Airmid Healthgroup’s Role in Shaping Medical Mask Testing Standards
by Dr. Angela Southey
At Airmid Healthgroup, we are committed to advancing international standards that improve product performance, safety, and health outcomes. Our Technical Manager, Naga Bonagiri, has joined two key committees through the National Standards Authority of Ireland (NSAI) and the European Committee for Standardization (CEN), focusing on the future of medical mask testing and respiratory protection devices.
Updating EN 14683 Medical Facemask Standard
Naga is an active member of the NSAI/TC067/WG02 committee, which follows the work of CEN/TC205/WG14. This group is revising EN 14683 – Medical facemasks: Requirements and test methods.
The revision comes as a result of the new EU Medical Device Regulation (MDR), which requires all medical device standards to align with updated legislation. This also presents an opportunity to enhance the standard with improvements in areas such as:
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Ergonomics and mask fit
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Comfort during extended use
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Sizing to suit diverse populations
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Modernized test methods for performance evaluation
Developing New Standards for Respiratory Infection Prevention
In addition, Naga has joined CEN/TC205/WG17, which is working on a new standard:
“Respiratory infection prevention devices for self- and third-party protection – Requirements for different performance classes and test methods.”
This standard addresses a major gap: reducing outward leakage to help prevent infection transmission. Current standards, including EN 14683, do not fully cover this aspect. The new framework aims to:
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Define categories of performance
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Support use across different ages, sizes, and abilities
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Apply to both vocational and community settings
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Provide flexibility for regulation under Medical Device (MD) or Personal Protective Equipment (PPE) rules
If successful, these new devices could offer stronger community protection than masks certified under EN 14683 alone.
Medical Mask Testing: International Collaboration
As part of his contribution, Naga traveled to Berlin in August 2022 to meet with international committee members. Discussions centered on test method development and the performance requirements for the upcoming standards.
Through these collaborations, Airmid Healthgroup is helping shape the future of medical mask testing, ensuring that new and existing products are assessed against the highest international standards.
We look forward to continuing this important work in partnership with NSAI, CEN, and international stakeholders.
Related Services at Airmid Healthgroup
Infection Control & Antimicrobial Technologies Testing Services
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Airmid Healthgroup, medical mask testing, respiratory infection prevention, EN 14683, EU MDR, PPE standards, international standards
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