医用防护用品的项目与分级

结论：先确定防护什么、防到什么程度，项目就清楚了

医用防护用品的检测项目，取决于两件事：防护的对象是什么，以及要求的防护等级。

防护对象决定了测什么类型的项目。 防颗粒物的测过滤效率；防液体喷溅的测阻液性能；防微生物穿透的测阻菌性能。

防护等级决定了限值和额外的项目。 高等级产品的限值更严，可能还有额外的考察。

除了防护性能，还有两类项目容易被低估： 舒适性（影响佩戴依从性）和材料安全性（与皮肤接触）。

产品类别与防护对象

过滤类产品的考察

过滤效率。 对规定粒径颗粒的过滤能力。

通气阻力或呼吸阻力。 影响佩戴的舒适和呼吸负担。

过滤效率与阻力的平衡。 提高效率通常增加阻力，这是产品设计的核心权衡。

泄漏率。 对密合型产品，从边缘泄漏的比例。过滤效率再高，密合不好也没有实际防护。

合成血液穿透。 对医用口罩，防止液体喷溅穿透。

微生物过滤效率。 对细菌的过滤能力。

「泄漏率」在密合型防护口罩上比过滤效率更能反映实际防护，因为泄漏的空气未经过滤直接进入。

阻隔类产品的考察

抗渗水性。 静水压下的液体阻隔。

抗合成血液穿透。 在规定压力下的血液阻隔。

抗微生物穿透。 干态和湿态的微生物穿透。

阻隔的分区。 手术衣的关键区域要求更高。

强度。 拉伸、撕裂、胀破，防止使用中破损。

落絮。 材料脱落的颗粒，手术环境中要控制。

「阻隔的分区」是手术衣的特点。 前胸和袖子是高风险区域，要求高于其他部位，测试取样应当覆盖关键区域。

手套的考察

针孔。 完整性的核心项，单个针孔就可能导致防护失效。

拉伸性能。 强度和伸长率。

老化后性能。 储存后的性能保持。

尺寸。 长度、宽度、厚度。

粉末。 有粉手套的粉末量，粉末可能引起反应。

蛋白质含量。 天然橡胶手套的致敏相关。

化学阻隔。 如果用于接触化学品。

「天然橡胶的蛋白质含量」与致敏风险相关，而医护人员因反复接触而致敏的风险较高。

舒适性与佩戴

呼吸阻力。 直接影响佩戴时长。

热湿舒适。 长时间佩戴的闷热感。

面部压迫。 口罩和护目镜对面部的压迫，长时间佩戴可能造成压伤。

视野。 护目和面屏的视野范围。

防雾。 护目类产品起雾影响使用。

穿脱的便利。 特别是脱除时的污染风险。

「面部压迫」在长时间佩戴中是实际问题，医护人员长时间佩戴密合型口罩造成面部压伤的情况并不少见，这一项虽然不是防护性能，但影响实际使用。

材料与皮肤接触

生物相容性。 与皮肤接触的部分。

致敏性。 特别是天然橡胶和某些化学处理。

刺激性。 长时间接触的刺激。

化学残留。 生产过程的残留物。

染料与助剂。 可能的刺激源。

分级与标识

防护等级的判定。 按性能指标确定等级。

标识的内容。 等级、适用场合、使用限制。

使用说明。 正确佩戴方法、佩戴时长、更换时机。

「正确佩戴方法」对防护效果影响很大，特别是密合型产品，佩戴不当时防护效果明显下降，图示化的说明比文字有效。

常见的不合格原因

过滤效率不足。 滤材性能或生产工艺问题。

呼吸阻力过大。 为追求效率牺牲了透气。

泄漏率超标。 密合设计或尺寸问题。

阻液性能不足。 材料或涂层问题。

强度不足。 使用中破损。

老化后性能下降。 储存稳定性问题。

「效率与阻力的平衡」是设计的核心难点，多数不合格集中在这个权衡上。

批次一致性的重要

防护用品量大，批次一致性直接关系实际防护：

滤材的批次差异。 影响过滤效率。

成型工艺的波动。 影响密合和泄漏。

焊接与粘合。 影响阻隔和强度。

原料的一致性。 影响多项性能。

建议对关键项目做批次监控，因为单批合格不代表批批合格，而使用者拿到的是随机的某一批。

送检准备的建议

提供产品的声称等级与适用场合；提供材料信息；说明生产工艺；准备足够样品（多数项目是破坏性的）；以及说明佩戴方式（影响泄漏率测试）。

使用场景的匹配

防护用品的选择应当与使用场景匹配，资料中说明清楚：

适用的暴露风险。 针对什么样的暴露场景。

不适用的场景。 哪些场景防护不足。

佩戴时长的建议。 超过多久应当更换。

与其他防护的配合。 口罩、护目、防护服的组合。

「不适用的场景」应当明确说明，因为使用者可能在防护不足的场景中使用，而外观上看不出差别。

补充说明

以上内容是通用的思路，具体到每个产品还要按实际情况调整。影响判断的因素包括：产品的具体结构与材料；目标市场的具体要求；使用场景的特点；以及企业自身的质量目标。

建议把这些因素在项目启动时就理清楚，而不是边做边调整——后者往往意味着重复工作。

我们的做法

做防护用品测试时，我们会先确认产品声称的防护对象和等级，因为这决定了测试项目和适用的限值。 声称不明确就开测，可能测的项目与实际需要不符。

对于密合型产品，我们建议泄漏率与过滤效率一起考察，因为两者共同决定实际防护效果，只看过滤效率可能高估防护能力。

舒适性相关的项目（呼吸阻力、面部压力）我们建议一并测，因为它们影响佩戴依从性，而依从性差的防护用品实际防护效果也会下降。

如果你有防护用品需要安排检测，想先理清项目和分级，可以把产品类型和声称发过来一起讨论，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，流程见检测流程。

English version

Conclusion. Test items for medical protective equipment depend on two things: what is being protected against, and the level of protection claimed. The protective target determines the type of item: particulate protection requires filtration efficiency, splash protection requires liquid barrier performance, and microbial protection requires barrier testing. The protection level determines limits and additional items, with higher grades facing stricter limits and possibly further examination. Beyond protective performance, two categories are commonly underestimated: comfort, which affects compliance in wearing, and material safety, since these products contact skin.

Products and protective targets. Medical face masks protect against droplets and particles and require filtration efficiency, breathing resistance and synthetic blood penetration. Respirators protect against particles and require filtration efficiency, leakage and breathing resistance. Isolation gowns protect against liquid and microorganisms and require liquid barrier, microbial barrier and strength. Surgical gowns protect against liquid and microorganisms and require liquid barrier, microbial barrier, linting and strength. Protective clothing protects against liquid, particles and microorganisms and requires barrier performance, whole-suit protection and strength. Gloves protect against liquid and microorganisms and require freedom from pinholes, strength and barrier performance. And face shields and eye protection guard against splash and require field of view, impact resistance and anti-fogging.

Examining filtration products. Filtration efficiency covers the capture of particles of specified size. Breathing resistance affects comfort and respiratory burden. The balance between efficiency and resistance is the core design trade-off, since raising efficiency usually raises resistance. Leakage covers the proportion entering around the seal on close-fitting products; however high the filtration efficiency, poor fit means no real protection. Synthetic blood penetration applies to medical masks against splash. And bacterial filtration efficiency covers capture of bacteria. Leakage reflects real protection better than filtration efficiency on close-fitting respirators, since leaked air enters unfiltered.

Examining barrier products. Hydrostatic resistance covers liquid barrier under pressure. Synthetic blood penetration resistance covers blood barrier at specified pressure. Microbial penetration resistance covers both dry and wet transmission. Barrier zoning applies to surgical gowns, where critical zones face higher requirements. Strength covers tension, tear and burst, preventing damage in use. And linting covers particles shed by the material, which must be controlled in surgical environments. Zoning is characteristic of surgical gowns: the chest and sleeves are high-risk areas facing higher requirements, and test sampling should cover the critical zones.

Examining gloves. Pinholes are the core integrity item, since a single pinhole can defeat protection. Tensile properties cover strength and elongation. Post-ageing performance covers retention after storage. Dimensions cover length, width and thickness. Powder content applies to powdered gloves, since powder can provoke reactions. Protein content relates to sensitisation in natural rubber latex gloves. And chemical barrier applies where chemicals are handled. Protein content in natural rubber latex relates to sensitisation risk, and healthcare workers face a higher risk through repeated exposure.

Comfort and wearing. Breathing resistance affects how long a product can be worn. Thermal and moisture comfort covers the heat and humidity of prolonged wear. Facial pressure covers the pressure masks and goggles exert, which can cause pressure injury over long periods. Field of view covers eye protection and face shields. Anti-fogging covers whether fogging impairs use. And ease of donning and doffing covers contamination risk during removal particularly. Facial pressure is a real problem in prolonged wear: pressure injuries from long shifts in close-fitting respirators are not rare, and while not a protective performance item it affects actual use.

Materials and skin contact. Biocompatibility covers skin-contacting parts. Sensitisation applies particularly to natural rubber latex and certain chemical treatments. Irritation covers prolonged contact. Chemical residues cover what manufacture leaves. And dyes and processing aids may act as irritants.

Grading and marking. Grading determines the protection level from performance results. Marking covers the level, intended application and limitations of use. And instructions cover correct donning, wear duration and when to change. Correct donning strongly affects protective performance, particularly for close-fitting products where poor fit markedly reduces protection, and illustrated instructions work better than text.

How we handle it. For protective equipment we confirm the claimed protective target and level first, since those determine the items and applicable limits. Testing without a clear claim risks testing items that do not correspond to the actual need. For close-fitting products we suggest examining leakage alongside filtration efficiency, since the two together determine real protection and efficiency alone may overstate it. We also suggest measuring comfort-related items including breathing resistance and facial pressure, since they affect compliance, and protective equipment worn inconsistently protects less in practice.

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