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| Standard ID | YY 0469-2023 (YY0469-2023) | | Description (Translated English) | Surgical mask | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | | Classification of Chinese Standard | C48 | | Classification of International Standard | 11.140 | | Word Count Estimation | -2,-13 | | Date of Issue | 2023-11-22 | | Date of Implementation | 2026-12-01 | | Older Standard (superseded by this standard) | YY 0469-2011 | | Administrative Organization | National Medical Protective Equipment Standardization Working Group (SAC/SWG 30) | | Proposing organization | State Drug Administration | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This standard specifies the technical requirements, test methods, marking, packaging, transportation and storage of medical surgical masks. This standard applies to disposable medical masks worn by medical staff in medical environments and invasive operating environments that contain potential risks of blood, body fluid, and secretion contamination. This standard does not apply to protective masks in medical and other working environments. | | Standard ID | YY 0469-2011 (YY0469-2011) | | Description (Translated English) | Surgical mask | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | | Classification of Chinese Standard | C48 | | Classification of International Standard | 11.040 | | Word Count Estimation | 15,123 | | Date of Issue | 2011-12-31 | | Date of Implementation | 2013-06-01 | | Older Standard (superseded by this standard) | YY 0469-2004 | | Quoted Standard | GB/T 14233.1-2008; GB/T 14233.2-2005; GB 15979-2002; GB/T 16886.5-2003; GB/T 16886.10-2005 | | Drafting Organization | Beijing Medical Device Testing | | Administrative Organization | State Food and Drug Administration, Beijing Medical Device Quality Supervision and Inspection Center | | Regulation (derived from) | China Food & Drug Administration Announcement 2011 No.106; Industry Standard Filing Announcement 2013 No.6 (Total No.162) | | Proposing organization | State Food and Drug Administration | | Issuing agency(ies) | China Food and Drug Administration | | Summary | This standard specifies the medical surgical masks (hereinafter referred to as masks) technical requirements, test methods, signs and instructions for use and packaging, transport and storage. This standard applies to the clinical staff in the course of invasive procedures, such as the wearing of disposable masks. | | Standard ID | YY 0469-2004 (YY0469-2004) | | Description (Translated English) | Technical requirements for surgical mask | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | | Classification of Chinese Standard | C48 | | Classification of International Standard | 11.140 | | Word Count Estimation | 14,157 | | Date of Issue | 2004-03-23 | | Date of Implementation | 2005-01-01 | | Drafting Organization | Beijing Medical Device Testing | | Administrative Organization | Beijing Medical Device Testing Institute | | Regulation (derived from) | SFDA [2004] No. 86; industry standard filing Notice 2013 No. 6 (No. 162 overall) | | Proposing organization | State Food and Drug Administration | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This standard specifies the medical surgical masks (hereinafter referred to as masks) the technical requirements, test methods, marking and instructions for use and the packaging, transportation and storage. This standard applies to clinical staff in invasive procedures in the process of wearing, for the treatment of patients receiving invasive procedures and implementation of medical personnel to provide protection to stop the blood, body fluids and spatter spread medical surgical masks. |
YY 0469-2023
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
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.
3.4 bacterial filtration efficiency; BFE
Under specified testing conditions, the mask's ability to filter out bacteria-containing
suspended particles.
NOTE: Usually, it is expressed as a percentage.
3.5 flame retardation properties
The ability to prevent itself from being ignited, flaming and smoldering.
3.6 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 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
5.8 Flame retardation properties
Number of samples: Use at least 3 samples for testing.
Test process: The distance between the top of the burner and the lowest part of the
sample is set to (20±2) mm. Set the flame height to (40±4) mm. The temperature of the
flame at (20±2) mm above the burner tip is set to (800±50)℃.
Place the sample on the headform. Set the linear speed of the head model at the tip of
the nose to (60±5) mm/s. Record the effect of the sample after one pass through the
flame. Report the sum of the afterburning time (the time the material continues to burn
with flame after the ignition source is removed) and the smoldering time (the time the
material continues to burn without flame after the flaming combustion terminates, or
after the ignition source is removed).
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.
5.11 Biocompatibility
5.11.1 Sample preparation
Take the mask tape 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.
5.11.2 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.
5.11.3 Skin irritation
The test is conducted using the animal skin irritation test specified in GB/T 16886.10.
5.11.4 Delayed hypersensitivity reaction
The maximum dose for delayed 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 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.
Annex A
(normative)
Preparation method for synthetic blood
A.1 Reagents
The formula for synthetic blood consists of the following:
Sodium carboxymethyl cellulose (CMC, medium viscosity): 2 g
Tween 20 or equivalent other surfactant: 0.06 g or an amount of other surfactant
Sodium chloride (analytical grade): 4.5 g
Methylisothiazolone (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
until completely dissolved. Weigh Tween 20 or equivalent other surfactant in a small
beaker and add water and mix well.
Add Tween 20 solution or equivalent other surfactant to the above solution of sodium
carboxymethyl cellulose. Wash the beaker several times with distilled water and add to
the previous solution.
Dissolve sodium chloride in the solution. Add MIT and amaranth dye. Dilute with water
to 1000 g.
Adjust the pH of the synthetic blood to 7.3±0.1 with 2.5 mol/L sodium hydroxide
solution.
Use a surface tensiometer to measure the surface tension of synthetic blood. The result
shall be (0.042±0.002) N/m. If it is outside this range, it cannot be used.
Erlenmeyer flask (250 mL~500 mL). Petri dish. Pipettes (1 mL, 5 mL, 10 mL). Sterile
glass bottle (100 mL~500 mL). Inoculation loop. Test tube stopper. Test tube (16
mm×150 mm).
B.1.3 Reagents
B.1.3.1 The formula of tryptic soy peptone agar medium (TSA) is as follows (taking 1
000 mL as an example):
a) Tryptone: 15 g;
b) Soybean papain hydrolysate: 5 g;
c) Sodium chloride: 5 g;
d) Agar: 15 g;
e) Final pH 7.3±0.2 (25℃).
B.1.3.2 The formula of tryptic soybean liquid medium (TSB) is as follows (taking 1
000 mL as an example):
a) Tryptone: 17 g;
b) Soybean papain hydrolysate: 3 g;
c) Sodium chloride: 5 g;
d) Dipotassium hydrogen phosphate: 2.5 g;
e) Glucose: 2.5 g;
f) Final pH 7.3±0.2 (25℃).
B.1.3.3 The formula of peptone water is as follows (taking 1 000 mL as an example):
a) Peptone: 10 g;
b) Sodium chloride: 5 g;
c) Final pH 7.2±0.2 (25℃).
B.1.3.4 Staphylococcus aureus (ATCC 6538).
B.2 Sample pretreatment
Before the test, place the sample in an environment with a temperature of (21±5)℃ and
a relative humidity of (85±5)% for at least 4 h.
B.3 Preparation of bacterial suspension for testing
Staphylococcus aureus (ATCC 6538) is inoculated into an appropriate amount of TSB
medium. Incubate at (37±2)℃ for (24±2) h with shaking. Dilute the above culture with
peptone water to a concentration of approximately 5×105 CFU/mL.
B.4 Test procedures
Do not put the sample into the test system first. The gas flow rate through the sampler
is controlled at 28.3 L/min. The time for delivering bacterial suspension to the nebulizer
is set to 1 min. The air pressure and sampler run time are set to 2 min. Collect bacterial
aerosol onto TSA medium as a positive control. After the test is completed, take out the
agar plate and mark it with the layer number. Place a new agar plate. Clamp the test
sample to the upper end of the sampler, with the inside of the mask facing the aerosol.
Follow the procedure above for sampling. After a batch of test samples has been tested,
test the positive control test again. Finally, collect the air sample in the aerosol chamber
for 2 min as a negative control. During this process, bacterial suspension cannot be
delivered to the nebulizer.
A test system (Figure B.2) that can perform positive control collection and sample
collection at the same time can also be used, but the consistency between channels shall
be ensured.
Incubate the agar plate at (37±2)°C for (48±4)h. The colony-forming units formed by
the aerosol of bacterial particles are then counted (r). Use the sampling hole conversion
table (Table B.1) to convert it to the corrected particle count value P (levels 1 and 2 are
not corrected). The sum of the values at all levels of the positive control group is used
as the positive control value to determine the average level of bacterial aerosol particles
delivered to the test sample. The calculation method for the test sample group is the
same as that for the positive control group. The number of positive control bacteria shall
be controlled between 1700 CFU and 3000 CFU. Otherwise, the spray conditions (spray
flow rate or concentration and volume of the transported bacterial solution) need to be
adjusted. The average particle diameter (MPS) of bacterial aerosol is calculated
according to formula (B.1) and shall be (3.0±0.3) μm. Negative controls shall have no
colony growth.
......
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.
......
YY 0469-2004
Technical requirements for surgical mask
ICS 11.140
C48
People's Republic of China Pharmaceutical Industry Standard
Medical surgical mask technical requirements
Released on.2004-03-23
2005-01-01 implementation
State Food and Drug Administration released
Foreword
4.2 and 4.7 of this standard are recommended, others are mandatory.
Appendix A and Appendix B of this standard are normative appendices.
This standard was proposed by the State Food and Drug Administration.
This standard is under the jurisdiction of Beijing Medical Device Testing Center.
This standard was drafted. Beijing Medical Device Inspection Institute.
The main drafters of this standard. Hu Dongmei, Song Lianyou, Su Jian.
Medical surgical mask technical requirements
1 range
This standard specifies the technical requirements, test methods, signs and instructions for use, and packaging and transportation of medical surgical masks (hereinafter referred to as masks).
And storage.
This standard applies to patients who are worn by clinical staff during invasive procedures, for patients undergoing treatment and for invasive procedures.
Medical staff provide protective surgical masks that block the spread of blood, body fluids and spatters.
2 Normative references
The terms in the following documents become the terms of this standard by reference to this standard. All dated references, followed by all
Modifications (not including errata content) or revisions do not apply to this standard, however, parties to agreements based on this standard are encouraged to study
Is it possible to use the latest version of these files? For undated references, the latest edition applies to this standard.
GB/T 191 packaging storage and transportation icon
GB/T 4745-1997 Textile fabrics - Determination of moisture resistance
GB/T 14233.2-1993 Methods of test for medical infusion, blood transfusion, and injecting machines - Part 2
GB 15980-1995 Hygienic standard for disposable medical supplies
GB/T 16886.10-2000 Biological evaluation of medical devices - Part 10. Stimulation and sensitization test
3 Terms and definitions
The following terms and definitions apply to this standard.
3.1
Provided by clinical staff during invasive procedures, for patients who are treated and for medical staff who perform invasive procedures
A mask that protects against the spread of blood, body fluids and splashes.
3.2
a mixture of red dyes, surfactants, thickeners and distilled water, whose surface tension and viscosity can represent blood and other
Body fluids and have a color similar to blood.
[ASTMF1862-00a, definition 3.1.9]
Note. The synthetic blood used in this standard test does not have all the characteristics of blood or body fluids, such as polarity (wet), coagulability, and cellular matter.
3.3
The effectiveness of medical mask materials to prevent the passage of bacteria in aerosol form; expressed as aerosols from medical mask materials at specified flow rates
The percentage of filtration.
[ASTMF2101-01, definition 3.1.4]
3.4
A particulate, solid, liquid or solid and liquid particulate matter such as dust, smoke, mist and microorganisms suspended in the air.
[GB/T 18664-2002, definition 3.1.15]
......
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