5.1 This procedure should be used for in vivo evaluation of the performance of antibacterial handwash products that are intended to reduce the skin micro flora following repeated use. Activity against the combined transient and resident micro flora may be assessed. Historically counts from the first basin are considered to be transients.4 ,6 The latter measurement is probably more meaningful as the resident population is more stable.5.1.1 This test method is applicable for testing all forms of topical antimicrobial handwash formulations.1.1 This test method covers determining the effectiveness of an antibacterial handwash for reducing the level of aerobic bacterial flora on the hands, following an extended period of use.1.2 A knowledge of microbiological techniques is required for these procedures.1.3 In this test method metric units are used for all applications, except for distance. In this case, inches are used and metric units follow in parentheses.1.4 Performance of this procedure requires the knowledge of regulations pertaining to the protection of human subjects. (Title 21 CFR, Part 50).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 and health practices and determine the applicability of regulatory limitations prior to use.
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X1.2 SignificanceX1.2.1 Concentrations of trace metals are measured as extracts in simulated body fluids. The metal’s concentration in extracts is based on the surface area of the plastic extracted from which the total amount of metal deliverable to the patient may be estimated.AbstractThis specification covers the properties for polyethylene plastics for use in medical device applications involving human tissue contact devices, short term indwellings, and fluid transfer devices. Biocompatibility tests must be conducted on the final products as the biocompatibility of these materials as a class has not been established. Plyethylene plastics should consist of basic polymers with ethylene as essentially the sole monomer. The compound may contain optional adjuvant substances required in polymer production or fabrication. The final compound should yield a consistent absorption spectrum characteristic of the established formulation. The polyethylene plastics should be tested using the specified physical test procedures for density, melt flow, tensile properties, compressive properties, stiffness, flexural fatigue, and other flexural properties.1.1 This specification covers polyethylene plastics (as defined in Terminology D883) intended for use in medical device applications involving human tissue contact devices, short-term indwellings of 30 days or less, and fluid transfer devices. The biocompatibility of these materials as a class has not been established. Biocompatibility tests must be conducted on the final product.1.2 This specification is not applicable to ultra-high molecular weight polyethylenes (UHMWPE) plastics, such as those used in joint implants, and so forth.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 and health practices and determine the applicability of regulatory limitations prior to use.
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4.1 Field QA demonstrates the effectiveness of field quality control procedures. Effective QA facilitates the collection of statistically significant data that is defendable scientifically and in a court of law. QA also involves the use of consistent procedures, increasing the validity of data comparison among sampling locations and events.4.2 This guide should be used by a professional or technician who has training or experience in groundwater sampling.1.1 This guide covers the quality assurance (QA) methods that may be used to assure the validity of data obtained during the sampling of a groundwater monitoring well. QA is any action taken to ensure that performance requirements are met by following standards and procedures. Following QA practices becomes even more critical if the data must be validated in a court of law. Under certain conditions, it may be necessary to follow additional or different QA practices from those listed in this guide. QA practices should be based upon data quality objectives, site-specific conditions, and regulatory requirements.1.2 This standard addresses QA procedures used in the field and does not refer to laboratory QA procedures.1.3 This standard also 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 to determine the applicability of regulatory limitations prior to use.1.4 This standard provides guidance for selecting and performing various field QA procedures. This document cannot replace education or experience and should be used in conjunction with professional judgement. Not all of the procedures are applicable in all circumstances. This ASTM standard is not intended to represent or replace the standard of care by which the adequacy of a given professional service must be judged, nor should this document be applied without consideration of a project’s many unique aspects. The word “standard” in the title of this document means only that the document has been approved through the ASTM consensus process.
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5.1 All X-ray systems are subject to changing efficiencies, so a practice for checking the overall operation is needed. This practice will assure the operator of an optimized image when ambient conditions are controlled and the X-ray high voltage generator is adjusted as prescribed.5.2 The densities of some tire cord materials are very close to that of the rubber matrix in which they are enclosed, so the resolving capability of an X-ray system is critical to the detection of abnormalities. The rubber-cord pie disk provides a means for optimizing the resolving power in a particular apparatus and for comparing its performance over any period of time.5.3 The rubber-cord pie disk can be used to compare the performances of X-ray systems in different laboratories. It can also be used in special cases to optimize system performance for a particular sector or cord-type, as may be required for examining a specific tire.1.1 This practice describes the construction and use of a rubber-cord pie-shaped standard disk for demonstrating the discernment capability of an X-ray imaging system.1.2 This practice is applicable to direct viewing (fluoroscopic) X-ray imaging systems and film, plate or paper (radiographic) X-ray imaging systems that are used for checking the construction consistency of pneumatic tires.1.3 The values stated in SI units are to be regarded as the standard.1.4 This standard does not purport to address the safety concernss 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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