[product name] disposable product package.
[specifications] type i (vaginal type) type ii (c-section type)
[name of registrant] henan jianqi medical equipment co. ltd.
the dingluan industrial zone in changyuan county.
[contact number] 0373-8690789.
[after-sales service unit] henan jianqi medical equipment sales co., ltd.
[name of production enterprise] henan jianqi medical equipment co., ltd.
the dingluan industrial zone in changyuan county.
[production address] dingluan industrial zone, changyuan county.
[contact information] 0373-8690789.
[production license] the food and drug regulatory apparatus is permitted to be made in 20080036.
[registration certificate no.] yu ordnance note 20172640088.
[technical requirements no.] yu ordnance note 20172640088.
[structure and composition] type i (natural birth type), type ii (c-section type) consists of basic configuration and optional configuration. i type (natural product) basic configuration: disposable medical pad, disposable therapeutic towel, pant leg; type ii (c-section type) basic configuration: disposable medical pad, disposable use of the hole towel, disposable therapeutic napkin, pant leg. choose configuration: disposable medical rubber examination gloves, disposable masks, disposable use hats, disposable gown, medical absorbent gauze pieces, to protect the umbilical cord and umbilical cord clamp, umbilical cord cap, umbilical cord, medical cotton swabs, medical cotton ball, disposable medical cloth, medical suture needle, the absorbable surgical suture, one-time use of single, medical absorbent gauze pad, disposable sterilized rubber surgical gloves, medical gauze bandages, adhesive wound paste, disposable sterile maternal bleeding calculation wipes, shoe covers, medical sterile protective casing.
[product performance] 1. no damage, no stain or impurities should be found in all parts of the bag; the sewing parts should be sewn firmly, the needle code is uniform, straight, no crease, no jump needle, open line, leakage phenomenon; folded parts should be folded neatly; the stitch length is not less than 8 stitches in 3cm. 2. the operation clothes should be free of mildew, no damage, no stains and no impurities; the needle code should be uniform, straight, no crease, no jump needle, open line and leak. the hot pressing of the operating clothes should be uniform, straight, no wrinkle, no leakage pressure; the material of the chest film (if any) is coated nonwovens, plastic films or nonwovens, and the dimensions should not be less than 40cm x 60cm, and the tolerance: 10cm; if it is not less than 35g/m2, the film should be flat, free of bubbles and dissociation. if there is plastic film on the sleeve, the plastic film should not be damaged, and the thickness of plastic film should be no less than 0.01mm; plastic film should not be damaged, the thickness of plastic film should not be less than 0.01mm; the specification of non-woven fabric shall not be less than 20g/m2; the longitudinal fracture strength should be greater than or equal to 13n, and the transverse fracture strength should be greater than or equal to 8n; the surgical sleeves should be no less than 35g/m2, and the film should be flat, free of bubbles and separated. there is plastic film in the sleeve, the plastic film should not be damaged, the thickness of plastic film should not be less than 0.01mm. (if any); the sewing or hot pressing should be strong, and the strength should be greater than 10n. the rupture strength of each belt and the joint of the operating garment should be greater than 10n. the performance of the operating clothes should meet the requirements of table 2. the suture line should not show strong blue fluorescence in the test a test in appendix d of yy 0594-2006 standard. the total amount of soluble in water should not exceed 0.50%. 3. disposable medical mats shall be qualified products with medical device registration certificate. 4. one-time use of the hole towel shall be the qualified product for obtaining the medical device registration certificate. 5. disposable therapeutic towels shall be qualified products to obtain registration certificate of medical devices. 6. the non-woven fabric should not be less than 30g/m2, and the film should be flat, free of bubbles and separation. the pant leg made of hot pressure should be straight, no leakage pressure, and fracture strength should not be less than 5n. 7. disposable rubber inspection gloves shall be qualified products for obtaining medical device registration certificate. 8. disposable masks shall be qualified products for obtaining registration certificate of medical devices. 9. the disposable use of the hat shall be a qualified product for obtaining the medical device registration certificate. 10. the medical absorbent gauze piece shall be the qualified product for obtaining the medical device registration certificate. 11. the umbilical cord should be clean and free of pollution. the length shall not be less than 42cm; the weight should not be less than 8 times of its own weight. cotton and viscose gauze should meet their requirements according to yy 0331-2006 standard 5.5 test. according to the 5.9 test of yy 0331-2006, the subsidence time should not exceed 10s; according to the 5.3 test of yy 0331-2006, the solution should not be pink. the content of cotton formaldehyde should be less than 20mg/kg; the ph value of cotton cloth: 4.0 ~ 7.5; if water spines are used for non-woven fabric, the longitudinal fracture strength of non-woven fabric should be greater than or equal to 13n, and the transverse fracture strength should be greater than or equal to 8n. the peel strength of adhesive tape should not be less than 10n. the adhesive should not be greater than 2.5mm. the peel strength should be no less than 1.0n /cm. 12. the edges of the umbilical cord should be smooth, free of burr, and the closure should be flexible and firm. 13. if absorbent cotton gauze is used, cotton fiber should meet the requirements of the identification test a, b and c. if the cotton viscose cotton fiber is used, it should meet the requirements of the identification test a and c; the viscose fiber should meet the requirements of identification test b; the luster of the product shall meet the requirements of the identification test d; the solution should not be pink; only occasionally a small number of isolated foreign fibers exist; cotton and viscose gauze should meet its requirements; the yarn number of each 100mm should meet the requirements set out in table 1 and table 2 of yy 0331-2006. the quality of each square metre (in grams) shall comply with the requirements of yy 0331-2006 standard table 1 and table 2. the minimum breaking force per 50mm (in newtons) should meet the requirements of yy 0331-2006. the sinking time shall be no more than 10s; the total amount of soluble in ether should not be greater than 0.50%; the surface active substance foam should not exceed 2m. the total amount of soluble in water should not be greater than 0.50%; the solution should not be blue, purple, light red or light brown; the color of the obtained liquid should not be darker than the control liquid specified in appendix a. the quality loss of absorbent cotton gauze should not be greater than 8.0%; the quality loss of cotton viscose blended yarn should not be greater than 11.0%; the total amount of sulphate ash should meet the requirements of table 3 of yy 0331-2006. the suture should not show strong blue fluorescence; the total amount of soluble in water should not exceed 0.50%. 14. the performance of umbilical cord should conform to the requirements specified in gb/t 6836-2007. 15. medical cotton swabs shall be qualified products for obtaining registration certificate of medical devices. 16. the medical cotton ball shall be a qualified product for obtaining the medical device registration certificate. 17. disposable medical package should not be less than 20g/m2; the longitudinal fracture strength of nonwoven fabric should be greater than or equal to 13n, and the transverse fracture strength should be greater than or equal to 8n. if the package is made of hot pressure, the hot pressing part should be firm and not cracked. 18. the medical suture needle shall be a qualified product for obtaining the medical device registration certificate. 19. non-absorbable surgical sutures shall be qualified products for obtaining registration certificate of medical devices. 20. single use should be the qualified product for obtaining medical device registration certificate. 21. the medical absorbent gauze pad shall be the qualified product for obtaining the medical device registration certificate. 22. disposable sterilized rubber surgical gloves shall be qualified products obtained from medical device registration certificate. 23. the medical gauze bandage shall be a qualified product for obtaining the medical device registration certificate. 24. self-adhesive wound care should be a qualified product to obtain medical device registration certificate. 25. disposable sterile maternal bleeding should be a qualified product to obtain the medical device registration certificate. 26. the shoe cover is made of non-woven fabric, coated non-woven fabric or plastic film, and the appearance shall have no holes. the shoe cover made of hot pressure should be straight, no leakage pressure, and the fracture strength should be no less than 5n. the elongation ratio of elastic band should be 1:2.2-1:3. the elastic recovery rate should be 75.0%; the specification of non-woven fabric shall not be less than 20g/m2; the longitudinal fracture strength should be greater than or equal to 17.0n, and the transverse fracture strength should be greater than or equal to 3.0n; film nonwovens used shall be not less than 30 g / ㎡, film should level off, without bleb, separation phenomenon; the plastic film shall not be damaged, and the thickness of the plastic film shall not be less than 0.01mm. 27. the sterile protective cover shall be a qualified product for obtaining the medical device registration certificate. 28. the name, specification and quantity of the goods in the package shall meet the requirements of table 1 and table 2. 29. bags should be sterile. 30. the residue of ethylene oxide should not be greater than 5ug/g.
[scope of application] applicable to clinical obstetrics and gynecology clinical obstetrics and gynecology.
contraindication: no absolute contraindication.
1. this product is a disposable product, which is damaged in packaging and is strictly prohibited to be used and destroyed after use.
2. see packaging seal or label on the production batch number, and the sterilization date is in the outer packing box.
3. this product is sterilized by ethylene oxide.
[use method] 1. select the applicable patient's specifications and model, and then open the package after the outer packing is in good condition.
2. take out the accessories according to the surgical needs.
3. after the product is finished, it should be treated with medical waste to avoid pollution.
[storage method] 1. this product is used in the carriage and hold of the cabins, and is kept clean, without pressure, sunshine and rain and snow.
2. handle gently in handling and avoid violent collision;
3. the product shall be stored away from the fire source, and the relative humidity shall not exceed 80%, without corrosive gas and well-ventilated and clean environment.
[production date] see packaging seal or label.
expiry date: see packaging seal or label.
[label, package logo]
[specification preparation date] february 7, 2017.
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