YY/T 0969-2023 PDF English
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YY/T 0969-2023: Single-use medical face mask---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/YYT0969-2023
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
Foreword
This document was drafted in accordance with the rules given in GB/T 1.1-2020
"Directives for standardization - Part 1.Rules for the structure and drafting of
standardizing documents".
This document replaces YY/T 0969-2013 "Single-use medical face mask". Compared
with YY/T 0969-2013, in addition to the structural adjustments and editorial
modifications, the main technical changes in this document are as follows.
a) Change the definition for "bacterial filtration efficiency" (see 3.1 of this Edition;
3.1 of Edition 2013);
b) Change the definition for "airflow resistance" (see 3.2 of this Edition; 3.2 of
Edition 2013);
c) Change the requirements for "appearance" (see 4.1 of this Edition; 4.1 of Edition
2013);
d) Change the requirements for "structure and dimensions" (see 4.2 of this Edition;
4.2 of Edition 2013);
e) Change the requirements for "nose clip" (see 4.3 of this Edition; 4.3 of Edition
2013);
f) Change the requirements for "mask strap" (see 4.4 of this Edition; 4.4 of Edition
2013);
g) Change the requirements for "airflow resistance" (see 4.6 of this Edition; 4.6 of
Edition 2013);
h) Change the requirements for "microbiological indicators" (see 4.7 of this Edition;
4.7 of Edition 2013);
i) Change the requirements for "cytotoxicity" (see 4.9.1 of this Edition; 4.9.1 of
Edition 2013);
j) Change the test method for "nose clip" (see 5.3 of this Edition; 5.3 of Edition 2013);
k) Change the test method for "mask strap" (see 5.4 of this Edition; 5.4 of Edition
2013);
l) Change the test method for "airflow resistance" (see 5.6 of this Edition; 5.6 of
Edition 2013);
m) Change the test method for "microbiological indicators" (see 5.7 of this Edition;
5.7 of Edition 2013);
n) Change the test method for "ethylene oxide residual amount" (see 5.8 of this
Edition; 5.8 of Edition 2013);
o) Change the test method for "biocompatibility" (see 5.9 of this Edition; 5.9 of
Edition 2013);
p) Change "marks" (see Chapter 6 of this Edition; Chapter 6 of Edition 2013).
Attention is drawn to the possibility that some of the elements of this document may be
the subject of patent rights. The issuing authority shall not be held responsible for
identifying any or all such patent rights.
This document was proposed by National Medical Products Administration.
This document shall be under the jurisdiction of National Standardization Working
Group on Medical Protective Equipment (SAC/SWG 30).
The drafting organizations of this document. Beijing Institute of Medical Device
Inspection (Beijing Medical Biological Protective Equipment Inspection and Research
Center), Guangdong Institute of Medical Device Quality Supervision and Inspection,
Xinjiang Uygur Autonomous Region Drug Inspection Institute (Xinjiang Uygur
Autonomous Region Medical Device Inspection and Testing Center), Beijing
University of Chemical Technology, Jiangxi 3L Medical Products Group Co., Ltd.,
Yadu Holding Group Co., Ltd., Wenjiang Medical Products Co., Ltd., Zhende Medical
Products Co., Ltd., Ogilvy Medical Products Co., Ltd., Ningbo Kangjiale Medical
Equipment Co., Ltd.
Main drafters of this document. Liu Simin, Luo Qingxiang, Sun Peng, Wang Dan, Tong
Xiaofeng, Liu Mingyu, Yang Xiaomeng, Chen Ming, Cao Mengjie, Huang Lihao, Liu
Keyang, Huang Yongfu, Zhang Yaping, Zhao Dan, Li Hua, Zhang Juan, Li Jian, Li
Yueling, Hu Guangyong.
Versions of standard substituted by this document are.
- YY/T 0969-2013 that was first issued in 2013;
- This is the first revision.
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
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.
5.4 Mask strap
5.4.1 Earhook mask
Carry out the test on at least 3 samples.
Fix the main part of the mask above the two connection points of the test mask strap so
that the mask maintains its natural shape and the two connection points are horizontal.
Apply a static pulling force of 15 N in the middle of the mask belt to make the mask
strap and the mask body in the same plane, as shown in Figure 1a). Maintain 5 s. Take
the other side of the same mask and repeat the above test.
If the sample mask strap and any connection points are not disconnected, the breaking
strength is recorded as ≥15 N. If disconnection occurs, record the disconnection location
(mask strap or connection point) and the breaking strength < 15 N.
5.4.2 Strap mask
Carry out the test on at least 3 samples.
Fix the mask body so that the mask strap and the mask body are on the same plane.
Apply a static pulling force of 10 N to the end of the mask strap in the direction shown
in Figure 1b). Maintain 5 s. Take the other side of the same mask and repeat the above
test.
If the sample mask straps and connections are not disconnected, the breaking strength
is recorded as ≥10 N. If disconnection occurs, record the disconnection location (mask
strap or connection) and the breaking strength < 10 N.
If there is no fixed connection between the mask strap and the mask body, the mask
strap shall be removed. One end is fixed, and the other end is loaded with a static tension
force of 10 N. Maintain 5 s. If the mask strap is not broken, the breaking strength is
recorded as ≥10 N. If breakage occurs, record the breaking strength as < 10 N.
5.5 Bacterial filtration efficiency (BFE)
Carry out the test on at least 3 samples. The test method is carried out according to the
test method for bacterial filtration efficiency in YY 0469.Determine whether the results
meet the requirements of 4.5.
5.6 Airflow resistance
Number of samples. use at least 5 samples for testing.
Test process. the test location shall be at the center of the mask (mouth and nose when
worn). Select 3 non-overlapping test areas. The gas flow rate for testing needs to be
adjusted to (8.0±0.2) L/min. The diameter of the sample test area is 25 mm. The test
area is 4.9 cm2.
Calculate airflow resistance (ΔP) according to formula (1). Results are reported as
pressure difference per square centimeter of area (Pa). If the calculated average of the
results of the three test areas of each sample meets the requirements of 4.6, it will be
judged to be qualified.
5.7 Microbial indicators
5.7.1 Microbial Limits
The test is conducted in accordance with the membrane filtration method specified in
Microbial Enumeration Method in Microbial Limit Examination of Non-sterile
Products (General Chapter 1105) in Part IV of Edition 2020 of the Pharmacopoeia of
the People's Republic of China. The total number of aerobic bacteria, mold and yeast is
added together.
Preparation of test solution. At least 2 minimum packages are randomly selected. Take
no less than 10 g of the test sample. Cut into pieces and use a diluent containing 0.1%
(mL/mL) polysorbate 80 (or other non-bacterial surfactant), such as pH 7.0 sterile
sodium chloride-peptone buffer, or pH 7.2 phosphate. buffer, or 0.9% sterile sodium
chloride solution. Prepare a 1.50 (g/mL) test solution. Mix thoroughly.
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.
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;
f) product technical requirement number;
g) product registration certificate number;
h) identification of the inner and outer sides and instructions on how to wear them;
i) storage conditions;
j) "single-use" words or symbols;
k) if it is a sterilized product, there shall be a corresponding sterilization mark, and
the sterilization method used shall be indicated;
l) scope of application.
7 Packaging, transportation and storage
7.1 Packaging
7.1.1 Masks shall be packaged to prevent mechanical damage and contamination before
use.
7.1.2 If ethylene oxide is used for disinfection or sterilization, the packaging shall be
made of breathable materials.
7.2 Transportation and storage
Carry out in accordance with the conditions stipulated in the contract or the
requirements of the instructions for use.
Bibliography
......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
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