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YY/T 0866-2011 (YY/T 0866-2024 Newer Version) PDF English


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YY/T 0866-2024English359 Add to Cart 4 days Total inward leakage(TIL) determination method of protective face maskfor medical use Valid
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YY/T 0866-2011: PDF in English (YYT 0866-2011)

YY/T 0866-2011 PHARMACEUTICAL INDUSTRY STANDARD OF THE PEOPLE’S REPUBLIC OF CHINA ICS 11.140 C 48 Total Inward Leakage Determination Method of Protective Face Mask for Medical Use ISSUED ON: DECEMBER 31, 2011 IMPLEMENTED ON: JUNE 1, 2013 Issued by: China Food and Drug Administration Table of Contents Foreword ... 3  1 Scope ... 4  2 Normative References ... 4  3 Terms and Definitions ... 4  4 Test Methods ... 5  5 Evaluation of Test Results ... 10  Bibliography ... 12  Total Inward Leakage Determination Method of Protective Face Mask for Medical Use 1 Scope This Standard stipulates the determination method for total inward leakage of protective face mask for medical use. This Standard is applicable to the evaluation of total inward leakage of half-facepiece protective face mask for medical use (hereinafter referred to as face mask). The evaluation of the leakage performance of other protective face masks may take this Standard as a reference. 2 Normative References The following documents are indispensable to the application of this document. In terms of references with a specified date, only versions with a specified date are applicable to this document. In terms of references without a specified date, the latest version (including all the modifications) is applicable to this document. GB/T 2428-1998 Head-face Dimensions of Adults GB/T 10000-1988 Human Dimensions of Chinese Adults 3 Terms and Definitions The following terms and definitions are applicable to this document. 3.1 Half Facepiece Half facepiece refers to close-fitting face mask that can cover mouth and nose, or, mouth, nose and jaw. [GB 2626-2006, Definition 3.8] 3.2 Total Inward Leakage; TIL Total inward leakage refers to under the test conditions specified by the laboratory, the ratio of the concentration of simulant leaking into the mask from all mask components, including the filter element, to the concentration of the simulant in the inhaled air when the subject inhales, expressed in percentage. Total inward leakage is constituted of three factors: leakage due to loose-fitting of face when opening, without any restrictions; b) The minimum pressure change that a pressure sensor can determine is approximately 5 Pa (0.05 mbar). In addition, it can be connected to a probe inserted into a hole on the mask. The threshold of this sensor is adjustable; the sensor can acquire differential signals that exceed the threshold from any direction. When the subject’s head movement generates accelerated speed, the connected sensor shall be able to work stably; c) An interface system that can activate the valve in response to a signal from the pressure sensor; d) A timing device that is used to record the ratio of the sampling time to the total time of the entire breathing cycle. During the test, aerosol concentration in the closed test chamber is monitored through an independent sampling system, so as to avoid contamination of the mask sampling line. If possible, an independent flame photometer is recommended. If there is no second photometer, on the premise of using an independent sampling system to sample aerosol in the closed test chamber, it is also feasible to use the same photometer. However, it will take time to restore the photometer to a clean background. 4.1.6 Sampling probe Sampling probe shall be securely fixed in the mask in a sealed manner; be as close as possible to the centerline of the mask. During the determination, measures shall be taken (provide dry air) to prevent the test probe from being affected by condensation of the sampling probe. The probe shall be adjusted to the center of the breathing area. During the operation, ensure that the sampling probe does not affect normal wearing or the shape of the mask. 4.1.7 Sampling pump If there is no pump matching the photometer, an adjustable-flow pump may be used to collect air sample in the mask. Adjust the pump to collect sample, at a constant flow rate of 1 L/min, from the sampling probe. In accordance with the performance of the photometer, if necessary, dilute the sample with clean air. 4.1.8 Pressure detection probe Near the sampling probe, install another probe; connect it to the pressure sensor. 4.1.9 Test reagent In the closed test chamber, the average mass concentration of NaCl shall be (8 ± 4) mg/m3. The deviation of the entire effective working space shall not exceed 10%. The 4.4 Test Process 4.4.1 Method and principle During the test, subjects wearing a mask shall walk on a treadmill in a closed test chamber. A certain concentration of NaCl aerosol flows into the closed test chamber. In the inspiration phase of the breathing cycle, sample and analyze the air in the mask; determine the NaCl concentration. By making a hole on the mask and inserting a probe, export the collected samples. Insert another probe to test pressure change inside the mask and actuate a switching valve, so that merely the inhaled air can be sampled. 4.4.2 Test 4.4.2.1 Preparation Ask the subjects to read the mask manufacturer’s wearing instructions. If the mask has more than one specification, ask the subjects to choose a most suitable size. If necessary, test organizer shall demonstrate to the subjects how to properly wear the mask in accordance with the wearing instructions. In addition, make it clear to the subjects that the mask may be adjusted during the test. If the subjects adjust the mask, the system must be reset, then, redo relevant parts of the test. After each subject wears the mask, the organizer shall ask “Is the mask suitable?” If the answer is “Yes”, then, continue the test. If the answer is “No”, ask the subject to leave the test; report the actual situation and switch to another subject. 4.4.2.2 Test procedures In accordance with the following procedures, conduct the test: a) In the initial stage of the test, ensure that the test airflow is turned off; b) The subjects enter the closed test chamber; connect to a face sampling probe. The subjects walk on the treadmill at the speed of 5 km/h for 2 minutes. Determine the concentration of aerosol inside the mask; consider it as the background level and record it as the zero point. When the reading becomes stable, read the background value; c) Enable the test airflow; d) The subjects continue to walk for 2 min, or, walk till the test airflow becomes stable; e) Meanwhile, the subjects who are still walking shall take the following five actions: ......
 
Source: Above contents are excerpted from the PDF -- translated/reviewed by: www.chinesestandard.net / Wayne Zheng et al.