Medical Devices and Services

ASTM F2413-18 Specification for Performance Requirements for Protective (Safety) Toe Cap Footwear

ASTM F2413-18 Specification for Performance Requirements for Protective (Safety) Toe Cap Footwear Scope:  This specification covers minimum requirements for the performance of footwear to protect against a variety of workplace hazards that can potentially result in injury. ASTM F2413-18 does not aim to lay a detailed manufacturing or purchasing specification, but it can be used...

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ASTM F2100-19 Specification for Performance of Materials Used in Medical Face Masks

Scope: ASTM F2100-19 covers performance requirements for materials used to make medical face masks. This specification classifies a range of medical face mask materials based on their performance.  The list of specified properties represents industry practices for characterizing material performance, but does not include all aspects of performance that may be necessary to protect health...

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ASTM F3502-21 Standard Specification for Barrier Face Coverings

Scope: ASTM F3502-21 ensures that the barrier face coverings meet the stated requirements by providing a means to reduce the number of expelled droplets and aerosols from the wearer’s nose and mouth into the air, and reduce the amount of inhaled particulate matter by the wearer. This specification deals with all barrier face coverings intended...

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ASTM D4236 Standard Practice for Labeling Art Materials for Chronic Health Hazards

Scope: To develop the precautionary labels for art materials and provide hazard and precautionary statements based upon science and medical communities, ASTM D 4236 describes the practice. This practice concerns those chronic health hazards known to be associated with a product or product component when the component is present in a physical form, volume, or...

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ASTM D6319 Standard Specification for Nitrile Examination Gloves for Medical Application

ASTM D6319 Standard Specification for Nitrile Examination Gloves for Medical Application Scope: ASTM D6319: This specification covers certain nitrile rubber gloves required for medical examinations and diagnostic and therapeutic procedures. This specification covers nitrile rubber examination gloves that fit hands, paired gloves, and gloves by size.  The Referee test methods are given in the table...

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ASTM D6370-99 Compositional Analysis of Rubber by Thermogravimetry (TGA)

Scope: ASTM D6370-99 test method is used to determine the composition of rubber. The information obtained from this test is used in quality control, material screening, and other occasions where a compositional analysis or comparison to a known material is required. This test method is not suitable for rubber compounds containing filler materials that decompose...

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ASTM D6355 -07 Test for Human Repeat Insult Patch Testing of Medical Gloves

Scope: ASTM D6355-07 test method is used to determine the probability of allergic reaction when medical devices such as gloves come in contact with human tissue. All medical devices must be safe and effective for their intended use. Since medical devices such as gloves come in contact with human tissue, they should be tested for...

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ASTM D7907 Determination of Bactericidal Efficacy of Medical Gloves

Scope: ASTM D7907 is useful for the evaluation of bactericidal efficacy against a wide range of germs and circumstances, allowing manufacturers to compare performance. There are four specific bacteria listed against which antibacterial efficacy is compared. Procedure: In ASTM D7907, two test methods are intended to measure the amount of bactericidal efficacy of gloves under...

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Medical Mask Bacterial filtration test ASTM F2101

Scope: The standard method ASTM F2101 specifies a test for determining Bacterial Filtration Efficiency (BFE) of medical face mask materials. The testing principle is to subject the face side of the mask to an aerosol containing droplets of 3.0-microns size inoculated with Staphylococcus Aureus,at a prescribed flow rate that corresponds to normal human respiration. BFE...

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