外贸好消息:美国CDC接受KN95中国标准口罩等!

近期,美国疾病控制与预防中心(CDC)发布《N95口罩供应优化策略:危机/替代方案》,指出新冠肺炎疫情期间,当N95口罩供给无法满足需求时,可以选择其他国家和地区指定标准口罩,作为N95口罩合适的替代品。中国标准GB 2626-2006 和GB/T 18664—2002口罩也在目录之中。

外贸好消息:美国CDC接受KN95中国标准口罩等!

Crisis/Alternate Strategies

These crisis capacity or alternate strategies accompany and build on the conventional and contingency capacity strategies. The following measures are not commensurate with current U.S. standards of care. However, individual measures or a combination of these measures may need to be considered during periods of expected or known N95 respirator shortages. It is important to consult with entities that include some combination of: local healthcare coalitions, federal, state, or local public health officials, appropriate state agencies that are managing the overall emergency response related to COVID-19, and state crisis standards of care committees. Even when state/local healthcare coalitions or public health authorities can shift resources between health care facilities, these strategies may still be necessary.

When N95 Supplies are Running Low

Personal Protective Equipment and Respiratory Protection

Use of respirators beyond the manufacturer-designated shelf life for healthcare delivery

Consideration can be made to use N95 respirators beyond the manufacturer-designated shelf life for care of patients with COVID-19, tuberculosis, measles, and varicella. However, respirators beyond the manufacturer-designated shelf life may not perform to the requirements for which they were certified. Over time, components such as the straps and nose bridge material may degrade, which can affect the quality of the fit and seal. Many models found in U.S. stockpiles and stockpiles of healthcare facilities have been found to continue to perform in accordance with NIOSH performance standards. However, fluid resistance and flammability were not assessed. Use of the N95 respirators recommended in Release of Stockpiled N95 Filtering Facepiece Respirators Beyond the Manufacturer-Designated Shelf Life: Considerations for the COVID-19 Response can be considered. It is optimal to use these respirators in the context of a respiratory protection program that includes medical evaluation, training, and fit testing. If used in healthcare delivery, it is particularly important that HCP perform the expected seal check, prior to entering a patient care area. CDC does not recommend using N95s beyond the manufacturer-designated shelf life in surgical settings.

Use of respirators approved under standards used in other countries that are similar to NIOSH-approved N95 respirators

Other countries approve respirators for occupational use and approve respirators to these standards. These products are evaluated using some methods similar to those used by NIOSH, and some methods that are different, but are expected to protect HCPs. These respirators are expected to provide protection to workers. Those with equivalent or similar protection to NIOSH-approved respirators may be available to provide respiratory protection to workers exposed to harmful airborne particulate matter. These devices are expected to be suitable alternatives to provide protection during the COVID-19 response when supplies are short. The country, conformity assessment standards, acceptable product classifications, standards and guidance documents, and protection factor determination are provided in alphabetical order. All of these respirators have protection factors of at least 10 in the countries listed below, as outlined in the standards and guidance documents specified.

来源:

https://www.cdc.gov/coronavirus/2019-ncov/hcp/respirators-strategy/crisis-alternate-strategies.html

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