Overview
EN ISO 22610:2006 (ISO 22610:2006) specifies a microbiological test method to determine the resistance to wet bacterial penetration of barrier materials used in surgical drapes, gowns and clean air suits. Published by CEN/ISO in 2006, the standard defines the principle, apparatus, sample preparation and procedure for assessing how bacteria carried by a liquid can migrate through a material when subjected to mechanical rubbing. It is intended for use with other product standards (for example the EN 13795 series) and supports regulatory conformity for medical devices.
Key topics and requirements
- Scope and principle: Measures resistance of a 25 cm × 25 cm test specimen to bacteria-laden liquid under mechanical abrasion and contact with an inoculated donor material placed face down on the specimen.
- Microbiological test method: Uses agar plates, defined nutrient media and a specified test setup to capture any bacteria that penetrate the material; the method is intended for experienced microbiology laboratories.
- Apparatus and consumables: Includes details on the test rig (donor, carrier material, fingers/abrading elements), use of a thin HDPE film cover and holding rings to apply tensile force (see Annex A).
- Sample preparation and conditioning: Specimens and donor materials are prepared and conditioned according to referenced standards (e.g., ISO 139).
- Reporting and performance monitoring: Specifies required test report elements and internal controls, including use of reference materials and repeatability checks.
- Normative references: Cross-references quality, sterilization and textile testing standards (e.g., ISO 11607, ISO 13485, ISO 13934 series).
Applications and users
Who benefits from EN ISO 22610:2006:
- Medical device manufacturers of surgical drapes, gowns and clean air suits for product development, quality control and CE marking support.
- Microbiology and testing laboratories performing barrier performance testing to verify resistance to wet bacterial penetration.
- Regulatory and compliance teams using harmonized methods to demonstrate conformity with EU directives and national regulations.
- Procurement and infection-control professionals in hospitals who need objective performance data to select barrier materials that reduce the risk of device-related infections.
Practical uses:
- Comparing materials and constructions during R&D
- Batch verification and quality assurance
- Supporting claims about barrier performance in technical documentation
Related standards
- EN 13795 series (surgical drapes and gowns) - intended to be used alongside ISO 22610
- ISO 11607 (packaging for terminally sterilized devices)
- ISO 13485 (medical device quality management)
- ISO 139 (conditioning and testing atmospheres) and other textile test standards
Keywords: EN ISO 22610:2006, ISO 22610:2006, surgical drapes, gowns, clean air suits, wet bacterial penetration, barrier material, bacterial penetration test, medical device testing, CEN.
