YY 0469-2023 PDF English
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Sterile drainage catheters and accessory devices for single use
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YY 0469-2023: Sterile drainage catheters and accessory devices for single use---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/YY0469-2023
YY
MEDICAL INDUSTRY STANDARD OF
THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.140
CCS C 48
Replacing YY 0469-2011
Surgical mask
Issued on: NOVEMBER 22, 2023
Implemented on: DECEMBER 01, 2026
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... 8
6 Marks... 12
7 Marks, transportation and storage... 13
Annex A (normative) Preparation method for synthetic blood... 14
Annex B (normative) Test method for bacterial filtration efficiency (BFE)... 15
Bibliography... 21
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 0469-2011 "Surgical mask". Compared with YY 0469-
2011, in addition to the structural adjustments and editorial modifications, the main
technical changes in this document are as follows.
a) Supplement the changed scope (see Chapter 1 of this Edition; Chapter 1 of Edition
2011);
b) Delete the terms and definitions of particulate matter, sterilization, delayed
hypersensitivity and irritation (see 3.3, 3.7, 3.8, 3.9 of Edition 2011). Add the
terms and definitions for particle filtration efficiency (PFE) and airflow resistance
(see 3.3, 3.6 of this Edition). Change the terms and definitions for surgical masks
and particle filtration efficiency (see 3.1, 3.3 of this Edition; 3.1, 3.4 of Edition
2011);
c) Changed the requirements for structure and dimension, nose clip, mask strap,
filtration efficiency, airflow resistance, microbial indicators, cytotoxicity, delayed
hypersensitivity reaction (see 4.2, 4.3, 4.4, 4.6, 4.7, 4.9, 4.11.1, 4.11.3 of this
Edition; 4.2, 4.3, 4.4, 4.6, 4.7, 4.9, 4.12, 4.13 of Edition 2011);
d) Change the titles of articles on resistance to synthetic blood penetration and
airflow resistance (see 4.5 and 4.7 of this Edition; 4.5 and 4.7 of Edition 2011);
e) Change the test methods for mask straps, airflow resistance, microbial indicators,
ethylene oxide residue, and biocompatibility (see 5.4, 5.7, 5.9, 5.10, 5.11 of this
Edition; 5.4, 5.7, 5.9, 5.10, 5.11, 5.12, 5.13 of Edition 2011);
f) Change the requirements for marks (see Chapter 6 of this Edition; Chapter 6 of
Edition 2011);
g) Change the method for preparing synthetic blood in Annex A to stipulate that other
surfactants equivalent to Tween 20 can also be used (see A.1 of this Edition; A.1
of Edition 2011);
h) Change the requirements for the number of positive control bacteria in bacterial
filtration efficiency (BFE) test method in Annex B. Add the average interception
diameter calculation formula (see Annex B of this Edition; B.4 of Edition 2011).
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).
Versions of standard substituted by this document are.
- It was YY 0469-2011 that was first issued in 2004.The first revision was in 2011;
- This is the second revision.
Surgical mask
1 Scope
This document specifies the technical requirements, test methods, marks, packaging,
transportation and storage for surgical masks.
This document is applicable to disposable medical masks worn by medical staff in
medical environments with potential risks of blood, body fluid, and secretion
contamination and in invasive operating environments.
This document does not apply to protective masks in medical and other working
environments.
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/T 0691-2008, Single-use medical face mask
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 surgical mask
A barrier that can cover the wearer's mouth, nose and jaw, and is used to prevent
pathogenic microorganisms and droplets exhaled by the wearer from directly
contaminating the patient or the surrounding environment, and to prevent the patient's
body fluids, blood and other splashes from penetrating the mask and affecting the
wearer. cause some damages.
3.2 synthetic blood
A mixture of red dye, surfactant, thickener, and distilled water whose surface tension
and viscosity can represent blood and other body fluids and have a color similar to
blood.
NOTE. The synthetic blood used in the tests in this document does not have all the characteristics
of blood or body fluids, such as polarity (wetness), coagulability, and cellular material.
3.3 particle filtration efficiency; PFE
Under specified testing conditions, the percentage of particulate matter filtered out by
the mask.
4 Technical requirements
4.1 Appearance
The appearance of the mask shall be neat and in good shape. There shall be no damage
or stains on the surface.
4.2 Structure and dimension
After the mask is worn, it shall cover the wearer's mouth, nose and chin. It shall comply
with the design dimensions and allowable deviations specified by the manufacturer. The
design of the mask shall be able to distinguish the direction of its inner and outer sides.
4.3 Nose clip
4.3.1 The mask shall be equipped with a nose clip or a design that replaces the nose clip.
4.3.2 Nose clips shall be made of malleable material. It shall be safe and secure, with
no sharp protrusions. The length shall be no less than 8.0 cm. If a design is used to
replace the nose clip, the design shall be able to fix the nose clip and provide a basic
seal when worn.
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 Resistance to synthetic blood penetration
After 2 mL of synthetic blood is sprayed onto the outer side of the mask at a pressure
of 16.0 kPa (120 mmHg), there shall be no penetration on the inner side of the mask.
4.6 Filtration efficiency
4.6.1 Bacterial filtration efficiency (BFE)
The bacterial filtration efficiency of the mask shall be no less than 98%.
4.6.2 Particle filtration efficiency (PFE)
The filtration efficiency of the mask against non-oily particles shall be no less than 80%.
4.7 Airflow resistance
The airflow resistance for gas exchange on both sides of the mask shall be less than 60
Pa.
4.8 Flame retardation properties
Mask materials shall be made of non-flammable materials. The mask shall not burn for
more than 5 s after leaving the flame.
4.9 Microbial indicators
4.9.1 Microbiological limits (products supplied in a non-sterilized manner)
The total number of microorganisms shall be ≤30 CFU/g.
4.9.2 Sterility (products supplied in a sterilized manner)
Masks shall undergo a validated sterilization process. Products shall be sterile.
4.10 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.
5 Test methods
5.1 Appearance
Carry out the test on at least 3 samples. Conduct visual inspection.
5.2 Structure and dimension
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 to keep the mask in its natural shape. 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 belt and the mask body in the same plane, as shown in
Figure 1a). Maintain 5 s. If the mask straps and any connection points are not
disconnected, it is deemed to meet the requirements of 4.4.1.If disconnection occurs,
the disconnection location (mask strap or connection point) shall be reported.
5.4.2 Strap mask
Carry out the test on at least 3 samples. Fix the mask body so that the mask belt 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. If the mask straps and
connections are not disconnected, it is deemed to meet the requirements of 4.4.2.If
disconnection occurs, the disconnection location (mask strap or connection point) shall
be reported.
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 does not break, it is deemed to meet the
requirements of 4.4.2.
5.5 Resistance to synthetic blood penetration
Carry out the test on at least 3 samples. Sample pretreatment and test methods are
carried out in accordance with the provisions of YY/T 0691-2008.Determine whether
the result meets the requirements of 4.5.Synthetic blood is prepared according to the
method specified in Annex A of this document.
5.6 Filtration efficiency
a) Earhook mask b) Strap mask
5.6.1 Bacterial filtration efficiency (BFE)
Carry out the test on at least 3 samples. The test method is carried out in accordance
with the provisions of Annex B. Determine whether the results meet the requirements
of 4.6.1.
5.6.2 Particle filtration efficiency (PFE)
Number of samples. Use at least 3 samples for testing.
Sample pretreatment. Before the test, take the sample out of the package and place it in
an environment with a temperature of (38±2.5)℃ and a relative humidity of (85±5)%
for at least (25±1) h. Seal the sample in an airtight container. The test shall be completed
within 10 h after the sample pretreatment is completed.
Test conditions. The test conditions are ambient temperature (25±5)℃ and relative
humidity (30±10)%. The concentration of sodium chloride aerosol particles shall not
exceed 200 mg/m3.Count median diameter (0.075±0.020) μm. The geometric standard
deviation of particle distribution is ≤1.86.The test air flow is set to (30±2) L/min, and
the cross-sectional area of the airflow is 100 cm2.
NOTE. The count median diameter (CMD) of 0.075 μm is approximately the mass median
aerodynamic diameter (MMAD) of 0.3 μm.
5.7 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 (Pa). If the calculated average of the results
of the three test areas of each sample meets the requirements of 4.7, it will be judged to
be qualified.
5.9 Microbial indicators
5.9.1 Microbiological 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 results for total aerobic bacteria, mold and yeast
counts are added together.
Preparation of test solution. At least 2 smallest 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.
5.9.2 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.
5.10 Residual amount of ethylene oxide
Conduct the test in accordance with the provisions of 9.4 in GB/T 14233.1-2022.
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 expiry date;
e) manufacturer’s name and contact information;
f) implementation standard number or 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;
l) product purpose.
7 Marks, transportation and storage
7.1 Packaging
Masks shall be packaged to prevent mechanical damage and contamination prior to use.
7.2 Transportation and storage
Carry out in accordance with the conditions stipulated in the contract or the
requirements of the instructions for use.
......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
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