产品结构: 本产品由保护套、针管、针座、和注射器组成。
Product structure: The product consists of protective cover, needle tube, needle seat and syringe.
产品用途: 一次性使用配药注射器主用于临床输液和注射时的配药和溶药。
Product Usage: Disposable syringe for mixing medicines is mainly used to mix and dissolve medicine in clinical transfusion and injection.
规格型号:Model:
注射器型号 Syringe Model:20ml、30ml、50ml
配药针规格Needle spec:16# 斜口型Bevel、侧孔型 side pinprick
产品标准: YZB/豫0006-2007
产品特点:Product feature:
1、本产品采用医用高分子材料制造,经环氧乙烷灭菌, 环氧乙烷残留量应不大于10微克/克,产品应无菌、无热原、溶血率不大于5%、无急性全身毒性。
The products are made of medical high polymer, sterilized by EO, the residual EO should not be more than 10mg/m, product should be sterilization, pyrogen-free, and hemolytic rate not more than 5%, no acute systemic toxicity.
2、注射器表面必须清洁无杂质,不得有毛边、毛刺、塑流、缺损等缺陷。
The surface of the syringe must be clear and pure; rough edge, burr, plastic stream, defect are not allowed.
3、注射器外套应有足够透明度,能清晰地看到基准线。
The outer barrel of the syringe should be transparent enough; bench line can be seen distinctly.
4、注射器的内表面(包括橡胶活塞),不得有明显可见的润滑剂汇聚。
No any evident lubricant collection on the internal surface of the syringe (including the plunger).
5、橡胶活塞应无胶丝、胶屑、外来杂质、喷霜。
Rubber plunger should not be rubber thread, rubber chipping, foreign impurity, spray frost.
6、标尺的分度容量线及计量数字印刷应完整,字迹清楚,线条清晰,粗细均匀。
The scale mark and measure figure on the ruler should be printed completely, neat writing, legible line and even thickness.
7、偏头式注射器,锥头在外套封底端偏离中心,应位于外套卷边短轴一侧的中心线上,且锥头轴线与外套内壁表面最近点之间距离不得大于4.5mm。
Hemilateral cone head syringe, the cone head is out of center on the bottle of the barrel, should be located at the central line of short minor axis side of the curling edge, and the nearest distance between the cone head axis and the barrel internal surface not longer than 4.5mm.
8、产品的其他相关技术指标均应符合GB 15810-2001的相关要求。
9、产品说明: 一次性使用,用后销毁。
Descript ion: Single use only, discards after use.
10、有效期: 三年
Shelf life: 3 years