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Disposable surgical masks the eu EN 14683 test items and test requirements

by:Copper Plus     2021-01-24
EN14683 standard specifies the structure of the surgical masks, design, performance requirements and test methods, the purpose is to limit in the process of surgery, and other similar requirements of medical environment, patients with infectious diseases from the staff to infection. Have certain surgical masks of germs can effectively reduce or with clinical symptoms of patients with asymptomatic patients the spread of bacteria, viruses from the nose and mouth. Let's take a look at surgical masks EN14683 CE certification standards shall apply. EN 14683 test items and test requirements: 1, the material and structure require surgical masks is a kind of medical apparatus and instruments, usually by placing, glue or molded in fabric layer between the filtering layers. The scheduled during the period of using, surgical masks may not be divided or tear. When choosing filters and filter material, should pay attention to cleanliness, No particulate matter) 。 2, the design requirements, surgical masks should be can install closely in the wearer's nose, mouth and chin of medical apparatus and instruments, and to ensure that the mask can fit closely on both sides. Surgical masks may have a different shape and structure, and other functions, such as the function of preventing mist with or without a mask ( To protect the wearer from splash and water droplets) Or bridge of the nose, By maintaining a joint to enhance joint) with nose Outline) 。 3, the performance requirements of general requirements: if is suitable for the asepsis, deal with manufactured goods or samples cut from the finished products for all tests. Bacteria filtration efficiency ( BFE) : Type1 95 or higher, Type2, microbiological cleanliness (984 or more Biological load) When, in accordance with EN ISO 11737 - 1 testing, biological load should be 30 or less surgical masks cfu/g. Surgical masks CE EN14683 standard test procedures: the first step: provide product pictures and application form; The second step: Chinese lab quotation according to the information; The third step: after client confirm the price, sign the registration form and service agreement and pay the full project cost, and ready to test samples; Step 4: the customer arrange to mail samples to the lab test; Step 5: test pass, report to complete, project, issue the certificate of CE certification.
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