What Is Sterilized Gauze?

Made of absorbent cotton gauze, which is basically used for medical or medical disinfection and sterilization. The product is white and strong in water absorption. It is used by medical units for external debridement and health care.

Sterilized gauze sheet

Right!

Made of absorbent cotton gauze, which is basically used for medical or medical disinfection and sterilization. The product is white and strong in water absorption. It is used by medical units for external debridement and health care.

Chinese name

Sterilized gauze sheet

Customer Group Object

Medical device manufacturers, hospitals

product material

One side paper + one side plastic film

product preserve period

Three to five years (antibacterial)

Generally, according to customer requirements, medical sterilization packaging bag reference picture Manufacturer qualifications: ISO13485 certification, CFR820, US FDA certification, 100,000-level purification workshop, 5000 square meters plant, registered capital of 5 million

ISO11607, EN868 and GB / T19633

ISO14644, ISO10993, ISO14971, ISO11135 / GB18279 ethylene oxide sterilization, ISO11137 irradiation sterilization, ISO11134 / GB18278 / ISO17665 (NEW) damp heat

Paper paper bag; paper plastic bag; blister cover material; blister paper; dialysis paper; plastic bag; aluminum foil bag

Suitable sterilization methods for medical or medical sterilization:
EO ethylene oxide sterilization, steam high temperature and high pressure steam wet heat sterilization, gamma cobalt 60 radiation sterilization, plasma sterilization (non-paper).
product material:
One side paper (DuPont tyvek Tyvek paper / French medical dialysis paper / British medical blister paper) + one side composite plastic film. As shown:
Customer Group Object:
Medical device manufacturer, or hospital product shelf life:
Three to five years (antibacterial)
Working principle and using method:
Medical devices are packed in packaging bags (products), then sealed, sterilized and disinfected. The packaging bags (products) are passed through the sterilization factor and semi-dialysis permeability without bacteria. After professional testing of EN868, it shows that the aging and antibacterial of packaging bags (products) can reach 3 to 5 years.
Object:
Medical gloves, medical syringes, hemostatic gauze, surgical towels, medical catheters, tracheal intubation, surgical gowns, protective clothing, intravascular catheters, indwelling needles, electrosurgical pens, heparin caps, tee cocks, roar caps, balloons, artificial Packaging quality of joints, occluders and other medical consumables and high-end medical devices:
Testing of the peeling force of the edge seal; no paper scraps during separation; no leakage of the edge seal bacteria test

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Sterilization bag catalog Sterilization bag type: Sterilization bag-Sterilization packaging History Medical device Sterilization bag packaging Introduction Sterilization bag Related regulations Standards Sterilization bag Basic principles Sterilization bag Function Sterilization barrier system evaluation Disinfection Type of bacteria bag: Sterilized bag (sterilized packaging):
(Already directly called medical packaging bags, sterilization bags, sterilization packaging bags, sterilization packaging bags, sterilization bags, medical dialysis bags)
Medical paper-plastic packaging bag: Three-side sealing bag composed of medical dialysis paper + medical composite film Medical sterilization paper bag / sterilized paper bag: glued medical dialysis paper + coated medical dialysis paper Medical composite bag: medical composite film + Medical composite film Plastic bags with dialysis paper can be divided according to the sealing position: header bags, mid-sealed bags, etc. aluminum foil bags easy to tear bags and other bags medical blister boxes for medical device sterilization packaging Cold cavity + glued medical dialysis paper composed of blister material (PETG, PETA, PET, PS, PA, etc.) Blister material + composite aluminum foil or other materials, etc. Medical dialysis paper for online packaging: can be printed The medical dialysis paper base paper + coated adhesive can be used for medical sterilization tube bags with sterilization and discoloration indication (alias: medical sterilization roll bag, medical sterilization tube bag, medical sterilization roll bag).
Sterilization bags-sterilization packaging history Medical device sterilization packaging belongs to an emerging field of development, it can be said that it belongs to the emerging industry worldwide, and is still in the cumulative accumulation, and the development in China is particularly slow. Began to understand medical equipment packaging bags around 2005, and gradually integrated with international medical equipment sterilization packaging. In 2007, it was further valued by the country. Introduction to medical device sterilization bag packaging The definition of medical device sterilization packaging should be understood as: packaging for medical device products, which can be sterilized, can be subjected to aseptic operations (such as clean opening), and can provide acceptable Microbial barrier performance, a packaging system that can protect the product before and after sterilization and maintain a sterile environment inside the system for a certain period of time (labeled expiration date) after sterilization. Because this concept usually does not include external protective packaging systems (buffer packaging and collective packaging, etc.), medical device sterilization packaging systems can also be referred to as "sterile barrier systems". There are three types of sterilization packaging for medical devices: 1.1 Soft blister molding-fill-heat-seal packaging system: This type of packaging can be divided into flexible and semi-rigid according to the thickness of the substrate of the molding part. , Its substrate is thermoformed into a pre-designed shape through the adjustment of temperature, vacuum absorption and pressure on a specific blister packaging equipment, and is heat-sealed with the corresponding top material to form a three-dimensional molding packaging system that meets the requirements. The characteristics of this type of packaging are: high degree of automation, high efficiency, low cost of individual packaging, good matching of packaging system and content shape, etc., but it involves equipment and mold investment, and has certain requirements for output, which is usually used in very large production scales. Large first- and second-class medical device products, such as various syringes, gauze tablets, surgical gowns, and medical catheter intubations, etc., as well as simple third-class medical devices, such as intravenous indwelling needles! 1.2 Hard blister box-cover material packaging system: This type of packaging is directly heat-sealed with various shaped blister boxes that are suitable for heat-sealing and shaped according to pre-cut cover materials. For so-called hard blister, It is more related to the thickness of the sheet used for blister molding, usually between 0.4-1.2mm, and the materials involved are mainly PVC, PP, PE, PS, PET, PETG from the low end to the high end. And PC, among which the three materials PS, PET and PETG are commonly used; PVC is gradually being eliminated due to safety and environmental protection issues; PP and PE are two conventional polymer materials. Physical and mechanical performance limitations are not many in this field; PCs are only used in very few fields due to high cost, typically in the case of dry heat sterilization. This type of rigid blister box is generally purchased, and then heat-sealed with the lid material at the medical device manufacturer, and ordinary heat-sealing equipment can be used. 1.3 Various types of bag packaging systems: including various types of bags: paper plastic bags, etc., top bags, window bags, air-seal bags, paper bags, aluminum foil composite bags with Tyvek, etc. The actual situation to design and produce, in short, it is difficult to completely summarize its type and application range! Domestically, these products, such as head bags, window bags, and air-sealing bags, are popular among many medical device companies because of their special design of breathable windows, which saves material costs. The latest 2006 edition of the sterilization bag related regulations and standards was officially issued in April 2006. It has two parts. The first part is mainly about packaging materials, aseptic barrier systems and packaging systems, and the second part is mainly about the related The problem of process confirmation of sterilization packaging of medical devices, so as to distinguish the two main contents of aseptic packaging according to the packaging system design and packaging process confirmation. More importantly, in this version, the European popular EN868 standard system has been formally absorbed and merged. As a result, the conflicting general system EN868-1 has been abolished, and the selective integration of 9 EN868-2 to -10 has been absorbed. Regarding the sub-standards of specific materials and products, this in fact announced that the global uniform medical device sterilization packaging standard was finally born in 2006, which is ISO11607-2006. Others are YY / T0698, which was implemented on December 1, 2010, and also GB / T19633, ASTM-F88 sealing, ASTM-F1929 dye penetration, ASTMF1980 accelerated aging, and YYT_0681.1-2009_ aseptic medical device packaging test. Method_Part 1: Guidance on accelerated aging test, ISO15223 / YY0446 medical device label marking and information providing symbol, GB / T191 packaging storage and transportation pictogram, ASTMF1608 microbial barrier, GB / T15171 bubble test, no explosion (ASTMF-1150 / ASTMF-2054) Basic principle of sterilization bag, such as sterilization gas and other sterilization factor size <package size aperture size <bacterial size, sterilization packaging materials pass through sterilization factor (such as ETO ethylene oxide, high temperature steam, gamma cobalt 60 rays, etc.), but is semipermeable to bacteria. In order to design a reasonable medical device sterilization packaging system, the following basic principles must be followed: 3.1 "Packaging" is part of the product: packaging here refers to "sterile barrier system", because the failure of the sterile barrier system means medical treatment Device products fail and the potential risks are greater because such failures are often less detectable or overlooked. Therefore, for product development or technical designers in the medical device industry, pay special attention to this point and focus on product packaging design, because this is also part of the product's own design. 3.2 "Primary Packaging System" = "Aseptic Barrier System": This and the first point echo each other, and have been most directly reflected in ISO11607-2006, the most authoritative international standard for medical devices. It directly redefined the "primary packaging system" in the previous version as a 'sterile barrier system, which is also the original source of this concept! 3.3 Emphasis on the safety and continuous stability of packaging: because of the special nature of medical device products, The safety of its packaging is directly related to the safety of the patients who use the device (of course, some low-end medical device products may not have such serious consequences). In this age of life, no one can ignore this. One point. To achieve the absolute safety of sterilization packaging, consult an experienced professional company or person in the industry, choose proven packaging materials, sufficient and scientifically based experimental design, and strict experimental operations. References are considered to be Correct historical experience and experimental data should be taken into account. As for the emphasis on continuous stability of packaging quality, this is extinguishing Under the conditions that the major premise of packaging safety has been met, then the next issue that should be considered. In fact, this is also a requirement to meet the absolute security of packaging. According to the industrial experience of domestic and foreign decades, in addition to strictly abiding by the set of ISO13485, In addition to the quality management system standards designed for the medical device industry, in general, scientific and strict packaging process confirmation is also an effective method to ensure continuous and stable packaging quality. Sterilization bags are used for EO ethylene oxide / STEAM high temperature steam / GAMMA Cobalt 60 irradiation / Plasma ray sterilization, put the medical equipment to be sterilized into the packaging bag, and then seal it tightly, then sterilize, sterilize the gas, and then sterilize the radiation through the packaging bag. It can be analyzed and emitted, and bacteria cannot enter (because the aperture of the packaging material is semi-permeable, allowing sterilization gas and radiation to enter and exit, but preventing bacteria). It is the selection of the packaging bag that is semi-permeable. This ensures that the medical equipment in the package is free of sterilization, before handling, transportation, and storage until the nurse in the operating room of the hospital opens it. Yes, the booklet can be opened directly at the end, and no more sterilization is needed. The antibacterial effective period of the materials in different packaging bags is generally 3-5 years. Under the condition that the packaging bags are not damaged, the medical devices in the packaging bags can be guaranteed. 3 to 5 years are sterile. Sterile barrier system evaluation of the sterilization bag? According to the choice of product packaging materials, the evaluation content includes:-system requirements-verification of the microbial barrier system of the packaging material-biological products and packaging materials Compatibility and toxicity-Physicochemical properties of packaging materials-Adaptability of packaging materials and sterilization processes-Adaptability of packaging materials and molding and sealing processes-Adaptability of packaging materials and label printing 7.2 Microbiological barrier systems for packaging materials Evaluation basis: ISO11607-2003 agar contact attack test. Question: This test method has expired? Is it necessary to use F1608 test method, this method can only be tested by third parties. Biocompatibility and toxicity of products and packaging materials Evaluation basis: ISO10993-1: 2003 "Biological evaluation of medical devices-Part1: Evaluation and testing" Physical and chemical properties of packaging materials Evaluation method: tensile strength of packaging materials before and after sterilization The test compares the change in tensile strength of the packaging material before and after sterilization. The compatibility evaluation method of the packaging material and the sterilization process: the product is tested for initial contamination of the product before sterilization, and the product is tested for sterility after the sterilization. Adaptive visual evaluation of the molding and sealing process:-Heat sealing strength according to ASTMF 1886: 1998 "Standard test methodfordfordmining integrity of seals formed packaging by visual inspection"-According to ASTMF 88: 2000 "Standard test method for burst testing offlexible packages sealings using internal air pressurization without internal training components" Packaging Integrity-According to ASTMF1929: 1998 "Standardtestmethodfordetectingsealleaksinporousmedicalpackagingbydyepenetration"
Precautions:
Do not use it if it is damaged. Second use is prohibited!
reference document:
GB / T19633-2005 Packaging of final sterilized medical devices GB / T5402-2003 Determination of air permeability of paper and cardboard (medium range) Gurley method ISO / DIS22611 Test method for anti-infectious clothing clothing resistance to aerosol penetration by microorganisms ISO22612 -2005 Anti-infectious clothing, protective clothing, microbial contamination, and dust penetration test method ASTMF1980 "Standard Guide for Accelerated Aging Tests for Sterile Medical Device Packaging"