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YY 0469-2011 (YY0469-2011)

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YY 0469-2011: PDF in English
YY 0469-2011
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.140
C 48
Replacing YY 0469-2004
Surgical mask
ISSUED ON: DECEMBER 31, 2011
IMPLEMENTED ON: JUNE 01, 2013
Issued by: China Food and Drug Administration
Table of Contents
Foreword ... 3 
1 Scope ... 5 
2 Normative references ... 5 
3 Terms and definitions ... 5 
4 Technical requirements ... 7 
5 Test methods ... 9 
6 Marking ... 12 
7 Packaging, transportation, and storage ... 13 
Appendix A (Normative) Preparation method of synthetic blood ... 14 
Appendix B (Normative) Test method for bacterial filtration efficiency (BFE) . 15 
Bibliography ... 20 
Surgical mask
1 Scope
This Standard specifies the technical requirements, test methods, marking,
instructions for use, packaging, transportation, and storage of surgical mask
(hereinafter referred to as mask).
This Standard applies to disposable masks worn by clinical medical personnel
during invasive operations.
2 Normative references
The following documents are indispensable for the application of this document.
For the dated references, only the editions with the dates indicated are
applicable to this document. For the undated references, the latest edition
(including all the amendments) are 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 16886.5-2003 Biological evaluation of medical devices - Part 5: Test
for in vitro cytotoxicity
GB/T 16886.10-2005 Biological evaluation of medical devices - Part 10:
Tests for irritation and delayed-type hypersensitivity
3 Terms and definitions
The following terms and definitions apply to this document.
3.1 Surgical mask
It is used to cover the mouth, nose, and lower jaw of the user, providing a
physical barrier to prevent direct penetration of pathogenic microorganisms,
body fluids, particle, etc.
Individual exposure to an allergen produces specific T cell-mediated
immunological memory induction, which causes delayed-type
hypersensitization after re-exposure to the allergen.
[GB/T 16886.10-2005, definition 3.5]
3.9 Irritation
A local non-specific inflammatory reaction caused by one, multiple, or
continuous contact with a material.
[GB/T 16886.10-2005, definition 3.11]
4 Technical requirements
4.1 Appearance
The mask shall be neat in appearance and in good shape. The surface shall
not be damaged or stained.
4.2 Structure and size
After the mask is worn, it shall cover the wearer’s nose, mouth to the lower jaw.
It shall conform to the design size and tolerances marked.
4.3 Nose clip
4.3.1 The mask shall be equipped with a nose clip, which is made of a plastic
material.
4.3.2 The length of nose clip shall be no less than 8.0 cm.
4.4 Mask belt
4.4.1 The mask belt shall be easy to wear and take.
4.4.2 The breaking strength at the joint of each mask belt and the mask body
shall be no less than 10 N.
4.5 Synthetic blood penetration
After 2 mL of synthetic blood is sprayed at a pressure of 16.0 kPa (120 mmHg)
to the outer side of mask, no penetration shall occur on the inner side of mask.
4.6 Filtration efficiency
4.6.1 Bacterial filtration efficiency (BFE)
5 Test methods
5.1 Appearance
USE 3 samples to test. Inspect visually. It shall meet the requirements of 4.1.
5.2 Structure and size
USE 3 samples to test. WEAR actually. USE general-purpose or special
measuring tools to measure. It shall meet the requirements of 4.2.
5.3 Nose clip
5.3.1 USE 3 samples to test. Inspect visually and wear actually. It shall meet
the requirements of 4.3.1.
5.3.2 USE 3 samples to test. USE general-purpose or special measuring tools
to measure. It shall meet the requirements of 4.3.2.
5.4 Mask belt
5.4.1 USE 3 samples to test. CHECK the adjustment conditions by wearing. It
shall meet the requirements of 4.4.1.
5.4.2 USE 3 samples to test. USE a static tension of 10 N to measure for 5 s.
The result shall meet the requirements of 4.4.2.
5.5 Synthetic blood penetration test
Number of samples: USE 3 samples to test.
Sample pretreatment: The sample is pretreated at a temperature of (21±5)°C
and relative humidity (85±5)% for at least 4 h and tested within 1 min after taking
out.
Test process: FIX the sample on the sample clamp on the instrument (see
Figure 1). At 30.5 cm from the sample center, 2 mL of synthetic blood with a
surface tension of (0.042±0.002)N/m (see Appendix A for the preparation
method) is horizontally sprayed at a pressure of 16.0 kPa (120 mmHg) from the
needle tubing with an inner diameter of 0.84 mm to the target area of the sample
under test. Within 10 s after taking out, inspect visually.
Result treatment: CHECK the inner side of sample for penetration. If suspicious
by visual inspection, an absorbent cotton swab or the like can be used to wipe
the inside of the target area; then it is judged whether or not there is synthetic
blood penetration. The result shall meet the requirements of 4.5.
b) According to the method specified in Clause 2 of GB/T 14233.2-2005,
perform the sterility test. The result shall comply with the requirements of
4.9.2.
5.10 Ethylene oxide residue
According to the gas chromatography specified in GB/T 14233.1-2008, perform
the test. The result shall meet the requirements of 4.10.
5.11 Skin irritation
According to the method specified in 6.3 of GB/T 16886.10-2005, perform the
test. The result shall meet the requirements of 4.11.
5.12 Cytotoxicity
According to the method specified in 8.2 of GB/T 16886.5-2003, perform the
test. The result shall meet the requirements of 4.12.
5.13 Delayed-type hypersensitization
According to the method specified in 7.5 of GB/T 16886.10-2005, perform the
test. The result shall meet the requirements of 4.13.
6 Marking
The minimum package of mask shall have a clear Chinese mark. If the package
is transparent, the mark shall be visible through the package. The mark shall at
least include:
a) Product name;
b) Production date and (or) batch number;
c) Manufacturer’s name and contact information;
d) Executive standard number;
e) Product registration certificate number;
f) Instructions for use;
g) Storage conditions;
h) “One-time use” words or symbols;
i) For a sterilized product, there shall be a corresponding sterilization mark;
Appendix A
(Normative)
Preparation method of synthetic blood
A.1 Reagents
Formula composition of synthetic blood:
Sodium carboxymethylcellulose (CMC, medium viscosity) 2 g
Tween 20 0.06 g
Sodium chloride (analytically pure) 4.5 g
Methylisothiazolinone (MIT) 0.5 g
Amaranth dye 1.0 g
Distilled water ADD to 1 L
A.2 Preparation method
DISSOLVE sodium carboxymethylcellulose in 0.5 L of water; MIX on a magnetic
stirrer for 60 min. WEIGH Tween 20 in a small beaker; ADD water to mix well.
ADD Tween 20 solution to the above solution of sodium carboxymethylcellulose;
USE distilled water to wash the beaker several times and add to the former
solution.
DISSOLVE sodium chloride in the solution. ADD MIT and amaranth dye. USE
water to dilute to 1000 g.
USE 2.5 mol/L sodium hydroxide solution to adjust the pH of the synthetic blood
to 7.3±0.1.
USE a surface tension meter to measure the surface tension of the synthetic
blood. The result shall be (0.042±0.002)N/m. If beyond this range, it cannot be
used.
B.1.2 Materials
Conical flask (250 mL~500 mL); plate; straw (1 mL, 5 mL, 10 mL); stainless-
steel test tube rack; sterile glass bottle (100 mL~500 mL); inoculating loop;
stopper; test tube (16 mm×150 mm).
B.1.3 Reagents
Trypsin soy agar (TSA); trypsin soy broth (TSB); peptone water; staphylococcus
aureus ATCC 6538.
B.2 Sample pretreatment
Before the test, the sample is pretreated in an environment with a temperature
of (21±5)°C and a relative humidity of (85±5)% for at least 4 h.
B.3 Preparation of bacterial suspension for test
Staphylococcus aureus ATCC 6538 is inoculated in an appropriate amount of
trypsin soy broth and shake-cultured at (37±2)°C for (24±2)h. Then, USE 1.5%
peptone to dilute the above culture to a concentration of about 5×105 CFU/mL.
B.4 Test procedures
Sample is not placed first in the test system. The gas flow rate through the
sampler is controlled at 28.3 L/min. The time for delivering the bacterial
suspension to the sprayer is set to 1 min. The air pressure and sampler running
time are set to 2 min. The bacterial aerosol is collected on trypsin soy agar as
a positive quality control value. USE this value to calculate the aerosol flow rate.
It shall be (2200±500)CFU, otherwise the culture concentration needs to be
adjusted. Calculate the mean particle diameter (MPS) of bacterial aerosol; it
shall be (3.0±0.3)μm. The geometric standard deviation of bacterial aerosol
distribution shall not exceed 1.5.
After the positive quality control test is completed, the agar plate is taken out
and marked with the layer number. Then, PLACE a new agar plate and clamp
the test sample to the upper end of sampler, with the surface under test upward.
SAMPLE according to the above procedures.
After the test of a batch of test samples is completed, the positive quality control
is tested again. Then, air sample in the aerosol chamber is collected for 2 min
as a negative quality control. During this process, the bacterial suspension
cannot be delivered to the sprayer.
A test system which can simultaneously perform positive quality control
collection and sample collection (see Figure B.2) may also be used.
......
(Above excerpt was released on 2019-08-17, modified on 2021-06-07, translated/reviewed by: Wayne Zheng et al.)
Source: https://www.chinesestandard.net/PDF.aspx/YY0469-2011