Foreword
Codeofchina.com is in charge of this English translation. In case of any doubt about the English translation, the Chinese original shall be considered authoritative.
This document is developed in accordance with the rules given in GB/T 101-2020 Directives for standardization - Part 1: Rules for the structure and drafting of standardizing documents.
This document replaces GB 19083-2010 Technical requirements for protective face mask for medical use. In addition to structural adjustments and editorial changes, the following main technical changes have been made with respect to GB 19083-2010:
a) The normative references are modified (see Clause 2 hereof; Clause 2 of Edition 2010);
b) The terms and definitions of dead space and total inward leakage are added (see 3.2 and 3.3 hereof);
c) The term and definition of fit factor is deleted (see 3.3 of Edition 2010);
d) The requirements for breathing resistance, dead space and total inward leakage are added (see 4.4, 4.5 and 4.6 hereof);
e) The requirements for airflow resistance, water resistance and tightness of surface are deleted (see 4.5, 4.7 and 4.12 of Edition 2010);
f) The requirements for resistance to synthetic blood penetration are modified (see 4.7 hereof, 4.6 of Edition 2010);
g) The requirements for microbial indexes are modified (see 4.8 hereof; 4.8 of Edition 2010);
h) The requirements for biocompatibility are added (see 4.11 hereof).
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. The issuing body of this document shall not be held responsible for identifying any or all such patent rights.
This document was proposed by and is under the jurisdiction of the National Medical Products Administration of the People’s Republic of China.
The previous editions of this document are as follows:
——It was first issued as GB 19083-2003 in 2003, and first revised in 2010;
——This is the second revision.
Protective face mask for medical use
1 Scope
This document specifies the requirements, markings, instructions for use, packaging, and storage of disposable protective face mask for medical use (hereinafter referred to as "face mask"), and describes the corresponding test methods.
This document is applicable to self-inhalation filter type face masks (half face masks) used in medical work environments to filter particulate matter in the air, block droplets, blood, body fluids, secretions, etc.
This document is not applicable to masks that protect against any chemical gases and vapors.
2 Normative references
The following documents contain requirements which, through reference in this text, constitute provisions 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.
GB2626-2019 Respiratory protection - Non-powered air-purifying particle respirator
GB/T 14233.1-2022 Test methods for infusion, transfusion, injection equipments 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/T16886.10 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
GB/T 32610-2016 Technical specification of daily protective mask
YY 0469 Surgical mask
YY/T0691-2008 Clothing for protection against infectious agents - Medical face masks - Test method for resistance against penetration by synthetic blood (fixed volume, horizontally projected)
YY/T 0866 Total inward leakage determination method of protective face mask for medical use
Pharmacopoeia of the People's Republic of China (Edition 2020) Volume IV
ISO 16900-5: 2016/Amd.1:2018 Respiratory protective devices - Methods of test and test equipment - Part 5: Breathing machine, metabolic simulator, RPD headforms and torso, tools and verification tools/Amendment 1: RPD head forms front and side view
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
filtering efficiency
percentage of particles removed by the face mask under specified testing conditions
3.2
dead space
volume of gas that has been re-inhaled from a previous exhalation
Note: It is expressed by the volume fraction of carbon dioxide in inhaled gas.
[Source: GB/T 12903-2008, 5.3.10]
3.3
total inward leakage; TIL
ratio of the concentration of simulated agent leaked into the face mask from all parts (including face mask) during the inhalation process to that of simulated agent in the testing environment under the specified laboratory testing environment
[Source: GB/T 12903-2008, 5.3.7, modified]
3.4
fit
degree of fit between the periphery of the mask and the specific user's face
4 Requirements
4.1 Basic requirements
The materials and structure design of face mask shall meet the following requirements:
a) The appearance of the face mask is free of damage and stains;
b) The face mask can cover the wearer's mouth and nose, and can tightly fit the face;
c) The face mask shall not be equipped with exhalation valve;
d) The face mask is equipped with a nose clip or an alternative design, which serves as a fixing and sealing function when worn;
e) The mask strip is made of elastic material or adjustable design, which is convenient to wear and remove and can firmly fix the mask on the face.
4.2 Connection strength of mask strip
4.2.1 the breaking strength of each mask strip shall not be less than 10N.
4.2.2 The breaking strength at each connection point between mask strip and mask body shall not be less than 10N.
4.3 Filtering efficiency
Under the condition of specified detection flow, the filtering efficiency of the face mask for non-oily particles shall meet those specified in Table 1.
5 Test methods
6 Marking and instructions for use
7 Packaging and storage
Annex A (Informative) Test method of suitability before face mask selection
Bibliography
Foreword i
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
5 Test methods
6 Marking and instructions for use
7 Packaging and storage
Annex A (Informative) Test method of suitability before face mask selection
Bibliography
Foreword
Codeofchina.com is in charge of this English translation. In case of any doubt about the English translation, the Chinese original shall be considered authoritative.
This document is developed in accordance with the rules given in GB/T 101-2020 Directives for standardization - Part 1: Rules for the structure and drafting of standardizing documents.
This document replaces GB 19083-2010 Technical requirements for protective face mask for medical use. In addition to structural adjustments and editorial changes, the following main technical changes have been made with respect to GB 19083-2010:
a) The normative references are modified (see Clause 2 hereof; Clause 2 of Edition 2010);
b) The terms and definitions of dead space and total inward leakage are added (see 3.2 and 3.3 hereof);
c) The term and definition of fit factor is deleted (see 3.3 of Edition 2010);
d) The requirements for breathing resistance, dead space and total inward leakage are added (see 4.4, 4.5 and 4.6 hereof);
e) The requirements for airflow resistance, water resistance and tightness of surface are deleted (see 4.5, 4.7 and 4.12 of Edition 2010);
f) The requirements for resistance to synthetic blood penetration are modified (see 4.7 hereof, 4.6 of Edition 2010);
g) The requirements for microbial indexes are modified (see 4.8 hereof; 4.8 of Edition 2010);
h) The requirements for biocompatibility are added (see 4.11 hereof).
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. The issuing body of this document shall not be held responsible for identifying any or all such patent rights.
This document was proposed by and is under the jurisdiction of the National Medical Products Administration of the People’s Republic of China.
The previous editions of this document are as follows:
——It was first issued as GB 19083-2003 in 2003, and first revised in 2010;
——This is the second revision.
Protective face mask for medical use
1 Scope
This document specifies the requirements, markings, instructions for use, packaging, and storage of disposable protective face mask for medical use (hereinafter referred to as "face mask"), and describes the corresponding test methods.
This document is applicable to self-inhalation filter type face masks (half face masks) used in medical work environments to filter particulate matter in the air, block droplets, blood, body fluids, secretions, etc.
This document is not applicable to masks that protect against any chemical gases and vapors.
2 Normative references
The following documents contain requirements which, through reference in this text, constitute provisions 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.
GB2626-2019 Respiratory protection - Non-powered air-purifying particle respirator
GB/T 14233.1-2022 Test methods for infusion, transfusion, injection equipments 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/T16886.10 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
GB/T 32610-2016 Technical specification of daily protective mask
YY 0469 Surgical mask
YY/T0691-2008 Clothing for protection against infectious agents - Medical face masks - Test method for resistance against penetration by synthetic blood (fixed volume, horizontally projected)
YY/T 0866 Total inward leakage determination method of protective face mask for medical use
Pharmacopoeia of the People's Republic of China (Edition 2020) Volume IV
ISO 16900-5: 2016/Amd.1:2018 Respiratory protective devices - Methods of test and test equipment - Part 5: Breathing machine, metabolic simulator, RPD headforms and torso, tools and verification tools/Amendment 1: RPD head forms front and side view
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
filtering efficiency
percentage of particles removed by the face mask under specified testing conditions
3.2
dead space
volume of gas that has been re-inhaled from a previous exhalation
Note: It is expressed by the volume fraction of carbon dioxide in inhaled gas.
[Source: GB/T 12903-2008, 5.3.10]
3.3
total inward leakage; TIL
ratio of the concentration of simulated agent leaked into the face mask from all parts (including face mask) during the inhalation process to that of simulated agent in the testing environment under the specified laboratory testing environment
[Source: GB/T 12903-2008, 5.3.7, modified]
3.4
fit
degree of fit between the periphery of the mask and the specific user's face
4 Requirements
4.1 Basic requirements
The materials and structure design of face mask shall meet the following requirements:
a) The appearance of the face mask is free of damage and stains;
b) The face mask can cover the wearer's mouth and nose, and can tightly fit the face;
c) The face mask shall not be equipped with exhalation valve;
d) The face mask is equipped with a nose clip or an alternative design, which serves as a fixing and sealing function when worn;
e) The mask strip is made of elastic material or adjustable design, which is convenient to wear and remove and can firmly fix the mask on the face.
4.2 Connection strength of mask strip
4.2.1 the breaking strength of each mask strip shall not be less than 10N.
4.2.2 The breaking strength at each connection point between mask strip and mask body shall not be less than 10N.
4.3 Filtering efficiency
Under the condition of specified detection flow, the filtering efficiency of the face mask for non-oily particles shall meet those specified in Table 1.
5 Test methods
6 Marking and instructions for use
7 Packaging and storage
Annex A (Informative) Test method of suitability before face mask selection
Bibliography
Contents of GB 19083-2023
Foreword i
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
5 Test methods
6 Marking and instructions for use
7 Packaging and storage
Annex A (Informative) Test method of suitability before face mask selection
Bibliography
