歡迎訪問中科光析科學技術研究所官網！
- 聯(lián)系我們
- 關注微信
歡迎訪問中科光析科學技術研究所官網！
免費咨詢熱線
400-640-9567|
醫(yī)用面罩檢測項目報價？??解決方案？??檢測周期？??樣品要求？ |
點 擊 解 答?? |
本標準規(guī)定了醫(yī)用防護口罩的技術要求、試驗方法、標志與使用說明及包裝、運輸和貯存。本標準適用于醫(yī)療工作環(huán)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醫(yī)用防護口罩。
本標準給出了檢測醫(yī)用面罩防合成血噴濺穿透性能的實驗室試驗方法。本標準主要用于評價制作醫(yī)用面罩的材料或某些結構的性能。本標準不評價醫(yī)用面罩的設計、結構、界面或其他能影響醫(yī)用面罩總體保護能力(如過濾效率和壓降)的因素。本試驗不評價醫(yī)用面罩的透氣性或其他影響醫(yī)用面罩呼吸舒適性的性能。本試驗評估醫(yī)用面罩的防護性能。本試驗不評估醫(yī)用面罩對經空氣傳播，或沉積在醫(yī)用面罩表面體液形成氣溶膠穿透傳播的防護能力。
YY/T 1551的本部分規(guī)定的試驗方法適用于對輸液、輸血器具用空氣過濾器成品的細菌截留能力進行評價。輸液、輸血器具用空氣過濾膜材細菌截留能力的評價可參考本部分。本試驗宜由經培訓的試驗人員在生物安全實驗室中進行操作。
本標準適用于醫(yī)療人員于手術、雷射、隔離、牙科或其它醫(yī)療程序時配戴之面罩，主要用途為防止病人與醫(yī)護人員之間微生物、體液及粒狀物質之傳遞與感染
本標準規(guī)定量測醫(yī)用面罩材料細菌過濾效率的試驗法，由過濾前之細菌量和過濾后之細菌殘存量之比值評估醫(yī)用面罩材料的細菌過濾效率
本標準規(guī)定在短時間內（0到2.5s）以高速度定量之合成血液對醫(yī)用面罩穿透阻力之試驗法。以目視檢測合成血液是否穿透判定醫(yī)用面罩之合格與否
本標準規(guī)定醫(yī)用面罩之通氣性試驗法
This International Standard describes a laboratory test method for measuring the resistance of medical face masks to penetration by a splash of synthetic blood.nThis International Standard 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 mask's design, construction, interfaces or other factors which may affect the overall protection offered by the medical face mask and its operation (such as filtration efficiency and pressure drop).nThis test method does not evaluate the performance of medical face masks as a protection against contamination via airborne exposure pathways or in the prevention of the penetration of aerosolized body fluids deposited on the medical face mask.
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 mm Hg, and 160 mm Hg). 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 applications. 5.6x00a0;This test method differs from Test Method F1670 by dispensing a stream of 2 mL of synthetic blood against the target area of a complete medical mask specimen whereas Test Method F
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.
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.
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.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.
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 also apply to 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.
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
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.1.7 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.
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.
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/ASQC 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 determined......
Domaine d'applicationLe présent document spécifie les exigences de fabrication, de conception et de performance, ainsi que les méthodes d'essai relatives aux masques à usage médical destinés à limiter la transmission d'agents infectieux des membres de l'équipe médicale aux patients lors d'actes chirurgicaux et d'autres actes médicaux aux exigences similaires. Un masque à usage médical présentant une barrière antimicrobienne appropriée peut également s'avérer efficace pour diminuer l'émission d'agents infectieux venant du nez et de la bouche d'un patient présentant des sympt?mes cliniques ou asymptomatique.La présente Norme européenne ne s'applique pas aux masques exclusivement destinés à la protection individuelle des membres de l'équipe.Il existe des normes relatives aux masques destinés à la protection individuelle des voies respiratoires.L'Annexe A apporte des informations aux utilisateurs des masques à usage médical.
前沿科學
微信公眾號
中析研究所
抖音
中析研究所
微信公眾號
中析研究所
快手
中析研究所
微視頻
中析研究所
小紅書