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4.1 This guide is an educational tool for tank owners, operators, and other users and is not intended for use in certifying compliance with the Federal technical standards for underground storage tanks.4.2 The intent of this guide is to provide an overview of the general requirements. This guide is intended for users who are generally familiar with the requirements of 40 CFR Part 280. The user is advised that this guide does not contain the level of detail necessary to make the determination of whether specific equipment or services meet the detailed technical performance requirements of 40 CFR Part 280.4.3 This guide does not cover state and local requirements, that can be more stringent than the federal rules. Owners and operators are responsible for meeting federal, state, and, in some circumstances, local requirements. It is recommended that owners and operators familiarize themselves with these requirements as well.4.4 Owners or operators may use the sample checklist in Appendix X1 to assist them in determining operational conformance or they may develop their own checklist based upon this guide.4.5 This guide and accompanying appendixes are not intended to be used by state or local UST program authorities as a regulatory or administrative requirement for owners or operators. Use of this guide and appendixes by owners and operators is intended to be a voluntary educational tool for the purposes described in 4.1.1.1 This guide covers information for evaluating tank systems for operational conformance with the Federal technical standards (including the financial responsibility requirements) for underground storage tanks (USTs) found at 40 Code of Federal Register (CFR) Part 280.1.2 This guide does not address the corrective action requirements of 40 CFR Part 280.1.3 To the extent that a tank system is excluded or deferred from the federal regulations under Subpart A of 40 CFR Part 280, it is not covered by this guide.1.4 Local regulations may be more stringent than federal regulation and the reader should refer to the implementing agency to determine compliance.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 This guide describes the use of test methods in Guides F3275 and F3276 to assess the service life of a brush part intended to clean a medical device.5.2 In the case of a brush part intended to clean a lumen, the force required to move a brush part within a tube, an indicator of the friction a brush exerts on a surface, is a measurable parameter that can change over time and will decrease as the brush part loses integrity.5.3 In the case of a brush part intended to clean the external surface, the force required to move the brush across a surface and the pressure the brush exerts on that surface are measurable parameters that can change over time and will decrease as the brush part loses integrity.5.4 By providing objective, repeatable methods for evaluating performance under test conditions, this guide can improve the ability to assess the effectiveness of various brush part designs.1.1 This guide describes methods for assessing the service life, under prescribed laboratory conditions, of a brush part designed to clean a medical device. The method utilizes force testers to mechanically actuate a brush part at a constant rate. This action continues until the brush part demonstrates a significant reduction in cleaning power as measured by the force exerted during testing.1.2 The test methods utilized in this guide are those described in Guides F3275 and F3276. In this guide, the number of repetitions is open-ended and determined by the measurable fatigue of the brush part as measured by a reduction in force, as well as any observation of wear or damage to the brush part.1.3 Brushes designed to clean medical devices after clinical use play an important role in the effective reprocessing of those medical devices. Instructions for use from the brush manufacturer should supply information related to the service life of the brush. This may be stated in terms of (1) a time period; (2) the number of uses; (3) inspection of the brush for wear and damage.1.4 Inspection for wear should always be a part of the instructions for use of a brush. Application of this guide can help to determine like mode(s) of observable failure of a brush part.1.5 Units—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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This test method details the standard procedures for the determination of the bond and cohesion of one-part elastomeric solvent release-type sealants after high- and low-temperature aging. The materials and apparatuses needed for this test procedure are an extension machine, a forced-draft type oven, a convection type oven, a freezer chest or cold box, mortar blocks, glass plates, aluminum alloy plates, and polyethylene spacer bars. This test method also requires the use of the following reagents: acetone or methyl ethyl ketone solvents; detergent solution; and distilled water.1.1 This test method determines the bond and cohesion of one-part, elastomeric, solvent release-type sealants after high- and low-temperature aging.1.2 The subcommittee with jurisdiction is not aware of any similar ISO standard.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.NOTE 1: Currently there is no ISO standard similar to this test method.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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