血液透析相关器械检测清单

结论：血液接触和液体通路完整性是所有透析产品的共同主线

血液透析涉及多类产品：透析机、透析器、血液管路、穿刺针、透析液浓缩物、以及水处理设备。

共同的主线有两条：

血液接触。 血液在体外循环，接触管路、透析器膜、接头。接触面积大、接触时间长（每次数小时，每周多次），血液相容性的要求相应严格。

液体通路的完整性。 泄漏意味着失血或空气进入，后果严重。所有通路部件的密封和连接强度都要验证。

产品类别与考察重点

透析器的考察

清除率。 对不同分子量溶质的清除能力。

超滤系数。 单位压力下的超滤量。

膜面积。 有效膜面积。

预充容量。 体外循环的血容量。

耐压。 膜和外壳的耐压能力。

破膜。 膜破裂时的表现和检出。

血液相容性。 膜材料与血液的相互作用。

微粒。 冲洗后的微粒释放。

残留物。 生产过程和灭菌过程的残留。

「膜的破裂」是需要考察的失效模式，因为破膜意味着血液与透析液混合，后果严重。设备应当能检出破膜（通过血液泄漏检测）。

血液管路的考察

强度。 拉伸、抗压、接头的抗拉。

密封。 各连接处的密封性、耐压。

管路的抗折。 折弯后是否堵塞。

透明度。 便于观察血液和气泡。

与泵的配合。 泵段的耐磨和弹性保持。泵段在蠕动泵中反复挤压，是磨损和微粒的来源。

微粒。 冲洗和使用中产生的微粒。

血液相容性。 材料与血液的相互作用。

增塑剂的迁移。 如果使用含增塑剂的材料。

「泵段的耐久」是管路的关键项。 蠕动泵持续挤压泵段数小时，泵段材料可能疲劳、产生微粒、甚至破裂。应当做实际泵送条件下的耐久验证。

透析机的考察

电气安全与电磁兼容。 通用要求。

液路系统。 密封、流量控制、温度控制、电导率控制。

监测精度。 温度、电导率、压力、流量、超滤量的监测精度。

超滤控制精度。 这是关键性能，超滤量偏差直接影响患者的液体平衡。

报警系统。 压力、温度、电导率、气泡、血液泄漏、断电等报警。

气泡检测。 空气进入血管的后果严重，检测能力要验证。

血液泄漏检测。 检出透析液侧的血液。

消毒功能。 机器的自身消毒程序及效果。

断电应对。 停电时的安全状态与血液回输。

「超滤控制精度」和「气泡检测」是透析机的两个核心安全项。 前者关系到治疗效果和患者的血流动力学稳定，后者关系到空气栓塞的风险。

血液相容性的要求

透析产品的血液接触是大面积、长时间、反复的，评价要求相应：

溶血。 血细胞的破坏。

凝血系统。 对凝血功能的影响。

血小板。 黏附与活化。

补体激活。 膜材料容易引起补体反应。

白细胞。 白细胞的活化与减少。

试样的状态。 最终产品状态，经过灭菌和冲洗。

「补体激活」在透析膜材料上是重点，因为膜面积大、接触时间长，补体激活可能引起临床反应。

水与浓缩物

水质。 化学指标、微生物、内毒素。透析用水的水质要求高于饮用水。

浓缩物的成分。 各成分的含量与允差。

配比精度。 稀释后的最终浓度。

微生物与内毒素。 浓缩物本身的要求。

包装。 防止污染和成分变化。

「内毒素」是透析用水的关键指标，因为内毒素可能透过膜进入血液，引起发热反应。

复用相关的考察

部分地区存在透析器复用，相关的考察包括：

复用后的性能。 清除率、超滤系数的保持。

复用次数。 性能下降到限值对应多少次。

消毒剂残留。 复用处理后的残留。

完整性测试。 复用前的完整性检查方法。

「复用后的性能衰减」需要数据支撑，而不是凭经验规定次数。

设备与耗材的配合

透析机与耗材是配套使用的，配合关系要验证：

管路与泵的配合。 泵段尺寸与泵头的匹配，不匹配会影响流量精度。

透析器与机器的连接。 接头的匹配与密封。

流量精度受耗材影响。 泵段的弹性和尺寸直接影响血流量的准确性。

传感器与管路的配合。 压力监测、气泡检测依赖管路在传感器中的正确安装。

兼容范围的声明。 机器声称兼容哪些耗材。

「血流量精度受泵段影响」是实际问题。 不同厂家的管路泵段尺寸和弹性不同，同一台机器用不同管路，实际血流量可能有差异。兼容性声明中的耗材都应当验证流量精度。

消毒与维护

透析机需要频繁消毒，相关考察包括：消毒程序的有效性；消毒剂残留的去除；液路系统的生物膜控制；以及维护周期与项目。

「消毒剂残留」要验证，因为残留会随透析液进入与血液接触的界面。

穿刺针的考察

穿刺针直接接触血管，考察内容包括：

锐利度。 穿刺所需的力，影响患者感受和血管损伤。

强度。 针体的抗弯和抗断，断针留在体内后果严重。

流量。 在规定压力下的流量，影响治疗效率。

针尖形状。 影响穿刺和流量。

固定翼与管路连接。 连接的牢固性。

血液相容性。 与血液的直接接触。

「针体的抗断」是必须验证的，因为断针是严重的不良事件。

我们的做法

承接透析相关委托时，我们会把血液相容性和微粒作为重点项目，试样使用最终状态的产品（经过灭菌和规定的冲洗），因为这两项的结果对试样状态很敏感。

对于管路产品，我们建议做泵段在实际泵送条件下的耐久验证，并在耐久后检测微粒 ——这对应的是实际治疗中数小时连续泵送的情形。

如果你有透析相关产品需要安排检测，想先理清项目清单，可以把产品资料发过来一起讨论，或者直接联系：132 4819 8029。能力范围见服务介绍，流程见检测流程，更多内容见知识库。

English version

Conclusion. Haemodialysis involves several product categories: dialysis machines, dialysers, blood tubing sets, fistula needles, dialysis concentrates and water treatment equipment. Two lines run through all of them. Blood contact, since blood circulates extracorporeally through tubing, dialyser membrane and connectors over a large area for long periods, several hours at a time and several times a week, making haemocompatibility requirements correspondingly strict. And fluid pathway integrity, since leakage means blood loss or air entry with serious consequences, so sealing and joint strength must be verified throughout.

Focus by product. Dialysers require membrane performance, clearance, ultrafiltration and haemocompatibility. Blood tubing requires strength, sealing, haemocompatibility and particulates. Fistula needles require sharpness, strength, flow and haemocompatibility. Dialysis machines require electrical safety, monitoring accuracy, alarms and the fluid pathway. Concentrates require composition, proportioning and microbiological quality. And water treatment requires water quality, microbiology and endotoxin.

Examining dialysers. Clearance covers removal of solutes across molecular weights. The ultrafiltration coefficient covers ultrafiltration per unit pressure. Membrane area covers the effective surface. Priming volume covers the extracorporeal blood volume. Pressure resistance covers membrane and housing. Membrane rupture covers behaviour and detection when a membrane fails. Haemocompatibility covers membrane-blood interaction. Particulates cover release after rinsing. And residues cover what manufacture and sterilisation leave behind. Membrane rupture is a failure mode requiring examination, since it mixes blood with dialysate with serious consequences, and the machine should detect it through blood leak monitoring.

Examining blood tubing. Strength covers tension, compression and joint tensile strength. Sealing covers integrity and pressure resistance at each connection. Kink resistance covers whether bending occludes the lumen. Transparency allows blood and air to be seen. Pump segment compatibility covers wear resistance and retention of elasticity, since the segment is repeatedly compressed in a peristaltic pump and is a source of wear and particulates. Particulates cover what rinsing and use generate. Haemocompatibility covers material-blood interaction. And plasticiser migration applies where plasticised materials are used. Pump segment durability is the critical tubing item: a peristaltic pump compresses the segment continuously for hours, and the material may fatigue, shed particles or rupture. Verify durability under actual pumping conditions.

Examining dialysis machines. Electrical safety and electromagnetic compatibility follow the general requirements. The fluid system covers sealing, flow control, temperature control and conductivity control. Monitoring accuracy covers temperature, conductivity, pressure, flow and ultrafiltration volume. Ultrafiltration control accuracy is key performance, since deviation directly affects the patient's fluid balance. The alarm system covers pressure, temperature, conductivity, air, blood leak and power failure alarms. Air detection matters because air entering the circulation has serious consequences, so detection capability must be verified. Blood leak detection covers blood appearing on the dialysate side. Disinfection function covers the machine's self-disinfection programme and its effectiveness. And power failure provisions cover the safe state and blood return. Ultrafiltration control accuracy and air detection are the two core safety items: the first bears on treatment effectiveness and haemodynamic stability, the second on the risk of air embolism.

Haemocompatibility requirements. Blood contact in dialysis covers a large area for long periods, repeatedly, and evaluation follows. Haemolysis covers damage to blood cells. Coagulation covers effects on clotting. Platelets cover adhesion and activation. Complement activation matters because membrane materials readily provoke it. Leucocytes cover activation and depletion. And specimens must be in final product condition, sterilised and rinsed. Complement activation is the focus for membrane materials, since large area and long contact make complement-mediated clinical reactions possible.

Water and concentrates. Water quality covers chemical parameters, microbiology and endotoxin, with dialysis water held to a higher standard than drinking water. Concentrate composition covers the content and tolerance of each constituent. Proportioning accuracy covers the final concentration after dilution. Microbiology and endotoxin apply to the concentrate itself. And packaging must prevent contamination and compositional change. Endotoxin is the key parameter for dialysis water, since it can cross the membrane into the blood and provoke pyrogenic reactions.

Reuse considerations. Where dialyser reuse is practised, examination covers performance after reuse, meaning retention of clearance and ultrafiltration coefficient; the number of reuses corresponding to performance falling to the limit; disinfectant residues after reprocessing; and integrity test methods before reuse. Performance decline through reuse needs data rather than an experience-based limit on cycles.

How we handle it. For dialysis work we treat haemocompatibility and particulates as priority items, using final-condition product, sterilised and rinsed as specified, since both are sensitive to specimen condition. For tubing sets we suggest verifying pump segment durability under actual pumping conditions and measuring particulates afterwards, which corresponds to the hours of continuous pumping in an actual treatment.

Send us the product documentation and we will work through the item list. Phone or WeChat: +86 132 4819 8029.