Experimental Quality Assessment Of Sterile Nonwoven Surgical Gowns And Verification Of A Two-Stage Acceptance Method
Keywords:
nonwoven fabric, sterile surgical gown, quality margin coefficientAbstract
The paper presents experimental results for a single-use surgical gown made of SMS nonwoven fabric and sterilised with ethylene oxide. Physical-mechanical, biological, barrier and package-integrity indicators were measured. Priority control indicators were identified from the relation between the quality margin coefficient and the process capability index. The sterility test result and the sterility assurance level were interpreted separately, and resistance to 36-month storage and to external influences was assessed. A two-stage acceptance method, in which mandatory safety requirements are checked before the integral quality index is calculated, was verified on production lots.
References
Shohobidinova D.E. Bir martalik steril tibbiy buyumlar sifatini integral baholashning kvalimetrik modeli [A qualimetric model for integral quality assessment of single-use sterile medical devices] // Standart. — 2023. — No. 4. — P. 28–35. (In Uzbek)
Shohobidinova D.E. Bir martalik steril jarrohlik xalatining sifat ko‘rsatkichlari va ularning xalqaro standartlarga muvofiqligi [Quality indicators of single-use sterile surgical gowns and their conformity with international standards] // Standartlashtirish va texnik tartibga solish. — 2024. — No. 2. — P. 19–28. (In Uzbek)
ISO 11737-2:2019. Sterilization of health care products — Microbiological methods — Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process. — Geneva: ISO, 2019.
ASTM F1980-21. Standard Guide for Accelerated Aging of Sterile Barrier Systems and Medical Devices. — West Conshohocken: ASTM International, 2021.
ILAC-G8:09/2019. Guidelines on Decision Rules and Statements of Conformity. — Silverwater: ILAC, 2019.
ISO 10993-5:2009. Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity. — Geneva: ISO, 2009.
Russell S.J. (ed.). Handbook of Nonwovens. — Cambridge: Woodhead Publishing, 2007. — 530 p.
ISO 11135:2014. Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices. — Geneva: ISO, 2014.
