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GB 19083-2010 (GB19083-2010)

Chinese standards (related to): 'GB 19083-2010'
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GB 19083-2010English70 Add to Cart 0--3 minutes. Auto immediate delivery. Technical requirements for protective face mask for medical use GB 19083-2010 Valid GB 19083-2010
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BASIC DATA
Standard ID GB 19083-2010 (GB19083-2010)
Description (Translated English) Technical requirements for protective face mask for medical use
Sector / Industry National Standard
Classification of Chinese Standard C44
Classification of International Standard 11.100
Word Count Estimation 10,151
Date of Issue 2010-09-02
Date of Implementation 2011-08-01
Older Standard (superseded by this standard) GB 19083-2003
Quoted Standard GB/T 191; GB/T 2428-1998; GB/T 4745-1997; GB/T 5549-1990; GB/T 14233.1-2008; GB/T 14233.2-2005; GB 15979-2002; GB/T 16886.10-2005; GB/T 18664-2002; YY/T 0691-2008; YY/T 0700-2008
Drafting Organization Beijing Medical Device Testing
Administrative Organization National Medical clinical testing laboratories and in vitro diagnostic systems Standardization Technical Committee
Regulation (derived from) Announcement of Newly Approved National Standards No. 4 of 2010 (total 159)
Proposing organization State Food and Drug Administration
Issuing agency(ies) Administration of Quality Supervision, Inspection and Quarantine of People's Republic of China; Standardization Administration of China
Summary This Chinese standard specifies the medical protective 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 medical work environment, filter the air of particulate matter, barrier spray, blood, body fluids, secretions and other self-absorption filter respirator.


GB 19083-2010: PDF in English
GB 19083-2010
ICS 11.100
C 44
NATIONAL STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
Replacing GB 19083-2003
Technical Requirements for Protective Face
Mask for Medical Use
ISSUED ON: SEPTEMBER 2, 2010
IMPLEMENTED ON: AUGUST 1, 2011
Jointly issued by: The General Administration of Quality Supervision,
Inspection and Quarantine (AQSIQ);
Standardization Administration Committee (SAC) of The
People’s Republic of China.
Table of Contents
Foreword ... 3 
1 Scope ... 4 
2 Normative References ... 4 
3 Terms and Definitions ... 6 
4 Technical Requirements ... 6 
5 Test Methods ... 8 
6 Markings and Instructions for Use ... 11 
7 Packaging And Storage ... 13 
Appendix A (Informative) Preparation of Synthetic Blood ... 14 
Appendix B (Normative) Fitness Test Method ... 16 
References and Original Chinese Documents ... 19 
Foreword
In this Standard, Section 4.10 is recommendatory and other Sections are mandatory.
This Standard replaces GB 19083-2003 "Technical Requirements for Protective Face
Mask for Medical Use".
Compared with GB 19083-2003, this Standard has the major changes detailed as follows:
——The applicable “Scope” of the standard was revised;
——The "Normative References” was supplemented and revised;
——The terms and definitions were added and changed;
——The dimensional requirement of mask was deleted;
——The length requirement of nasal splint was deleted;
——The "Fit" requirement and test method were added;
——The technical requirement of "Skin irritation" was revised according to GB/T
16886.10-2005 and the test method was defined;
——The technical requirement of markings and instructions for use was deleted;
——The original test method for oxirane residue specified in GB 15980-1995 was
replaced by the gas chromatography method of GB/T 14233.1-2008;
——The test method of microorganism indexes was revised.
In this Standard, Appendix B is normative and Appendix A is informative.
This Standard was proposed by State Food and Drug Administration.
This Standard is under the jurisdiction of the National Technical Committee on Clinical
Laboratory Testing and Invitro Diagnostic Test Systems of Standardization Administration of
China.
Drafting organization of this Standard: Beijing Institute of Medical Device Testing
Chief drafting staffs of this Standard: Su Jian, Bi Chunlei, Liao Xiaoman and Zhang
Zhaoyuan.
The previous standard replaced by this standard is:
——GB 19083-2003.
NATIONAL STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
Replace 19083-2003
Technical Requirements for Protective Face Mask
for Medical Use
1 Scope
This Standard specifies the technical requirements, test methods, markings and
instructions for use, packaging, transportation and storage for protective face mask for
medical use (hereinafter referred as mask).
This Standard is applicable to non-powered air-purifying medical protective face mask -
used in medical service environments to filter particulate matters in air and to separate spray,
blood, body fluid, secretion, etc.
2 Normative References
Those provisions contained in following documents, through quotation of this Standard,
constitute the provisions of this Standard. For dated document, subsequent amendments
(excluding the corrections) or revisions of the document do not apply. However, parties who
have signed agreement based on these standards are encouraged to investigate the possibility
of adopting the most recent editions of the standards indicated below (subsequent
amendments or revisions). For any undated documents, the latest edition of the document
applies.
GB/T 191 Packaging-Pictorial Marking for Handling of Goods
GB/T 2428-1998 Head-face Dimensions of Adults
GB/T 4745-1997 Textile Fabrics-Determination of Resistance to Surface Wetting-Spray
Test
GB/T 5549-1990 Surface Active Agents Determination of Surface Tension by Drawing
up Liquid Films
GB/T 14233.1-2008 Test Methods for Infusion, Transfusion, Injection Equipments 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 16886.10-2005 Biological Evaluation of Medical Devices-Part 10: Tests for
Irritation and Delayed-type Hypersensitivity
GB/T 18664-2002 Selection, Use and Maintenance of Respiratory Protective Equipment
YY/T 0691-2008 Clothing for Protection against Infectious Agents-Medical Face
Masks-Test Method for Resistance against Penetration by Synthetic Blood (Fixed Volume,
Horizontally Projected)
YY/T 0700-2008 Clothing for Protection against Contact with Blood and Body
Fluids-Determination of the Resistance of Protective Clothing Materials to Penetration by
Blood and Body Fluids-Test Method Using Synthetic Blood
3 Terms and Definitions
For the purposes of this Standard, the following terms and definitions apply.
3.1
Filtering efficiency
The percentage number of filtering particulate matters in air under specified conditions
3.2
Fit
The degree of mask periphery fitting to the face of a specific user
3.3
Fit factor
The ratio of the testing agent’s concentration outside the mask to the testing agent’s
concentration leaking into the mask, which is quantitatively measured during the testees
wearing masks for simulating actions, process and operation
4 Technical Requirements
4.1 Basic requirement of mask
The mask shall cover the wearer's nose and mouth and shall be of a good facial fit and
without broken holes, stain or expiratory valve.
4.2 Nasal splint
4.2.1 The mask shall have a nasal splint.
4.2.2 The nasal splint shall be adjustable.
4.3 Mask harness
4.3.1 The mask’s harness shall be adjustable conveniently.
4.3.2 The mask’s harness shall be of sufficient strength to fix the mask. The breaking strength
of the junction between each mask harness and the mask body shall not be less than 10N.
4.4 Filtering efficiency
With the gas flow at 85L/min, the filtering efficiency of mask to non-oily particles shall
comply with the requirements specified in Table 1.
Table 1 Filtering Efficiency Gradation
Gradation Filtering efficiency %
Grade 1 ≥95
Grade 2 ≥99
Grade 3 ≥99.97
4.5 Gas flow resistance
With the gas flow at 85L/min, the mask inspiration resistance shall not exceed 343.2Pa
(35mmH2O).
4.6 Synthetic blood penetration
With spraying 2mL synthetic blood on the mask at 10.7 kPa in pressure, no penetration
shall occur to the inner side of the mark.
4.7 Surface wetting resistance
The outside surface spray rating of the mask shall not be less than those specified in
Grade 3 of GB/T 4745-1997.
4.8 Microorganism indexes
4.8.1 The mask shall meet the microorganism index requirement of GB 15979-2002, as
detailed in Table 2.
4.8.2 Masks with letters concerning sterilization or asepsis marked on the packaging shall be
aseptic.
Table 2 Microorganism Indexes of Mask
Total bacterial
colony count
CFU/g
Coliform
bacteria
Pseudomonas
aeruginosa
Staphylococcus
aureus
Hemolytic
streptococcus
Total fungus
colony count
CFU/g
≤200 Not detectable Not detectable Not detectable Not detectable ≤100
4.9 Oxirane residue
The oxirane residue of oxirane-sterilized masks shall not exceed 10μg/g.
4.10 Flame retardation
The materials used shall not be of flammability and their continuous-flaming time shall
not exceed 5s.
4.11 Skin irritation
The primary irritation scoring of the mask materials shall not exceed 1.
4.12 Fit
The mask shall be so designed to provide a good fit and the overall fit factor of the mask
shall not be less than 100.
5 Test Methods
5.1 Basic requirement of mask
Take 3 masks and observe at 300 lx~700 lx. They shall meet the requirement of 4.1.
5.2 Nasal splint
It shall be adjusted as specified in the instructions and shall comply with 4.2.
5.3 Mask harness
5.3.1 Sample quantity: take and unpack 4 masks – two of them shall undergo temperature
pretreatment; and the other two do not undergo temperature pretreatment.
5.3.2 Condition for temperature pretreatment:
Pretreatment condition:
a) Keep in 70℃±3℃ environment test chamber for 24h;
b) Keep in-30℃±3℃ environment test chamber for 24h.
After temperature pretreatment, keep at room temperature for at least 4h.
5.3.3 The result of visual inspection and the result measured by tension test device shall meet
the requirement of 4.3.
5.4 Filtering efficiency and gas flow resistance test
5.4.1 Sample quantity: take 6 mask samples for the test. Three of them shall undergo
temperature pretreatment and the other three do not undergo temperature pretreatment.
5.4.2 Condition for temperature pretreatment:
Pretreatment condition:
a) Keep in 70℃±3℃ environment test chamber for 24h;
b) Keep in-30℃±3℃ environment test chamber for 24h.
After temperature ......