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LEGISLATION AND STANDARDS European Standards ... EN149:2001 differs from EN149:1991 in that it is mandatory for all products tested to ... EN136 Full Face Masks This standard specifies the requirements for full face masks for use as part of a respiratory protective device. These facepieces may be used in negative pressure systems, powered or ...

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The standards developed and published by the European Committee for Standardization CEN start with EN, such as EN 149-2001 and EN 14683-2019 involved in this article, implemented in 34 EU countries, the standards themselves are not mandatory, but may be subject to laws and regulations of EU countries The reference becomes the technical ...

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Mask Standards Vary by Country. Each country has their own certification standard for each mask type. For example, Europe uses the EN 14683 standard for surgical masks, whereas China uses the YY 0469 standard. Each standard varies a little by country, however they are broadly similar.

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May 30, 2020 · For example, in the United States and Canada, N95 are common; in Australia and New Zealand you'll see P2 masks more often; in China, KN95 is the standard. Mask manufacturer 3M, which specialises in filtering facepiece respirators (FFR) masks, offers the following explanation of the main differences between each mask type.

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EU • CE certification EN149-2001 AUSTRALASIA • Complies with AS/NZS 1716:2012 • AS/NZS 1715:2009. CHINA • Disposable surgical mask – in accordance with China’s pharmaceutical industry standard YY/ t0969-2013,

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Face masks are usually divided into medical masks and protective respirators. US and EU requirements, medical masks (made in China) must meet the relevant standards (ASTM F2100-11 - 21 CFR 878.4040 & CE MDD 93/42/EEC - EN14683:2014), the most important thing is to register the product locally (US: Designated US Agent + FDA Registration + FDA510K Premarket Notification, EU: Designated EU ...

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surgical mask. Surgical masks are used inside the operating room or in other sterile areas of the procedure to protect the patient’s environment from contamination. According to ASTM standard (USA), a minimum filtration rate of 95% is required to be considered a medical / surgical mask.

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The EU standard for personal protective masks is EN149. Masks are divided into three categories: FFP1 / FFP2 and FFP3. All masks exported to the European Union must obtain CE certification, which is a compulsory product safety certification system implemented by the European Union to protect members of EU countries.

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Reference standards for mask grades in different countries. China: GB15979-2002 Hygienic Standard for Disposable Sanitary Products. GB19083-2010 Technical requirements for medical protective masks. GB / T 32610-2016 daily protective mask technical specifications. YY / T 0969-2013 disposable medical mask. YY 0469-2011 surgical masks. Australia:

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b. Gb2626-2006 according to the leakage rate of mask and the filtering efficiency of mask itself, masks are divided into three grades: 90 (Kn90, kp90), 95 (kn95, kp95), 100 (kn100, kp100). This standard is closer to international standards, such as EU standard en149, NIOSH certification of the United States, as 1716 of Australia, js-t-8151 of ...

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View reliable Medical Supply manufacturers on Made-in-China. This category presents Face Mask, Mask, from China Medical Supply suppliers to global buyers., page 2

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KN100 Face Masks (China) KN100 masks should have a least 99.97% particle filtration rate and are effective in blocking fine particles such as asbestos, bacteria, and copier toner. KN100 masks are suitable to be worn in the fields of chemical engineering, pharmaceutical and constructional sites for its exceptional filtering capacity.

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