物理性能的试验方法
1. 材料
材料供应商提供证明。
2. 尺寸
以通用或专用量具测量。
3. 采血针的静脉针的刚性，韧性，耐腐蚀性
标准：按GB15811-2001中4.3条规定的方法进行。
① 刚性检验方法：将一规定的力施加到两端被支撑的针管的规定跨距的中心，测量其针管的挠度值。
② 韧性检验方法：将针管的一端固定，从固定点到规定跨距的针管上施加一个力，首先向一个方向，然后向其相反方向弯曲一个规定的角度，如此反复弯曲规定次数。
③ 耐腐蚀性检验方法：将针管的一部分在氯化钠溶液中浸泡规定时间后，将浸泡的部位与未浸泡部位比较，用目力观察腐蚀痕迹
翻译。
4. 采血针器身密合性
采血针各出入口封闭，抽真空至负压50kPa后浸入20~30℃水中15秒，观察应无水进入。
5. 采血针的静脉针保护套
用目力检验。
6. 圆锥孔分离力
标准：按GB18671-2002中6.3.1条进行。
方法：输液针针柄与针管连接处施加20N的轴向静拉力持续10s，应不断开或松动。
Test Method for Physical Properties
1. Material
The certification shall be provided by the material supplier.
2. Size
It shall be measured by common or special gauges.
3. Rigidity, toughness and corrosion resistance of scalp vein set for puncture needle
Standard: comply with the methods specified in Section 4.3 of GB15811-2001
a) Test method for rigidity: apply the specified force to the center of regulated span for needle tube, whose two ends are supported, and measure the flexibility value of the needle tube.
b) Test method for toughness: fix one end of the needle tube and apply force to the needle tube from the fixed point to regulated span, bending into a specified angle, first towards one direction and then towards the opposite direction. Bend the needle tube repeatedly until reach the required times.
c) Test method for corrosion resistance: after immersing part of the needle tube into sodium chloride solution for required time, compare the immersed part and non-immersed part and observe the corrosion trace visually.
4. Tightness of puncture needle tube
Seal the inlets and outlets of puncture needle. Pump the vacuum into the 50kPa of negative pressure and immerse the needle into the water of 20~30℃ for 15 seconds. Observe that there shall be no water flowing in.
5. Protective sleeve of scalp vein set for puncture needle
Inspect visually.
6. Separating force of conical bore
Standard: apply with Section 6.3.1 of GB18671-2002.
Method: apply the axial quiet tensile of 20N to the joint of infusion needle handle and needle tube for 10s. It should not disconnect or loose.
化学性能的试验方法
1. 还原物质
标准：按照GB/T14233.1-1998中5.2.1条进行。
方法：直接滴定法。 高锰酸钾是强氧化剂，在酸性介质中，高锰酸钾与还原物质作用，
2. 酸碱度
标准：按照GB/T14233.1-1998中5.4.1条进行。
方法：取标准检验液和空白对照液，用酸度计分别测定其PH值，以两者之差作为检验结果。
2. 紫外吸光度
标准：按照GB/T14233.1-1998中5.7条进行。
方法：取标准检验液，用0.45μm的微孔滤膜过滤，在5h内用1cm检验池以空白对照液为参比在规定的波长范围内测定吸光度。
3. 重金属
标准：按照GB/T14233.1-1998中5.6.1条进行。
方法：在弱酸性溶液中，铅，铬，铜，锌等重金属能与硫代乙酰胺作用生成不溶性有色硫化物。以铅为代表制备标准溶液进行比色，测定重金属的总含量
德语口译。
4. 蒸发残渣
标准：按照GB/T14233.1-1998中5.5条进行。
方法：蒸发皿预先在105℃干燥恒重，精确称重。取标准检验液50ml加入蒸发皿中，在水浴上蒸干并在105℃恒温箱中干燥至恒重。同法测定空白对照液。
5. 环氧乙烷残留量
标准：按照GB/T14233.1-1998中9条进行。
方法：气相色谱法（仲裁法）。在一定温度下，用萃取剂——水萃取样品中所含环氧乙烷（EO），用顶空气相色谱法测定环氧乙烷含量。
Test Method for Chemical Properties
1. Reduction Substance
Standard: apply with Section 5.2.1 of GB/T14233.1-1998.
Method: direct titration. As one of the strong oxidizers, potassium permanganate can react with the reduction substance.
2. pH Value
Standard: apply with Section 5.4.2 of GB/T14233.1-1998.
Method: Take standard test solution and blank control solution and determine their Ph values by acidimeter. The difference between the two values is the result for test.
3. UV Absorbance
Standard: apply with Section 5.7 of GB/T14233.1-1998.
Method: Take standard test solution and filter it with micro porous filter membrane of 0.45μm. Taking the blank control solution as reference, absorbance can be determined by 1cm test gauge in the regulated wavelength range within 5 hours.
4. Heavy Metal
Standard: apply with Section 5.6.1 of GB/T14233.1-1998.
Method: in the weakly acidic solution, heavy metals such as lead, chrome, copper, zinc and etc. can react with thioacetamide and generate colored sulfide. Taking lead as the typical substance, prepare standard test solution for color compression and determine the total content of heavy metals.
5. Evaporation residue
Standard: apply with Section 5.5 of GB/T14233.1-1998
Method: evaporating dish shall be dried at 105℃ to constant weight before hand and weighed precisely. Take 50ml standard test solution and add into the evaporation dish. Evaporate it to dryness on water-bath and then dry it to constant weight in 105℃ calorstat. The blank control solution can be determined in the same say.
6. Ethylene oxide residue
Standard: comply with Section 9 of GB/T14233.1-1998.
Method: Gas chromatography (arbitration method). At a certain temperature, extract the ethylene oxide (EO) contained in the sample by water. The content of ethylene oxide can be determined by headspace gas chromatography.
