内窥镜送检：光学、机械与再处理

结论：再处理耐受是内窥镜检测中容易被低估的部分

内窥镜的检测涉及三个方面：光学性能（能看清楚）、机械性能（能操作、能承受）、以及再处理耐受（能反复清洗消毒灭菌）。

前两方面比较直观，第三方面容易被低估。 但内窥镜是重复使用器械，每次使用后都要经历完整的再处理流程——清洗、消毒或灭菌、干燥、存储。一台内窥镜在使用寿命中要经历数百到数千次这样的循环。

再处理对材料、粘接、密封、涂层的作用是累积的，而累积到一定程度的失效可能表现为漏液、图像劣化、操作失灵。

项目的组织

光学性能的考察

分辨力。 能分辨的最小细节，通常用分辨力靶测试。

视场角。 观察范围。

方向角。 视轴与器械轴的夹角。

畸变。 图像的几何失真程度。

色彩还原。 对颜色的还原准确性。临床上颜色是判断的依据之一，色彩失真会影响判断。

照明均匀性。 视野内照明的均匀程度。

照度。 照明的强度是否足够。

景深。 清晰成像的距离范围。

「色彩还原」在诊断类内窥镜上很重要，因为黏膜的颜色变化是重要的观察指标。

机械性能的考察

弯曲角度。 各方向的弯曲范围。

操作力。 控制弯曲所需的力，过大会导致操作疲劳。

弯曲的回复。 松开控制后是否回到直位。

弯曲耐久。 反复弯曲的循环寿命。弯曲部是内窥镜的高频受力部位。

插入部的柔韧性。 弯曲刚度，影响插入的顺畅性。

抗拉与抗扭。 意外受力时的承受能力。

器械通道。 通道的通畅性、器械通过的顺畅度。

「弯曲耐久」应当做足够的循环次数，并在循环后复测弯曲角度、操作力、以及密封性——弯曲部的反复动作可能导致外皮疲劳和密封失效。

密封性的考察

这是内窥镜的关键安全项：

整机气密。 在规定压力下的泄漏量。

各密封点。 弯曲部、接口、按钮、通道口。

再处理后的密封。 经过清洗消毒循环后是否仍然密封。

泄漏检测功能。 部分内窥镜有泄漏检测接口，其功能要验证。

密封失效的后果。 液体进入内部，造成图像劣化、电气风险、以及无法彻底再处理带来的感染风险。

「再处理后的密封」是必须验证的。 新品密封良好，经过数百次再处理循环后密封件老化、粘接劣化，可能出现微小泄漏而不易察觉。

再处理耐受的验证

循环次数。 按声称的使用寿命确定循环次数。

完整流程。 按说明书规定的完整再处理流程，含清洗剂、消毒剂、灭菌方式。

中间检查。 在循环过程中的不同时点检查性能，得到劣化趋势。

循环后复测。 光学性能、机械性能、密封性、外观。

多种方法的组合。 如果声称支持多种消毒灭菌方式，各方式都要验证，或者按最严的验证。

「中间检查」能得到劣化趋势，比只测循环前后有用——它能说明性能是逐步下降还是在某个时点突然劣化。

清洗有效性的考察

再处理不只是耐受，还包括能否洗干净：

通道的可清洗性。 细长的器械通道能否被有效清洗。

结构的清洗可及性。 有无难以清洗的死角。

清洗效果的验证。 用模拟污染物验证清洗流程的有效性。

干燥。 通道内的水分能否被去除，残留水分影响消毒效果和储存。

「通道的可清洗性」是设计上的关键。 通道细长且可能有弯曲，清洗刷能否到达、冲洗能否覆盖全部内壁，都要验证。

送检准备的建议

提供完整的再处理说明。 清洗剂、消毒剂、灭菌方式、流程步骤、参数。

提供声称的使用寿命。 以及对应的再处理循环次数。

提供配套附件。 清洗刷、密封帽、测漏器等。

提供光学参数的设计值。 便于对照。

准备足够样品。 再处理循环试验周期长，可能需要专用样品。

说明适配的器械。 通过器械通道使用的附件。

电子内窥镜的额外项目

含电子成像元件的内窥镜，还要考察：

电气安全。 漏电流、隔离、患者连接部分的要求。

电磁兼容。 发射与抗扰度，图像质量在干扰下的保持。

图像处理。 电子图像的处理与显示。

发热。 图像传感器和照明的发热，特别是接触人体的前端。

电缆与连接器。 电气连接的可靠性和耐再处理。

「前端发热」是电子内窥镜的关注点，因为成像元件和照明都在前端，而前端与黏膜接触。

使用与维护资料

资料中应当包含：再处理的完整流程与参数；每次使用前后的检查；泄漏检测的方法与频次；存储要求；维修与保养的周期；使用寿命与更换判断；以及不可使用的情形。

「泄漏检测的频次」建议明确，因为泄漏是内窥镜的关键失效模式，而定期检测能在问题扩大前发现。

附件与配套器械

通过器械通道使用的附件同样需要考察：附件与通道的配合尺寸；附件通过时对通道内壁的磨损；附件本身的性能与生物相容性；以及附件是一次性还是可重复使用。

「附件对通道内壁的磨损」是长期使用中的问题，反复通过的器械可能划伤通道内壁，而划痕会成为难以清洗的位置。

我们的做法

承接内窥镜委托时，我们建议把再处理循环后的性能复测作为重点项目，特别是密封性和光学性能。这两项的劣化直接关系到安全和诊断质量，而新品数据反映不出来。

弯曲耐久试验我们建议与再处理循环结合——交替进行弯曲循环和再处理循环，这更接近实际使用的情况，因为实际中两种作用是交替发生的。

如果你有内窥镜类产品需要安排送检，想先理清项目和再处理验证的安排，可以把产品资料和再处理说明发过来一起讨论，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. Endoscope testing covers three areas: optical performance, meaning the ability to see clearly; mechanical performance, meaning the ability to be operated and to withstand use; and reprocessing tolerance, meaning the ability to be cleaned, disinfected and sterilised repeatedly. The first two are intuitive and the third is underestimated. Endoscopes are reusable, undergoing a complete reprocessing cycle after every use: cleaning, disinfection or sterilisation, drying and storage. Across its service life an endoscope undergoes hundreds to thousands of such cycles. Reprocessing acts cumulatively on materials, adhesive joints, seals and coatings, and accumulated damage may present as leakage, image degradation or loss of control.

Organising the items. Optical performance covers resolution, field of view, distortion, colour and illumination. Image transmission covers the quality of the fibre bundle or electronic imaging. Mechanical performance covers articulation angle, operating force and durability. Structural integrity covers sealing, pressure resistance and joint strength. Reprocessing covers tolerance of cleaning, disinfection and sterilisation. Electrical safety applies to endoscopes containing electronic components. Biocompatibility covers patient-contacting parts. Accessories and channels cover the instrument channel and air and water supply. And environmental and mechanical testing covers drop, vibration, temperature and humidity.

Examining optical performance. Resolution covers the smallest detail distinguishable, usually tested with a resolution target. Field of view covers the observable extent. Direction of view covers the angle between optical and instrument axes. Distortion covers geometric deviation in the image. Colour reproduction covers accuracy of colour, which matters because colour informs clinical judgement and distortion affects it. Illumination uniformity covers evenness across the field. Illuminance covers whether illumination is adequate. And depth of field covers the range over which the image is sharp. Colour reproduction matters particularly in diagnostic endoscopes, since changes in mucosal colour are an important observation.

Examining mechanical performance. Articulation angle covers the range in each direction. Operating force covers the effort to control articulation, excessive force causing fatigue. Articulation recovery covers whether the tip returns to straight when released. Articulation durability covers cycle life, the bending section being the highest-duty area. Insertion tube flexibility covers bending stiffness, which affects ease of insertion. Tensile and torsional strength cover tolerance of accidental loading. And the instrument channel covers patency and smooth passage of instruments. Perform sufficient articulation cycles and re-measure articulation angle, operating force and sealing afterwards: repeated movement of the bending section can fatigue the outer sheath and compromise sealing.

Examining sealing. This is the critical safety item for endoscopes. Whole-instrument leak testing measures leakage at a specified pressure. Individual seal points cover the bending section, connectors, buttons and channel ports. Sealing after reprocessing establishes whether it holds after cleaning and disinfection cycling. And leak test functions, where an endoscope has a leak test port, require verification. Seal failure admits liquid, causing image degradation, electrical risk and, because thorough reprocessing becomes impossible, infection risk. Sealing after reprocessing must be verified: a new instrument seals well, while after hundreds of cycles seals age and adhesive joints degrade, and small leaks may develop unnoticed.

Verifying reprocessing tolerance. Set the cycle count from the claimed service life. Follow the complete process as the instructions specify, including cleaning agents, disinfectants and sterilisation method. Inspect at intervals during cycling to obtain the degradation trend. Re-measure afterwards, covering optical performance, mechanical performance, sealing and appearance. And cover combinations of methods, verifying each claimed disinfection and sterilisation method or verifying to the most severe. Intermediate inspection yields the degradation trend, which is more useful than measuring only before and after because it shows whether performance declines gradually or deteriorates suddenly at some point.

Examining cleaning effectiveness. Reprocessing involves not only tolerance but whether the instrument can be cleaned. Channel cleanability covers whether a long narrow instrument channel can be cleaned effectively. Structural accessibility covers whether any areas resist cleaning. Cleaning validation uses simulated soil to verify the process. And drying covers removal of moisture from channels, since residual water affects disinfection and storage. Channel cleanability is a design-critical matter: channels are long, narrow and possibly curved, and whether brushes reach and flushing covers the whole inner wall must be verified.

Preparing for submission. Provide complete reprocessing instructions covering agents, sterilisation methods, process steps and parameters. State the claimed service life and the corresponding cycle count. Provide accessories including cleaning brushes, sealing caps and leak testers. Provide design values for optical parameters for comparison. Prepare enough samples, since reprocessing cycle testing takes a long time and may need dedicated units. And describe compatible instruments passed through the channel.

How we handle it. For endoscopes we suggest treating performance re-measurement after reprocessing cycling as a priority item, sealing and optical performance especially, since their degradation bears directly on safety and diagnostic quality while new-instrument data reveal nothing about it. We suggest combining articulation durability with reprocessing cycling, alternating the two, which is closer to real use where both act in alternation.

Send us the product documentation and reprocessing instructions and we will work through the items and cycling arrangements. Phone or WeChat: +86 132 4819 8029.