ISO 22610:2018 PDF

Overview

ISO 22610:2018 specifies a standardized test method and associated apparatus to determine the resistance of surgical drapes, gowns and clean air suits (medical devices) to the penetration of bacteria carried by a liquid when subjected to mechanical rubbing. The method uses microbiological techniques (donor material inoculated with a defined bacterial suspension, agar plates, incubation and colony counts) and is intended for laboratories experienced and equipped for microbiological testing.

Key topics and requirements

• Scope and intent: Measures wet bacterial penetration through protective textiles used for patients, clinical staff and equipment.
• Test principle: An inoculated polyurethane donor sheet is placed on the test specimen, covered by HDPE film and held by metal rings. An abrasion‑resistant “finger” rubs the assembly over an agar plate while liquid migration can carry bacteria through the specimen to the agar surface.
• Test protocol: The method includes a strict timeline (tests performed in consecutive 15‑minute intervals), repeated measurements (five consecutive tests with the same assembly) and colony counting after incubation. Results are expressed as a percentage of penetration relative to the initial bacterial load.
• Biological materials: Uses a defined bacterial test organism (document specifies a strain change from earlier edition) and requires a controlled bacterial inoculum and donor preparation.
• Equipment and controls: Detailed specification of test apparatus (donor, cover film, rings, abrasion finger, agar plates), reagents and environmental and bacterial challenge controls to ensure valid, repeatable results.
• Handling of antimicrobial materials: If test material contains antimicrobial agents, the standard requires inactivation or additional assessment of residual antibacterial activity and reporting of such treatments.
• Validity and precision: The 2018 revision tightened tolerances on equipment, specimen handling and procedure to improve repeatability and reproducibility compared with the 2006 edition.

Applications and users

• Medical device manufacturers (surgical gowns, drapes, clean air suits, sterile packaging) use ISO 22610:2018 to demonstrate product barrier performance and support regulatory compliance.
• Independent testing laboratories perform the wet bacterial penetration test as part of product development, quality control and conformity assessment.
• Regulatory bodies and procurement teams reference test data when assessing infection‑control claims.
• Healthcare organizations and infection‑prevention specialists use results to inform selection of protective textiles for invasive procedures.

Related standards

• ISO 11607‑1 (packaging for terminally sterilized medical devices)
• ISO/IEC 17025 (competence of testing laboratories)
• ISO 17665‑1 (sterilization of health care products - moist heat)

Keywords: ISO 22610:2018, surgical drapes, gowns, clean air suits, wet bacterial penetration, test method, donor, bacterial inoculum, Bacillus atrophaeus, agar plates, medical device testing.