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What is the CE certification process for N95 mask exported to the European Union _ Protection

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What is the CE certification process for N95 mask exported to the European Union _ Protection

Original title: What is the CE certification process for N95 mask exported to the EU? Can the KN-type mask with exhalation valve in line with GB2626 be used? Because doctors and patients wearing masks can not guarantee that they are healthy and virus-free (infectious during the incubation period), and the airflow of masks with exhalation valves is only one-way protection, which can not cut off the transmission route very well. From the perspective of epidemic control, two-way protection is the most correct way, so it is not recommended that such masks be used in current medical institutions. (The GB 19083 also explicitly mentions that "there shall be no breather valve".) Well, maybe you don't quite believe what we say, so let's take a look at the demand of the front line in Wuhan. Recently, Wuhan front-line protective equipment is in short supply. Many hospitals have issued a "Notice of Receiving Loving Donations". If you take a closer look at these notices, you will find that almost all hospitals are very clear that the protective equipment they need (medical protective masks) are required to meet the GB 19083-2010. Not GB2626-2006/2019! Protective mask standard: GB 19083-2010 Having said all that, what are the differences between GB19083 and GB2626? In fact, GB19083-2010 "Technical Requirements for Medical Protective Masks" is the real source of the technical standards for protective masks in the medical industry. Reading through the original text of the national standard, it has many similar technical parameters with GB2626. For example, it also has three levels of filtration efficiency, and also detects the filtration of non-oily particles (compared with KN type masks). However, it directly abandons the parameter requirements of oily particles (that is,Full Body Disposable Coverall, completely different from KP type masks), while the first level is ≥ 95%, and the highest level 3 is ≥ 99.97%, which is equivalent to directly benchmarking KN95 and KN100, without the lower level of KN90. That is to say, the lowest standard of GB19083 filtering performance is equivalent to the KN95 standard of GB2626. However,KN95 Mask for Epidemic Prevention and Control, please note that there is no "N95" in GB19083 in China, but "Grade 1", "Grade 2" and "Grade 3" are used to express the filtration efficiency grade. Generally, Grade 1 can meet the requirements of "N95/KN95". That is to say, as long as any "medical protective mask" meets the GB19083 standard, it has absolutely reached the filtration efficiency of N95 and KN95. In addition, like the surgical mask of YY0469-2011, GB19083 also puts forward the requirement of "synthetic blood penetration", and also adds a parameter requirement of "surface moisture resistance", which clarifies the protective effect of medical protective masks on blood, body fluids and other liquids, CE Certificate KN95 Mask ,Medical Quickly Delivery Antivirus Coverall, which is not found in GB2626. Now you should know what are the differences between the masks that meet the two different national standards of GB2626 and GB19083? (1) The KN type respirator conforming to GB2626 cannot be used for medical operations, especially for high-risk operations such as tracheotomy and tracheal intubation, which may splash, because it cannot guarantee that the respirator will not be wet. (2) Grade 1 or above masks conforming to GB19083 can not only achieve 95% filtration, but also prevent liquid penetration, and can be used for various operations in medical institutions. (3) It conforms to the surgical mask of YY0469, with less than 95% filterability, but it can prevent liquid penetration. Because its tightness with the face is not as good as that of medical protective masks, it is generally not used for the protection of high-risk operations, but it can meet the operation of ordinary risks. Since August 1, 2009, the standard of Respiratory Protective Equipment Self-priming Filter Particulate Respirator (GB2626-2006) has been implemented, which specifies three levels of protection for particulate matter: KN90, KN95 and KN100. The protection grades for oily particles are KP90, KP95 and KP100. Filtration efficiency: 90%, 95%, 99.97%. KN100 and KP100 are of high protection grade. The national standard GB2626-2006 stipulates that the filter element of the dust mask is permanently marked with the national standard, year number and protection grade mark of "GB2626-2006-KN100". The higher the protection level and filtration efficiency, the higher the safety of dust masks. Expand the full text Many mask manufacturers will be required to do GB2626 standard certification, especially in online shopping malls will be required to provide GB2626-2006 standard quality inspection report! It can help enterprises to obtain qualified test reports smoothly. ? Provide improvement suggestions for the products submitted for inspection, so as to reduce the trouble of retest. 1. Range of protective masks The standard for protective masks specifies the basic requirements, test methods, identification and instructions for use, packaging, transportation and storage of medical protective masks (hereinafter referred to as masks). This standard is applicable to self-priming filter type dust-proof medical protective masks that can filter particles in the air and block harmful gas droplets, blood, body fluids, secretions, etc. 2 Normative References The following documents contain provisions which, through reference in this text, constitute provisions of this standard. For dated references, subsequent amendments (excluding corrigenda) to, or revisions of, any of these publications do not apply. However, parties to agreements based on this standard are encouraged to investigate the possibility of applying new editions of these documents. For undated references,3 Ply Disposable Protective Face Mask, the new edition is applicable to this standard. GB 2626-2006 Standard for Respiratory Protective Equipment Self-priming Filter Particulate Respirator GB/T191-2000 Pictorial marks for packaging, storage and transportation GB/T 4745-1997 Textile Fabrics-Determination of Resistance to Surface Moisture-Water Test 15980 Hygienic standard for single use medical products GB/T 16886.7-2001 Biological Evaluation of Medical Devices-Part 7: Ethylene Oxide Sterilization Residue GB/T 16886. 10-2000 Biological Evaluation of Medical Devices-Part 10: Tests for Irritation and Sensitization Back to Sohu, see more Responsible Editor:. zjyuan-group.com

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