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YY/T 0969-2023 PDF in English


YY/T 0969-2023 (YY/T0969-2023, YYT 0969-2023, YYT0969-2023)
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YY/T 0969-2023: PDF in English (YYT 0969-2023)

YY/T 0969-2023
YY
MEDICAL INDUSTRY STANDARD OF
THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.140
CCS C 48
Replacing YY/T 0969-2013
Single-use medical face mask
ISSUED ON: NOVEMBER 22, 2023
IMPLEMENTED ON: DECEMBER 01, 2025
Issued by: National Medical Products Administration
Table of Contents
Foreword ... 3
1 Scope ... 5
2 Normative references ... 5
3 Terms and definitions ... 5
4 Technical requirements ... 6
5 Test methods ... 7
6 Marks ... 10
7 Packaging, transportation and storage ... 11
Bibliography ... 12
Single-use medical face mask
1 Scope
This document specifies the technical requirements, test methods, marks, packaging,
transportation and storage for single-use medical face mask.
This document is applicable to single-use face masks that cover the user's mouth, nose
and jaw, and are worn in general medical environments to block exhaled or sprayed
pollutants from the oral and nasal cavities.
This document does not apply to medical protective masks and medical surgical masks.
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 14233.1-2022, Test methods for infusion, transfusion, injection equipment for
medical use -- Part 1: Chemical analysis methods
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, Sterile drainage catheters and accessory devices for single use
Part IV of Edition 2020 of the Pharmacopoeia of the People's Republic of China
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1 bacterial filtration efficiency; BFE
Under specified testing conditions, the mask's ability to filter out bacteria-containing
suspended particles.
NOTE: It is usually expressed as a percentage.
3.2 airflow resistance
The resistance of the mask under the specified area and specified flow rate.
NOTE: It is expressed as pressure difference per unit area.
4 Technical requirements
4.1 Appearance
The mask shall be clean in appearance and in good shape. There shall be no obvious
defects such as damage, stains, sharp protrusions, etc. on the surface.
4.2 Structure and dimensions
After the mask is worn, it shall cover the wearer's mouth, nose and chin. It shall comply
with the marked dimensions and allowable deviations specified by the manufacturer.
The design of the mask shall be able to distinguish its inner and outer sides.
4.3 Nose clip
4.3.1 The mask shall be equipped with a nose clip or a structure that replaces the nose
clip.
4.3.2 The structure of the nose clip or nose clip replacement shall be such that the mask
can be effectively fixed on the nose and fit well to the nose area. The length of the nose
clip shall be no less than 50% of the marked length on the side where the nose clip is
located.
4.4 Mask strap
4.4.1 Earhook mask
The sum of the breaking strengths of each mask strap and the two connection points
between each mask strap and the mask body shall not be less than 15 N.
4.4.2 Strap mask
The breaking strength of each mask strap and the connection between each mask strap
and the mask body shall be no less than 10 N. If there is no fixed connection point
between the mask strap and the mask body, the breaking strength of each mask strap
shall be no less than 10 N.
4.5 Bacterial filtration efficiency (BFE)
The bacterial filtration efficiency of the mask shall be no less than 95%.
4.6 Airflow resistance
The airflow resistance for gas exchange on both sides of the mask shall be less than 40
Pa.
4.7 Microbial indicators
4.7.1 Microbiological limits (products supplied in a non-sterilized manner)
The total number of microorganisms shall be ≤30 CFU/g.
4.7.2 Sterility (products supplied in a sterilized manner)
Masks shall undergo a confirmed sterilization process and the product shall be sterile.
4.8 Residual amount of ethylene oxide (if applicable)
If the mask has been sterilized or disinfected with ethylene oxide, the residual ethylene
oxide content shall not exceed 10 μg/g.
4.9 Biocompatibility
4.9.1 Cytotoxicity
The relative cell proliferation rate (survival rate) of the mask is not less than 70%.
4.9.2 Skin irritation
The primary irritation score of the mask shall not be greater than 0.4.
4.9.3 Delayed type hypersensitivity reaction
The delayed type hypersensitivity reaction of the mask shall not be greater than level 1.
5 Test methods
5.1 Appearance
Carry out the test on at least 3 samples. Conduct visual inspection.
5.2 Structure and dimensions
Carry out the test on at least 3 samples. Actually wear it and measure it with a general
or special measuring tool.
5.3 Nose clip
Carry out the test on at least 3 samples. Conduct visual inspection. Measure with general
or special measuring tools, and perform actual wearing.
5.7.2 Sterility
Carry out in accordance with the test methods specified in the Sterility Inspection Act
(General Chapter 1101) in Part IV of Edition 2020 of the Pharmacopoeia of the People's
Republic of China. The treatment of the test article and the inoculation culture medium
shall be carried out according to the provisions of dressing the test article in the direct
inoculation method.
5.8 Residual amount of ethylene oxide
Conduct the test in accordance with the provisions of 9.4 in GB/T 14233.1-2022.
5.9 Biocompatibility
5.9.1 Sample preparation
Take the mask strap and the main mask material and mix them according to the area
ratio of 1:3 as a test sample. The leach solution of this test sample is prepared in
accordance with the requirements of GB/T 16886.12.
5.9.2 Cytotoxicity
After the test sample extract is diluted 2 times with complete cell culture medium, the
cytotoxicity test is carried out according to the MTT method in GB/T 16886.5.
5.9.3 Skin irritation
The test is conducted using the animal skin irritation test specified in GB/T 16886.10.
5.9.4 Delayed type hypersensitivity reaction
The maximum dose for delayed type hypersensitivity reaction in guinea pigs specified
in GB/T 16886.10 is used for the test.
6 Marks
The minimum sales unit of masks shall have clear Chinese marks. The mark shall at
least include:
a) product name;
b) model, specifications and information showing dimensions;
c) production date and/or batch number;
d) use period or expiration date;
e) manufacturer’s name and contact information;
......
 
Source: Above contents are excerpted from the PDF -- translated/reviewed by: www.chinesestandard.net / Wayne Zheng et al.