Abstract: Abstract: Objective To test the hemolysis of the halogenated butyl rubber stopper for injection，medical injectors and medical infusion sets producing，operating or using in Hebei，in order to evaluate their biological safety．Method According to the national standard，using static in vitro direct contact hemolysis，by the experimental animal rabbit heart blood，the hemolysis ratios of infusion sets for single use，sterile injector for single use and halogenated butyl rubber stopper with injection of 10 batches of sample were tested respectively． ，and analyzed and compared in vitro hemolysis degree of the three categories of products． Result The hemolysis rates of the tested samples ＜ 5%． Conclusion Hemolysis of the tested samples is all in line with the provisions of relevant product standards，show that the three kinds of products have definite biological safety in hemolysis．

Key words: <p>medical infusion set, medical injector, halogenated butyl rubber stopper, hemolysis ratio, biological safety</p>

摘要： 摘要: 目的通过测定河北省内生产、销售或正在使用的医用输液器、注射器具和注射用卤化丁基胶塞的溶血性，以评价其生物安全性。方法依据国标，采用体外静态直接接触溶血法，以实验兔心脏血为材料，分别测定了一次性输液器、一次性无菌注射器和注射用卤化丁基胶塞各10 批样品的溶血率，并对该3 类产品体外溶血程度进行了比较。结果所测样品的溶血率均＜ 5%。结论所测样品的溶血性均符合相关产品标准的规定，表明该3 类产品在溶血方面具有一定的生物安全性。

关键词: <, p>, 医用输液器, 医用注射器, 卤化丁基胶塞, 溶血率, 生物安全性<, /p>