This standard specifies the requirements, test methods,, marking, instructions for use as well as packaging, transport and storage of single-use medical face mask (hereinafter referred to as “face mask”).
This standard is applicable to single-use face masks covering the mouth, nose and lower jaw of the users, which are worn in general medical environment to block exhaled or expelled pollutants from the oral cavity and nasal cavity.
This standard is not applicable to protective face mask and surgical masks for medical use.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
GB/T 14233.1-2008 Test methods for infusion, transfusion, injection equipments 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
YY 0469 Surgical mask
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
bacterial filtration efficiency; BFE
the percentage of bacteria-containing suspended particles filtered out by the face mask material at the specified flow rate
3.2
airflow resistance
the resistance of the face mask at the specified area and flow rate, expressed by pressure difference,
in Pa.
4 Requirements
4.1 Appearance
The appearance of the face mask shall be clean and in good shape, and the surface shall not be damaged or stained.
4.2 Structure and dimension
The face mask shall be able to cover the mouth, nose and lower jaw of the wearer after it is properly put on. It shall comply with the design dimension, and the maximum deviation shall not exceed ±5%.
4.3 Nose clip
4.3.1 The face mask shall be equipped with a nose clip made of pliable materials.
4.3.2 The length of the nose clip shall be no less than 8.0 cm.
4.4 Face mask strips
4.4.1 The face mask strips shall be easy to be put on and taken off.
4.4.2 The breaking strength at the connection point between each strip and the face mask body shall not be less than 10 N.
4.5 Bacterial filtration efficiency (BFE)
The bacterial filtration efficiency of the face mask shall not be less than 95%.
