Medical Surgical Face Masks: Technical Requirements and Testing Processes
Today, medical surgical masks play a vital role in preventing the spread of infections for both healthcare professionals and patients. These masks, used especially in hospitals, operating rooms, and other healthcare settings, must be manufactured according to specific standards and undergo various tests. The EN 14683 European Standard defines the manufacturing and performance requirements for surgical masks, detailing features such as bacterial filtration efficiency, breathability, splash resistance, and biocompatibility.
Classification and Usage Areas of Surgical Masks
Medical surgical masks are categorized into three main types based on their intended use and performance levels:
- Type I: Designed primarily for patients. It is used in low-risk environments and meets basic filtration requirements.
- Type II: Suitable for healthcare workers. It offers higher bacterial filtration efficiency and is preferred in intensive healthcare settings.
- Type IIR: Has the same features as Type II masks but also provides splash resistance. It offers extra protection against blood and other body fluids, enhancing safety during surgical procedures.
Type II and Type IIR masks, specifically designed for healthcare workers, help minimize infection risks, protecting both users and patients.
Tests Applied to Surgical Masks
Various tests are conducted to ensure the reliability and effectiveness of surgical masks. These tests, performed in accordance with the EN 14683 standard, are critical in guaranteeing the safe use of masks in the healthcare sector.
1. Bacterial Filtration Efficiency (BFE) Test
This test evaluates the mask’s ability to filter bacteria. It determines how effectively the mask can block bacteria-containing particles from the external environment. A high BFE rating indicates that the mask is more effective in reducing infection risks.
2. Differential Pressure (Breathability) Test
This test measures the breathability of the mask, assessing whether users can wear it comfortably. Masks that provide high protection should also allow for easy breathing. Therefore, they should not exhibit excessive resistance to airflow.
3. Splash Resistance (Synthetic Blood Penetration Test)
Mandatory for Type IIR masks, this test measures the mask's resistance to blood or other body fluids. During the test, synthetic blood is sprayed onto the mask at a specific pressure to check whether the fluid penetrates the inner surface. This is particularly vital for masks used in surgical operations.
4. Microbial Cleanliness (Bioburden) Test
This test is conducted to determine whether the mask has any microbial contamination during production and packaging. Even non-sterile medical masks must meet certain microbial load limits. The Bioburden test verifies whether the masks fall within the acceptable limits for safe usage.
5. Biocompatibility Tests
These tests check whether the mask causes any irritation or allergic reactions when in contact with the skin. For masks designed for long-term use, it is essential to use skin-friendly materials.
FFP Masks and Protection Levels
In addition to surgical masks, FFP (Filtering Facepiece Particulate) masks are widely used in various industrial and healthcare sectors. FFP masks provide respiratory protection against dust, smoke, and aerosols. According to the European Union’s EN 149:2001 + A1:2009 standard, they are classified into three categories:
- FFP1: Provides low-level protection against particulates.
- FFP2: Offers medium-level filtration and helps prevent the spread of respiratory diseases.
- FFP3: Provides the highest level of protection and acts as an effective barrier against viruses, bacteria, and toxic particles.
During pandemics such as COVID-19, the use of FFP2 and FFP3 masks has significantly increased. These masks are widely preferred by healthcare professionals in high-risk areas.
Importance and Usage Standards of Medical Surgical Masks
Medical surgical masks are among the most crucial personal protective equipment, not only in the healthcare sector but also in daily life, protecting individuals from airborne diseases. However, to ensure effective protection, masks must be properly manufactured and pass necessary tests.
International standards such as EN 14683 and EN 149 guarantee that masks provide high levels of protection and comfort, preventing the spread of infections. To ensure the safety of healthcare professionals and individuals, it is essential to choose masks that have been tested and approved by accredited laboratories.
If you would like to learn more about the testing processes and certification of surgical masks, or if you have any testing requests, feel free to contact us.