitters are notified six months prior to their expiration date via email notifications.
Approvals can be renewed for additional five-year terms; the renewal fee is $125.00. Approvals can be revised (modified) after being approved; however, the manufacturer must apply for a revision; the revision fee is $125.00. Revising a file does not extend the expiration date of the original approval.
If an approved plumbing product is modified or additional assertions of function or performance are made, the approval shall be considered null and void, unless the change is submitted to the Department for review and the approval is reaffirmed.