避孕与计生器械检测要求

结论：功能失效的后果特殊，可靠性要求相应高

避孕与计生器械的一个特点是：功能失效的后果是意外妊娠，这是使用者明确要避免的结果。

所以这类产品的可靠性要求高，而可靠性依赖几件事：

屏障的完整性。 对屏障类产品，任何微小的孔洞都可能导致失效。

材料的强度与弹性。 使用中不破裂、不变形。

位置的保持。 对留置类产品，位置改变或脱落会导致失效。

长期的稳定。 长期使用的产品，材料和功能要在整个使用期内保持。

产品类别

屏障类产品的考察

完整性（针孔）。 用规定方法检出微小孔洞。这是核心的安全项，因为一个针孔就可能导致失效。

爆破体积与压力。 反映材料的强度和弹性。

拉伸性能。 断裂强力和伸长率。

尺寸。 长度、宽度、厚度。

润滑剂。 量、分布、与材料的相容。

包装完整性。 包装破损会导致产品老化。

老化后的性能。 储存后的强度和完整性保持。

「老化后的性能」是这类产品的关键，因为产品可能在仓库和零售环节储存较长时间，而材料会老化。加速老化后的性能验证是必要的。

「针孔检测」的方法和取样量决定了检出能力，取样量不足时，低比例的针孔可能检不出来。

宫内装置的考察

尺寸与形状。 与宫腔的适配。

材料。 长期与子宫内膜接触。

释放性能。 含药或含金属的装置，其释放速率和持续时间。

机械性能。 展开、变形、回弹。

放置与取出。 放置器的性能、尾丝的强度（取出需要）。

位置保持。 不易脱落。

长期稳定。 在体内多年的材料稳定性。

显影性。 影像下可见，便于确认位置。

「尾丝的强度」很实际，因为取出时通过牵拉尾丝，尾丝断裂会使取出变得困难，可能需要手术取出。

「长期稳定性」要按声称的使用年限验证，含药装置的释放曲线要覆盖整个使用期。

释放类产品的考察

对于含药物缓释的产品：

释放曲线。 在模拟条件下的释放速率随时间的变化。

释放的总量。 整个使用期内释放的总量。

释放的稳定性。 释放速率是否稳定，避免突释。

残留量。 使用期结束时的残留。

影响因素。 温度、介质、材料状态。

「突释」是需要避免的现象，初期释放量过大可能造成局部浓度过高。

材料与生物相容性

接触性质。 与黏膜接触或植入。

接触时间。 短时使用还是长期留置，差别很大。

项目。 按接触性质和时间确定。

天然材料的考虑。 某些产品使用天然橡胶，需要关注致敏性。

润滑剂与添加剂。 也要纳入评价。

长期植入的额外要求。 慢性毒性、植入反应。

「天然橡胶的致敏性」是已知的风险点，使用这类材料的产品应当明确标注，便于有相关病史的使用者避开。

无菌与包装

无菌要求。 植入或进入体腔的产品需要无菌。

灭菌方式。 与材料的相容，特别是含药产品。

包装。 保护产品、无菌屏障、便于使用。

有效期。 材料和功能的稳定性。

单个包装。 屏障类产品通常单个密封包装。

标识与说明

使用方法。 正确使用是可靠性的前提。

有效期。 过期产品的风险。

储存条件。 温度、避光的要求。

失效的可能。 说明产品不是绝对可靠的。

使用后的处理。

就医的情形。

「使用方法的说明」对屏障类产品尤其重要，因为使用不当是实际失效的主要原因之一，图示化的说明比文字更有效。

生产与质量控制

这类产品对过程控制的要求高：

原料控制。 原料的批次管理和检验。

过程参数。 成型、硫化、干燥等工序的参数控制。

在线检测。 关键项目的在线或逐个检测。

成品抽检。 按规定的抽样方案。

批次管理。 完整的批次记录和追溯。

环境控制。 生产环境的洁净度。

「逐个检测」对屏障类产品的某些项目是必要的，因为抽检对低比例缺陷的检出能力有限，而单个产品的缺陷就可能导致失效。

储存与流通

储存条件。 温度、湿度、避光的要求。

运输条件。 运输中的温度和机械条件。

货架期的管理。 先进先出、临期产品的处理。

零售环节。 零售点的储存条件可能不受控。

「零售环节的储存」是不受控的环节，产品可能长时间暴露于不适宜的温度，这也是老化后性能验证重要的原因。

常见的不合格原因

针孔检出。 成型或材料问题。

爆破性能不足。 材料强度或厚度不足。

老化后性能下降明显。 材料配方或包装问题。

释放曲线偏离。 含药产品的工艺问题。

尺寸不符。 成型或工艺控制问题。

包装密封不良。 影响产品的老化。

这几项中，老化后的性能下降是最需要通过配方和工艺改进解决的。

使用者教育的配合

这类产品的可靠性依赖正确使用，所以使用者教育是产品的一部分：图示化的使用说明；常见错误的提示；存放与携带的注意；以及失效后的应对。

「常见错误的提示」比单纯的正确步骤更有用，因为使用者往往是在某个具体环节出错。

我们的做法

做这类产品测试时，我们建议加速老化后的性能验证作为必做项，因为产品的储存和流通时间可能较长，而老化后的性能才是使用者实际拿到的产品的性能。

屏障类产品的完整性检测，取样量要足够，因为低比例的缺陷需要足够的样本量才能检出。

含释放功能的产品，释放曲线应当覆盖声称的使用期，并设多个时间点，而不只测初期的释放。

如果你有这类产品需要安排检测，想先理清项目，可以把产品类型和使用方式发过来一起讨论，或者直接联系：132 4819 8029。能力范围见服务介绍，送检要求见送检要求，其他问题见常见问题。

English version

Conclusion. Contraceptive devices share one characteristic: functional failure results in unintended pregnancy, which is precisely what the user set out to avoid. Reliability requirements are correspondingly high, and reliability depends on several things. Barrier integrity, since for barrier products any small hole may cause failure. Material strength and elasticity, so that the product neither ruptures nor distorts in use. Position retention, since for retained devices displacement or expulsion causes failure. And long-term stability, so that materials and function hold across the whole period of use.

Product categories. Barrier products such as condoms work by physical separation and are assessed for integrity, strength and lubrication. Intrauterine devices act locally and are assessed for materials, release and position retention. Subdermal implants release slowly and are assessed for release profile, materials and removal. Sterilisation-related instruments are surgical devices assessed for mechanical performance and reliability. And diagnostic and monitoring products are adjuncts assessed for accuracy.

Examining barrier products. Integrity, meaning freedom from pinholes, is detected by specified methods and is the core safety item, since a single pinhole may cause failure. Burst volume and pressure reflect material strength and elasticity. Tensile properties cover breaking force and elongation. Dimensions cover length, width and thickness. Lubricant covers quantity, distribution and compatibility with the material. Package integrity matters because damaged packaging ages the product. And post-ageing performance covers strength and integrity retention after storage. Post-ageing performance is critical for these products, since they may be stored in warehouses and retail for extended periods while materials age; verification after accelerated ageing is necessary. Pinhole detection capability depends on method and sample size, since a low defect rate may escape detection with an inadequate sample.

Examining intrauterine devices. Dimensions and shape must suit the uterine cavity. Materials contact the endometrium long-term. Release performance covers rate and duration for medicated or metallic devices. Mechanical properties cover deployment, deformation and recovery. Insertion and removal cover inserter performance and thread strength, which removal requires. Position retention covers resistance to expulsion. Long-term stability covers material behaviour over years in the body. And radiopacity allows position confirmation under imaging. Thread strength is a practical matter: removal is by traction on the thread, and a broken thread makes removal difficult and may require surgery. Long-term stability must be verified against the claimed duration, with release profiles for medicated devices covering the whole period.

Examining release products. For sustained-release products, the release profile covers rate against time under simulated conditions. Total release covers the quantity released across the period of use. Release stability covers whether the rate holds without burst release. Residual content covers what remains at the end of use. And influencing factors include temperature, medium and material condition. Burst release is to be avoided, since excessive early release can produce high local concentrations.

Materials and biocompatibility. Contact nature covers mucosal contact or implantation. Contact duration differs greatly between short-term use and long-term retention. Items follow nature and duration. Natural materials warrant attention, since some products use natural rubber latex with its sensitisation risk. Lubricants and additives must be included in the evaluation. And long-term implantation brings additional requirements for chronic toxicity and implantation response. Natural rubber latex sensitisation is a known risk, and products using it should be clearly labelled so that users with a relevant history can avoid them.

Sterility and packaging. Sterility is required for implanted products and those entering body cavities. The sterilisation method must be compatible with materials, particularly for medicated products. Packaging must protect the product, provide a sterile barrier and permit convenient use. Shelf life covers material and functional stability. And individual packaging applies to barrier products, which are normally sealed singly.

Marking and instructions. Instructions for use matter because correct use underpins reliability. Expiry dates cover the risk of expired product. Storage conditions cover temperature and light protection. The possibility of failure should be stated, since no product is absolutely reliable. Disposal after use should be described. And circumstances requiring medical attention should be stated. Instructions matter particularly for barrier products, since incorrect use is among the main causes of actual failure, and illustrated instructions work better than text.

How we handle it. For these products we suggest post-ageing performance verification as a standing item, since storage and distribution may take considerable time and post-ageing performance is what the user actually receives. For barrier product integrity testing, sample size must suffice, since detecting a low defect rate requires enough samples. For products with release functions, the release profile should cover the claimed period of use at several time points rather than early release alone.

Send us the product type and manner of use and we will work through the items. Phone or WeChat: +86 132 4819 8029.