醫(yī)用口罩檢測

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YY 0469-2023醫(yī)用外科口罩

本文件規(guī)定了醫(yī)用外科口罩的技術(shù)要求、試驗方法、標(biāo)志、包裝、運(yùn)輸和貯存。本文件適用于醫(yī)護(hù)人員在含有潛在血液、體液、分泌物污染風(fēng)險的醫(yī)療環(huán)境及有創(chuàng)操作環(huán)境佩戴的一次性醫(yī)用口罩。本文件不適用于醫(yī)用及其它工作環(huán)境下的防護(hù)口罩。

YY/T 0969-2013一次性使用醫(yī)用口罩

本標(biāo)準(zhǔn)規(guī)定了一次性使用醫(yī)用口罩(以下簡稱口罩)的要求、試驗方法、標(biāo)志、使用說明書及包裝、運(yùn)輸和貯存。本標(biāo)準(zhǔn)適用于覆蓋使用者的口、鼻及下頜,用于普通醫(yī)療環(huán)境中佩戴、阻隔口腔和鼻腔呼出或噴出污染物的一次性使用口罩。本標(biāo)準(zhǔn)不適用于醫(yī)用防護(hù)口罩,醫(yī)用外科口罩。

YY/T 0969-2023一次性使用醫(yī)用口罩

本文件規(guī)定了一次性使用醫(yī)用口罩的技術(shù)要求、試驗方法、標(biāo)志、包裝、運(yùn)輸和貯存。本文件適用于覆蓋使用者口、鼻及下頜，用于普通醫(yī)療環(huán)境中佩戴、阻隔口腔和鼻腔呼出或噴出污染物的一次性使用口罩。本文件不適用于醫(yī)用防護(hù)口罩、醫(yī)用外科口罩。

QB/T 5896-2023全自動一次性醫(yī)用口罩機(jī)

本文件規(guī)定了全自動一次性醫(yī)用口罩機(jī)的型式及工作環(huán)境、外觀質(zhì)量和結(jié)構(gòu)、機(jī)器性能、運(yùn)轉(zhuǎn)性能、控制功能、安全、電磁兼容等方面的要求，描述了相應(yīng)的試驗方法，并規(guī)定了檢驗規(guī)則和附件、標(biāo)志、包裝、運(yùn)輸和貯存。本文件適用于加工一次性醫(yī)用平面口罩的口罩機(jī)的設(shè)計、生產(chǎn)、研發(fā)和測試。

WS/T 472-2015口腔健康調(diào)查　檢查方法　

本標(biāo)準(zhǔn)規(guī)定了口腔健康調(diào)查中的基本檢查方法、評判標(biāo)準(zhǔn)、記錄代碼和記錄方法。本標(biāo)準(zhǔn)適用于或局部地區(qū)針對人群開展的口腔健康調(diào)查或疾病監(jiān)測，可根據(jù)不同的調(diào)查目的選擇不同的檢查內(nèi)容。

WS/T 509-2016重癥監(jiān)護(hù)病房醫(yī)院感染預(yù)防與控制規(guī)范

本標(biāo)準(zhǔn)規(guī)定了醫(yī)療機(jī)構(gòu)重癥監(jiān)護(hù)病房（intensive care unit, ICU)醫(yī)院感染預(yù)防與控制的基本要求、建筑布局與必要設(shè)施及管理要求、人員管理、醫(yī)院感染的監(jiān)測、器械相關(guān)感染的預(yù)防和控制措施、手術(shù)部位感染的預(yù)防與控制措施、手衛(wèi)生要求、環(huán)境清潔消毒方法與要求、床單元的清潔與消毒要求、便器的清洗與消毒要求、空氣消毒方法與要求等。本標(biāo)準(zhǔn)適用于各級綜合醫(yī)院依據(jù)有關(guān)規(guī)定設(shè)置的ICU。傳染病醫(yī)院ICU及兒科和新生兒ICU醫(yī)院感染的預(yù)防與控制可結(jié)合特點(diǎn)，參照本標(biāo)準(zhǔn)執(zhí)行。

SN/T 0626.7-2016進(jìn)出口速凍蔬菜檢驗規(guī)程 第7部分:食用菌

SN/T 0626的本部分規(guī)定了進(jìn)出口速凍食用菌的檢驗方法。本部分適用于進(jìn)出口速凍食用菌的抽樣方法和包裝、質(zhì)量、品質(zhì)、規(guī)格、安全衛(wèi)生項目的檢驗和結(jié)果合格評定。

SN/T 4165-2015入境郵(客)輪衛(wèi)生檢疫查驗規(guī)程

本標(biāo)準(zhǔn)規(guī)定了入境郵（客）輪衛(wèi)生檢疫查驗的內(nèi)容、方法、程序、結(jié)果判定和處置。本標(biāo)準(zhǔn)適用于入境郵（客）輪衛(wèi)生檢疫查驗。

SN/T 4858-2017國境口岸結(jié)核病監(jiān)測質(zhì)量控制規(guī)范

本標(biāo)準(zhǔn)規(guī)定了國境口岸開展肺結(jié)核監(jiān)測工作中胸部X線攝片、影像學(xué)診斷、樣本采集、實驗室檢測、肺結(jié)核病人后續(xù)監(jiān)管工作的質(zhì)量控制要求。本標(biāo)準(zhǔn)適用于國境口岸入出境人員肺結(jié)核監(jiān)測工作的質(zhì)量控制。

FZ/T 73049-2014針織口罩

本標(biāo)準(zhǔn)規(guī)定了針織口罩的規(guī)格、要求、試驗、判定規(guī)則、產(chǎn)品使用說明、包裝、運(yùn)輸和貯存。本標(biāo)準(zhǔn)適用于鑒定以針織面料為主要材料制成的口罩的品質(zhì)。本標(biāo)準(zhǔn)不適用于醫(yī)用口罩和勞動防護(hù)口罩。本標(biāo)準(zhǔn)不適用于年齡在36個月及以下的嬰幼兒服飾。

ASTM F1862/F1862M-2017醫(yī)用口罩抗人工合成血滲透的標(biāo)準(zhǔn)試驗方法(已知速度下固定體積的水平投影)

5.1x00a0;This test method offers a procedure for evaluating medical face mask resistance to synthetic blood penetration that is useful in establishing claims for penetration resistance performance of medical face masks and ranking their performance. However, this test method does not define acceptable levels of penetration resistance because this determination must be made by each responsible user organization based on its own specific application and conditions. Therefore, when using this test method to make claims for the performance of medical face masks, the specific conditions under which testing is conducted must be described. 5.2x00a0;Medical face masks are intended to resist liquid penetration from the splatter or splashing of blood, body fluids, and other potentially infectious materials. Many factors affect the wetting and penetration characteristics of body fluids, such as surface tension, viscosity, and polarity of the fluid, as well as the structure and relative hydrophilicity or hydrophobicity of the materials and the design of the mask itself. The surface tension range for blood and body fluids (excluding saliva) is approximately 0.042 to 0.060 N/m.7 To help simulate the wetting characteristics of blood and body fluids, the surface tension of the synthetic blood is adjusted to approximate the lower end of this surface tension range. The resulting surface tension of the synthetic blood is 0.042 x00b1; 0.002 N/m. 5.3x00a0;The synthetic blood mixture is prepared with a red dye to aid in visual detection and a thickening agent to simulate the flow characteristics of blood. The synthetic blood will not always duplicate the polarity, and thus the wetting behavior and subsequent penetration, of real blood and other body fluids through protective clothing materials. 5.4x00a0;During a medical procedure, a blood vessel is occasionally punctured resulting in a high velocity stream of blood impacting a protective medical face mask. The impact velocity depends on several factors, the most important being the blood pressure of the patient. Other factors include the size of the puncture and distance from the puncture. Because the pressure, and thus velocity drops quickly with large punctures, large punctures were not used to model the range of blood splatter velocities considered in this test. Furthermore, this test method is based on the assumption that the medical face mask will be in close proximity (within 300 mm or 12 in.) to the puncture area. The use of this test method is, therefore, based on selecting an appropriate blood pressure, finding the corresponding stream or impact velocity, and determining the valve time to create that stream velocity as shown in Appendix X1. 5.4.1x00a0;The mean human blood pressure generally varies over a range of about 10.7 to 16.0 kPa (80 to 120 mmHg).8 In this test method, medical face masks are tested at stream velocities corresponding to 10.7 kPa, 16.0 kPa, and 21.3 kPa (80 mmHg, 120 mmHg, and 160 mmHg). 5.5x00a0;This test method permits the use of other non-standard test pressures, stream velocities, fluid volumes, and specimen orientations for evaluating medical face mask penetration resistance consistent with specific app

ASTM F2100-2003醫(yī)用口罩用材料性能的標(biāo)準(zhǔn)規(guī)范

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.

ASTM F2100-2003a醫(yī)用口罩用材料性能的標(biāo)準(zhǔn)規(guī)范

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.

ASTM F2100-2019醫(yī)用口罩材料性能標(biāo)準(zhǔn)規(guī)范

1.1x00a0;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. 1.2x00a0;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. 1.3x00a0;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 apply to regulated respiratory protection, which may be necessary for some healthcare services. 1.4x00a0;The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.5x00a0;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. 1.6x00a0;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.

ASTM F2100-2019e1醫(yī)用口罩材料性能標(biāo)準(zhǔn)規(guī)范

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 apply to regulated 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.

ASTM F2100-2020醫(yī)用口罩用材料性能的標(biāo)準(zhǔn)規(guī)范

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. 1.1.1?This specification addresses medical masks with ties (surgical masks) and ear loops (procedure masks or isolation masks). 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 their overall barrier and breathability properties. 1.3.1?This specification does not include any specific design criteria for medical face masks; however, surgical masks are differentiated by having ties to allow adjustment of the medical face mask fit in comparison to procedure or isolation masks, which use ear loops to affix the mask to the wearer’s face. 1.4?This specification does not address requirements for regulated respiratory protection devices such as respirators, which may be necessary for some healthcare services and exposure to inhalation hazards. Note 1:?Performance requirements for NIOSH-approved N95 respirators are described in 42 CFR Part 84. Additional requirements for NIOSH-approved N95 respirators intended for use in healthcare settings are described in the Memorandum of Understanding between FDA and NIOSH. FDA/NIOSH MOU 225-18-006, November 2017 and the NIOSH Conformity Assessment Letter to Manufacturers, NIOSH CA 2018-1010, November 2018. 1.5?The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.6?The following precautionar

ASTM F2100-2021醫(yī)用口罩用材料性能的標(biāo)準(zhǔn)規(guī)范

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. 1.1.1?This specification addresses medical masks with ties (surgical masks) and ear loops (procedure masks or isolation masks). 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 their overall barrier and breathability properties. 1.3.1?This specification does not include any specific design criteria for medical face masks; however, surgical masks are differentiated by having ties to allow adjustment of the medical face mask fit in comparison to procedure or isolation masks, which use ear loops to affix the mask to the wearer’s face. 1.4?This specification does not address requirements for regulated respiratory protection devices such as respirators, which may be necessary for some healthcare services and exposure to inhalation hazards. Note 1:?Performance requirements for NIOSH-approved N95 respirators are described in 42 CFR Part 84. Additional requirements for NIOSH-approved N95 respirators intended for use in healthcare settings are described in the Memorandum of Understanding between FDA and NIOSH. FDA/NIOSH MOU 225-18-006, November 2017 and the NIOSH Conformity Assessment Letter to Manufacturers, NIOSH CA 2018-1010, November 2018. 1.5?The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.6?The following precautionar

ASTM F2101-2019用金黃色葡萄球菌生物氣溶膠評價醫(yī)用口罩材料的細(xì)菌過濾效率(BFE)的標(biāo)準(zhǔn)試驗方法

5.1x00a0;This test method offers a procedure for evaluation of medical face mask materials for bacterial filtration efficiency. This test method does not define acceptable levels of bacterial filtration efficiency. Therefore, when using this test method it is necessary to describe the specific condition under which testing is conducted. 5.2x00a0;This test method has been specifically designed for measuring bacterial filtration efficiency of medical face masks, using Staphylococcus aureus as the challenge organism. The use of S. aureus is based on its clinical relevance as a leading cause of nosocomial infections. 5.3x00a0;This test method has been designed to introduce a bacterial aerosol challenge to the test specimens at a flow rate of 28.3 L/mm. (1 ft3/min). This flow rate is within the range of normal respiration and within the limitations of the cascade impactor. 5.4x00a0;Unless otherwise specified, the testing shall be performed with the inside of the medical face mask in contact with the bacterial challenge. Testing may be performed with the aerosol challenge directed through either the face side or liner side of the test specimen, thereby, allowing evaluation of filtration efficiencies which relate to both patient-generated aerosols and wearer-generated aerosols. 5.5x00a0;Degradation by physical, chemical, and thermal stresses could negatively impact the performance of the medical face mask material. The integrity of the material can also be compromised during use by such effects as flexing and abrasion, or by wetting with contaminants such as alcohol and perspiration. Testing without these stresses could lead to a false sense of security. If these conditions are of concern, evaluate the performance of the medical face mask material for bacterial filtration efficiency following an appropriate pretreatment technique representative of the expected conditions of use. Consider preconditioning to assess the impact of storage conditions and shelf life for disposable products, and the effects of laundering and sterilization for reusable products. 5.6x00a0;If this procedure is used for quality control, perform proper statistical design and analysis of larger data sets. This type of analysis includes, but is not limited to, the number of individual specimens tested, the average percent bacterial filtration efficiency, and standard deviation. Data reported in this way help to establish confidence limits concerning product performance. Examples of acceptable sampling plans are found in references such as ANSI/ASQ Z1.4 and ISO 2859-1. 1.1x00a0;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. 1.2x00a0;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 determine......

ASTM F2101-2023使用金黃色葡萄球菌生物氣溶膠評估醫(yī)用口罩材料細(xì)菌過濾效率（BFE）的標(biāo)準(zhǔn)試驗方法

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 do 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. 1.7?This test method may also be used to measure the bacterial filtration efficiency (BFE) of other porous medical products such as surgical gowns, surgical drapes, and sterile barrier systems. 1.8?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