[product name] disposable surgical bag

[specification and model] common type I and type II; interventional type I and type II;

[name of registrant] Henan Jianqi medical device Co., Ltd

[residence] dingluan Industrial Zone, Changyuan County

[Tel.] 0373-8690789

[after sales service unit] Henan Jianqi medical equipment sales Co., Ltd

[name of manufacturer] Henan Jianqi Medical Equipment Co., Ltd

[residence] dingluan Industrial Zone, Changyuan County

[production address] dingluan Industrial Zone, Changyuan County

[contact information] 0373-8690789

[production license] ysyjx production license No. 20080036

[Registration Certificate No.] yxzz 20172640087

[technical requirements No.] yxzz 20172640087

[structure and composition] the general type I basic configuration of this product is composed of laparotomy sheet, disposable medium single, disposable treatment towel and disposable medical bag cloth; ordinary type II basic configuration: laparotomy sheet, disposable medium use single, disposable treatment towel, disposable hand clothing, disposable mask, disposable hat, disposable medical bag; intervention I Type I basic configuration: laparotomy sheet, disposable medium single, disposable treatment towel, disposable operating gown, disposable dispensing syringe, disposable sterilized rubber surgical gloves, disposable mask, disposable hat, medical degreasing gauze block, disposable medical bag, sterile plastic handle scalpel and medical tweezers; type II interventional basic configuration : laparotomy sheet, disposable medium single, disposable treatment towel, disposable operating clothes, disposable dispensing syringe, disposable sterile rubber surgical gloves, medical degreasing gauze pad, disposable mask, disposable hat, medical degreasing gauze block, medical cotton ball, disposable medical bag, sterile plastic handle scalpel, medical tweezers and sponge Brush, small bowl and square plate. Optional configuration: disposable medical pad, medical gauze bandage, medical sterile protective cover, medical suture needle, non absorbable surgical suture, self-adhesive wound protection patch, tourniquet, hemostatic forceps, elastic bandage, disposable suction connecting tube. The product should be sterile. After sterilization with ethylene oxide, the residual amount of ethylene oxide should not be more than 10 μ g / g. Disposable use.

[product performance] the package of the operation bag should be well sealed without cracks and holes; the accessories inside should be free from damage, stains and impurities; the sewing parts should be sewn firmly with uniform, straight needle size, no crease, needle skipping, stitching and leakage; the folding parts should be folded neatly. No less than 8 stitches should be sewn within 3cm; the operating clothes should be free of mildew, damage, stains and impurities; the stitches should be uniform, straight, without creases, stitch skipping, stitching and leakage; the hot pressed surgical clothes should be hot pressed evenly, straight, without creases or leakage; the chest film (if any) should be made of coated nonwovens, plastic films or nonwovens The size of cloth shall not be less than 40cm × 60cm; if coated nonwovens are used, it shall not be less than 35g / m2, and the film shall be flat, free of bubbles and separation; if there is a plastic film at the sleeve, the plastic film shall not be damaged, and the thickness of the plastic film shall not be less than 0.01mm; the specification of the non-woven fabric used shall not be less than 20g / m2; the longitudinal breaking strength shall be large When it is equal to or equal to 13N, the transverse breaking strength shall be greater than or equal to 8N; the coated nonwovens used for surgical sleeves shall not be less than 35g / m2, and the film shall be flat, free of bubbles and separation; there shall be plastic film at the sleeve, and the plastic film shall not be damaged, and the thickness of plastic film shall not be less than 0.01mm. (if any); firmness: the sewing or hot pressing part shall be firm, and the firmness shall be no less than 10N; the breaking strength of the joint between each tie and the operating clothes shall be no less than 10N; the performance of the operating clothes shall meet the requirements of table 5; the fluorescent substance of the suture shall be

According to the test a in Appendix D of YY 0594-2006, the suture should not show strong blue fluorescence; the total amount of soluble matter in water should not exceed 0.50%. 2. The single use list should be the qualified product with medical device registration certificate. 3. The specification of nonwovens used in laparotomy sheet should not be less than 20g / m2; the longitudinal breaking strength of nonwovens should be greater than or equal to 13N, and the transverse breaking strength should be greater than or equal to 8N. 4. Disposable treatment towel should be a qualified product with medical device registration certificate. 5. If the disposable medical wrapping cloth is made by hot pressing, the hot pressing part shall be firm without cracking; the specification of nonwovens used shall not be less than 20g / m2; the longitudinal breaking strength shall be greater than or equal to 13N, and the transverse breaking strength shall be greater than or equal to 8N. 6. Disposable masks should be qualified products with medical device registration certificate. 7. Disposable dispensing syringes should be qualified products with medical device registration certificate. 8. Disposable sterilized rubber surgical gloves should be qualified products with medical device registration certificate. 9. Medical absorbent gauze pad should be a qualified product with medical device registration certificate. 10. Disposable caps should be qualified products with medical device registration certificate. 11. Medical absorbent gauze should be qualified products with medical device registration certificate. 12. Medical cotton ball should be a qualified product with medical device registration certificate. 13. Sterile plastic handle scalpel shall be qualified product with medical device registration certificate, or its surface shall be smooth without obvious injection molding defects; handle flowers shall be neat and clear; marks (if any) on plastic handle shall be clear and complete; surgical blade connected with plastic handle shall conform to YY 0174-2005 in 4.2, 4.3, 4.4; blade and handle should be firmly connected; there should be a blade protection device. 14. The medical tweezers should be symmetrical, smooth in appearance, free from sharp edges, burrs, cracks, pockmarks and trachoma; the tweezers should have good elasticity; the two pieces of tweezers should be firmly connected, which should be able to withstand 15N tension without fracture; the lip teeth should be clear and complete, without missing teeth or rotten teeth; the guide pin and positioning pin of forceps should be fixed firmly, when the tweezers are opened and closed, the two pieces of forceps should be firmly connected, It should be flexible without jam; the handle of tweezers should be clear and complete without missing or rotten flowers. 15. The adhesive force between the sponge head and the brush shall not be less than 10N, and the joint shall not be loose. 16. The appearance of the small bowl should be smooth, without burr and injection flow; the thickness should not be less than 0.01mm. 17. The appearance of the square disk should be smooth without burr and injection flow; the thickness should not be less than 0.01mm. 18. Disposable medical pads should be qualified products with medical device registration certificate. 19. Medical gauze bandages should be qualified products with medical device registration certificate. 20. Medical sterile protective cover should be qualified product with medical device registration certificate. 21. Medical suture needle shall be qualified product with medical device registration certificate. 22. Non absorbable surgical suture shall be qualified product with medical device registration certificate. 23. The self-adhesive wound protection patch should be a qualified product with medical device registration certificate. 24. Tourniquet should be a qualified product with medical device registration certificate. 25. The shoe cover can be made of coated nonwovens, plastic film or nonwovens, and the appearance shall be free of holes; the shoe cover made by hot pressing shall be flat and flat without leakage pressure, and the breaking strength shall not be less than 5N. 26. The elongation ratio of elastic belt should be 1:2.2-1:3.0; the tensile elastic recovery rate should be 75.0%; the specification of nonwovens used should not be less than 20g / m2; the longitudinal breaking strength should be greater than or equal to 17.0n, The transverse breaking strength should be greater than or equal to 3.0N; the coated nonwovens should not be less than 30g / m2; the film should be flat, without bubbles and separation; the plastic film used should not be damaged, and the thickness of plastic film should not be less than 0.01mm. 27. The coated nonwovens used for sleeves shall not be less than 30g / m2, and the film shall be flat, free of bubbles and separation; the plastic film used shall not be damaged, and the thickness of the plastic film shall not be less than 0.01mm; the elongation ratio of elastic band shall be 1:2.2-1:3.0; the elastic recovery rate of tension shall be 75.0%; the sleeve made by hot pressing shall be hot pressed straight without leakage, and the breaking strength shall not be less than 5N. 28. The lips and teeth of hemostatic forceps should be clear, without missing teeth, rotten teeth and burr, with good elasticity and firmness. 29. Elastic bandages should be qualified products with medical device registration certificate. 30. Disposable suction connecting pipe shall be qualified product with medical device registration certificate. 31. The name, specification and quantity of the articles in the operation bag shall meet the requirements of Table 1, table 2, table 3 and table 4. 32. Sterile operation bag should be sterile. 33. The residual amount of ethylene oxide should be no more than 10ug / G after sterilization with ethylene oxide.

[scope of application] it is applicable to surgical operation in medical institutions.

[contraindications] no contraindications.

[precautions] 1. This product is disposable and its package is damaged. It is forbidden to use it and destroy it after use.

2. See the seal or label of the package for the batch number and the outer packing box for the sterilization date.

3. The product was sterilized by ethylene oxide.

[usage] 1. Select the specifications and models of the patients, and open the package after confirming that the outer package is in good condition.

2. According to the needs of surgery, the accessories can be used.

3. After the end of use, the product should be treated as medical waste to avoid pollution.

[storage method] 1. The product should be loaded and transported in covered carriage and cabin, and kept clean. It should not be under heavy pressure, direct sunlight, rain or snow.

2. Handle with care to avoid violent collision;

3. The product should be stored away from the fire source, the relative humidity is not more than 80%, no corrosive gas and well ventilated and clean environment.