Update: CDC的部分决定不翻译了。跟朋友讨论以后觉得能耐心把这种偏专业的文章看完的读者应该英文也不会差。写这个的初心不是为了科普或者推荐应该买那种,而是想提供一个可靠的信息源供有阅读理解能力和判断力的人看完自行决定。有兴趣的知友可以直接查看CDC的链接(见原文)。因为CDC的内容很翔实,推荐优先阅读以下几个可能大部分人比较感兴趣的部分:
What are the differences among these products? - 普通医用口罩、N95防护口罩、N95医用防护口罩之间的区别;How long can you wear the same N95 respirator? - 一个一次性N95防护口罩可以使用多久Can the products with an exhalation valve be used in healthcare? - 带呼吸阀的N95防护口罩是否可以作医护用途Does moisture build up in respirators? - N95防护口罩的水汽问题
私货-个人总结:
尽管防护等级越高越好,但考虑到当前全国性N95及N95医用口罩供应紧张的情况,建议大家根据暴露风险选择对应的口罩即可,把更高防护等级的口罩留给一线医护人员及病人。
低暴露风险(确诊病例较少的省市或接触流动人口较少的人):使用普通一次性医用口罩即可
高暴露风险(确诊病例较多的省市或接触流动人口较多的人):至少保证正确使用普通一次性医用口罩并适时更换,能够使用普通N95防护口罩更佳
直接病毒暴露(疑似/确诊病人,直接接触病人的医护人员及家属):使用N95医用防护口罩,病人应使用没有呼吸阀的N95医用防护口罩
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原文:
网上各种不知真假的信息太多了,提供一个基于以下两个可靠信息源的原文翻译(英文为网站原文,中文基于Google Translate + 人工修正,中文括号内的一般是我额外添加的内容。翻译如有错漏欢迎指出以便修正)。
美国食品药品监督管理局(FDA):
Masks and N95 Respirators美国疾病控制与预防中心(CDC):
NPPTL Respirator Trusted-Source, Healthcare Related Information, Healthcare FAQs第一部分是FDA的文章,先发出来;第二部分CDC的文章正在翻译中、内容较多稍后补上。实际上CDC的这部分有更多关于大家比较关心的问题的详细回答,看得懂的知友可以直接点链接看不必等我的更新
>>> FDA: 口罩与N95防护口罩
About Facemasks and N95 Respirators - 关于口罩与N95防护口罩
Facemasks and N95 respirators are examples of personal protective equipment that are used to protect the wearer from liquid and airborne particles contaminating the face. They are one part of an infection-control strategy. 口罩与N95防护口罩是典型的个人防护器具,用于避免佩戴者的口鼻暴露于环境污染物(液体、微小颗粒)之中,属于感染控制策略的一部分。
A facemask is a loose-fitting, disposable device that creates a physical barrier between the mouth and nose of the wearer and potential contaminants in the immediate environment. Facemasks are not to be shared and may be labeled as surgical, isolation, dental or medical procedure masks. They may come with or without a face shield. 口罩是一种佩戴松散的一次性防护器具,能为佩戴者口鼻与环境污染物之间的物理屏障。口罩不可共用,并分为外科、隔离、牙科或一般医疗操作用口罩。可能带有也可能不带有(全脸防护的)面罩。
Facemasks are made in different thicknesses and with different ability to protect you from contact with liquids. These properties may also affect how easily you can breathe through the facemask and how well the facemask protects you. 口罩的厚度与液体防护能力各有不同。这些不同也可能会影响您通过口罩呼吸的舒适程度以及口罩对您的保护程度。
If worn properly, a facemask is meant to help block large-particle droplets, splashes, sprays or splatter that may contain germs (viruses and bacteria), keeping it from reaching your mouth and nose. Facemasks may also help reduce exposure of your saliva and respiratory secretions to others. 如果佩戴得当,口罩有助于避免可能含有病毒和细菌的大颗粒液滴、飞沫等飞溅物进入您的口鼻的作用。口罩也有助于减少唾液和呼吸道分泌物对他人的暴露。
While a facemask may be effective in blocking splashes and large-particle droplets, a facemask, by design, does not filter or block very small particles in the air that may be transmitted by coughs, sneezes or certain medical procedures. Facemasks also do not provide complete protection from germs and other contaminants because of the loose fit between the surface of the facemask and your face. 尽管口罩可以有效地隔绝飞溅物与大颗粒液滴,但从设计上讲,口罩无法过滤或阻挡空气中很小的、由咳嗽、打喷嚏或某些医疗操作传播的颗粒。由于口罩对您口鼻与面部的包裹并不严密,口罩也不能完全隔绝细菌、病毒等其他污染物。
Facemasks are not intended to be used more than once. If your mask is damaged or soiled, or if breathing through the mask becomes difficult, you should remove the facemask, discard it safely, and replace it with a new one. To safely discard your mask, place it in a plastic bag and put it in the trash. Wash your hands after handling the used mask. 口罩不应重复使用。如果您的口罩已污损或逐渐使您呼吸困难,您应当取下口罩、安全丢弃、并更换新的口罩。为了安全丢弃您的口罩,请将其放在塑料袋中后再放入垃圾桶。处理污损的口罩以后,请洗手。
N95 Respirators - N95防护口罩
An N95 respirator is a respiratory protective device designed to achieve a very close facial fit and very efficient filtration of airborne particles. N95防护口罩是一种呼吸防护器具,旨在实现高效面部贴合与空气颗粒物过滤。
The ‘N95’ designation means that when subjected to careful testing, the respirator blocks at least 95 percent of very small (0.3 micron) test particles. If properly fitted, the filtration capabilities of N95 respirators exceed those of face masks. However, even a properly fitted N95 respirator does not completely eliminate the risk of illness or death. “N95”标记表示经过仔细测试后证明,该防护口罩可阻挡至少95%的微小(0.3微米)测试颗粒。如果佩戴正确,N95防护口罩的过滤能力将超过之前提到的口罩。但是,即使正确佩戴了N95防护口罩,也无法完全消除患病或死亡的风险。
N95 respirators are not designed for children or people with facial hair. Because a proper fit cannot be achieved on children and people with facial hair, the N95 respirator may not provide full protection. N95防护口罩不是为儿童或面部毛发较多的人专门设计的。由于无法保证与儿童及面部毛发较多的人的面部有效贴合,N95防护口罩可能无法提供相对全面的保护。
N95 Respirators for Use by the Public - 供公众使用的N95防护口罩
FDA has cleared certain filtering facepiece respirators (N95) for use by the general public. To work as expected, an N95 respirator requires a proper fit to your face. Generally, to check for proper fit, you should put on your respirator and adjust the straps so that the respirator fits tightly but comfortably to your face. For information on proper fit, refer to the manufacturer’s instructions. The Centers for Disease Control and Prevention (CDC) does not generally recommend facemasks and respirators for use in home or community settings. However, they may be appropriate for persons at increased risk of severe illness from influenza or other respiratory diseases. Please consult with your health care provider for more information about when to use N95 Respirators at home or in the community. FDA认证了数种供公众使用的过滤式N95防护口罩。为了达到设计防护效果,N95防护面罩需要能够与你的面部紧密贴合。通常,要检查是否紧密贴合,请戴上防护面罩并调节松紧带、使呼吸器紧密但舒适地贴合在您的脸部。有关正确佩戴口罩的详细信息,请参阅制造商的说明。疾病控制与预防中心(CDC)通常不建议在家庭或正常社区环境中使用N95防护口罩。但是,它们可能适合因流感或其他呼吸道感染而患严重疾病或受感染风险较高的人。请向您的医疗保健服务提供者咨询有关何时在家中或社区使用N95防护口罩的更多信息。
FDA has cleared the following N95 respirators for use by the general public in public health medical emergencies: 以下为FDA认可的、供公众在突发公共卫生医疗事件中使用的非职业用途N95防护口罩:
3M Particulate Respirator 8670F; 3M Particulate Respirator 8612F; Pasture Tm F550G Respirator; Pasture Tm A520G Respirator
These devices are labeled "NOT for occupational use.”
N95 Respirators in Industrial and Health Care Settings - 用于工业与卫生保健情境的N95防护口罩
Most N95 respirators are manufactured for use in construction and other industrial type jobs that expose workers to dust and small particles are regulated by the National Personal Protective Technology Laboratory (NPPTL) in the National Institute for Occupational Safety and Health (NIOSH), which is part of the Centers for Disease Control and Prevention (CDC). These products are labeled "For occupational use." 大多数N95防护口罩是为建筑和其他工业相关作业设计生产,这些作业会使工人暴露于灰尘和小颗粒中,并由美国疾病控制与预防中心(CDC)下属的国家职业安全与健康研究所(NIOSH)的国家个人防护技术实验室(NPPTL)监管。这些产品会被标记为“适用于职业用途”。
However, some N95 respirators are intended for use in a healthcare setting. Specifically, single-use, disposable respiratory protective devices used and worn by healthcare personnel during procedures to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. These N95 respirators are class II devices regulated by FDA, under 21 CFR 878.4040, and CDC NIOSH. Subject to certain conditions and limitations, N95s regulated under product code MSH are exempt from 510(k) premarket notification. FDA has a Memorandum of Understanding (MOU) with the CDC NIOSH which outlines the framework for coordination and collaboration between FDA and NIOSH for regulation of this subset of N95 respirators. 但是,有一些N95防护口罩旨在用于医疗机构。具体而言是医护人员在医疗操作中使用和佩戴的一次性呼吸保护装置,可保护患者和医护人员免受微生物、体液和颗粒物质的传播的影响。这些N95防护口罩是FDA根据21 CFR 878.4040和CDC NIOSH监管的II类设备。这类N95防护口罩受额外条件和限制的约束,受产品代码MSH监管的N95防护口罩免于510(k)要求的上市前通知。FDA 与CDC NIOSH 的谅解备忘录(MOU),其中概述了FDA与NIOSH之间协调和协作的框架,以监管这部分N95防护口罩。
(如果没有理解错的话N95医疗防护口罩跟其他N95防护口罩相比是另外受FDA监管的。目前我知道的N95医疗防护口罩有3M的1860和9132这两个型号)
General N95 Respirator Precautions - 注意事项
People with chronic respiratory, cardiac, or other medical conditions that make breathing difficult should check with their healthcare provider before using an N95 respirator because the N95 respirator can make it more difficult for the wearer to breathe. Some models have exhalation valves that can make breathing out easier and help reduce heat build-up. Note that N95 respirators with exhalation valves should not be used when sterile conditions must be maintained. 患有慢性呼吸、心脏病或其他呼吸困难的疾病的病人,在使用N95防护口罩前,应先咨询医师,因为N95防护口罩会使佩戴者的呼吸更加困难。有些型号配有呼气阀,可以使呼气更加轻松,并有助于减少热量积聚。请注意,当必须保持无菌环境时,不应使用带有呼气阀的N95防护口罩。
All FDA-cleared N95 respirators are labeled as "single use", disposable devices. If your respirator is damaged or soiled, or if breathing becomes difficult, you should remove the respirator, discard it properly, and replace it with a new one. To safely discard your N95 respirator, place it in a plastic bag and put it in the trash. Wash your hands after handling the used respirator. 所有FDA认证的N95防护口罩均为一次性使用。如果您的防护口罩已污损或逐渐使您呼吸困难,您应当取下防护口罩、安全丢弃、并更换新的防护口罩。为了安全丢弃您的防护口罩,请将其放在塑料袋中后再放入垃圾桶。处理污损的防护口罩以后,请洗手。 |