Evaluating performance characteristics of health care barrier products is essential to both practitioner and patient. Nelson Labs offers a unique combination of test services to assess these characteristics for surgical gowns and drapes as well as surgical masks and general-use face masks of all types to support marketing approvals and performance label claim verification. In addition, the lab offers medical respirator precertification test services for NIOSH submissions.
Surgical Gown and Drape Tests
For both single use and reusable gowns, barrier performance testing should be completed on the final, finished, pre-shipment gown, at the end of the stated shelf life of the gown. If the gown is intended to be reusable, barrier performance testing should also be performed at the end of the labeled use-life (maximum reprocessing cycles).
Nelson Labs offers barrier and non-barrier performance tests for surgical gowns and drapes in accordance with AAMI PB70 and EN 13795. Test requirements are dependent on the gown or drape classification (Level 1, 2, 3 or 4), standard or high performance for EN 13795. This includes liquid, blood, viral and other barrier property assessments or physical properties:
- Synthetic blood penetration
- Viral penetration
- Spray impact
- Hydrostatic pressure / Resistance to liquid penetration
- Resistance to wet bacterial and dry microbial penetration
- Evaluation of bursting strength (wet and dry)
- Tensile testing (wet and dry)
- Particle shedding or linting
- Biocompatibility tests
These tests may be performed for initial validation and product performance assessment; however, ongoing product monitoring should also be considered and reassessed periodically.
Surgical and General-Use Face Mask Tests
Medical manufacturers of surgical masks and general-use masks are required to follow ASTM F2100 (US submissions) and EN 14683 for CE marking (EU submissions). Nelson Labs provides viable organism filtration efficiency studies (bacterial and viral, BFE/VFE), latex particle filtration efficiency studies (PFE), assessment of synthetic blood penetration, differential pressure, flammability, microbial cleanliness and biocompatibility test services for medical face masks.
Respirator Precertification Tests (NIOSH)
Surgical masks, for the most part, are worn to prevent particles coming out of the mouth of the wearer from coming in contact with others. Respirators on the other hand are a tight fit and are used to protect the wearer from harmful particles coming in contact with them. To support manufacturers of medical masks or respirators seeking NIOSH certification, Nelson Labs provides pre-certification testing to support manufacturer label claims and marketing approval submissions in accordance with 42 CFR Part 84. Services include inhalation/exhalation, sodium chloride (NaCl) and dioctyl phthalate (DOP) filtration properties, and valve leak tests.
For manufacturers of medical-grade natural latex and synthetic gloves, Nelson Labs offers evaluation of glove leakage studies, tensile tests (aged and unaged), residual powder studies (aged and unaged), puncture resistance tests and physical dimensions verification. Latex (ELISA) tests are offered through a qualified third-party lab. US FDA glove detention studies and project support are also available for glove manufacturers.
Other Barrier Performance Tests
Many of the tests developed for masks and gowns can be used for assessment of other flat stock filter materials and sealed housed filters. Additional barrier performance studies are available upon request, including physical and custom studies.
If you have additional questions about Protective Barriers and Material Performance testing for surgical products, or would like to consult with the experts at Nelson Labs, just send us a request or call us at +1 (801) 290-7500.