A Two-Stage Approach to Quality Assessment of Sterile Medical Products Made of Nonwoven Fabric
DOI:
https://doi.org/10.37547/ijasr-06-03-10Keywords:
Nonwoven fabric, surgical gown, sterilityAbstract
Conventional quality indices for medical textiles add up all measured properties into one score, which allows a safety failure to be hidden behind good mechanical results. This paper proposes a two-stage procedure for sterile nonwoven products. At the first stage four mandatory safety conditions are checked as a logical gate; at the second stage the remaining properties are reduced to relative values, combined inside each group by the «weakest link» rule and weighted across groups. Group weights were obtained from a three-round Delphi survey of 24 experts combined with pairwise comparison (W = 0.79; CR = 0.053). For a test batch with three sub-standard properties the method gives Iq = 0.895 and a «sorting or rework» decision, whereas a plain weighted mean gives 0.968 and conditional acceptance.
References
1. EN 13795-1:2019. Surgical clothing and drapes – Requirements and test methods – Part 1: Surgical drapes and gowns.
2. EN 556-1:2001. Sterilization of medical devices – Requirements for medical devices to be designated «STERILE».
3. ISO 10993-5:2009. Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity.
4. ISO 11607-1:2019. Packaging for terminally sterilized medical devices – Part 1: Requirements for materials, sterile barrier systems and packaging systems.
5. Азгальдов Г.Г., Райхман Э.П. О квалиметрии. – М.: Издательство стандартов, 1973. – 172 с.
6. Гличев А.В. Основы управления качеством продукции. – М.: РИА «Стандарты и качество», 2001. – 424 с.
7. Saaty T.L. The Analytic Hierarchy Process. – New York: McGraw-Hill, 1980. – 287 p.
8. Kilinc F.S. A review of isolation gowns in healthcare: fabric and gown properties // Journal of Engineered Fibers and Fabrics. – 2015. – Vol. 10, No. 3. – P. 180–190.
9. Shohobidinova D.E. Bir martalik steril tibbiy buyumlar sifatini integral baholashning kvalimetrik modeli // Standart. – 2023. – № 4. – B. 28–35.
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Copyright (c) 2026 Shohobidinova Dilafruz Erkinjon qizi, Qosimov Axtam Akramovich
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