5.1 This test method is designed to evaluate the effectiveness of cleaning reusable medical instruments using a specified cleaning process.5.2 This test method may be used to determine the effectiveness of cleaning processes of recesses, hinged sites, lumina, or other difficult-to-reprocess areas of reusable medical instruments.5.3 This test method may also be used to verify the claims for any portion of the cleaning cycle.5.4 The recovery of surviving microorganisms may be accomplished using swabbing, rinsing, or total immersion of instruments.5.5 The efficacy of the elution methods or loss of the applied inoculum may be assessed by recovery of target organisms from control instruments that have not been subjected to the cleaning process.1.1 This test method is written principally for large medical instruments or instruments with internal channels or recesses (for example, flexible endoscopes) but may be used for any resuable medical instruments.1.2 This test method describes a procedure for testing the efficacy of a cleaning process for reusable medical instruments artificially contaminated with mixtures of microorganisms and simulated soil.1.3 The test method utilizes bacterial spores as tracers for foreign materials and quantifies their removal as a means of determining the efficacy of a cleaning process.1.4 The test method is designed for use by manufacturers of medical instruments and devices. However, it may also be employed by other individuals who have a knowledge of the instruments, techniques and access to appropriate facilities.1.5 Worst-case conditions can be represented by exaggerating a specific test parameter or otherwise intentionally simulating an extreme condition such as performing the test without cleaning solutions or utilizing instruments which are not new.1.6 The test procedure is devised to determine the efficacy of a cleaning process as applied to a particular instrument or group of instruments by simulating actual use situations.1.7 The test procedure may be performed on test instruments using a complete cleaning cycle or be limited to particular phases of the cycle such as precleaning, manual cleaning, automated cleaning, or rinsing.1.8 The test procedure is normally performed on a number of external and internal sites, but it may be restricted to one particular site on the instrument.1.9 A knowledge of microbiological and aseptic techniques and familiarity with the instruments is required to conduct these procedures.NOTE 1: Because contamination of the surfaces of instruments may occur as a result of rinsing with tap water, bacteria-free water should be used for all rinsing when a water rinse step is part of the cleaning directions.NOTE 2: Test methods to determine the effectiveness of cleaning medical instruments has only recently been actively debated, and research efforts are in their infancy. Because published experimental results are scarce, it is premature to dictate experimental reagents, conditions or acceptance criteria.NOTE 3: The total elimination of the target organisms is not the goal of cleaning. Therefore, there will almost always be a number of microorganisms surviving on the test instruments unless one of the solutions or processes disinfects or sterilizes the test instrument. The results of various clinical and laboratory tests suggest that cleaning processes alone can produce a 102 to 104 log10 reduction in bioburden. The exact reduction will depend upon the precise experimental conditions. The criteria for judging cleanliness should be determined and recorded before initiation of the test procedure.NOTE 4: This test protocol employs target spores as indicators or tracers for foreign materials and monitors their removal by the cleaning process. It is certainly possible that other particulate target materials, such as microbeads (latex beads) could be used in place of microbes. These alternate approaches would be more practical in those circumstances where microbiological expertise is limited.1.10 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.1.11 This standard may involve hazardous materials, operations, and equipment. 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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5.1 This guide is intended to provide machinery maintenance and monitoring personnel with a guideline for performing filter debris analysis as a means to determine machine condition. Correlating the filter contaminants to ‘normal’ and ‘abnormal’ lube system operation provides early indication of a contaminant or component wear related lube system problem. Analysis of the contaminant collected within the lube filter element provides a tool to identify the failure mode, its rate of progression, and the source of the contamination.5.2 FDA differs from traditional oil analysis in that the filter is sampled instead of the fluid. Debris from the filter is removed for analysis. FDA is an effective means of monitoring equipment wear because the wear history is efficiently captured in the filter matrix. Typically, more than 95 % of all released metal particles larger than the filter pore size are captured in the filter (1).5 In addition, other types of particulate contamination, including seal wear material and environmental contaminations are captured, which can also provide diagnostic information.1.1 This guide pertains to removal and analysis techniques to extract debris captured by in-service lubricant and hydraulic filters and to analyze the debris removed.1.2 This guide suggests techniques to remove, collect and analyze debris from filters in support of machinery health condition monitoring.1.3 Debris removal techniques range from manual to automated.1.4 Analysis techniques vary from visual, particle counting, microscopic, x-ray fluorescence (XRF), atomic emission spectroscopy (AES), and scanning electron microscopy energy dispersive x-rays (SEMEDX).1.5 This guide is suitable for use with the following filter types: screw on, metal mesh, and removable diagnostic layer filters.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 practice covers the requirements for the heat treatment of aluminum alloy castings from any casting process such as investment casting, permanent mould casting, sand casting, and others. It excludes castings that are used in specific aerospace applications or those made from wrought aluminum alloys. The aluminum alloys should be subjected to controlled heat treatment using the usual air chamber furnace or other heating media like lead baths, oil baths, fluidized beds, or even superheated steam. Air chambers may be oil or gas fired or may also be electrically heated but the atmosphere inside each should be controlled to prevent porosity. Quenching is normally performed by immersing castings in a hot-water bath. It is important that the furnace be calibrated before it is used initially and after any change in the furnace. Likewise, temperature-measurement systems should be regularly checked for accuracy.1.1 This practice covers, when specified by material specification or purchase order, the heat treatment of aluminum alloy castings from all casting processes.1.1.1 The heat treatment of aluminum alloy castings used in specific aerospace applications is covered in AMS 2771 and specific AMS material specifications.1.1.2 The heat treatment of wrought aluminum alloys is covered in Practice B918/B918M.1.2 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system are not necessarily exact equivalents; therefore, to ensure conformance with the standard, each system shall be used independently of the other, and values from the two systems shall not be combined.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 The purpose of these test methods is to define a procedure for evaluating the capability and effectiveness of cleaning agents to remove residues of a compound/product from surrogate surfaces (that is, coupons or beakers) of Materials of Construction. This test method also provides a procedure for determining the compatibility of cleaning agents with the Material of Construction prior to starting tests. Based on the outcome of the testing, suitable cleaning agents may be selected for further cleaning process development (see Guide D6361/D6361M).5.2 The potential critical cleaning parameters related to the cleaning agent(s) under study may also be examined using these tests. Potentially critical cleaning parameters include cleaning agent concentration, temperature, time, pH, foaming, type and strength of ultrasonic energy or agitation (if used), and others. These parameters may be varied (for example, using Design of Experiments) to determine their potential optimal settings for actual use.1.1 This test method covers a procedure for evaluating the effectiveness and capability of cleaning agents to remove contamination to the desired level. This includes removing drug residues from manufacturing equipment and residues from medical devices (Guide E3106), as well as systems for oxygen service.1.2 The test coupons/beakers described in this standard provide a representative surface to which contamination can be applied and tested for the ability of a cleaning agent to remove it.1.3 This test method is a laboratory scale approximation and the actual effectiveness of a particular cleaning agent depends upon the method (temperature, agitation, concentration, etc.) in which it is used and the characteristics of the article being cleaned, such as size, shape, and material. Final evaluation of the cleaning agent should include testing of actual products and cleaning processes.1.4 Units—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.1.5 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 safety of each compound on a case-by-case basis.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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Preface This is the first edition of CAN/CSA-ISO 10012, Measurement management systems - Requirements for measurement processes and measuring equipment, which is an adoption without modification of the identically titled ISO (International Organization

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