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《标准化工作导则 第1部分:标准化文件的结构和起草规则》的规定起草。
本文件代替GB 19083- -2010%医用防护口罩技术要求》,与GB 19083- 2010相比,除结构调整和编辑性改动外,主要技术变化如下:
a) 更改了规范性引用文件(见第2章,2010年版的第2章);
b)增加了 死腔、总泄漏率的术语和定义(见3.2、3.3);
c) 删除了适合因数的术语和定义(见2010年版的3.3);
d) 增加了呼吸阻力、死腔.总泄漏率的要求(见4.4.4.5.4.6);
e) 删除了气流阻力.表面抗湿性、密合性的要求(见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(见4.7,2010年版的4.6);
g) 更改了微生物指标的要求(见4.8,2010年版的4.8);
h) 增加了生物相容性的要求(见4.11)。
请注意本文件的某些内容可能涉及专利。本文件的发布机构不承担识别专利的责任。
本文件由国家药品监督管理局提出并归口。
本文件及其所代替文件的历次版本发布情况为:
——2003年首次发布为GB 19083-2003,2010年第一次修订;
——本次为第二次修订。
医用防护口罩
1 范围
本文件规定了一次性使用医用防护口罩(以下简称“口罩”)的要求、标志与使用说明及包装和贮存,描述了相应的试验方法。
本文件适用于医疗工作环境下,过滤空气中的颗粒物,阻隔飞沫、血液、体液、分泌物等的自吸过滤式口罩(半面罩)。
本文件不适用于防护任何化学气体和蒸气的口罩。
2 规范性引用文件
下列文件中的内容通过文中的规范性引用而构成本文件必不可少的条款。其中,注日期的引用文件,仅该日期对应的版本适用于本文件;不注日期的引用文件,其最新版本(包括所有修改单)适用于本文件。
GB2626--2019 呼吸防护 自吸过滤式防颗粒物呼吸器
GB/T 14233.1-2022 医用输液、输血、注射器具检验方法 第1部分:化学分析方法
GB/T 16886.5 医疗器械生物学评价 第5部分:体外细胞毒性试验
GB/T16886.10 医疗器械生物学评价 第10部分:刺激与皮肤致敏试验
GB/T 16886.12 医疗器械生物学评价 第12部分:样品制备与参照材料
GB/T 32610- 2016 日常防护型口罩技术规范
YY 0469 医用外科口罩
YY/T0691-2008 传染性病原体防护装备 医用面罩抗合成血穿透性试验方法(固定体积、水平喷射)
YY/T 0866 医用防护口罩总泄漏率测试方法
中华人民共和国药典(2020年版)四部
ISO 16900-5: 2016/Amd.1:2018 呼吸防护装置 测试方法和设备 第5部分:呼吸机、代谢模拟器、呼吸防护装置头模和体模、工具和验证手段/修订1:呼吸防护装置头模前视和侧视图( 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 术语和定义
下列术语和定义适用于本文件。
3.1
过滤效率 filtering efficiency
在规定检测条件下,口罩滤除颗粒物的百分比。
3.2
死腔 dead space
从前一次呼气中被重新吸入的气体的体积。
注:用CO2在吸入气中的体积分数表示。
[来源:GB/T 12903-2008,5.3.10]
3.3
总泄漏率total inward leakage; lL
在实验室规定测试条件下,受试者吸气时从包括口罩在内的所有部位泄漏人口罩内的模拟剂浓度与测试环境中模拟剂浓度的比值。
[来源:GB/T 12903- -2008,5.3.7,有修改]
3.4
密合性fit
口罩周边与具体使用者面部的贴合程度。
4 要求
4.1 基本要求
口罩材料和结构设计应符合以下要求:
a)口罩外观无破损 、污渍;
b)口罩能覆盖佩戴者的口鼻部,并能紧密贴合面部;
c) 口罩不应设置呼气阀;
d)口罩上配有鼻夹或替代鼻夹的设计,佩戴时起到固定和密合作用;
e)口罩带采用弹性材料或可调节设计,便于佩戴和摘除,能将口罩牢固地固定在脸上。
4.2 口罩带连接强度
4.2.1每根口罩带的断裂强力不应小于10N。
4.2.2口罩带与口罩体每个连接点处的断裂强力均不应小于10 N。
4.3过滤效率
规定检测流量条件下,口罩对非油性颗粒过滤效率应符合表1的要求。
5 试验方法
6 标志与使用说明
7 包装和贮存
附录A (资料性)口罩选用前的适合性检验方法
参考文件