眼科器械送检要点

结论：光学性能与光辐射安全是这类产品的两条主线

眼科器械大致分两类：一类是诊断或治疗设备（检眼设备、激光治疗设备、手术显微镜），另一类是植入或接触眼组织的产品（人工晶体、角膜接触镜、眼科手术器械）。

对设备类产品，两条主线是光学性能和光辐射安全。 光学性能决定能不能看清楚或者治疗效果；光辐射安全决定会不会对眼组织造成损伤。

对接触或植入类产品，主线是光学性能加生物相容性。 材料要能长期与眼组织相容，光学性能要满足视觉要求。

光辐射安全的考察

眼睛对光的敏感性高于其他组织，光源的辐射需要专门评估：

辐射的测量。 在规定位置测量各波段的辐射量。

波段的区分。 紫外、可见光、红外，各波段的危害机理不同。

危害的类别。 光化学危害（紫外和蓝光）、热危害（可见和红外）。

暴露时间。 危害与暴露时间相关，要按实际的使用时长评估。

分组与限值。 按辐射水平分组，各组对应不同的防护要求。

防护措施。 超出某个水平时需要的警示和防护。

「蓝光危害」在含白光光源的设备上要注意，因为白光光源中的蓝光成分可能较高，而蓝光的光化学危害在长时间暴露下值得关注。

「按实际使用时长评估」很重要。 同样的辐射水平，短时观察与长时间手术照明的累积暴露完全不同。

检眼与成像设备

光学性能。 分辨力、放大倍率、视场、畸变、色差。

照明。 照度、均匀性、色温。

测量功能。 如果设备有测量功能，精度要验证。

图像质量。 成像设备的图像分辨力、对比度、噪声。

与患者的接触。 接触部件的生物相容性与消毒。

固定与定位。 下颌托、额托的舒适性与清洁。

「接触部件的消毒」在眼科设备上很重要，因为眼部感染的传播风险高，而下颌托、接触镜这类部件与多位患者接触。

激光治疗设备

输出参数。 波长、功率、能量、脉宽、重复频率。

参数的准确性。 设定值与实际输出的偏差。

光斑特性。 光斑大小、形状、能量分布。

瞄准光。 瞄准光与治疗光的同轴性。

安全联锁。 门联锁、钥匙控制、紧急停止。

防护。 操作者的眼部防护要求、防护镜的规格。

分类与标识。 按激光的危害等级分类并标识。

「瞄准光与治疗光的同轴性」直接关系到治疗的准确性，偏差意味着治疗位置与预期不符。

人工晶体等植入产品

光学性能。 屈光度、成像质量、像差。

光学参数的标称与实测。 标称屈光度与实测的偏差。

紫外阻隔。 对紫外线的阻挡能力，保护视网膜。

材料性能。 力学性能、光学稳定性。

生物相容性。 长期眼内接触的要求。

灭菌与包装。 无菌屏障与有效期。

稳定性。 长期植入后的光学和材料稳定性。

「屈光度的实测偏差」是关键指标，因为它直接决定术后的视力效果，偏差过大意味着患者需要额外的矫正。

角膜接触镜类

光学参数。 屈光度、基弧、直径。

透氧性。 材料的透氧能力，关系到角膜健康。

含水量。 软镜的含水量及其稳定性。

表面特性。 湿润性、沉积物附着。

机械性能。 抗撕裂、弹性。

生物相容性。 与角膜和结膜的接触。

护理产品的相容性。 与配套护理液的相容。

「透氧性」对长时间配戴的镜片尤其关键，透氧不足会导致角膜缺氧和相关的并发症。

与眼接触的生物相容性

眼组织对刺激敏感，生物相容性的要求相应严格：

接触性质的判定。 与角膜、结膜、房水、玻璃体的接触各不相同。

接触时间。 短时使用的器械与长期植入的产品差别很大。

项目的确定。 按接触性质和时间确定，眼部接触通常需要眼刺激相关的评价。

材料的稳定性。 长期植入产品的材料降解。

加工残留。 抛光剂、清洗剂、脱模剂的残留。

「加工残留」在光学件上要特别注意，因为光学件的加工涉及研磨和抛光，残留物可能停留在表面微结构中。

送检准备的建议

提供光学参数的设计值。 便于对照。

提供光源的技术参数。 便于确定光辐射评估的范围。

提供各工作模式与参数范围。

准备配套附件。 接触镜、防护镜、专用工具。

提供材料信息。 生物相容性评价所需。

说明使用时长。 影响光辐射危害的评估。

各类产品的项目对照

这张表可以作为项目规划的起点，具体按产品的功能和预期用途调整。

使用与清洁

眼科设备的清洁消毒要求较高，资料中应当包含：各部件的清洁方法；接触患者部件的消毒方法与频次；消毒剂的适用与禁用；光学部件的清洁注意事项；以及清洁后的检查。

「光学部件的清洁」要专门说明，因为不当的清洁可能划伤镜片或损坏镀膜，影响光学性能。

送检时的常见问题

光源参数不全。 无法确定光辐射评估的范围。

使用时长未说明。 影响暴露评估的结论。

接触部件的材料信息缺失。 生物相容性无法评价。

配套附件未送。 影响完整性验证。

这几项在送检前确认清楚，能明显缩短沟通和等待的时间。

我们的做法

承接眼科设备委托时，我们会把光辐射安全的评估作为重点项目之一，并按实际的使用时长和使用距离设定评估条件——而不只按标准的默认条件，因为不同产品的实际使用场景差别很大。

对于与眼接触的部件，我们会关注加工残留和清洁度，这一项在光学件上的重要性高于一般部件。

如果你有眼科类产品需要安排送检，想先理清项目范围，可以把产品资料和使用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. Ophthalmic devices divide broadly into two groups: diagnostic and therapeutic equipment such as examination instruments, laser therapy devices and surgical microscopes; and products implanted into or contacting ocular tissue such as intraocular lenses, contact lenses and ophthalmic surgical instruments. For equipment, the two main lines are optical performance and optical radiation safety: optical performance determines whether the clinician can see clearly or the treatment is effective, and radiation safety determines whether ocular tissue is harmed. For contacting and implanted products, the main lines are optical performance and biocompatibility: materials must remain compatible with ocular tissue over time while optical performance meets visual requirements.

Optical radiation safety. The eye is more sensitive to light than other tissue, so light source emission requires specific assessment. Measure the emission at specified positions across wavelength bands. Distinguish the bands, since ultraviolet, visible and infrared act through different mechanisms. Identify the hazard categories, covering photochemical hazard from ultraviolet and blue light and thermal hazard from visible and infrared. Consider exposure duration, since hazard relates to exposure and assessment should follow actual use. Apply grouping and limits, with radiation level determining the group and each group carrying different protection requirements. And specify protective measures required above certain levels. Blue light hazard deserves attention in equipment with white light sources, since the blue component can be substantial and photochemical hazard matters over prolonged exposure. Assessing by actual duration matters too: the same radiation level accumulates very differently in brief examination and in prolonged surgical illumination.

Examination and imaging equipment. Optical performance covers resolution, magnification, field of view, distortion and chromatic aberration. Illumination covers illuminance, uniformity and colour temperature. Measurement functions, where present, require accuracy verification. Image quality covers resolution, contrast and noise for imaging equipment. Patient contact covers biocompatibility and disinfection of contacting parts. And positioning covers the comfort and cleanability of chin and forehead rests. Disinfection of contacting parts matters greatly in ophthalmology, where the risk of transmitting eye infection is high and chin rests and contact lenses touch many patients.

Laser therapy devices. Output parameters cover wavelength, power, energy, pulse duration and repetition rate. Parameter accuracy covers the deviation between setting and actual output. Spot characteristics cover size, shape and energy distribution. Aiming beam coaxiality covers alignment between aiming and treatment beams. Safety interlocks cover door interlocks, key control and emergency stop. Protection covers eye protection requirements for the operator and the specification of protective eyewear. And classification and marking follow the laser hazard class. Aiming beam coaxiality bears directly on treatment accuracy: deviation means treating somewhere other than intended.

Intraocular lenses and implants. Optical performance covers dioptric power, image quality and aberration. Nominal against measured optical parameters covers the deviation in dioptric power. Ultraviolet blocking covers protection of the retina. Material properties cover mechanical performance and optical stability. Biocompatibility follows long-term intraocular contact. Sterility and packaging cover the sterile barrier and shelf life. And stability covers optical and material behaviour after prolonged implantation. Deviation in measured dioptric power is the key measure, determining post-operative visual outcome directly; excessive deviation means the patient needs additional correction.

Contact lenses. Optical parameters cover dioptric power, base curve and diameter. Oxygen permeability covers the material's capacity to transmit oxygen, which bears on corneal health. Water content covers soft lens hydration and its stability. Surface characteristics cover wettability and deposit accumulation. Mechanical properties cover tear resistance and elasticity. Biocompatibility covers contact with cornea and conjunctiva. And care product compatibility covers the matching solutions. Oxygen permeability matters particularly for extended wear, since insufficient transmission causes corneal hypoxia and associated complications.

Biocompatibility for ocular contact. Ocular tissue is sensitive and requirements are correspondingly strict. Determining contact nature matters, since contact with cornea, conjunctiva, aqueous humour and vitreous differ. Contact duration matters, since brief instrument use and long-term implantation differ greatly. Item selection follows nature and duration, with ocular contact generally requiring eye irritation assessment. Material stability covers degradation in long-term implants. And processing residues cover polishing compounds, cleaning agents and release agents. Processing residues deserve particular attention on optical components, since grinding and polishing are involved and residues can lodge in surface microstructure.

Preparing for submission. Provide design values for optical parameters for comparison. Provide light source technical parameters to establish the scope of radiation assessment. Describe operating modes and parameter ranges. Prepare accessories including contact lenses, protective eyewear and special tools. Provide material information for biocompatibility evaluation. And state use durations, which inform radiation hazard assessment.

How we handle it. For ophthalmic equipment we treat optical radiation safety assessment as a priority item and set assessment conditions from actual use duration and working distance rather than standard default conditions alone, since real use scenarios differ considerably between products. For eye-contacting components we attend to processing residues and cleanliness, which matter more on optical components than on ordinary parts.

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