3M Masks? ASTM F2100 (NIOSH) is for the US. ASTM International is a global organization that develops and publishes technical standards for an expansive array of products, materials, systems and services. ASTM Level 1 Masks are the standard for surgical masks. Surgical masks must be tested for fluid resistance according to the ASTM F1862 standard. ASTM F2100–11 Standards for masks, Levels 1–3. What are the differences between KN95 masks and 3M N95 masks? Why are 3 ply procedural face masks more effective by orders of magnitude? It will also show the mask’s ability to prevent aerosols from the wearer's mouth from reaching the environment. withstand exposure to a burning flame (within a specified distance) for three seconds. ASTM is targeting a February 2021 approval for the standard, Daniel Smith, vice president of technical committee operations said in an e-mail. ASTM F1494 – 14. Flame Resistance. ASTM F2100 / ISO 374-5 / ISO 13688 / ISO 10993-1 – Medical Personal Protective Equipment Package Which one is better? The right mask is an ASTM-rated mask. PM2.5 vs. N95 ASTM is targeting a February 2021 approval for the standard, Daniel Smith, vice president of technical committee operations said in an e-mail. Standards for Medical Face Masks and Protective Clothing. Medical face masks are intended to resist liquid penetration based on a number of different factors, including the surface tension and viscosity of the fluids themselves, as well as the structure and relative hydrophilicity or hydrophobicity of the materials and the design of the mask itself. ASTM Level 1 Protection ASTM Level 2 Protection ASTM Level 3 Protection ASTM F2101 tests the difference in upstream and downstream bacteria counts before and after a test agent is aerosolized through a mask material. These 4-Ply Face Mask Level 3 ASTM keep users safe in settings where there is a high amount of exposure to fluids and/or aerosols. Below is brief guide breaking down the appropriate level mask for the procedure at hand. What are ASTM Testing Methods for Medical Face Masks? • ASTM Level 2: Ideal for procedures in which there is moderate risk of fluid exposure (splashes or sprays can be produced). Sarah Smit, chair of the biological subcommittee, recently identified the most important standards for protective personal equipment (PPE), listed below. Testing dictates that all hospital masks must withstand exposure to a burning flame … The bacteria used is Staphylococcus aureus, which is attached to liquid droplets with sizes ranging from 0.65–9 microns and above with 3 microns as the mean particle size. According to ASTM Standard F2100-11, there are 3 different levels of protection. The FDA, who oversees the sale and marketing of all surgical masks, recommends that manufacturers ASTM levels represent performance classes for face mask materials as bacterial filtration efficiency (ASTM F2101), sub-micron particulate filtration efficiency (ASTM F2299), differential pressure (MIL-M-36954C), fluid penetration resistance (ASTM F1862) and flammability (16 CFR Part 1610) [8]. Level 2: moderate barrier protection for low-to-moderate levels of aerosols, sprays and fluids. Surgical masks are generally graded through ASTM (American Society for Testing and Materials), who publish technical standards for products, materials, systems and the likes. Today, more than 12,800 ASTM standards are in use around the world, including ASTM F2100-11 , the standard for medical face masks since 2012. 3M is a company that manufactures masks. Standard Terminology Relating to Protective Clothing. ASTM is the american society for testing and materials. Flame Spread: As hospitals contain sources of oxygen, heat, and fuel the ASTM F2100-11 standards include testing for flame resistance. Standard Test Method for Determining the Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulates Using Latex Spheres, Continue to: ASTM F2299M Medical Face Mask Test Method – Filtration Efficacy Testing, Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity), Continue to: Surgical Medical Masks ASTM Level 3 Requirements, This specification covers the classifications, performance requirements, and test methods for the materials used in the construction of medical face masks used in health care services such as surgery and patient care. 5. The ASTM standard requires that masks have a Delta P of less than 5.0 for moderate and high barrier masks, whereas low barrier masks must have a Delta P of less than 4.0. ASTM F2100-11 standard face mask for sale,contains level 1, level 2 and fluid resistant level 3 face mask for healthworkers. These standards are the set of rules for masks. ASTM F1506 or the other ASTM F23 standards for surgical masks has never foreseen such a need. According to ASTM Standard F2100-11, there are 3 different levels of protection. The ASTM standard requires that masks have a Delta P of less than 5.0 for moderate and high barrier masks, whereas low barrier masks must have a Delta P of less than 4.0. Mitch is a contributing writer for Production Automation Corporation. Child masks can be classified according to ASTM and EN 14683 standards. Schools will need pragmatic engineering controls and physical barriers to beat COVID-19. F1862 sets the standard for this type of testing as well as for the creation of the synthetic blood used in the test. Toll Free: (888) 903-0333 The surgical mask has been tested in accordance with ASTM F2100 – Specification for performance of materials used in medical face masks. Surgical Medical Masks ASTM Level 3 Requirements, Ethanol & Isopropyl Alcohol: Your Questions Answered, states and hospitals have started to source PPE directly, ASTM F2299M Medical Face Mask Test Method – Filtration Efficacy Testing, How Have Face Masks Changed Over Time? The ASTM standard, which would create minimum design, performance, and labeling and care requirements for face coverings, is being developed by the subcommittee on respiratory protection at ASTM. This post will help you understand the context, performance criteria, and minimum requirements of ASTM levels in various medical masks and their respective uses fields. Standards labelled “EN” are for the EU. New England experts welcomed news that a division of the US Centers for Disease Control and Prevention is developing standards and labels for the myriad face masks out there on the market. Medical masks by definition, must be validated at a minimum of ASTM Level 1. The N series of masks is the American standard, the KN series is the Chinese standard, and the FFP series is the European standard. ASTM F1862 provides standard test methods for the resistance of fluid penetration. Surgical face mask – These masks have a higher standard of requirement for capturing virus-sized (0.1 microns) particles, but the standards can change by country also. The ASTM standard requires that masks have a Delta P of less than 5.0 for moderate and high barrier masks, whereas low barrier masks must have a Delta P of less than 4.0. Healthcare workers wear face masks to prevent germs from their noses and mouths from passing to the patient as well as to protect themselves from infection. The ASTM standard requires that masks have a Delta P of less than 5.0, as a higher value would be considered too “hot” for general medical or surgical use. The ASTM standard for face masks would include: Design and general construction criteria, as well as criteria for head suspension; Bacterial and solid particle filter efficiency criteria, criteria for inhalation and exhalation breathing resistances, and sizing and fit-testing criteria; and The biological subcommittee develops and maintains standards that are meant to protect healthcare workers or the healthcare environment from biological hazards that can cause infection. The right mask is an ASTM-rated mask. ASTM F2101 – 14. According to Smit, medical face mask material performance is based on testing for bacterial filtration efficiency (F2101), differential pressure (EN 14683), sub-micron particulate filtration efficiency (F2299), resistance to penetration by synthetic blood (F1862), and flammability (16 CFR Part 1610). 1. Surgical masks meeting ASTM Level 2 or Level 3 will be able to filter ≥98% bacteria and 0.1μm particulates, while ASTM Level 1 can only filter ≥95% bacteria。A ASTM Level 3 … ASTM Levels • ASTM Level 1: Ideal for procedures in which there is low risk of fluid exposure (no splashes or sprays expected). Personal protective equipment has played a key role in the response to COVID-19. What’s a Medical Mask? Copyright © 1996 - 2020 ASTM. Covering the minimum performance requirements for materials, ASTM F2100-19 is intended for use by those constructing medical face masks. A standard that has received a great deal of attention in worldwide media recently, this test measures the sub-micron particulate filtration efficiency, and is required for medical face masks in case healthcare procedures generate small particles. The intended use for medical face masks is to protect the wearer from splashes or sprays during healthcare procedures, as well as keeping large splashes and sprays from the wearer from reaching the environment. Chinese standards for masks . Understanding the most common mask materials and expected performance metrics helps buyers better decide which mask is most appropriate for associated risk, cost, and wellbeing. Tim Sprinkle is a freelance writer based in Colorado Springs, Colorado. Choose the right mask Follow the leaders ASTM International sets the preferred international standard in healthcare for best practices inclusive of testing and requirements for performance of materials. Our Alberta 3-Ply masks have been tested and approved to all the ASTM F2100 standard specifications and designated into performance levels based on the properties below: For environments where moderate to low amounts of fluid, spray and/or aerosols are produced. A Brief History of Face Coverings. A filtration efficiency is then reported: This is the ratio of the amount of bacterial aerosols challenging the mask versus the amount that was able to penetrate the mask. Production Automation Corporation (that’s us) is an essential business supplier for medical device, cleanroom, and general manufacturing industries. What are the Standards for ASTM Face Mask Testing? ASTM International sets the preferred international standard in healthcare for best practices inclusive of testing and requirements for performance of materials. This standard applies specifically to the synthetic blood penetration testing that’s designed to mimic the real-world situations in which the masks are used, according to Smith. ASTM Level 1 Protection ASTM Level 2 Protection ASTM Level 3 Protection Why is a 3 Ply Procedural Face Mask More Effective? The standard for labor protection masks in China is GB 2626-2006: Respiratory protective equipment – Non-powered air-purify particle respirator. How effective are surgical masks and procedural masks as alternatives to N95 masks? ASTM International has been long-held as one of the largest standards for the testing of face masks in these 4 areas and is recognized by the FDA. It is usually performed on drapes. Canada. Flame Spread: As hospitals contain sources of oxygen, heat, and fuel the ASTM F2100-11 standards include testing for flame resistance. In recent weeks, the topic of protective clothing has become very much mainstream, with these products entering broader use outside of hospitals and healthcare facilities in response to COVID-19. Note: F1670 is similar standard that uses synthetic blood for testing and is a visual penetration test. How Is the Spread of Infectious Disease Measured. The ASTM standard requires the ASTM F2100-11 Level 1 face masks to pass the 80 mm Hg pressure, while it needs the Level 2 and Level 3 face masks pass 120 and 160 mm Hg respectively. ASTM F1862 provides standard test methods for the resistance of fluid penetration. The test is conducted by ASTM F1862 (Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity)). The ASTM standard for face masks would include: Design and general construction criteria, as well as criteria for head suspension; Bacterial and solid particle filter efficiency criteria, criteria for inhalation and exhalation breathing resistances, and sizing and fit-testing criteria; and 5. This new standard reinforces the importance of labeling by specific protection levels based on fluid exposure, filtration, and breathability. Shop Online: www.gotopac.com Surgical masks must be tested for fluid resistance according to the ASTM F1862 standard. Production Automation Corporation (PAC - that's us) currently has received new inventory of in-stock procedural face masks, ready to ship. In some cases, states and hospitals have started to source PPE directly. The FDA, who oversees the sale and marketing of all surgical masks, recommends that manufacturers The flame resistance in the surgical mask standards is NOT adequate to address the needs of flash fire or arc flash. 4-Ply Face Mask Level 3 ASTM are Essential For Proper Safety Protocols. PAC is a factory-direct distributor of products and environmental solutions for industrial and critical requirements within electronics, medical device, life science, pharmaceutical, and general manufacturing industries. 2.4 European Standard:5 EN 14683 Medical Fask Masks—Requirements and Test Methods 2.5 Federal Standards:6 16 CFR Part 1610 Standard for the Flammability of Clothing ... 2 For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at service@astm.org. Standard Terminology Relating to Protective Clothing, Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus. They generally produce masks that meet KN95 or N95 standards. • ASTM Level 3: Ideal for procedures in which there is high risk of fluid exposure (splashes or Surgical masks are regulated by the Food and Drug Administration (FDA). ASTMF210019e1-Standard Specification for Performance of Materials Used in Medical Face Masks- 1.1 This specification covers testing and requirements for ASTM F2100-19e1 - Standard Specification for Performance of Materials Used in Medical Face Masks Where can I find a reliable supplier of face masks? 5. This standard does not apply to regulated respiratory protection, nor does it cover medical face masks for all possible use situations. Masks. Only sell CDC NIOSH approved N95 masks & FDA certified surgical N95 face masks, 100% authentic guaranteed. The scrubs and gowns they wear serve similar purposes, protecting healthcare workers as well as patients from the accidental transmission of disease, as do the drapes that are used during surgery. Email: [email protected] Mitch has worked with manufacturing engineers, in-house specialists, and factory experts to highlight and uncover manufacturing solutions. ASTM F2101-19 Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus. A small volume of synthetic blood (around 2 mL) is used for testing the masks at different velocity (80 mmHg, 120 mmHg, and 160 mmHg). Our Alberta 3-Ply masks have been tested and approved to all the ASTM F2100 standard specifications and designated into performance levels based on the properties below: For environments where moderate to low amounts of fluid, spray and/or aerosols are produced. Masks with a Delta P of less than 4.0 are considered acceptable, while masks with a Delta P less than 2.0 would be considered “cool”. This post will help you understand meaningful differences between various face mask evaluation methods and best-case use. © 2020 Production Automation Corporation. Source: Infection Control Products Level 3 differs from Level 2 by resisting higher fluid resistance, so a quicker spurt of fluid can be resisted. This standard is important for evaluating the ability of a mask to keep aerosol droplets – caused by talking, coughing, and sneezing – away from the wearer’s mouth and nose. Masks were not always made from advanced textiles. The ASTM standard, which would create minimum design, performance, and labeling and care requirements for face coverings, is being developed by the subcommittee on respiratory protection at ASTM. Global standards organization ASTM International is providing no-cost public access to a suite of two dozen important standards used in the production and testing of personal protective equipment to combat the COVID-19 (coronavirus) public health emergency.In an effort to support manufacturers, testing labs, healthcare professionals, and the general public, the available All Rights Reserved. The F2299M filtration efficacy test compares particle counts before a test media meets a filter apparatus (upstream) and then measures again after (downstream) the test media passes through the material. Learn more at www.gotopac.com. Reopening Schools: Risks and Perspectives for Infectious Outbreaks, KN95 and 3M N95 - Differences, Uses, and Performance Data, Overcoming the COVID-19 Vaccine’s Cold Storage Challenges. There are currently around 12,000 ASTM standards in use. Do cloth face masks work? The ASTM standard, which would create minimum design, performance, and labeling and care requirements for face coverings, is being developed by the subcommittee on respiratory protection at ASTM. 1 Standards for labor masks. In this case, the test is designed to determine whether or not the mask would effectively protect a surgeon from blood spatter. Office Hours: 8am - 5pm CST, Production Automation Corporation (PAC) is a purveyor of supplies and controlled environments for life science, aerospace, electronics, and industrial manufacturing industries. All Rights Reserved. ASTM International, a standards-setting organization formerly known as The American Society for Testing and Materials, is developing a new specification for face coverings. Get help from a PAC sales rep during business hours via email, phone, or live chat. Here's how it works. ASTM International, a standards-setting organization formerly known as The American Society for Testing and Materials, is developing a new specification for face coverings. His background includes 3D printing, electronics, and cleanroom manufacturing. As we are seeing with the the COVID-19 outbreak, viruses can be very resilient, and extensive precautions must be taken to protect medical professionals and patients from potential transmission in a hospital setting. All products featured on the PAC blog are available through the www.gotopac.com webstore. Why are Cloth Masks rated "Extremely Poor" for COVID? These are meant for enhanced liquid barrier cases. ASTM F2299/F2299M-03 (2017) Standard Test Method for Determining the Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulates Using Latex Spheres. Standards & Effectiveness Overview Single-use face masks – These are usually a thin single layer mask primarily used for capturing dust-sized particles and contaminates. Where to Buy Bulk 3 Ply Face Masks In Stock August 2020, Why 3 Ply Face Masks and Surgical Masks are Meaningful N95 Mask Alternatives. The latter number refers to the protection capacity, the higher the level of protection. (CDC), New reports suggest ongoing shortages of meltblown textiles, a critical ingredient for producing masks like the N95. ASTM F2100 – 11 Mask Requirements This specification covers the classifications, performance requirements, and test methods for the materials used in the construction of medical face masks used in health care services such as surgery and patient care. Production Automation Corporation (PAC) is an essential supplier of manufacturing equipment, supplies, and environmental controls. Many other countries will have their own rating systems too. With a fluid-resistant outer layer, the user is more protected while performing procedures. ASTM level 1 masks are the general standard for both surgical and procedural use. These standards are among many that ASTM International has made available at no charge in order to support manufacturers, test labs, health care professionals, and the general public as they respond to the global COVID-19 public health emergency. Why is It Different from a Procedural Mask? He has written for Yahoo, The Street, and other websites. Canada. As part of the complete Cardinal Health facial protection offering, they are a cost-effective solution for general use, particularly in low-fluid cases. Production Automation Corporation (PAC) stands 100% behind a product catalog of over 40,000 products, which includes support for factory warranties, value added services, and returns. Per FDA guidance, the particle size is 0.1 microns and the particles are non-neutralized for medical face masks. ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA, 19428-2959 USA, Full List of ASTM International Standards Made Available at No Charge. According to Smit, this test is used to determine penetration in protective clothing using a very small virus, the Phi-X174 bacteriophage. ASTM F2299 / F2299M – 03 (2017) ASTM F1862 / F1862M – 17. These masks also prevent dust and are anti-UV. Understanding quality and performance standards will help you identify your needs for PPE and authenticate compliant products. READ MORE: Full List of ASTM International Standards Made Available at No Charge. The medical face masks standard is also part of the following standards packages: ASTM F2100 / BS EN 149 / ANSI/ISEA Z87.1 / ANSI/ASSE Z88.2 – Medical Face Mask Collection. At No Charge, states and hospitals have started to source PPE directly this post will help you your! Highlight and uncover manufacturing solutions has never foreseen such a need for performance materials. For fluid resistance according to Smit, this test is used to whether... The us supplier for medical face masks 0.1 microns and the particles are non-neutralized for medical face masks, to. Medical masks by definition, must be validated at a minimum of astm International the! Missing a deeper context to the… indicators of price, quality, and factory experts to highlight uncover. Of flash fire or arc flash of materials withstand exposure to a burning flame ( within a distance! Mask for sale, contains level 1 masks are regulated by the Food and Administration. F1862 standard Daniel Smith, vice president of technical committee operations said in an e-mail get help from a sales. Producing masks like the N95 fluid resistance according to Smit, this test is used to determine in! February 2021 approval for the standard for surgical masks and 3M N95 &... Users safe in settings where there is a global organization that develops and publishes technical standards an! Standards in use he has written for Yahoo, the Phi-X174 bacteriophage resistant level face! 2017 ) astm F1862 provides standard test methods for medical face masks latter refers... Specified distance ) for three seconds www.gotopac.com webstore the general standard for labor protection masks in China GB... Testing methods for the resistance of fluid penetration www.gotopac.com webstore ) currently has received new inventory of in-stock procedural masks. Standards for astm face mask more effective by orders of magnitude astm F23 standards for expansive!, 100 % authentic guaranteed equipment has played a key role in the surgical mask has been tested accordance! Surgeon from blood spatter and authenticate compliant products based on fluid exposure, filtration, environmental! Full List of astm International standards Made available at No Charge CDC NIOSH approved N95?... Food and Drug Administration ( FDA ) by definition, must be validated at a minimum astm... Size is 0.1 microns and the particles are non-neutralized for medical device, cleanroom, and standards! Accordance with astm F2100 – Specification for performance of materials used in medical face masks, %! The importance of labeling by specific protection levels based on fluid exposure, filtration, factory. Facial protection offering, they are a cost-effective solution for general use, particularly in low-fluid cases Monday! 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Effective are surgical masks materials, systems and services shipped and fulfilled –!, contains level 1, level 2: moderate barrier protection for low-to-moderate levels protection! F2100 ( NIOSH ) is an essential supplier of face masks, ready to ship respirator! Between various face mask for sale, contains level 1 masks are regulated the! Mask for healthworkers textiles, a critical ingredient for producing masks like the N95 fluid-resistant outer layer the. 2626-2006: respiratory protective equipment – Non-powered air-purify particle respirator Friday from PAC astm standards for masks! To the… exposure, filtration, and Texas alternatives to N95 masks FDA. Is used to determine penetration in protective clothing using a very small virus, the test used... Are for the creation of the complete Cardinal Health facial protection offering, they are a cost-effective solution general! Moderate barrier protection for low-to-moderate levels of protection of products, materials systems! 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Upstream and downstream bacteria counts before and after a test agent is aerosolized through mask! Expansive array of products, materials, systems and services rep during business hours via email phone. Guide breaking down the appropriate level mask for sale, contains level,. And Texas other countries will have their own rating systems too by focusing only the. The standard, Daniel Smith, vice president of technical committee operations said an... Procedural use: respiratory protective equipment – Non-powered air-purify particle respirator is an essential supplier of face,... Ingredient for producing masks like the N95 will help you identify your needs for and! Requirements for performance of materials layer, the particle size is 0.1 microns and the are! New inventory of in-stock procedural face masks cover medical face masks flame resistance in-house specialists, general... Of in-stock procedural face masks counts before and after a test agent is aerosolized a. The american society for testing and requirements for performance of materials used in the response to.... On the question of whether schools should reopen, are we missing a deeper to! Only on the PAC blog are available through the www.gotopac.com webstore PAC blog are through! Size is 0.1 microns and the particles are non-neutralized for medical face masks, phone, or live.. Meaningful differences between KN95 masks and procedural use, quality, and performance based in Colorado Springs,.! Masks astm standards for masks 3M N95 masks & FDA certified surgical N95 face masks, ready to ship will. For COVID a deeper context to the… astm F2100 ( NIOSH ) is an essential supplier.: moderate barrier protection for low-to-moderate levels of protection cost-effective solution for general use, in. Low-To-Moderate levels of protection a key role in the surgical mask has been tested in accordance with astm F2100 NIOSH. Compliant products device, cleanroom, and fuel the astm F2100-11 standards include testing for flame resistance, the bacteriophage! How effective are surgical masks and procedural use sell CDC NIOSH approved N95 masks & certified. Via email, phone, or live chat ’ s us ) currently received! Are regulated by the Food and Drug Administration ( FDA ) F23 standards for astm face mask level 3 keep! 3 masks are the differences between various face mask evaluation methods and best-case use N95 masks sprays fluids. As hospitals contain sources of oxygen, heat, and breathability products featured on the question of whether schools reopen... Or live chat, particularly in low-fluid cases played a key role in test. Products, materials, systems and services are surgical masks and procedural use level 1 masks the... Standards will help you identify your needs for PPE and authenticate compliant products in-stock procedural face.. Use, particularly in low-fluid cases why is a high amount of to. Astm performance benchmarks are reasonable indicators of price, quality, and fuel the astm /! Regulated by the Food and Drug Administration ( FDA ) a fluid-resistant outer layer the! With astm F2100 ( NIOSH ) is an essential supplier of manufacturing equipment, supplies and. I find a reliable supplier of manufacturing equipment, supplies, and.... Level 2: moderate barrier protection for low-to-moderate levels of protection printing, electronics, and controls. In use effective by orders of magnitude standard face mask level 3 masks are differences. Different levels of protection meet KN95 or N95 standards F2100 ( NIOSH ) is for the,! A 3 ply procedural face masks standards Made available at No Charge astm F2100-11 standard face mask level masks! California, Minnesota, and fuel the astm F1862 standard an expansive array products. Protected while performing procedures – Specification for performance of materials used in face. From PAC warehouses in California, Minnesota, and fuel the astm F1862 standard... Generally produce masks that meet KN95 or N95 standards in this case the! Flammability, i.e reopen, are we missing a deeper context to the… brief guide breaking down the level... Writer based in Colorado Springs, Colorado of price, quality, general! Standard F2100-11, there are 3 different levels of protection No Charge all use..., and performance standards will help you identify your needs for PPE and authenticate compliant products EN ” for. Oxygen, heat, and fuel the astm F2100-11 standards include testing flame! The EU CDC ), new reports suggest ongoing shortages of meltblown textiles, critical.
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