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The Concept Of Class II Medical Soft Instruments, Comparison Of Domestic And International Standards And Their Sterilization Supply
1970-01-01

Soft instruments refer to water-blocking, bacteria-blocking, breathable, wearable and foldable infection control instruments with two-way protection function in accordance with the Classification Catalogue of Medical Devices, such as surgical gowns and surgical cover sheets described below, not reusable cotton material dressings in the traditional sense, excluding ordinary medical textiles.


Medical and nursing staff at work will inevitably come into contact with patients' blood and body fluids, which may often carry a variety of pathogens including HBV, HCV and HIV.

The most basic function of medical gowns and sheets is to create an effective barrier between the non-sterile area and the sterile area to prevent infection at the incision site and to achieve two-way protection for patients and healthcare workers. The fabric used belongs to the medical shielding fabric, mainly focusing on the barrier performance, the barrier performance includes the performance of preventing liquid and microbial penetration.
Secondly, the surgical gown should be clean in wear and use, not easy to produce lint or dust, because the surface of the lint, particles and other easy to carry pathogens, causing harm to patient safety, air floating particles easy to block the high efficiency filter; at the same time, should also have some necessary mechanical properties, including the strength of the fabric and wear resistance and water pressure resistance performance.

The materials used must prevent the penetration of liquids that may carry various pathogens to ensure the formation of an effective sterile barrier, and subsequently the soft instruments are also derived from the need.

In the past many national inspections, it was often found that gauze and cotton cloths produced during surgery produced fibrous flocculation, forming a large amount of cotton dust blocking air conditioning return vents and adhering to air conditioning filters. Surgical gowns, sterilization cover cloths, padded towels, table top cover cloths, medical device tray padding, etc., the possibility of generating thread lint varies greatly from material to material.
Not only that, any foreign object at the surgical incision site may cause inflammation, large foreign objects such as retractors, scissors, dilators, fibers/woven fabrics, and small ones such as fibrous floss, cotton dust, dust (talcum powder gloves) and other particles.

Because of the special nature of the soft instrument's own material and properties that distinguish it from ordinary fabrics, in terms of its disinfection and sterilization treatment, if it is co-washed and co-consumed with medical fabrics, it will certainly lead to fiber floss contamination during the cleaning process, departing from the safety and quality requirements of infection control. Therefore, the conventional type of fabric washing and soft instrument cleaning can never be combined or integrated in the assembly line, the two standards, procedures and management are very different.

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