The United States Trade Representative Office announced on March 12 that local tariffs on certain medical products such as masks and stethoscopes imported from China were cancelled. On March 17, the United States Centers for Disease Control and Prevention (CDC) released the "Optimizing N95 Mask Supply Strategy: Crisis / Alternative Strategy", which pointed out that during the COVID-19 epidemic, when the supply of N95 masks was insufficient, the standard masks produced according to the table below, A suitable replacement for N95 masks. These include masks produced using Chinese standards GB 2626-2006(KN95 Mask) and GB / T 18664-2002.
| Use of respirators approved under standards used in Other countries that are similar to NIOSH-approved N95 respirators | Use of respirators approved under standards used in other countries that are similar to NIOSH-approved N95 respirators | ||||||||
| Country | Performance Standard | Acceptable product classifications | Standards/Guidance Documents | Protection Factor ≥ 10 | Country | Performance Standard | Acceptable product classifications | Standards/Guidance Documents | Protection Factor ≥ 10 |
| Australia | AS/NZS 1716:2012 | P3 P2 | AS/NZS 1715:2009 | YES | Australia | AS/NZS 1716:2012 | P3 P2 | AS/NZS 1715:2009 | YES |
| Brazil | ABNT/NBR 13698:2011 | PFF3 PFF2 | Fundacentro CDU 614.894 | YES | Brazil | ABNT/NBR 13698:2011 | PFF3 PFF2 | Fundacentro CDU 614.894 | YES |
| China | GB 2626-2006 | KN 100 KP100 KN95 KP95 | GB/T 18664-2002 | YES | China | GB 2626-2006 | KN 100 KP100 KN95 KP95 | GB/T 18664-2002 | YES |
| Europe | EN 149-2001 | FFP3 FFP2 | EN 529:2005 | YES | E urope | EN 149-2001 | FFP3 FFP2 | EN 529:2005 | YES |
Original CDC announcement address:
https://www.cdc.gov/coronavirus/2019-ncov/hcp/respirators-strategy/crisis-alternate-strategies.html
Kn95 Mask is one of the levels specified in Chinese standard gb2626-2006. N95 is one of the grades specified in 42 CFR 84. The technical requirements and test methods of these two levels are basically the same, but they belong to different national standards. Therefore, the effect of kn95 is basically the same as that of N95.
Recently, Europe and the United States urgently relaxed access requirements for epidemic prevention materials such as masks (CE certification and FDA certification). Products that require agency certification can be exported before completing the compliance assessment process (that is, before obtaining the CE / FDA mark), but to ensure certification Work will continue to complete. (Details) Europe and the United States Urgently Relax Admission Requirements for Epidemic Materials
The competent authorities of EU member states can evaluate and centrally purchase quarantine products without CE marking during the epidemic period. The products can only be provided to medical personnel and cannot be sold on the market. If your product is not purchased centrally by the government and is to be sold on the local market, it does not fall into the scope of the above relaxed access conditions.
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