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5.1 This standard guide may be used by medical device manufacturers as part of their design plan and implementation of the validation of the cleaning instructions of their reusable medical devices.5.2 This guide helps medical device manufacturers to identify the appropriate method(s) for detecting and quantifying markers for the simulated-use test soil (see Guide F3208), thereby evaluating whether the medical device can be adequately cleaned.5.3 This guide describes various test methods for the different analytes.1.1 This standard guide provides methods and considerations for detecting and quantifying test soil(s) from reusable medical device(s) that result from simulated-use testing of medical devices during validation of the cleaning procedures as described in the instructions for use (IFU) provided by the medical device manufacturer.1.2 The methods described are for detecting and measuring markers (analytes) that are components within the most common test soils and are relevant to the clinical use of the device. Appropriate test soils without protein, carbon, or carbohydrates (for example, bone) will require other methods.1.3 This is a part of a series of ASTM standard guides for validating cleaning instructions. The scope of the first guide in the series is selecting appropriate test soils (Guide F3208). The second in the series (Guide F3293) describes methods for inoculating medical devices with test soil. The third in the series (Guide F3321) describes methods for extracting soils for measuring residual soil on medical devices after the performance of cleaning process. This is the fourth guide in the series and describes the methods of detecting and quantifying residual analytes on the device.1.4 Units—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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定价： 674元 加购物车

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4.1 Gas chromatography with sulfur selective detection provides a rapid means to identify and quantify sulfur compounds in various petroleum feeds and products. Often these materials contain varying amounts and types of sulfur compounds. Many sulfur compounds are odorous, corrosive to equipment, and inhibit or destroy catalysts employed in downstream processing. The ability to speciate sulfur compounds in various petroleum liquids is useful in controlling sulfur compounds in finished products and is frequently more important than knowledge of the total sulfur content alone.1.1 This test method covers the determination of volatile sulfur-containing compounds in light petroleum liquids. This test method is applicable to distillates, gasoline motor fuels (including those containing oxygenates) and other petroleum liquids with a final boiling point of approximately 230 °C (450 °F) or lower at atmospheric pressure. The applicable concentration range will vary to some extent depending on the nature of the sample and the instrumentation used; however, in most cases, the test method is applicable to the determination of individual sulfur species at levels of 0.1 mg/kg to 100 mg/kg.1.2 The test method does not purport to identify all individual sulfur components. Detector response to sulfur is linear and essentially equimolar for all sulfur compounds within the scope (1.1) of this test method; thus both unidentified and known individual compounds are determined. However, many sulfur compounds, for example, hydrogen sulfide and mercaptans, are reactive and their concentration in samples may change during sampling and analysis. Coincidently, the total sulfur content of samples is estimated from the sum of the individual compounds determined; however, this test method is not the preferred method for determination of total sulfur.1.3 The values stated in SI units are to be regarded as standard. The values given in parentheses after SI units are provided for information only and are not considered 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 This test method is used for determination of the carbon content of water from a variety of natural, domestic, and industrial sources. In its most common form, this test method is used to measure organic carbon as a means of monitoring organic pollutants in industrial wastewater. These measurements are also used in monitoring waste treatment processes.5.2 The relationship of TOC to other water quality parameters such as chemical oxygen demand (COD) and total oxygen demand (TOD) is described in the literature. 41.1 This test method covers the determination of total carbon (TC), inorganic carbon (IC), and total organic carbon (TOC) in water, wastewater, and seawater in the range from 0.1 mg/L to 4000 mg/L of carbon.1.2 This test method was used successfully with reagent water spiked with sodium carbonate, acetic acid, and pyridine. It is the user's responsibility to ensure the validity of this test method for waters of untested matrices.1.3 This test method is applicable only to carbonaceous matter in the sample that can be introduced into the reaction zone. The syringe needle or injector opening size generally limit the maximum size of particles that can be so introduced.1.4 In addition to laboratory analyses, this test method may be applied to stream monitoring.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 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.1.7 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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定价： 590元 加购物车

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