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How to differentiate between medical and non medical masks

by:Copper Plus     2021-01-06
How to differentiate between medical and non medical masks, 1013. HTML release date: 2020 - 07 - 13 11:14:42 masks from the purpose can be divided into two major categories of medical/non medical. As the name implies, surgical masks are mainly used for health protection, can be subdivided into medical protection, medical surgery, one-time medical three; Non surgical masks, also known as personal protective mask, according to the applicable scenario, can be subdivided into two types of particulate matter and daily protection. Different USES mask has different technical requirements, scope of application are also different 2, using the appearance and package information to distinguish medical/by non surgical masks masks structure by filtering valve. Belt filter valve mask is not usually surgical masks. Medical respirator standard GB 19803 - such as China 2010. 4. Three terms specified 'masks should not have exhalation valve', which can avoid the droplets, microorganisms, such as through the exhalation valve exhale, endangering others. And civil masks the exhalation valve is allowed, exhale through the exhalation valve can reduce resistance, thus is advantageous to the workers work long hours. Through the outer packing information on the formal way to tell the smallest unit package for the mask products should have the name of commodity, implement the information such as the standard and the degree of protection. Which express the information can be used as a point, tell the such as commodity name with 'Medical' or 'surgical' 'dominate' and other words in English, can determine for surgical masks commonly 3, applicable standard to distinguish the Medical/surgical masks surgical masks in different countries/regions for different standards and certification requirements, enterprises and individuals can be according to the product import countries/regions, differentiated by the applicable standard according to the product, the product standard and authentication information from the product packaging or producers to provide test report or certificate. Surgical masks export to USA belongs to the medical apparatus and instruments, suitable surgical masks material performance standards ( ASTM F2100) And by the us food and drug administration ( FDA) Management, shall be registered by 501 k or recent FDA released by other ways, for factory registration and medical device behind the column name can be listed in the United States. Therefore, exports to the United States the masks on the outer packing or test report or certificate with the above content, can be judged to be surgical masks. Export the non surgical masks are not of the 5, published in 2020, but the enterprise should pay attention to, by NIOSH certified products required to listed in the United States. Exports to the eu the eu medical/non surgical masks are to be labeled with CE mark, but different applicable standards. Surgical masks in the eu belongs to class I devices, can be divided into type I non sterile sterile two kinds, and must be in accordance with the European medical devices directive 93/42 / EEC ( MDD) Or the eu medical device regulations EU2017/745 ( MDR) Labeled with CE mark, the corresponding standard is EN14683, exports to the eu's mask packaging or the content of the test report, certificate, can be judged to be surgical masks. It is important to note that the sterile/non sterile state, according to mask the eu take different measures for conformity assessment not only sterile surgical masks enterprise CE conformity declaration itself, do not need to be certified by notified body. In ready after the corresponding documents and test report and other data, can complete conformance statement on its own. Sterile surgical masks must also by authorized notified body for CE certification. Exports to the eu non surgical masks do not belong to medical apparatus and instruments, but must be in accordance with the personal protective equipment section EU2016/425 ( PPE) Requirements, issued by authorized notified body for CE certificate and certificate, corresponding EN149 is the standard. Exports to other countries and regions mask product, other countries and regions can provide reference for the Chinese standard test certificates and registration for the record information judgment, China standard has three surgical masks, GB - 19083 2010年,YY 0469 - 2011年,YY / T 0969 - 2013, the use of the three standard production of mask can be judged to be surgical masks.
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