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Specification For Procedural Masks with Earloop

FutechLife Procedural Masks 

FDA standard approved FDA Establishment Registration and Device Listing with the US Food & Drug Administration, through UCL-REG SERVICE INC. ` 

Specification of Procedural Masks YY/T 0969-2013 Standard Sector / Industry: Medical Device & Pharmaceutical Industry Standard Classification of Chinese Standard: C48 Classification of International Standard: 11.140 Word Count Estimation: 9,963 Quoted Standard: GB/T 14233.1-2008; GB/T 14233.2-2005; GB 15979-2002; GB/T 16886.5; GB/T 16886.10; GB/T 16886.12; YY 0469 Drafting Organization: Beijing Medical Device Testing Administrative Organization: State Food and Drug Administration, Beijing Medical Device Quality Supervision and Inspection Center Regulation (derived from): State Food and Drug Administration Notice No. 36 of 2013; industry standard for filing Notice 2013 No. 12 (No. 168 overall) Proposing organization: State Food and Drug Administration Issuing agency(ies): State Food and Drug Administration Summary: This standard specifies the use of disposable medical masks (hereinafter referred to as masks) requirements, test methods, marking, manual and packaging, transportation and storage. This standard applies to cover the user's mouth,nose and jaw. 

YY/T 0969-2013 PHARMACEUTICAL INDUSTRY STANDARD OF THE PEOPLE’S REPUBLIC OF CHINA ICS 11.140 C 48 Single-use Medical Face Mask ISSUED ON: OCTOBER 21, 2013 IMPLEMENTED ON: OCTOBER 1, 2014 Issued by: China Food and Drug Administration 

1 Scope This Standard stipulates the requirements, test methods, marking, instruction manual and packaging, transportation and storage of single-use medical face mask (hereinafter referred to as face mask). 

This Standard is applicable to single-use medical face mask that covers user’s mouth, nose and jaw, and blocks exhalation or ejection of pollutants from the oral and nasal cavity in general medical environment. This Standard is inapplicable to medical protective mask and surgical mask. 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 14233.1-2008 Test Methods for Infusion, Transfusion, Injection Equipment for Medical Use - Part 1: Chemical Analysis Methods GB/T 14233.2-2005 Test Methods for Infusion, Transfusion, Injection Equipment for Medical Use - Part 2: Biological Test Methods GB 15979-2002 Hygienic Standard for Disposable Sanitary Products GB/T 16886.5 Biological Evaluation of Medical Devices - Part 5: Tests for In- vitro Cytotoxicity GB/T 16886.10 Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization GB/T 16886.12 Biological Evaluation of Medical Devices - Part 12: Sample Preparation and Reference Materials 3 Terms and Definitions The following terms and definitions are applicable to this document. 5.3.2 Randomly draw 3 samples for tests. Take out nose clip; use a universal or special measuring instrument to measure it; the result shall comply with the requirements in 4.3.2. 5.4 Face Mask Band 5.4.1 Randomly draw 3 samples for tests. By wearing it, inspect the adjustment; the result shall comply with the requirements in 4.4.1. 5.4.2 Randomly draw 3 samples for tests. Use 10 N of static tension to measure it; maintain for 5 s; the result shall comply with the requirements in 4.4.2. 5.5 Bacterial Filtration Efficiency (BFE) Randomly draw 3 samples for tests. In accordance with the test method for bacterial filtration efficiency in YY 0469, conduct the tests; the result shall comply with the requirements in 4.5. Source material – test results to BFE > 95% based on YY/T0969-2013 standard. Being the effectiveness of a medical mask in capturing (percentage) aerosol droplets containing bacteria. 

5.6 Airflow Resistance 5.6.1 Randomly draw 3 samples for tests. 5.6.2 Test position: take the central part of face mask for tests. 5.6.3 Test process: gas flow rate for tests shall be adjusted to (8 ± 0.2) L/min. The diameter of sample testing area shall be 25 mm. The sample testing area shall be A. Use differential pressure gauge or equivalent equipment to determine the differential pressure on both sides of face mask. In accordance with Formula (1), calculate the airflow resistance; the result shall comply with the stipulations in 4.6. Where, ∆P---differential pressure value per square centimeter of test sample, expressed in (Pa/cm2); M---differential pressure value of test sample, expressed in (Pa); A---testing area of sample, expressed in (cm2). 5.7 Microbial Indexes In accordance with sample marking, select from the following tests: a) In accordance with the method specified in Appendix B in GB 15979-2002, conduct the test; the result shall comply with the requirements in 4.7.1. f) Instruction manual (at least include front-and-back identification, and wearing method); g) Conditions of storage; h) Character or symbol of “single-use”; i) If it is sterilized product, there shall be corresponding marking of sterilization; the adopted sterilization method and validity period of sterilization shall be indicated; j) Specifications and sizes; k) Product usage. 6.2 Instruction Manual Instruction manual shall at least provide the following information: a) Product name; b) Name, address and contact information of manufacturer; c) Product usage and usage restrictions; d) Necessary examination before usage; e) How to use (at least include front-and-back identification) Related standard: YY/T 0616.5-2019 YY/T 0616.3-2018 

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