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美国FDA紧急授权使用包括N95在内的呼吸器具

2020-03-10
3972 作者: 北测检测
On March 2, 2020, in a joint effort, the U.S.Food and Drug Administration and the Centers for Disease Control and Preventiontook action to make more respirators, including certain N95s, available tohealth care personnel. Currently, the majority of respirators on the market areindicated for use in industrial settings. Today’s action allows certainNational Institute for Occupational Safety and Health (NIOSH) approvedrespirators not regulated by the FDA to be used in a health care setting duringthe coronavirus (COVID-19) outbreak, thereby maximizing the number ofrespirators available to meet the needs of the U.S. health care system.

2020年3月2日,经过美国食品药品管理局(简称FDA)和疾病控制和预防咨询中心(简称CDC)的共同努力,以确保包括N95在内的更多呼吸器具可供医护人员使用。目前,市面上绝大多数的呼吸器具均作工业用途使用。当前的行动,准许某些仅获得了美国国家职业与健康研究所(简称NIOSH)批准,但未获得FDA许可的呼吸器具器械,在新型冠状病毒(COVID-19)爆发期间,用于卫生保障措施使用。


N95口罩认证

 
In the meantime, the FDA issued an Emergency UseAuthorization (EUA) for emergency use of, (1) all disposable filteringfacepiece respirators (FFRs) approved by the National Institute forOccupational Safety and Health (NIOSH), in accordance with 42 CFR Part 84, asnon-powered air-purifying particulate FFRs, and (2) FFRs that wereNIOSH-approved but have since passed the manufacturers' recommended shelf-life,for use in healthcare settings by healthcare personnel (HCP) to prevent wearerexposure to pathogenic biological airborne particulates during FFR shortagesresulting from the Coronavirus Disease 2019 (COVID-19) outbreak.
与此同时,FDA发布了关于紧急授权使用声明(简称EUA),并宣布以下类别器械可供医护人员在医疗环境条件下用作紧急授权使用。以防止佩戴者由于防护器具的短缺,在新型冠状病毒(COVID-19)爆发期间,暴露在致病性病毒环境下:
(1)所有根据美国联邦法规42 CFR Part 84,并经美国国家职业与健康研究所(简称NIOSH)批准,作为无动力空气颗粒物净化装置使用的一次性过滤式面罩呼吸器具(FFRs)
(2)获得美国国家职业与健康研究所(简称NIOSH)批准,但是超过了制造商规定的货架寿命/有效期的一次性过滤式面罩呼吸器具(FFRs),

U.S. FDA has provided a list for approved holder as below:

美国FDA提供了一份持有此类器械的公司名单,如下:

3M Company
Moldex-Metric, Inc.
Honeywell International Inc.
Louis M. Gerson Company, Inc.
Honeywell Int’l. Inc.
Mine Safety Appliances Company
Kimberly-Clark Corporation
O&M Halyard, Inc.
Prestige Ameritech
Dentec Safety Specialists Corp.
Alpha Pro-Tech
Makrite Industries, Inc.
Dräger Safety AG & Co. KGaA
Jahan Company t/a IREMA Ireland
Industrias Saver
KOS Protección S.A.S
Japan Vilene
Koken, Ltd.
San M Package Co., Ltd.
Shigematsu Works Co., Ltd.
M/s. Magnum Health & Safety Pvt. Ltd.
Venus Safety & Health Pvt., Ltd.
Dobu Life Tech Co. Ltd.
Ever Green Co., Ltd.
Profit Royal Pharmaceutical Ltd.
Aero Pro Co., Ltd
AOK Tooling Limited
Aswan International Corp.
Champak Enterprise Co., Ltd.
Fido Mask Company
Guangzhou Harley Commodity Company Limited
Innonix Technologies Limited
Jinfuyu Industrial Co., Ltd.
Master & Frank Ent. Co. Ltd.
Rizhao Sanqi Medical & Health Articles Co.,  Ltd.
San Huei United Company, Ltd.
Shanghai Dasheng Health Products Manufacture  Co., Ltd.
Shanghai Gangkai Purifying Products Co., Ltd.
Shining Star Electronic Technology Co., Ltd
Suzhou Fangtian Industries Co., Ltd.
Suzhou Sanical Protective Product Manufacturing  Co., Ltd.
XiantaoZhongyi Safety Protection Products Co.,  Ltd.
Paul Boye, Inc
Global Safety First
NITTA Corp. S.A.

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