FDA要求：过滤式口罩呼吸器（供公众在突发公共卫生事件中使用）。
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FDA要求：
过滤式口罩呼吸器（供公众在突发公共卫生事件中使用）。
Filtering facepiece respirator for use by the general public in public health medical emergencies.

第880部分-普通医院和个人使用设备

G分部-综合医院和个人使用的杂项设备

880.6260过滤式口罩呼吸器，供公众在突发公共卫生事件中使用。

（a）识别。 公众在突发公共卫生医疗事件中使用的过滤式面罩呼吸器是一种一次性半面罩无动力空气净化颗粒呼吸器，旨在覆盖穿戴者的鼻子和嘴巴，以帮助减少穿戴者的暴露在公共卫生医疗紧急情况下对致病性生物空气传播颗粒的污染。该设备由聚合材料制成，旨在紧密贴合脸部并通过过滤颗粒材料起作用。

（b）分类。 II类（特殊控制）。特殊控件是：

（1）根据42 CFR第84部分的规定，获得美国国家职业安全与健康研究所（NIOSH）的认证，其为最低过滤效率等级为N95的无动力空气净化颗粒呼吸器。

（2）FDA指导文件，标题为：“工业和食品药品监督管理局工作人员指南； II类特殊控制指导文件：过滤面罩呼吸器，供公众在突发公共卫生事件中使用。” 有关获取本指导文件副本的信息，请参见880.1（e）。

[72 FR 36362，2007年7月3日]


摘自FDA网站：https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=880.6260

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TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES

PART 880 -- GENERAL HOSPITAL AND PERSONAL USE DEVICES

Subpart G--General Hospital and Personal Use Miscellaneous Devices

Sec. 880.6260 Filtering facepiece respirator for use by the general public in public health medical emergencies.

(a) Identification. A filtering facepiece respirator for use by the general public in public health medical emergencies is a device that is a disposable half-facepiece non-powered air-purifying particulate respirator intended for use to cover the nose and mouth of the wearer to help reduce wearer exposure to pathogenic biological airborne particulates during a public health medical emergency. The device is made of polymeric materials and is intended to fit closely to the face and to function by filtering particulate material.

(b) Classification. Class II (special controls). The special controls are:

(1) Certification by the National Institute for Occupational Safety and Health (NIOSH) as a non-powered air-purifying particulate respirator with a minimum filtration efficiency classification of N95, in accordance with 42 CFR part 84.

(2) The FDA guidance document entitled: "Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Filtering Facepiece Respirator for use by the General Public in Public Health Medical Emergencies." See 880.1(e) for information on obtaining a copy of this guidance document.

[72 FR 36362, July 3, 2007]