Hospital Water Filter Performance Specification VHA Directive 1061.rev3_2024.docx

Hospital Water Filter Performance Specification VHA Directive 1061 / ASHRAE 188-2017 & ASHRAE 514-2023 Ultra-filters and Sub-Micron Filtration to filter Environmental Protection Agency (EPA) quality drinking water to remove microbiological contaminants. Filters retain bacteria, viruses and endotoxin. By providing ultrapure water for patient washing and drinking, the filters aid in infection control.

Must produce water that is suitable for wound cleansing Must produce water for cleaning of equipment used in medical procedures Must produce water suitable for washing of surgeon's hands.

Filters are not intended to provide water that can be used as a substitute for USP sterile water.

Minimum requirements:

• FDA 510k Class II Clearance (mandatory) *Published ASHRAE 514, 2023

• Ice machine / Drinking & Bottle Filling (in-line), Sink (in-line) / Shower (in-line) filter must have 5nm (.005) micron porosity or smaller

◦ 15kDa particulate retention

◦ 11-log reduction of Bacteria

◦ 8-log reduction of Viruses

◦ 5-log reduction of Endotoxins

◦ FDA Clearance for up to 180-days – (no exceptions) ◦ No known equivalent Terminal “POU” Point of Use, Sub-Micro Filtration Sink and Shower Filter must have a 100nm (.1) micron porosity or smaller

· 9-log reduction of Bacteria

· FDA Clearance for up to 90-days – (no exceptions)

· No known equivalent Minimum Operating conditions and Performance:

· Must be capable of supporting an opening pressure of between 75 - 100psi

· Must have the ability to perform from 3 to 6 months without replacement.

· Installations MUST meet Uniform and State plumbing codes related to healthcare hand washing sinks and accessibility “ADA”. (no exceptions)