By Benjamin L. Miller, Department Manager Aerobiology, B.S., RM (NRCM)
Nelson Laboratories recently added ISO 22610 to its suite of barrier tests for gowns and drapes – making Nelson Labs one of only a few in the U.S. that can perform the test outside of Europe. The standard is one manufacturers should use in order to receive a CE (Conformité Européenne) mark for gowns, drapes and clean air suits in the European Union (EU).
EN 13795 lays out the test methods, performance requirements and performance levels for use in the EU. EN 13795 ranks barrier performance by resistance to bacterial penetration per the ISO 22610 test, which uses a donor material that has been inoculated with Staphylococcus aureus bacteria that is forced through the material onto a petri dish. The resistance performance of the barrier is ranked according to the Barrier Index.
To meet FDA requirements, manufacturers follow the U.S. standards. There are a few standards that can be used, but ASTM F1671 – Resistance to viral penetration is widely recognized as the most stringent barrier test and those products that perform well are considered to offer the highest level of barrier protection.
Both geographical areas (U.S. and EU) require testing widely accepted by their regulatory agencies. If manufacturers plan to just market in the U.S. then they will want to utilize the appropriate ASTM test. Those who market to Europe should use the ISO 22610 method. Those who plan to market to both areas can now have both testing methodologies performed at Nelson Labs to help them receive approval in both locations and agencies.