1.1 This specification establishes design, performance, documentation, and labeling requirements and provides test methods for protective clothing used in preventing exposure to liquid chemotherapy and other liquid hazardous drugs.1.1.1 The principal requirement of this specification is permeation resistance testing of the protective clothing barrier material and seams to a specified battery of seven chemotherapy drugs. Two levels of protective clothing barrier material and seam performance are established for complying with Part A labeling requirements specific to these seven liquid chemotherapy drugs.1.1.1.1 Broad chemotherapy drug protection is based on the protective clothing barrier material and seams demonstrating breakthrough detection times of 30 min or more for the seven specified chemotherapy drugs.1.1.1.2 Selective chemotherapy drug protection is based on the protective clothing barrier material and seams demonstrating breakthrough detection times of 30 min or more for at least five of the seven specified chemotherapy drugs.1.1.2 It is also possible to report permeation resistance test results for additional liquid chemotherapy and other liquid hazardous drugs of interest as determined by the manufacturer or end user organization using the same breakthrough detection criteria for individual drugs for complying with the Part B labeling requirements.1.1.3 Protective clothing meeting this specification is also required to meet minimum flammability requirements, and if used as a medical device, biocompatibility (if used for breached skin contact), and demonstrate sterility assurance, if sterilized prior to use.1.1.4 Physical properties that indicate the strength, durability, and breathability of the protective clothing are optionally reported.1.1.5 Additional requirements are established for the label and user information to be provided for protective clothing meeting this specification.1.1.6 This specification also requires products intended to be used as medical devices such as surgical gowns and isolation gowns to meet the respective requirements of AAMI PB70, Specification F2407/F2407M, and Specification F3352/F3352M, as applicable.1.2 This specification does not address all conditions of exposure for individuals who wear protective clothing in the manufacture, transport, compounding, preparation, and administration of liquid chemotherapy and other hazardous drugs in addition to patient care activities and spills where contaminated items with these drugs are encountered.1.3 This specification does not address chemotherapy drugs or hazardous drugs that may be encountered in the form of a vapor or aerosol and does not provide any criteria for respiratory protection.1.4 This specification does not address the selection, use, or care of protective clothing used for protection against liquid chemotherapy or other liquid hazardous drugs. While this specification does not specifically determine which barrier material to select, the results of the tests described in this specification are useful for selecting barrier materials by comparing the test results among different materials under consideration. See USP 800, Hazardous Drugs—Handling In Healthcare Settings, for specific guidelines on the selection, use, and care of personal protective equipment for protection of healthcare workers against chemotherapy or other hazardous drugs.1.5 This specification is intended to provide the basis for manufacturers or suppliers to make specific claims that protective clothing products provide protection against liquid chemotherapy and other liquid hazardous drugs.1.6 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.1.7 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.1.8 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.

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4.1 Interfacial tension measurements on electrical insulating liquids provide a sensitive means of detecting small amounts of soluble polar contaminants and products of oxidation. A high value for new mineral insulating oil indicates the absence of most undesirable polar contaminants. The test is frequently applied to service-aged mineral oils as an indication of the degree of deterioration.NOTE 1: Different liquid matrixes are reviewed in Appendix X1.1.1 This test method covers the measurement of the interfacial tension between insulating liquid that has a relative density (specific gravity) less than water and water, under non-equilibrium conditions.1.2 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. See 7.2 for a specific warning statement.1.3 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.

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This test method indicates the presence of hydrophilic compounds. These compounds can be an indicator of contaminants in new oil and in used oil, oxidation or deterioration of the oil or materials of construction in contact with the oil.1.1 This test method covers a comparatively rapid procedure particularly applicable for field use for measuring, under nonequilibrium conditions, the interfacial tensions of electrical insulating oils of petroleum origin against water. This test method has been shown by experience to give a reliable indication of the presence of hydrophilic compounds. This test method may not be applicable for highly viscus insulating fluids.1.2 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.

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4.1 This specification covers the minimum performance criteria for flame resistance and other requirements for rainwear used by workers with the potential to be simultaneously exposed to wet weather conditions and either hydrocarbon or petrochemical industrial fires.4.2 The purchaser has the option to perform or have performed any of the tests required by this specification in order to verify the performance of the rainwear.4.3 This specification for rainwear shall not be construed as a requirement for the use of any particular rainwear material.1.1 This specification establishes applicable test methods, minimum physical and thermal performance criteria, a suggested sizing guide, and suggested purchasing information for rainwear for use by workers who are potentially exposed to industrial hydrocarbon fires or other petrochemical fire hazards.1.1.1 This specification does not apply to rainwear used for thermal electric arc flash hazards. Specification of rainwear for these electric arc flash hazards is addressed in Specification F1891.1.2 The objective of this specification is to prescribe function and performance criteria for rainwear that meets a minimum level of thermal and physical performance when exposed to a laboratory-simulated fire exposure.1.3 This specification is not intended to serve as a detailed manufacturing or purchasing specification, but can be referenced in purchase contracts to ensure that minimum performance requirements are met.1.4 Controlled laboratory tests used to determine compliance with the performance requirements of this specification shall not be deemed as establishing performance levels for all situations to which wearers of this protective clothing are potentially exposed.1.5 This specification does not attempt to establish in-service care and use of this flame-resistant rainwear.1.6 The values stated in SI units are to be regarded as standard. The values given in parentheses are mathematical conversions to inch-pound or other units that are commonly used for thermal testing.1.7 The following safety hazards caveat pertains to Sections 7 and 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.1.8 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.

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5.1 The different procedures and methods are designed to be used to produce survival data after microorganisms are exposed to antimicrobial agents in order to calculate values that can be used to analyze and rationalize the effectiveness of antimicrobial agents when tested using other, often applied test methods.5.2 The data from these test procedures may be used in the selection and design of other tests of effectiveness of antimicrobial agents, some of which may be required by regulatory agencies to establish specific claims. Basic kinetic information about killing rate often serves as the initial information on which a testing program can be built.1.1 This guide covers the methods for determining the death rate kinetics expressed as D-values. These values can be derived from the construction of a kill curve (or survivor curve) or by using other procedures for determining the number of survivors after exposure to antimicrobial chemicals or formulations. Options for calculations will be presented as well as the method for calculation of a concentration coefficient.1.1.1 The test methods are designed to evaluate antimicrobial agents in formulations to define a survivor curve and to subsequently calculate a D-value. The tests are designed to produce data and calculate values that provide basic information of the rate-of-kill of antimicrobial formulations tested against single, selected microorganisms. In addition, calculated D-values from survivor curves from exposure at different dilutions of antimicrobial can be used to show the effect of dilution by calculation of the concentration exponent, η (2). D-value determination assumes the ideal of first-order killing reactions that are reflected in a straight-line reduction in count where a count-versus-time plot is done. The goal here is not to determine the time at which no survivors are found, but to determine a standard value that can be used in processing and exposure determinations or used to estimate dilutions.1.1.2 As an example of potential use of kill curve data, the published FDA, OTC Tentative Final Monograph for Health-Care Antiseptic Drug Products, Proposed Rule, June 17, 1994 has suggested the testing of topically applied antimicrobial products using survival curve (or kill curve) calculations. The methods described in this guide are applicable to these products, but adjustments such as the use of antifoaming agents when the reaction mixture is stirred may be necessary to counteract the presence of detergents in many formulations. Frequently the sampling for these tests is done after very short intervals of exposure to the formulation, such as 30 and 60 s. This methodology also has been applied to preservative testing of antimicrobial ingredients in more complex cosmetic formulations (5).1.2 The test methods discussed should be performed only by those trained in microbiological techniques.1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.1.4 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.1.5 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.

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5.1 The practical life of an internal combustion engine is most often determined by monitoring its oil consumption. Excessive oil consumption is cause for engine repair or replacement and can be symptomatic of excessive wear of the piston ring or the cylinder bore or both. More wear-resistant materials of construction can extend engine life and reduce cost of operation. Although components made from more wear-resistant materials can be tested in actual operating engines, such tests tend to be expensive and time consuming, and they often lead to variable results because of the difficulty in controlling the operating environment. Although bench-scale tests do not simulate every aspect of a fired engine, they are used for cost-effective initial screening of candidate materials and lubricants. The test parameters for those tests are selected by the investigator, but the end result is a pair of worn specimens whose degree of wear needs to be accurately measured. The use of curved specimens, like segments of crowned piston rings, presents challenges for precise wear measurement. Weight loss or linear measurements of lengths and widths of wear scars may not provide sufficient accuracy to discriminate between small differences in wear. This guide is intended to address that problem.1.1 This guide describes a profiling method for use accurately measuring the wear loss of compound-curved (crowned) piston ring specimens that run against flat counterfaces. It does not assume that the wear scars are ideally flat, as do some alternative measurement methods. Laboratory-scale wear tests have been used to evaluate the wear of materials, coatings, and surface treatments that are candidates for piston rings and cylinder liners in diesel engines or spark ignition engines. Various loads, temperatures, speeds, lubricants, and durations are used for such tests, but some of them use a curved piston ring segment as one sliding partner and a flat or curved specimen (simulating the cylinder liner) as its counterface. The goal of this guide is to provide more accurate wear measurements than alternative approaches involving weight loss or simply measuring the length and width of the wear marks.1.2 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.1.3 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.

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This practice covers procedures that can be followed to safeguard against the possible embrittlement of steel hot-dip galvanized after fabrication, and outlines test procedures for detecting embrittlement. Conditions of fabrication may induce a susceptibility to embrittlement in certain steels that can be accelerated by galvanizing. Open-hearth, basic-oxygen, and electric-furnace steels shall be used for galvanizing. Other materials that can be galvanized include continuous cast slabs, steel or iron castings, and wrought iron. The material shall undergo cold working and thermal treatment. Embrittlement of steel shapes, steel castings, threaded articles, and hardware items shall be tested using a bend test , a universal testing machine, or by means of a press with the load applied slowly, until fracture of the galvanized test specimen occurs.1.1 This practice covers procedures that can be followed to safeguard against the possible embrittlement of steel hot-dip galvanized after fabrication, and outlines test procedures for detecting embrittlement. Conditions of fabrication may induce a susceptibility to embrittlement in certain steels that can be accelerated by galvanizing. Embrittlement is not a common occurrence, however, and this discussion does not imply that galvanizing increases embrittlement where good fabricating and galvanizing procedures are employed. Where history has shown that for specific steels, processes and galvanizing procedures have been satisfactory, this history will serve as an indication that no embrittlement problem is to be expected for those steels, processes, and galvanizing procedures.1.2 This practice is applicable in either inch-pounds or SI units. Inch-pounds and SI units are not necessarily exact equivalents. Within the text of this practice and where appropriate, SI units are shown in brackets.1.3 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.1.4 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.

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5.1 This practice is to determine if a test substance can inactivate viruses in suspension.5.2 Regulatory agencies may require additional testing using in vitro (Practice E1053, Test Method E2197) or in vivo (Test Method E1838) carrier tests for product registration purposes.1.1 This practice is intended to demonstrate the virucidal activity of test substances with viruses in suspension.1.2 It is the responsibility of the investigator to determine whether Good Laboratory Practice regulations (GLPs) are required and to follow them where appropriate (40 CFR, Part 160 for EPA submissions and 21 CFR, Part 58 for FDA submissions).1.3 Refer to the appropriate regulatory agency for performance standards of virucidal efficacy.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 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. The user should consult a reference for the laboratory safety recommendations.21.6 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.

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5.1 Methods such as D3273 Standard Test Method for Resistance to Growth of Mold on the Surface of Interior Coatings in an Environmental Chamber and D3274 Standard Test Method for Evaluating the Degree of Surface Disfigurement of Paint Films by Fungal or Algal Growth or Soil or Dirt Accumulation provide means for assessing mold and algal staining on paints. The Test Method E1428 Evaluating the Performance of Antimicrobials in or on Polymeric Solids Against Staining by Streptomyces species (A Pink Stain Organism) is used for solid polymeric materials, but is not appropriate for all antimicrobial technologies.5.2 This test method provides a technique for evaluating antimicrobials in or on polymeric materials against staining by Streptomyces species and should assist in the prediction of performance of treated articles under actual field conditions.1.1 This test method is intended to assess susceptibility of polymer materials, as well as products that may directly contact the treated polymer, to staining by the Actinomycete Streptomyces species.1.2 This test method is also suitable for evaluating dark-pigmented test samples since the bacterial growth inhibition can be assessed.1.3 Familiarity with microbiological techniques is required. This test method should not be used by persons without at least basic microbiological training.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 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.

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5.1 Vegetative biofilm bacteria are phenotypically different from suspended planktonic cells of the same genotype. Biofilm growth reactors are engineered to produce biofilms with specific characteristics. Altering either the engineered system or operating conditions will modify those characteristics. The goal in biofilm research and efficacy testing is to choose the growth reactor that generates the most relevant biofilm for the particular study.5.2 The purpose of this test method is to direct a user in how to grow, treat, sample and analyze a Pseudomonas aeruginosa biofilm using the MBEC Assay. Microscopically, the biofilm is sheet-like with few architectural details as seen in Harrison et al (6). The MBEC Assay was originally designed as a rapid and reproducible assay for evaluating biofilm susceptibility to antibiotics (2). The engineering design allows for the simultaneous evaluation of multiple test conditions, making it an efficient method for screening multiple disinfectants or multiple concentrations of the same disinfectant. Additional efficiency is added by including the neutralizer controls within the assay device. The small well volume is advantageous for testing expensive disinfectants, or when only small volumes of the disinfectant are available.1.1 This test method specifies the operational parameters required to grow and treat a Pseudomonas aeruginosa biofilm in a high throughput screening assay known as the MBEC (trademarked)2 (Minimum Biofilm Eradication Concentration) Physiology and Genetics Assay. The assay device consists of a plastic lid with ninety-six (96) pegs and a corresponding receiver plate with ninety-six (96) individual wells that have a maximum 200 μL working volume. Biofilm is established on the pegs under batch conditions (that is, no flow of nutrients into or out of an individual well) with gentle mixing. The established biofilm is transferred to a new receiver plate for disinfectant efficacy testing.3, 4 The reactor design allows for the simultaneous testing of multiple disinfectants or one disinfectant with multiple concentrations, and replicate samples, making the assay an efficient screening tool.1.2 This test method defines the specific operational parameters necessary for growing a Pseudomonas aeruginosa biofilm, although the device is versatile and has been used for growing, evaluating and/or studying biofilms of different species as seen in Refs (1-4).51.3 Validation of disinfectant neutralization is included as part of the assay.1.4 This test method describes how to sample the biofilm and quantify viable cells. Biofilm population density is recorded as log10 colony forming units per surface area. Efficacy is reported as the log10 reduction of viable cells.1.5 Basic microbiology training is required to perform this assay.1.6 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.1.7 ASTM International takes no position respecting the validity of any patent rights asserted in connection with any item mentioned in this standard. Users of this standard are expressly advised that determination of the validity of any such patent rights, and the risk of infringement of such rights, are entirely their own responsibility.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 this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.1.9 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.

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