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
前言
本文件按照GB/T 101-2020《標準化工作導則 第1部分：標準化文件的結構和起草規則》的規定起草。
本文件代替GB 19083- -2010%醫用防護口罩技術要求》，與GB 19083- 2010相比,除結構調整和編輯性改動外，主要技術變化如下：
a) 更改了規范性引用文件(見第2章，2010年版的第2章)；
b)增加了 死腔、總泄漏率的術語和定義(見3.2、3.3)；
c) 刪除了適合因數的術語和定義(見2010年版的3.3)；
d) 增加了呼吸阻力、死腔.總泄漏率的要求(見4.4.4.5.4.6)；
e) 刪除了氣流阻力.表面抗濕性、密合性的要求(見2010年版的4.5.4.7.4.12)；
f) 更改了抗合成血液穿透性的要求(見4.7，2010年版的4.6)；
g) 更改了微生物指標的要求(見4.8,2010年版的4.8)；
h) 增加了生物相容性的要求(見4.11)。
請注意本文件的某些內容可能涉及專利。本文件的發布機構不承擔識別專利的責任。
本文件由國家藥品監督管理局提出并歸口。
本文件及其所代替文件的歷次版本發布情況為：
——2003年首次發布為GB 19083-2003，2010年第一次修訂；
——本次為第二次修訂。
醫用防護口罩
1 范圍
本文件規定了一次性使用醫用防護口罩(以下簡稱“口罩”)的要求、標志與使用說明及包裝和貯存，描述了相應的試驗方法。
本文件適用于醫療工作環境下，過濾空氣中的顆粒物,阻隔飛沫、血液、體液、分泌物等的自吸過濾式口罩(半面罩)。
本文件不適用于防護任何化學氣體和蒸氣的口罩。
2 規范性引用文件
下列文件中的內容通過文中的規范性引用而構成本文件必不可少的條款。其中，注日期的引用文件，僅該日期對應的版本適用于本文件；不注日期的引用文件，其最新版本（包括所有修改單）適用于本文件。
GB2626--2019 呼吸防護 自吸過濾式防顆粒物呼吸器
GB/T 14233.1-2022 醫用輸液、輸血、注射器具檢驗方法 第1部分：化學分析方法
GB/T 16886.5 醫療器械生物學評價 第5部分：體外細胞毒性試驗
GB/T16886.10 醫療器械生物學評價 第10部分：刺激與皮膚致敏試驗
GB/T 16886.12 醫療器械生物學評價 第12部分：樣品制備與參照材料
GB/T 32610- 2016 日常防護型口罩技術規范
YY 0469 醫用外科口罩
YY/T0691-2008 傳染性病原體防護裝備 醫用面罩抗合成血穿透性試驗方法(固定體積、水平噴射)
YY/T 0866 醫用防護口罩總泄漏率測試方法
中華人民共和國藥典(2020年版)四部
ISO 16900-5: 2016/Amd.1:2018 呼吸防護裝置 測試方法和設備 第5部分:呼吸機、代謝模擬器、呼吸防護裝置頭模和體模、工具和驗證手段/修訂1:呼吸防護裝置頭模前視和側視圖( 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 術語和定義
下列術語和定義適用于本文件。
3.1
過濾效率 filtering efficiency
在規定檢測條件下，口罩濾除顆粒物的百分比。
3.2
死腔 dead space
從前一次呼氣中被重新吸入的氣體的體積。
注：用CO2在吸入氣中的體積分數表示。
[來源：GB/T 12903-2008，5.3.10]
3.3
總泄漏率total inward leakage; lL
在實驗室規定測試條件下，受試者吸氣時從包括口罩在內的所有部位泄漏人口罩內的模擬劑濃度與測試環境中模擬劑濃度的比值。
[來源：GB/T 12903- -2008，5.3.7，有修改]
3.4
密合性fit
口罩周邊與具體使用者面部的貼合程度。
4 要求
4.1 基本要求
口罩材料和結構設計應符合以下要求：
a)口罩外觀無破損 、污漬;
b)口罩能覆蓋佩戴者的口鼻部，并能緊密貼合面部；
c) 口罩不應設置呼氣閥；
d)口罩上配有鼻夾或替代鼻夾的設計，佩戴時起到固定和密合作用；
e）口罩帶采用彈性材料或可調節設計，便于佩戴和摘除，能將口罩牢固地固定在臉上。
4.2 口罩帶連接強度
4.2.1每根口罩帶的斷裂強力不應小于10N。
4.2.2口罩帶與口罩體每個連接點處的斷裂強力均不應小于10 N。
4.3過濾效率
規定檢測流量條件下，口罩對非油性顆粒過濾效率應符合表1的要求。
5 試驗方法
6 標志與使用說明
7 包裝和貯存
附錄A （資料性）口罩選用前的適合性檢驗方法
參考文件
