ISO 22609:2004

Overview

ISO 22609:2004 specifies a laboratory test method for measuring the resistance of medical face masks to penetration by synthetic blood. The method simulates a high‑velocity splash (fixed volume, horizontally projected) such as might occur from a punctured blood vessel and reports pass/fail results based on visual detection of synthetic blood on the wearer side of the mask. ISO 22609 primarily evaluates material performance or specific material constructions used in medical face masks-not mask design, fit, filtration efficiency or breathability.

Key topics and technical requirements

• Test challenge: A fixed volume (2 ml) of synthetic blood is horizontally projected at the mask surface to mimic splatter from a puncture.
• Synthetic blood properties: Surface tension is adjusted to approx. (0.042 ± 0.002) N/m to represent blood wetting characteristics (Annex B covers preparation).
• Test velocities / pressures: Specimens are tested at stream velocities corresponding to human blood pressures of 10.6 kPa, 16.0 kPa and 21.3 kPa (80, 120 and 160 mm Hg).
• Apparatus: Requires a specimen‑holding fixture (convex platform, ~300 mm from canula tip), fluid reservoir, pneumatic‑controlled valve, valve controller and a small‑diameter cannula (parts list in Annex A).
• Acceptance criteria: Results are reported pass/fail; masks are rated at the highest pressure for which specimens meet an AQL of 4.0 (sampling per ISO 2859‑1).
• Reporting: Test procedure, apparatus calibration, specimen orientation, and visual inspection criteria are documented; alternative set‑ups (targeting plate) are permitted if operational characteristics are equivalent.
• Scope limits: ISO 22609 does not address airborne/aerosol exposure, filtration efficiency, pressure drop (breathability), mask design/fit, or aerosolized body fluid penetration.

Applications and users

ISO 22609 is used by:

• Medical face mask manufacturers for product development, material selection and quality control.
• Independent testing laboratories performing certification and comparative performance testing.
• Regulatory bodies and procurement teams assessing mask resistance to liquid splash in healthcare settings.
• R&D teams evaluating new barrier materials or material constructions for protective masks.

Practical uses include benchmarking material splash resistance, guiding material choices that balance liquid protection with breathability, and supporting claims about mask resistance to blood and body‑fluid splatter.

Related standards

• ISO 16603 / ISO 16604 (continuous and microbiological synthetic blood tests) - for extended exposure/hydrostatic tests.
• ISO 304 (surface tension measurement) and ISO 2859‑1 (sampling procedures) are normative references.
• ISO 22609 is based on ASTM F1862 and includes informative annexes for apparatus parts and synthetic blood preparation.

Note: Use ISO 22609 to assess liquid splash resistance of mask materials; combine with filtration and fit testing when evaluating overall protective performance.