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医用面罩检测

第三方医用面罩检测机构北检(北京)检测技术研究院拥有齐全的检测仪器和多领域检测团队,数据科学严谨,检测设备齐全。能提供全方位检测服务,7-15个工作日便可出具医用面罩检测报告。

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发布时间:2023-03-25 14:38:40 浏览量:49 所属栏目:产品检测

检测项目(部分)

抗合成血穿透性

检测样品(部分)

医用面罩

检测标准(部分)

行业标准 YY/T 0691-2008 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)
【适用范围】本标准给出了检测医用面罩防合成血喷溅穿透性能的实验室试验方法。rn本标准主要用于评价制作医用面罩的材料或某些结构的性能。本标准不评价医用面罩的设计、结构、界面或其他能影响医用面罩总体保护能力(如过滤效率和压降)的因素。rn本试验不评价医用面罩的透气性或其他影响医用面罩呼吸舒适性的性能。本试验评估医用面罩的防护性能。本试验不评估医用面罩对经空气传播,或沉积在医用面罩表面体液形成气溶胶穿透传播的防护能力。
【中国标准分类】  C40  医药器械 【国际标准分类】  11.100-实验室医学
地方标准 CNS 14774-2003 医用面罩
【适用范围】本标准适用于医疗人员于手术、雷射、隔离、牙科或其他医疗程序时配戴之面罩,主要用途为防止病人与医护人员之间微生物、体液及粒状物质之传递与感染
【中国标准分类】  C48  医药器械 【国际标准分类】  11.040.30-外科器械和材料
地方标准 CNS 14775-2003 医用面罩耐人工血渗透性试验方法(已知速度下固定量水平喷射)
【适用范围】本标准规定量测医用面罩材料细菌过滤效率的试验法,由过滤前之细菌量和过滤后之细菌残存量之比值评估医用面罩材料的细菌过滤效率
【中国标准分类】  C05  医药、卫生、劳动保护综合 【国际标准分类】  11.120.20-医用材料
国外标准 ASTM F1862-2007 医用面罩耐合成血渗透性的试验方法(已知速度下固定量的水平喷射)
【适用范围】

1.1 This test method is used to evaluate the resistance of medical face masks to penetration by the impact of a small volume (~2 mL) of a high velocity stream of synthetic blood. Medical face mask pass/fail determinations are based on visual detection of synthetic blood penetration.

1.2 This test method does not apply to all forms or conditions of blood-borne pathogen exposure. Users of the test method must review modes for face exposure and assess the appropriateness of this test method for their specific application.

1.3 This test method primarily addresses the performance of materials or certain material constructions used in medical face masks. This test method does not address the performance of the medical face masks design construction or interfaces or other factors with the potential to affect the overall protection offered by the medical face mask and its operation (such as filtration efficiency and pressure drop). Procedures for measuring these properties are contained in Test Methods F 2101 and MIL-M-36954C.

1.4 This test method does not address breathability of the medical face mask materials or any other properties affecting the ease of breathing through the medical face mask. This test method evaluates medical face masks as an item of protective clothing. This test method does not evaluate the performance of medical face masks for airborne exposure pathways or in the prevention of the penetration of aerosolized body fluids deposited on the medical face mask.

1.5 The values stated in SI units or inch-pound units are to be regarded separately as standard. The pressure values stated in each system are not exact equivalents. However as the corresponding velocities are within 1 % of each other (see X1.4.2) reporting of the results in either units is permitted.

This standard does not purport to address all of the safety concerns if any associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

【中国标准分类】  C05  医药、卫生、劳动保护综合 【国际标准分类】  11.120.20-医用材料
国外标准 ASTM F2100-2004 医用面罩用材料性能的标准规范
【适用范围】

1.1 This specification covers testing and requirements for materials used in the construction of medical face masks that are used in providing health care services such as surgery and patient care.

1.2 This specification provides for the classification of medical face mask material performance. Medical face mask material performance is based on testing for bacterial filtration efficiency differential pressure sub-micron particulate filtration efficiency resistance to penetration by synthetic blood and flammability.

1.3 This specification does not address all aspects of medical face mask design and performance. This specification does not specifically evaluate the effectiveness of medical face mask designs as related to the barrier and breathability properties. This specification does not also apply to respiratory protection which may be necessary for some health care services.

1.4 The values stated in SI units or in other units shall be regarded separately as standard. The values stated in each system must be used independently of the other without combining values in any way.

1.5 The following precautionary caveat pertains only to the test methods portion Section 9 of this specification: This standard does not purport to address all of the safety concerns if any associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

【中国标准分类】  C48  医药器械 【国际标准分类】  11.120.20-医用材料
国外标准 ASTM F2100-2011(2018) 医用面罩材料性能规格
【适用范围】1.1 This specification covers testing and requirements for materials used in the construction of medical face masks that are used in providing healthcare services such as surgery and patient care. 1.2 This specification provides for the classification of medical face mask material performance. Medical face mask material performance is based on testing for bacterial filtration efficiency differential pressure sub-micron particulate filtration efficiency resistance to penetration by synthetic blood and flammability. 1.3 This specification does not address all aspects of medical face mask design and performance. This specification does not specifically evaluate the effectiveness of medical face mask designs as related to the barrier and breathability properties. This specification does not also apply to respiratory protection which may be necessary for some healthcare services. 1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.5 The following precautionary caveat pertains only to the test methods portion Section 9 of this specification: This standard does not purport to address all of the safety concerns if any associated with its use. It is the responsibility of the user of this standard to establish appropriate safety health and environmental practices and determine the applicability of regulatory limitations prior to use. 1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
【中国标准分类】  C46  医药器械 【国际标准分类】  11.140-医院设备
国外标准 ASTM F2101-2019 用金黄色葡萄球菌生物气溶胶评定医用面罩材料细菌过滤效率的试验方法
【适用范围】

1.1 This test method is used to measure the bacterial filtration efficiency (BFE) of medical face mask materials employing a ratio of the upstream bacterial challenge to downstream residual concentration to determine filtration efficiency of medical face mask materials.

1.2 This test method is a quantitative method that allows filtration efficiency for medical face mask materials to be determined. The maximum filtration efficiency that can be determined by this method is 99.9 %.

1.3 This test method does not apply to all forms or conditions of biological aerosol exposure. Users of the test method should review modes for worker exposure and assess the appropriateness of the method for their specific applications.

1.4 This test method evaluates medical face mask materials as an item of protective clothing but does not evaluate materials for regulatory approval as respirators. If respiratory protection for the wearer is needed a NIOSH-certified respirator should be used. Relatively high bacterial filtration efficiency measurements for a particular medical face mask material does not ensure that the wearer will be protected from biological aerosols since this test method primarily evaluates the performance of the composite materials used in the construction of the medical face mask and not its design fit or facial-sealing properties.

1.5 Units—The values stated in SI units or inch-pound units are to be regarded sep

【中国标准分类】  C47  医药器械 【国际标准分类】  11.140-医院设备
国外标准 ASTM F2101-2014 医用面罩用材料性能规格
【适用范围】

1.1 This specification covers testing and requirements for materials used in the construction of medical face masks that are used in providing health care services such as surgery and patient care.

1.2 This specification provides for the classification of medical face mask material performance. Medical face mask material performance is based on testing for bacterial filtration efficiency differential pressure sub-micron particulate filtration efficiency resistance to penetration by synthetic blood and flammability.

1.3 This specification does not address all aspects of medical face mask design and performance. This specification does not specifically evaluate the effectiveness of medical face mask designs as related to the barrier and breathability properties. This specification does not also apply to respiratory protection which may be necessary for some health care services.

1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

1.5 The following precautionary caveat pertains only to the test methods portion Section 9 of this specification: This standard does not purport to address all of the safety concerns if any associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

【中国标准分类】  C46  医药器械 【国际标准分类】  11.140-医院设备
国外标准 ASTM F2101-2007 用金黄色葡萄球菌生物气悬体评定医用面罩材料细菌过滤效率的试验方法
【适用范围】

1.1 This test method is used to measure the bacterial filtration efficiency (BFE) of medical face mask materials employing a ratio of the upstream bacterial challenge to downstream residual concentration to determine filtration efficiency of medical face mask materials.

1.2 This test method is a quantitative method that allows filtration efficiency for medical face mask materials to be determined. The maximum filtration efficiency that can be determined by this method is 99.9 %.

1.3 This test method does not apply to all forms or conditions of biological aerosol exposure. Users of the test method should review modes for worker exposure and assess the appropriateness of the method for their specific applications.

1.4 This test method evaluates medical face mask materials as an item of protective clothing but does not evaluate materials for regulatory approval as respirators. If respiratory protection for the wearer is needed a NIOSH-certified respirator should be used. Relatively high bacterial filtration efficiency measurements for a particular medical face mask material does not ensure that the wearer will be protected from biological aerosols since this test method primarily evaluates the performance of the composite materials used in the construction of the medical face mask and not its design fit or facial sealing properties.

1.5 Units The values stated in SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore each system shall be used independently of the other. Combining values from the two systems may result in nonconformance of the standard.

1.6 This test method does not address breathability of the medical face mask materials or any other properties affecting the ease of breathing through the medical face mask material.

This standard does not purport to address all of the safety concerns if any associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

【中国标准分类】  C47  医药器械 【国际标准分类】  11.140-医院设备
国外标准 ASTM F2299/F2299M-2003(2010) 通过采用胶乳球体的微粒测定医用面罩用材料耐渗透性初始效率的试验方法
【适用范围】

This test method measures the initial filtration efficiency of materials used in medical face masks by sampling representative volumes of the upstream and downstream latex aerosol concentrations in a controlled airflow chamber.

This test method provides specific test techniques for both manufacturers and users to evaluate materials when exposed to aerosol particle sizes between 0.1 and 5.0 x03BC;m.

This test method establishes a basis of efficiency comparison between medical face mask materials.

This test method does not establish a comprehensive characterization of the medical face mask material for a specific protective application.

This test method does not assess the overall effectiveness of medical face masks in preventing the inward leakage of harmful particles.

The design of the medical face mask and the integrity of the seal of the medical face mask to the wearer''s face are not evaluated in this test.

This test method is not suitable for evaluating materials used in protective clothing for determining their effectiveness against particulate hazards.

In general clothing design is a significant factor which must be considered in addition to the penetration of penetration of particulates.

1.1 This test method establishes procedures for measuring the initial particle filtration efficiency of materials used in medical facemasks using monodispersed aerosols.

1.1.1 This test method utilizes light scattering particle counting in the size range of 0.1 to 5.0 x03BC;m and airflow test velocities of 0.5 to 25 cm/s.

1.2 The test procedure measures filtration efficiency by comparing the particle count in the feed stream (upstream) to that in the filtrate (downstream).

1.3 The values stated in SI units or in other units shall be regarded separately as standard. The values stated in each system must be used independently of the other without combining values in any way.

1.4 The following precautionary caveat pertains only to the test methods portion Section 10 of this specification. This standard does not purport to address all of the safety concerns if any associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

【中国标准分类】  C48  医药器械 【国际标准分类】  11.120.20-医用材料
国外标准 AS 4381-2015 资讯处理--资讯互换用25.4MM(1 in)穿孔纸带卷盘与轴心之尺度
【适用范围】
【中国标准分类】  L64  计算机 【国际标准分类】  33.160.40-视频系统
国家标准 GB 19083-2010 医用防护口罩技术要求
【适用范围】本标准规定了医用防护口罩的技术要求、试验方法、标志与使用说明及包装、运输和贮存。
本标准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医用防护口罩。
【中国标准分类】  C44  医药器械 【国际标准分类】  11.100-实验室医学
行业标准 JY/T 0457-2014 职业院校护理专业仪器设备装备规范
【适用范围】本标准规定了中、高等职业院校护理专业教学和实训用仪器设备的装备规范,包括装备的分类、要求等内容。
本标准适用于中、高等职业院校护理专业教学和实训用仪器设备的装备。其它职业院校和培训机构相关专业教学仪器设备的装备可参照执行。
【中国标准分类】  Y51  文教、体育、娱乐用品 【国际标准分类】  03.180-教育
国家标准 GB 2771-1987 医用橡皮膏
【适用范围】
【中国标准分类】  C73  医药器械 【国际标准分类】  13.340.30-呼吸保护装置
国家标准 GB 3152-1982 医用缝合针通用技术条件
【适用范围】
【中国标准分类】  C73  医药器械 【国际标准分类】  13.340.20-头部防护设备
国家标准 GB 4015-1983 炉窑护目镜和面罩
【适用范围】
【中国标准分类】  C47  劳动安全技术 【国际标准分类】  11.080.10-消毒设备
国家标准 GB 4793.4-2001 测量、控制及实验室用电气设备的安全 实验室用处理医用材料的蒸压器的特殊要求
【适用范围】本标准适用于蒸压器,包括那些具有自动装载和卸载系统的蒸压器,其自动装载和卸载系统装有使用绝对压力范围为0-500kPa的蒸汽的压力容器,其目的是用于处理医用材料和实验室处理过程,例如用于消毒灭菌。
【中国标准分类】  N09  仪器、仪表综合 【国际标准分类】  19.080-电工和电子试验
国家标准 GB 4793.8-2008 测量、控制和实验室用电气设备的安全要求 第2-042部分:使用有毒气体处理医用材料及供实验室用的压力灭菌器和灭菌器的专用要求
【适用范围】本标准适用于包括带自动装载和卸载系统的压力灭菌器和灭菌器,它们有一个使用有毒气体的灭菌室 用于处理医用材料及供实验室处理使用,比如用于灭菌。
如果压力灭菌器在同一装置内安装有用于加湿的蒸汽发生器,则本标准规定的适用安全要求,也同样适用于蒸汽发生器。
【中国标准分类】  C47  医药器械 【国际标准分类】  11.080.10-消毒设备
国家标准 GB 5579-1985 医用X射线设备高压电缆插头插座连接
【适用范围】本标准适用于医用X射线设备的三芯和四芯高压电缆插头插座,该部件为医用X射线设备的高压接插件。
【中国标准分类】  K13  电工材料和通用零件 【国际标准分类】  11.040.50-射线照相设备
国家标准 GB 5665-1985 医用诊断X线机械装置通用技术条件
【适用范围】本标准适用于医用诊断X线机械装置)。本标准不适用于计算机断层(CT)机械装置。
【中国标准分类】  G45  医药器械 【国际标准分类】  11.140-医院设备
国家标准 GB 8279-2001 医用X射线诊断放射卫生防护要求
【适用范围】本标 准 规 定了医用诊断X射线机(不包括C形臂X射线机)防护性能、X射线机机房防护设施和医rn用X射线诊断防护安全操作的技术要求。rn本标 准 适 用于医用诊断X射线机的生产和使用。本标准不适用于介人放射学、血管造影等特殊检n查和X射线CT检查。
【中国标准分类】  C57  卫生 【国际标准分类】  13.280-辐射防护
国家标准 GB 8279-1987 医用诊断X线卫生防护标准
【适用范围】
【中国标准分类】  G86  卫生 【国际标准分类】  71.100.20-工业气体
国家标准 GB 8982-1998 医用氧
【适用范围】本标准规定了医用氧产品的技术要求、试验方法以及包装、标志等。本标准适用于由低温法分离空气而制取的气态氧和液态氧,主要用于呼吸和医疗目的。
【中国标准分类】  G86  其他化工产品 【国际标准分类】  71.100.20-工业气体
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