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Quality control of medical non-woven fabrics
by：Sunshine
2021-04-10
1. Medical non-woven fabrics are different from ordinary non-woven fabrics and composite non-woven fabrics.
Ordinary non-woven fabrics do not have bacteria resistance; composite non-woven fabrics have good waterproof effect and poor air permeability, and are generally used for surgical gowns and surgical bed sheets; medical non-woven fabrics are made of spunbond, meltblown, and spunbonded (SMS ) Is laminated by the process of anti-bacterial, hydrophobic, air-permeable, and dander-free. It is used for the final packaging of sterilized items and is disposable without cleaning.
2. Quality standard requirements for medical non-woven fabrics: The medical non-woven fabrics used for the final packaging materials of sterilized medical devices should meet the specifications of GB/T19633 and YY/T0698.2 at the same time.
3. The validity period of the non-woven fabric: the validity period of the medical non-woven fabric itself is generally 2 to 3 years. The validity period of the products of different manufacturers is slightly different, please refer to the instructions for use. Aseptic items packaged in medical non-woven fabrics should have an expiration date of 180 days and are not affected by sterilization methods.
4. The non-woven fabric used for packaging sterilized items should be 50g/m2 plus or minus 5 grams.
5. When medical non-woven fabrics are used for packaging surgical instruments, a closed packaging method should be used. Two layers of non-woven fabrics should be packaged twice. Repeated folding can form a long curved path to prevent microorganisms from 'easy' entering into sterilization. Inside the package, two layers of non-woven fabrics cannot be used for one package.
6. After high-temperature sterilization of medical non-woven fabrics, the internal results will change, which will affect the penetration and antibacterial performance of the sterilization medium. Therefore, medical non-woven fabrics must not be sterilized repeatedly.
7. Due to the hydrophobic properties of non-woven fabrics, excessive and heavy metal instruments are sterilized by high temperature, and condensation water is formed during the cooling process, which is easy to produce wet packs. Therefore, pad water-absorbing materials in the large equipment package, appropriately reduce the loading capacity of the sterilizer, leave gaps between the sterilization packages, appropriately extend the drying time, and try to avoid the generation of wet packages.
8. 'Tyvek' non-woven fabrics should be used for hydrogen peroxide low-temperature plasma, and medical non-woven fabrics containing plant fibers cannot be used, because plant fibers will absorb hydrogen peroxide.
9. Although medical non-woven fabrics are not medical devices, they are related to the quality of sterilization of medical devices. The quality of medical non-woven fabrics as packaging materials and packaging methods are essential to ensure the level of sterility.
10. Refer to the inspection report and product batch inspection report provided by the manufacturer, and check the physical and chemical properties of the medical non-woven fabric to ensure the quality of the products used.
Ordinary non-woven fabrics do not have bacteria resistance; composite non-woven fabrics have good waterproof effect and poor air permeability, and are generally used for surgical gowns and surgical bed sheets; medical non-woven fabrics are made of spunbond, meltblown, and spunbonded (SMS ) Is laminated by the process of anti-bacterial, hydrophobic, air-permeable, and dander-free. It is used for the final packaging of sterilized items and is disposable without cleaning.
2. Quality standard requirements for medical non-woven fabrics: The medical non-woven fabrics used for the final packaging materials of sterilized medical devices should meet the specifications of GB/T19633 and YY/T0698.2 at the same time.
3. The validity period of the non-woven fabric: the validity period of the medical non-woven fabric itself is generally 2 to 3 years. The validity period of the products of different manufacturers is slightly different, please refer to the instructions for use. Aseptic items packaged in medical non-woven fabrics should have an expiration date of 180 days and are not affected by sterilization methods.
4. The non-woven fabric used for packaging sterilized items should be 50g/m2 plus or minus 5 grams.
5. When medical non-woven fabrics are used for packaging surgical instruments, a closed packaging method should be used. Two layers of non-woven fabrics should be packaged twice. Repeated folding can form a long curved path to prevent microorganisms from 'easy' entering into sterilization. Inside the package, two layers of non-woven fabrics cannot be used for one package.
6. After high-temperature sterilization of medical non-woven fabrics, the internal results will change, which will affect the penetration and antibacterial performance of the sterilization medium. Therefore, medical non-woven fabrics must not be sterilized repeatedly.
7. Due to the hydrophobic properties of non-woven fabrics, excessive and heavy metal instruments are sterilized by high temperature, and condensation water is formed during the cooling process, which is easy to produce wet packs. Therefore, pad water-absorbing materials in the large equipment package, appropriately reduce the loading capacity of the sterilizer, leave gaps between the sterilization packages, appropriately extend the drying time, and try to avoid the generation of wet packages.
8. 'Tyvek' non-woven fabrics should be used for hydrogen peroxide low-temperature plasma, and medical non-woven fabrics containing plant fibers cannot be used, because plant fibers will absorb hydrogen peroxide.
9. Although medical non-woven fabrics are not medical devices, they are related to the quality of sterilization of medical devices. The quality of medical non-woven fabrics as packaging materials and packaging methods are essential to ensure the level of sterility.
10. Refer to the inspection report and product batch inspection report provided by the manufacturer, and check the physical and chemical properties of the medical non-woven fabric to ensure the quality of the products used.
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