What is ISO 16604?
ISO 16604:2004 specifies a laboratory test method for determining the resistance of protective garment materials to blood-borne pathogen penetration. This test method employs a surrogate microorganism in a continuous liquid contact environment. The ISO 13994 test apparatus is used to determine whether protective clothing is "pass" or "fail" based on the detection of viral penetration at a certain hydrostatic pressure.
This test procedure isn't always reliable when it comes to evaluating protective gear with thick inner liners that absorb the challenge fluid quickly.
A sensitive assay approach is used in this diagnostic method. This test method may not be acceptable for use as a material or protective garment quality control or assurance procedure due to the length of time necessary to execute it.
Using a bacteriophage to simulate resistance penetration by blood-borne infections (i.e. "virus" penetration simulation) – ISO 16604
The "virus" test and categorization follow ISO 16603 guidelines, with the exception that the contamination is a bacteriophage (Phi-X-174) rather than synthetic blood. A bacteriophage is a virus that infects bacteria and replicates inside them. The bacteriophage (Phi-X-174) is used as a stand-in for viruses that are harmful to humans. It has a similar size and form like HCV, but it may also act as a surrogate for HBV and HIV. Experts must analyse inferences for protection from other infections on a case-by-case basis.