Anti-mite barrier covers are manufactured from textiles with filtration properties usually validated by different certification labels. Although only textile certifications are mandatory, some covers are manufactured using processes ISO 13485 certified, subjecting covers to more stringent quality control measures.
The objective of the study was to evaluate the benefit of ISO 13485 certification on the liability of the final product.
In this study six different batches of micro-woven (MWC) and non-woven polyester polyamide (NWP) textiles went through the quality control processes required by the norm ISO 13485.
Upon reception, textiles pore sizes were measured using an optical microscope (Bresser, USA).
Textile permeability was then tested using a Rotomitest, apparatus composed of two compartments separated by the sample. Der p1 allergens were placed in compartment 1 and the apparatus was set to rotate for 18 hours.
Der p1 allergens that passed through the sample to compartment 2 were then measured with a Der p1 ELISA kit (Citeq Biologics, Netherlands).
Values, expressed as mean +/- SEM, were compared using two-way ANOVA.
Pore sizes were found to be smaller for MWC than for NWP textiles (4 vs 11 µm).
NWP fabrics showed irregular pore sizes, with 2 batches having pore size greater than 5 µm.
Permeability results showed that NWP fabrics are significantly more permeable to Der p1 allergen compared to MWC tissue (23,6ng +/- 0.7 vs 3,4ng +/- 0.02).
Thus, ISO 13485 quality controls allowed for dismissal of 2 out of 6 batches of unsatisfactory NWP textiles.
In addition to the initial test on textiles, as for medical devices of higher class, monitoring manufacturing processes certification is necessary to ensure the quality of the finished product, especially when using nonwoven fabric. Therefore, ISO 13485 certification is a relevant criteria for anti-mite covers quality and thus effectiveness.