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ISO 22609:2004 Test method for measuring the resistance of medical face masks to penetration by a splash of synthetic blood
Medical practitioners and healthcare professionals who are involved in treating and caring for injured or sick individuals are often exposed to body fluids capable of disease transmission. Diseases caused by various microorganisms can pose a significant threat to their health. Therefore, healthcare professionals must wear medical face masks and other protective apparel to avoid the possibility of infections. However, these masks and protective clothing must be tested for their efficacy before they can be claimed as effective. ISO 22609 provides a standard test method for evaluating the resistance of medical masks to penetration by a splash of synthetic blood.
ISO 22609 Test Method
- Preconditioned test samples are fixed on the specimen-holding fixture.
- Synthetic blood is then sprayed horizontally onto the specimen mask to replicate the conditions of the mask being splashed by a punctured blood vessel.
- If the mask has pleats, spread them out during mounting to expose a single material layer, using the specimen’s center as the target area.
- Resistance of test samples is evaluated at three different velocities corresponding to human blood pressures, i.e., 10.6 kPa, 16.0 kPa, and 21.3 kPa.
- Test results show the efficacy of masks at each velocity.
- The highest blood pressure level at which medical face mask samples exhibit an acceptable quality limit of 4.0 determines the rating assigned to the mask.
- Any evidence of synthetic blood penetration on the side of the medical face mask contacting the wearer’s face constitutes failure. Results are reported as ‘pass/fail’.
Importance of ISO 22609 Test
In medical settings, healthcare providers and workers face an increased vulnerability to contracting infections due to their direct exposure to patient wounds and bodily fluids. This increases the risk of exposure to various infections in hospital environments. To address this, splash-resistant masks have been developed to serve as a pivotal line of defense by forming a barrier for healthcare workers against potentially infectious bodily fluids and other secretions. ISO 22609 plays an important role in substantiating the performance of medical face masks claiming to have splash-resistant barrier properties. It serves as a standard guideline that helps manufacturers meet registration criteria set by regulatory authorities.
Pros and Cons of ISO 22609 standard
Pros
- Standardization: Provides a standardized test method to measure the penetration resistance of medical face masks, thus ensuring consistent, accurate, and reliable test results.
- Protective Assurance: Assures that the medical face masks offer a reliable level of protection against blood and body fluid splashes.
- Regulatory Compliance: Assists manufacturers in meeting regulatory requirements and accelerates the approval process of medical face masks in various markets.
- Realistic Simulation: Tests the masks under conditions that resemble actual use by simulating high-velocity blood splashes that healthcare workers could encounter in real life.
- Quality Control: Improves quality control procedures by identifying defective or substandard masks that may not provide the required protective performance criteria.
- International Recognition: Being an ISO standard, it is widely recognized and accepted internationally and contributes to global standardization in the testing of medical face masks.
Cons
- Limited Scope: Primarily tests the resistance of masks to the penetration of synthetic blood. Other critical factors concerning mask performance are not measured or evaluated, including filtration efficiency, breathability, and overall fit.
- Specific to Liquid Penetration: Does not consider protection against airborne pathogens or aerosolized particles, which are two other significant routes of infection transmission in healthcare settings.
- Resource Intensive: Equipment, materials, and controlled environmental conditions are required for performing the test, thus setting up and maintaining such testing in a laboratory can be quite resource-intensive.
- Pass/Fail Criteria: Binary pass/fail results do not provide detailed information regarding the degree of protection or variation across performance with different masks.
- Preconditioning Requirements: The requirement to precondition specimens in high-humidity environments complicates the testing process and is time-consuming.
- Potential for False Security: By not accounting for degradation factors such as wear, laundering, and sterilization for reusable masks, it may give a false sense of security regarding long-term performance.
- Not Comprehensive: Does not include all types of exposure scenarios, such as long fluid contact times or high-pressure exposure conditions.
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FAQs
ISO 22609 is an international standard that specifies the test methods and requirements for the evaluation of surgical face masks against penetration by synthetic blood.
This test is applicable to medical masks claiming to have splash-resistant barrier properties.
This test takes 4-5 weeks to complete.
This test ensures that the tested face mask is capable of providing effective protection against penetration of body fluids such as blood, which might carry infectious agents, thus reducing the risk of disease transmission in medical settings.
This test confirms the effectiveness of medical face masks against high-velocity blood splash scenarios. Masks are subjected to synthetic blood under controlled conditions, and penetration on the side contacting a wearer’s face is indicated as a failure.
Some of the key performance criteria evaluated through this test include the resistance to penetration by synthetic blood at various pressures: 10.6, 16.0, and 21.3 kPa, which relate to human blood pressures. The masks are tested for preventing blood penetration under these conditions.
This test is conducted to protect healthcare workers from biological hazards by ensuring that the medical face masks used by them can withstand synthetic blood splashes. This simulates real-life scenarios where masks need to provide a barrier against blood and body fluids for possible infectious agents.
The importance of splash resistance in this test is due to its ability to simulate real-world conditions where medical professionals might get exposed to high-velocity splashes of blood during various surgical procedures. Thus, ensuring face masks are resistant to such splashes is crucial for protecting workers from infections.
This test contributes to regulatory compliance by providing a standardized method to evaluate the blood penetration resistance of medical face masks. Compliance is usually required by regulatory bodies to ensure the safety and effectiveness of medical protective equipment.
Materials typically tested include the various fabrics and layers used in the construction of medical face masks. This includes any different materials or thicknesses specified at different locations of the mask.
The frequency of testing is not defined in the standard. However, products should be tested when there is a change in the material, design, or process that may affect performance. Regular testing can also be carried out as a part of quality assurance procedures.
Common challenges include ensuring consistent synthetic blood application, controlled conditions, accurate penetration resistance measurement, and potential results influenced by apparatus setup and specimen preparation.
Limitations of this test include not considering all exposure scenarios and not evaluating other features like breathability, filtration efficiency, or mask fit and design.
The test evaluates reusable protective equipment by applying pre-treatment techniques like laundering and sterilization to simulate expected use conditions, ensuring the protective performance remains intact after repeated use.
The test differs from other standards by focusing on a fixed volume, high-velocity splash scenario with synthetic blood, whereas standards such as ISO 16603 and ISO 16604 involve continuous contact under hydrostatic pressure and microbiological challenges.
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