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TEST REPORT EN 149 Respiratory Protective Devices — Filtering Half Masks to Protect Against Particles — Requirements, Testing, Marking

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TEST REPORT EN 149 Respiratory Protective Devices — Filtering Half Masks to Protect Against Particles — Requirements, Testing, Marking Report No.: BTK20200212010PPE Page 1 of 26 TEST REPORT EN 149 Respiratory protective devices — Filtering half masks to protect against particles — Requirements, testing, marking Report Reference No. .................... : BTK20200212010PPE Tested by (name + signature) ....... : Man Li Approved by (name + signature) . : Dexter Chan Date of issue .................................. : 2020-03-13 Total number of pages .................. : 26 Testing Laboratory ........................ : Guangzhou Bestek Testing Services Co., Ltd Address .......................................... : Unit F503, 5th Floor of Xinshuikeng Trade Square, No.10 of Shixin Road, Dalong Street, Panyu District, Guangzhou City, Guangdong Province, P.R. China. Applicant’s name........................... : Guangzhou Meisu Industrial Co., Ltd. Address .......................................... : Room 101, Building 5, No.58, Shenshan Zhushui 1st Road, Jianggao Town, Baiyun District, Guangzhou (Self-documentated) Test specification: Standard ......................................... : EN 149:2001+A1:2009 Test procedure .............................. : CE-PPE Non-standard test method………..: N/A Test Report Form No. .................... : EN 149_B Master TRF ..................................... : Dated 2014-09 Trade Mark ..................................... : None Manufacturer ................................. : Guangzhou Meisu Industrial Co., Ltd. Room 101, Building 5, No.58, Shenshan Zhushui 1st Road, Jianggao Town, Baiyun District, Guangzhou (Self-documentated) Test item description .................... : KN95 Face Mask Model/Type reference ................... : MS-KN95-01, MS-KN95-02, MS-KN95-03, MS-KN95-04 Guangzhou Bestek Testing Services Co., Ltd TRF No. EN 149_B Report No.: BTK20200212010PPE Page 2 of 26 Classification ................................. : FFP1 FFP2 FFP3 List of Attachments (including a total number of pages in each attachment): This report has total 26 numbers, include annex I. Annex I: Photos document, 2 pages. Summary of testing: tests performed (name of test and test clause) The tested samples comply with the requirements of EN 149:2001+A1:2009. Summary of compliance with National Differences National differences for Europe groups were taken into account. Copy of marking plate KN95 Face Mask Model: MS-KN95-01 EN 149:2001+A1:2009 FFP2 NR D Manufacturer: Guangzhou Meisu Industrial Co., Ltd. Address: Room 101, Building 5, No.58, Shenshan Zhushui 1st Road, Jianggao Town, Baiyun District, Guangzhou (Self-documentated) Note: - The Markings are attached on external enclosure and visible during normal use. - The height of CE mark should be minimum 5,0mm. - The importer name and address were marked on the product. Guangzhou Bestek Testing Services Co., Ltd TRF No. EN 149_B Report No.: BTK20200212010PPE Page 3 of 26 Possible test case verdicts: - test case does not apply to the test object ............. : N/A - test object does meet the requirement .................. : P (Pass) - test object does not meet the requirement............. : F (Fail) Testing .................................................................... : Date of receipt of test item ....................................... : 2020-02-12 Date (s) of performance of tests .............................. : 2020-02-12 to 2020-03-13 General remarks: The test results presented in this report relate only to the object tested. This report shall not be reproduced, except in full, without the written approval of the Issuing testing laboratory. "(See Enclosure #)" refers to additional information appended to the report. "(See appended table)" refers to a table appended to the report. Throughout this report a comma / point is used as the decimal separator. General product information: 1. This product, named KN95 Face Mask, for Household and similar used. Guangzhou Bestek Testing Services Co., Ltd TRF No. EN 149_B Report No.: BTK20200212010PPE Page 4 of 26 EN 149 Clause Requirement + Test Result - Remark Verdict 4 Description — A particle filtering half mask covers the nose and P mouth and the chin and may have inhalation and/or exhalation valve(s). The half mask consists entirely or substantially of P filter material or comprises a facepiece in which the main filter(s) form an inseparable part of the device. It is intended to provide adequate sealing on the P face of the wearer against the ambient atmosphere, when the skin is dry or moist and when the head is moved. Air enters the particle filtering half mask and passes P directly to the nose and mouth area of the facepiece or, via an inhalation valve(s) if fitted. The exhaled air flows through the filter material P and/or an exhalation valve (if fitted) directly to the ambient atmosphere. These devices are designed to protect against both P solid and liquid aerosols. 5 Classification — Particle filtering half masks are classified according P to their filtering efficiency and their maximum total inward leakage. There are three classes of devices: FFP1, FFP2 FFP2 P and FFP3. The protection provided by an FFP2 - or FFP3 - P device includes that provided by the device of lower class or classes. In addition, particle filtering half masks are P classified as single shift use only or as re-usable (more than one shift)." 6 Designation — Particle filtering half masks meeting the P requirements of this European Standard shall be designated in the following manner: Particle filtering half mask EN 149, year of P publication, classification, option (where "D" is an option for a non re-useable particle filtering half mask and mandatory for re-useable particle filtering half mask). 7 Requirements — 7.1 General P In all tests all test samples shall meet the P requirements. 7.2 Nominal values and tolerances P Unless otherwise specified, the values stated in this P European Standard are expressed as nominal values. Except for temperature limits, values which are not P stated as maxima or minima shall be subject to a Guangzhou Bestek Testing Services Co., Ltd TRF No. EN 149_B Report No.: BTK20200212010PPE Page 5 of 26 EN 149 Clause Requirement + Test Result - Remark Verdict tolerance of ± 5 %. Unless otherwise specified, the ambient temperature for testing shall be (16 - 32) °C, and the temperature limits shall be subject to an accuracy of ± 1 °C. 7.3 Visual inspection P The visual inspection shall also include the marking P and the information supplied by the manufacturer. 7.4 Packaging P Particle filtering half masks shall be offered for sale P packaged in such a way that they are protected against mechanical damage and contamination before use. Testing shall be done in accordance with 8.2. P 7.5 Material P Materials used shall be suitable to withstand P handling and wear over the period for which the particle filtering half mask is designed to be used. After undergoing the conditioning described in P 8.3.1 none of the particle filtering half masks shall have suffered mechanical failure of the facepiece or straps. Three particle filtering half masks shall be tested. P When conditioned in accordance with 8.3.1 and P 8.3.2 the particle filtering half mask shall not collapse. Any material from the filter media released by the P air flow through the filter shall not constitute a hazard or nuisance for the wearer. Testing shall be done in accordance with 8.2. P 7.6 Cleaning and disinfecting P If the particle filtering half mask is designed to be P re-usable, the materials used shall withstand the cleaning and disinfecting agents and procedures to be specified by the manufacturer. Testing shall be done in accordance with 8.4 and P 8.5. With reference to 7.9.2, after cleaning and P disinfecting the re-usable particle filtering half mask shall satisfy the penetration requirement of the relevant class. Testing shall be done in accordance with 8.11. P 7.7 Practical performance P The particle filtering half mask shall undergo P practical performance tests under realistic conditions. These general tests serve the purpose of checking P the equipment for imperfections that cannot be determined by the tests described elsewhere in this Guangzhou Bestek Testing Services Co., Ltd TRF No. EN 149_B Report No.: BTK20200212010PPE Page 6 of 26 EN 149 Clause Requirement + Test Result - Remark Verdict standard. Where practical performance tests show the P apparatus has imperfections related to wearer's acceptance, the test house shall provide full details of those parts of the practical performance tests which revealed these imperfections. Testing shall be done in accordance with 8.4. P 7.8 Finish of parts P Parts of the device likely to come into contact with P the wearer shall have no sharp edges or burrs. Testing shall be done in accordance with 8.2. P 7.9 Leakage P 7.9.1 Total inward leakage P The laboratory tests shall indicate that the particle P filtering half mask can be used by the wearer to protect with high probability against the potential hazard to be expected. The total inward leakage consists of three P components: face seal leakage, exhalation valve leakage (if exhalation valve fitted) and filter penetration. For particle filtering half masks fitted in accordance P with the manufacturer’s information, at least 46 out of the 50 individual exercise results for total inward leakage shall be not greater than 25 % for FFP1 N/A 11 % for FFP2 P 5 % for FFP3 N/A and, in addition, at least 8 out of the 10 individual P wearer arithmetic means for the total inward leakage shall be not greater than 22 % for FFP1 N/A 8 % for FFP2 P 2 % for FFP3. N/A Testing shall be done in accordance with 8.5. P 7.9.2 Penetration of filter material P The penetration of the filter of the particle filtering P half mask shall meet the requirements of Table 1. A total of 9 samples of particle filtering half masks P shall be tested for each aerosol. Testing in accordance with 8.11 using the P Penetration test according to EN 13274-7, shall be performed on: - 3 samples as received; P Guangzhou Bestek Testing Services Co., Ltd TRF No. EN 149_B Report No.: BTK20200212010PPE Page 7 of 26 EN 149 Clause Requirement + Test Result - Remark Verdict - 3 samples after the simulated wearing treatment P described in 8.3.1.
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