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本站編輯:杭州欣浩醫(yī)療科技有限公司
發(fā)布日期:2018-05-29 14:44
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【產(chǎn)品名稱】: 自粘性傷口護(hù)貼 

【規(guī)格型號】:Ⅰ型、Ⅱ型、Ⅲ型、Ⅳ型

【主要結(jié)構(gòu)組成】:自粘性傷口護(hù)貼根據(jù)材質(zhì)不同可分為四個型號:由水刺法非織造布、吸收芯墊、離型紙制成為I型;由水刺法非織造布、離型紙制成為II型;由透明薄膜膠帶、吸收芯墊、離型紙制成為III型;由透明薄膜膠帶、離型紙制成為IV型。

【產(chǎn)品性能】:1、基布應(yīng)色澤一致、薄厚均勻、表面潔凈平整,無脫膠、污漬、雜質(zhì)、破損和漏膠等現(xiàn)象。

                      2、切邊整齊,吸收芯墊置于護(hù)貼的正中位置,允差±5mm,無自然脫落現(xiàn)象。

                      3、基布應(yīng)平整地附著于保護(hù)離型紙上,無翻邊、無卷邊和疊邊現(xiàn)象。                                                              

                      4、離型紙應(yīng)完全覆蓋在護(hù)貼的基布上,無基布、吸收芯墊外露現(xiàn)象。

                      5、持粘性:按YY/T 0148-2006 附錄B中第B.2章試驗時,在烘箱內(nèi)試驗期間,貼于不透鋼板 的頂端下滑應(yīng)不超過2.5mm。

                      6、剝離強(qiáng)度:按YY/T 0148-2006 附錄B中第B.2章試驗時,粘貼膠帶每1cm寬度所需的平均力應(yīng)不小于1.0 N。

                      7、基布的含膠量:粘膠層的含膠量應(yīng)≥35g/m2。

                      8、吸收芯墊吸水性:其飽和吸水比應(yīng)>1:6。

                      9、護(hù)貼應(yīng)無菌,無菌有效期兩年。

                      10、經(jīng)環(huán)氧乙烷滅菌的護(hù)貼,其環(huán)氧乙烷殘留量應(yīng)不超過10μg/g。

                      11、護(hù)貼對人體皮膚應(yīng)無刺激。

                      12、護(hù)貼對人體皮膚應(yīng)無遲發(fā)型超敏反應(yīng)。

                      13、護(hù)貼細(xì)胞毒性應(yīng)不大于2級。

【適用范圍】:用于手術(shù)切口及留置動、靜脈導(dǎo)管時貼敷皮膚用及術(shù)后或外傷創(chuàng)面貼敷,  嬰兒肚臍口創(chuàng)口保護(hù)。

【使用方法】:打開包裝,撕去隔離紙貼于切口的覆蓋。

【注意事項】:本品僅限一次性使用,用后銷毀。本品經(jīng)環(huán)氧乙有 效期兩年。包裝破損嚴(yán)禁使用。    

【生產(chǎn)日期】:見合格證或包裝封口處。

【生產(chǎn)批號】:見合格證或包裝封口處。

【失效日期】:見合格證或包裝封口處。

【禁忌癥】:暫無發(fā)現(xiàn)

【貯   存】:在相對濕度不超過80%,無腐蝕性氣體、清潔、 通風(fēng)良好的庫房內(nèi)。

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[product name]: self adhesive wound care

[specifications] type I, II, III, IV

[main structure composition]: self adhesive wound patch can be divided into four models according to different materials: spunlaced nonwovens, absorption pads, and off type paper made into I type; II type by spunlace nonwovens and off type paper system; III type by transparent film tape, absorption pad, off type paper, transparent film tape, The form paper is IV.

[product performance]: 1, the base cloth should be uniform in color, uniform in thickness, clean and smooth in appearance, no degumming, stains, impurities, breakage and glue leakage.

2, trimming trimming, absorption core pad placed in the middle of the protective pad, tolerance difference of + 5mm, no natural shedding phenomenon.

3, the base cloth should be attached to the protection of the type paper, without flanging, no curling and overlapping. 4, the release paper should be completely covered on the base of the protective clothing, without the base cloth and the absorbing core mat.

5, sticky: according to chapter YY/T B.2 of appendix B of test 0148-2006, during the oven test, the top of the steel plate should be slipped below 2.5mm.

6, peel strength: according to the chapter B.2 of appendix B of YY/T 0148-2006, the average force required for sticking tape should be less than 1 N per 1cm width.

7. The amount of glue contained in the base cloth: the adhesive content of the adhesive layer should be more than 35g/m2.

8, absorbing core pad water absorption: its saturated water absorption ratio should be > 1:6.

9. The protective paste should be aseptic and the aseptic period is two years.

10. The ethylene oxide residue of ethylene oxide sterilized patch should not exceed 10 g/g.

11, the protective paste should not be irritating to the skin of the human body.

12. There should be no delayed hypersensitivity to human skin.

13. The cytotoxicity of the paster should not be more than 2.

[scope of application]: apply for skin incision with surgical incision and indwelling catheter, and post operation or wound surface application.

[use method]: open the package, tear off the isolation paper and stick it to the coverage of the incision.

[note]: This product is restricted to one time use and destroyed after use.  This product is valid for two years by epoxy B. The breakage of the packing is strictly prohibited.

[production date]: see the certificate or seal.

[production batch number]: see the certificate or seal.

Expiration date: see the certificate or seal.

[contraindication]: no discovery for the time being

Storage: in a storeroom without corrosive gas, clean and well ventilated in a relative humidity of not more than 80%.


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