Original Title: KN95 Mask CE Certification Application Process Detailed Explanation of Class II Medical Devices How to Do CE Certification Text/Source "Shenzhen Jiaheng Testing Certification" Authorization KN95 mask is a kind of mask with particulate matter filtration efficiency in our country. If you want to export it to the European Union, you need to refer to the requirements of PPE regulations in CE certification. The anti-particulate mask belongs to Class III PPE equipment. Masks are substances and mixtures that pose a health risk and require Class III equipment. Application process for CE certification of KN95 mask: 1. Confirm the standard of product The applicable standard of KN95 is EN149: 2001 + A1: 2009, which is roughly equivalent to the European standard FFP2. 2. Identify the relevant instructions After confirming the standard, you should find the EU directive or regulation corresponding to the product. Masks are personal protective equipment, which used to belong to the PPE directive. Recently, the EU upgraded the PPE directive, and a new regulation (EU) 2016/425 appeared. From 2019, the new Regulation (EU) 2016/425 will be enforced, ending the transition. Personal protective equipment products are divided into 1-3 categories. Masks belong to products with high risk factor and are classified as three categories. To apply for CE certification,
Medical Disposable Coverall, factory audit Module D or annual sampling test Module C2 is required to maintain annual supervision audit or test. Keep the CE certificate valid. Expand the full text 3. Select a qualified laboratory After finding the PPE regulation and EN 149 standard, it is necessary to find a qualified EU Notified Body laboratory, because personal protective equipment must be CE certified by the European Notified Body. The test plan is prepared by the test laboratory, and the samples to be prepared are also proposed by the laboratory. Generally speaking,
CE Certificate KN95 Mask ,
Against Bacteria Breathable KN95 Face Mask, the masks with three requirements of FFP1, FFP2 and FFP3 need to be tested separately, and the masks with valves need to be tested partially. Detailed product difference description shall be provided for specific test items. 4. Testing and auditing Prepare 60 qualified samples and send them to the laboratory for testing. 5. Technical documents are required for KN95 respirator to apply for CE certification, and each technical document will be reviewed by itself according to the requirements of PPE directive. It mainly includes: 1) Table of contents A list detailing all the contents of the technical documentation. 2) Revision record table The technical documentation shall be updated each time it is revised. 3) Product description Identification of the manufacturer of the product, unique identification of the product by name, reference number, etc., and full details of its intended use. 4) Simple drawings or photographs Product images 5) Component list Details of all materials including material specifications and relevant certificates of conformity from suppliers. 6) Essential Health and Safety Requirements List (BHSR List) A detailed list of the essential health and safety requirements for PPE compliance with the PPE Directive, including details of the standards to which the PPE adheres and the degree of protection provided. The Essential Health and Safety Requirements Checklist (PCA038) should be used. 7) Test report Copy of test report showing compliance with PPE directive BHSR, ensuring all materials and variants are covered. 8) Marking A copy of the actual tag. 9) User information A copy of the manufacturer's information notice must be provided in English and the language of the country of destination and include at least the following items: Name and address of the manufacturer and/or his authorized representative. Storage, use, cleaning, maintenance and service information. The performance recorded in the test. Suitable PPE accessories and corresponding spare parts. Provide a protection category. Information about the expiration of the PPE and any of its components. The packaging is suitable for transportation. Explain the meaning of any marks. 10) Quality plan The quality plan shall include details of the processes, controls and testing facilities used to ensure continued conformity of the product to the requirements of the Directive. This may be in the form of a cross-reference to a register of the adopted quality system that has been approved by the accreditation body 11) Ability to handle design changes Change the program details. 12) Power of Attorney When the technical documentation is prepared by an authorized representative, a copy of the manufacturer's authorization shall be included 13) Draft EC Declaration of Conformity The draft documentation is completed by the manufacturer/authorized representative, and once the EC type-examination and certification documentation is completed and held by the manufacturer/authorized representative. 14) Document retention statement. The manufacturer "will retain copies of its product technical documentation for at least 10 years from the certification of the product's final production date statement.". 15) Comment/complaint procedure. Details on how to notify the notified body of an end-user complaint about the product. 16) Issue CE certificate If the B + C2 mode is selected, the issuing speed will be faster. You can also choose B + D mode,
Full Body Disposable Coverall, annual factory audit, no need for sampling, follow-up maintenance costs will be lower. Return to Sohu to see more Responsible Editor:.
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