4.1 Fabrics intended for this end-use should meet all of the requirements listed in Table 1.(A) There is more than one standard test method that can be used to measure breaking strength, bursting strength, tear strength, and lightfastness. These test methods cannot be used interchangeably since there may be no overall correlation between them (see Note 2, Note 3, Note 4, Note 5, and Note 9).(B) Class in colorfastness and SA rating is based on a numerical scale of 5.0 for negligible color change, color transfer, or wrinkling to 1.0 for very severe color change, color transfer, or wrinkling. The numerical rating in Table 1 or higher is acceptable.(C) AATCC Gray Scale for Color Change.(D) AATCC Gray Scale for Staining.(E) AATCC 9-Step Chromatic Transference Scale.(F) For durable-press fabrics only.(G) The development of a standard method has been referred to the American Association of Textile Chemists and Colorists.4.2 It should be recognized that fabric can be produced utilizing an almost infinite number of construction variables (e.g., type of fibers, percentage of fibers, yarn twist, yarn number, warp and pick count, chemical and mechanical finished). Additionally, fashion and aesthetics dictate that the ultimate consumer may find acceptable articles made from fabrics that do not conform to all of the requirements in Table 1.4.2.1 Hence, no single performance specification can possibly apply to all the various fabrics that could be utilized for this end-use.4.3 The uses and significance of particular properties and test methods are discussed in the appropriate sections of the specified test methods.1.1 This performance specification covers the requirements for all knit, lace, foam back, stitch-bonded, conventional weights, and sheer woven fabrics to be used in the manufacture of curtains and draperies.1.2 This performance specification is applicable to all fabrics except those made of glass.1.3 For those properties where fabric direction is pertinent, these requirements apply to the length and width directions for woven fabric and to both the wale and course directions for knit fabric.1.4 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in non-conformance with the 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 This test method is intended for the determination of the radiant heat performance value of a material, a combination of materials, or a comparison of different materials used in flame resistant clothing for workers exposed to radiant thermal hazards.5.2 This test method evaluates a material’s heat transfer properties when exposed to a heat exposure at a constant value and systematically varied durations. Air movement at the face of the specimen and around the calorimeter can affect the measured heat transferred due to forced convective heat losses. Minimizing air movement around the specimen and test apparatus will aid in the repeatability of the results.5.3 This test method accounts for the thermal energy contained in the exposed test specimen after the radiant heat exposure has ceased. Higher values of Radiant Heat Performance rating determined in this test associate to higher values of radiant energy protection against a predicted skin burn injury.5.4 This test method maintains the specimen in a static, vertical position and does not involve movement except that resulting from the exposure procedure.5.5 This test method specifies two standard sets of exposure conditions, 21 kW/m2 (0.5 cal/cm2s) and 84 kW/m2 (2.0 cal/cm2s). Either can be used.5.5.1 If a different set of exposure conditions is used, it is likely that different results will be obtained.5.5.2 The optional use of other conditions representative of the expected hazard, in addition to the standard set of exposure conditions, is permitted. However, the exposure conditions used must be reported with the results along with a determination of the exposure energy level stability.1.1 This test method measures thermal protective characteristics of flame resistant textile materials subjected to a standardized radiant heat exposure relative to a predicted second-degree skin burn injury.1.1.1 This test method is not applicable to textile materials that are not flame resistant.NOTE 1: The determination of a textile material’s flame resistance shall be made prior to testing and done according to the applicable performance or specification standard, or both, for the textile material’s end-use.1.1.2 This test method accounts for the thermal energy contained in an exposed test specimen after the standardized radiant heat exposure has ceased.1.2 This test method is used to measure and describe the response of materials, products, or assemblies to heat under controlled conditions, but does not by itself incorporate all factors required for fire hazard or fire risk assessment of the materials, products, or assemblies under actual fire conditions.1.3 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.1.4 This standard does not purport to address 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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1 Scope This part of ISO 5841 specifies requirements for reports on the clinical performance in humans of population samples of pulse generators or leads, intended for long-term implantation as cardiac pacemakers, hereinafter referred to as devices. It

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This performance specification covers the design characteristics and associated test methods that relate specifically to the flame resistance of textile materials used in the fabrication of basic protection level occupational apparel worn by electrical workers who are exposed to momentary electric arc and related thermal hazards such as exposure to open flame and radiant heat. When evaluated in accordance with the test procedures enlisted herein, knit fabrics and woven fabrics of different fabric weights shall conform to individually specified values of the following properties: colorfastness such as laundering shade change, dry-cleaning shade change, and dimensional change; initial flammability characteristics and flammability characteristics after 25 washes/dry-cleaning such as char length and afterflame time; and arc test rating. Knit fabrics shall additionally be tested and adhere accordingly to bursting strength characteristics. Conversely, woven fabrics shall also be tested and adhere accordingly to breaking load, tear resistance, and seam slippage characteristics.1.1 This performance specification identifies minimum performance requirements to determine the (a) arc rating of fabrics, (b) flame resistance of fabrics and subassemblies, (c) mechanical durability of the fabrics and subassemblies, (d) the minimum garment construction and performance requirements, and (e) the garment labeling requirements for the completed protective clothing worn by workers exposed to flames and electric arcs.1.1.1 The minimum requirements for garment labeling are intended to provide end users with adequate information to select garments with the appropriate arc rating.1.1.2 End users are required to perform an assessment to determine the level of hazard and the required arc rating of the protective clothing for their individual hazards.1.1.2.1 The end user risk assessments are outside the scope of this standard.1.2 This performance specification does not address coated or laminated protective clothing commonly used for rainwear applications in an arc hazard environment. Performance requirements related to this category of protective clothing are detailed in Specification F1891.1.3 This performance specification does not address hand protection. Performance and test requirements related to hand protection are detailed in OSHA 1910.138, Specification D120, and Test Method F2675/F2675M.1.4 The care and maintenance requirements for laundering electric arc flash protective clothing are outside the scope of this standard. Refer to Guides F1449 or F2757 related to industrial or home laundering.1.5 This standard should be used to evaluate and describe the properties of materials, products, or assemblies in response to heat and flame under controlled laboratory conditions. It should not be used to describe or appraise the fire hazard or fire risk of materials, products, or assemblies under actual fire conditions.1.5.1 The results of this evaluation may be used as elements of a fire-risk assessment that takes into account all of the factors that are pertinent to an assessment of the fire hazard of a particular end use.1.6 The values stated in SI units are to be regarded as the standard. The values given in parentheses are for information only.1.7 The following precautionary caveat pertains only to the test methods portion, Section 7, of this performance 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 energy input rate test is used to confirm that the powered sink is operating properly prior to further testing.5.2 Preheat energy and time can be useful to food service operators to manage power demands and to know how quickly the powered sink can be ready for operation when filled with cold water.NOTE 2: It is typically recommended that powered sinks be filled with hot water prior to use. This test is useful for operations that have a limited supply of domestic hot water and would need to use cold water to fill the sink to capacity.5.3 Idle energy rate and pilot energy rate can be used to estimate energy consumption during standby periods.5.4 Washing cycle energy consumption can be used by the food service operator to estimate energy consumption during operating periods.1.1 This test method evaluates the energy consumption of powered open warewashing sinks. The food service operator can use these tests to evaluate and select a suitable washing device and understand its energy consumption.1.2 This test method applies to powered open warewashing sinks (powered sinks) with the following characteristics: a large main water sink with electrically powered water pump(s) and multiple high flow water nozzles. The unit may include gas or electric heaters to maintain water temperature. These powered sinks are designed to run for predetermined cycle duration and accommodate pots and pans of various shapes and sizes as well as cooking utensils. They are intended for stand alone use and require little supervision. The powered sink will be tested for the following (where applicable):1.2.1 Maximum energy input rate (10.2),1.2.2 Preheat energy consumption and duration (10.3),1.2.3 Idle energy rate (10.4),1.2.4 Pilot energy rate, if applicable (10.5), and1.2.5 Washing cycle energy consumption (10.6).NOTE 1: This test method applies only to the powered portion of the unit. Other compartments (sanitizing, rinsing, and so forth) are not evaluated.1.3 The values stated in inch-pound units are to be regarded as standard. The values given in parentheses are mathematical conversions to SI units that 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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This specification covers the standards for graded Trinidad Lake modified asphalt binders. Grading is related to the average seven-day maximum pavement design temperature, the intermediate pavement design temperature, and the minimum pavement design temperature. The Trinidad Lake modified asphalt binder shall be prepared by adding the Trinidad Lake asphalt modifier to base asphalt produced from the refining of petroleum crude. The base asphalt binder shall be homogenous, and free from water or any deleterious materials.1.1 This specification covers performance-graded Trinidad Lake modified asphalt binders. Grading designations are related to the LTPPBind Online calculated maximum pavement design temperature and the minimum pavement design temperature.NOTE 1: For more information on LTPPBind Online, see https://infopave.fhwa.dot.gov/Tools/LTPPBindOnline accessed July 10, 2023.1.2 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.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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5.1 The energy input rate test is used to confirm that the conveyor toaster is operating properly prior to further testing.5.2 Preheat energy and time can be useful to food service operators to manage power demands and to know how quickly the conveyor toaster can be ready for operation.5.3 Idle energy rate and pilot energy rate can be used to estimate energy consumption during non-cooking periods. In addition, a power saving mode (if applicable) will demonstrate energy savings during idle periods.5.4 Production capacity information can help an end user to better understand the production capabilities of a conveyor toaster as it is used to cook a typical food product and this could help in specifying the proper size and quantity of equipment. If production information is desired using a food product other than the specified test food, the test method could be adapted and applied.1.1 This test method evaluates the energy consumption and cooking performance of conveyor toasters including radiant and contact toasters. The food service operator can use this evaluation to select a conveyor toaster and understand its energy consumption.1.2 This test method is applicable to gas and electric conveyor toasters.1.3 The conveyor toaster can be evaluated with respect to the following (where applicable):1.3.1 Energy input rate and preheat temperature profile (10.2),1.3.2 Preheat energy consumption and time (10.3),1.3.3 Idle energy rate (10.4),1.3.4 Pilot energy rate (if applicable, 10.5),1.3.5 Cooking energy rate (10.8), and1.3.6 Production capacity (10.8).1.4 The values stated in inch-pound units are to be regarded as standard. The SI units given in parentheses are for information only.1.5 This test method 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, 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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1.1 This safety performance specification provides requirements for safety in design and installation when using a suction-limiting vent system for suction entrapment prevention in swimming pools, spas, hot tubs, or wading pools.1.2 The purpose of the vent is to relieve the vacuum at the suction outlet(s) caused by any blockage of the suction outlet(s). The vent is intended to prevent body entrapment at the suction outlet(s) and may also mitigate limb entrapment. It is not intended to prevent other injuries caused by the suction outlet(s) such as hair entrapment, mechanical entrapment, or evisceration.1.3 The values stated in inch-pound units are to be regarded as standard. The values given in parentheses are mathematical conversions to SI units that 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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This specification covers asphalt binders graded by performance. Grading designations are related to the average seven-day maximum pavement design temperature, and minimum pavement design temperature. Asphalt binder shall be prepared by the refining of crude petroleum by suitable methods, with or without the addition of modifiers, which may be any organic material of suitable manufacture that is used in virgin or recycled condition, and that is dissolved, dispersed or reacted in asphalt cement to enhance its performance. This specification incorporates an aid for determining the critical low cracking temperature using a combination of test procedures.1.1 This specification2 covers asphalt binders graded by performance. Grading designations are related to the LTPPBind Online calculated maximum pavement design temperature and the minimum pavement design temperature. This specification contains Tables 1 and 2. Table 2 incorporates Practice D6816 for determining the critical low cracking temperature using a combination of Test Method D6648 and Test Method D6723 test procedures. If no table is specified, the default is Table 1.NOTE 1: For more information on LTPPBind Online, see https://infopave.fhwa.dot.gov/Tools/LTPPBindOnline accessed May 23, 2023.NOTE 2: For asphalt cements graded by penetration at 25 °C, see Specification D946/D946M. For asphalt cements graded by viscosity at 60 °C, see Specification D3381/D3381M.NOTE 3: AASHTO R 29 provides non-mandatory information for determining the performance grade of an asphalt binder.1.2 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.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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5.1 This test method is intended to be used for the evaluation of EFVs manufactured for use on residential and small commercial thermoplastic natural gas service lines. Possible applications of the test include product design and quality control testing by a manufacturer and product acceptance testing by a natural gas utility.5.2 The user of this test method should be aware that the flows and pressures measured in the test apparatus may not correlate well with those measured in a field installation. Therefore, the user should conduct sufficient tests to ensure that any specific EFV will carry out its intended function in the actual field installation used.1.1 This test method covers a standardized method to determine the performance of excess flow valves (EFVs) designed to limit flow or stop flow in thermoplastic natural gas service lines.21.2 All tests are intended to be performed using air as the test fluid. Unless otherwise stated, all flow rates are reported in standard cubic feet per hour of 0.6 relative density natural gas.1.3 The test method recognizes two types of EFV. One type, an excess flow valve-bypass (EFVB), allows a small amount of gas to bleed through (bypass) after it has tripped, usually as a means of automatically resetting the device. The second type, an excess flow valve-non bypass (EFVNB), is intended to trip shut forming an essentially gas tight seal.1.4 The performance characteristics covered in this test method include flow at trip point, pressure drop across the EFV, bypass flow rate of the EFVB or leak rate through the EFVNB after trip, and verification that the EFV can be reset.1.4.1 Gas distribution systems may contain condensates and particulates such as organic matter, sand, dirt, and iron compounds. Field experience has shown that the operating characteristics of some EFVs may be affected by accumulations of these materials. The tests of Section 11 were developed to provide a simple, inexpensive, reproducible test that quantifies the effect, if any, of a uniform coating of kerosene and of kerosene contaminated with a specified amount of ferric oxide powder on an EFV's operating characteristics.1.5 Excess flow valves covered by this test method will normally have the following characteristics: a pressure rating of up to 125 psig (0.86 MPa); a trip flow of between 200 ft3/h and 2500 ft3/h (5.66 m3/h and 70.8 m3/h) at 10 psig (0.07 MPa); a minimum temperature rating of 0°F(–18°C), and a maximum temperature rating of 100 °F (38 °C).1.6 The EFVs covered by this test method shall be constructed to fit piping systems no smaller than 1/2 CTS and no larger than 11/4 IPS, including both pipe and tubing sizes.1.7 Tests will be performed at 67 °F ± 10 °F (19.4 °C ± 5.5 °C). Alternative optional test temperatures are 100 °F ± 10 °F (37.7 °C ± 5.5 °C) and 0 ± 10°F (–18 ± 5.5°C). All flow rates must be corrected to standard conditions.1.8 This test method was written for EFVs installed in thermoplastic piping systems. However, it is expected that the test method may also be used for similar devices in other piping systems.1.9 The values stated in inch-pound units are to be regarded as standard. The values given in parentheses are mathematical conversions to SI units that are provided for information only and are not considered standard.1.10 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. For specific precautions, see Section 8.1.11 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 provides test methods for evaluating the performance characteristics of a brush part designed to clean internal channel(s) of a medical device.5.1.1 The force required to move a brush part within a tube, an indicator of the friction a brush exerts on a surface, is a parameter of cleaning effectiveness and should be measured.5.1.2 The removal of soil from a tube by a brush part moved in a tube is a further indicator of the effectiveness of a brush to loosen and remove soil from a tube and should be measured.5.2 By providing objective, repeatable methods for evaluating performance, this guide can improve the ability to assess the effectiveness, under test conditions, of various brush part designs.1.1 Brushes used to clean a medical device after clinical use play an important role in effective reprocessing. This guide describes methods for characterizing, under prescribed laboratory conditions, the efficacy of brush parts designed to clean the internal channels of medical devices. The methods utilize a force tester to mechanically actuate a brush part within a channel: (1) Methods to measure, at an established speed, the force required to move a brush within a channel; (2) Methods utilize the same force tester and protocols to measure soil removal from a soiled tube, another indicator of performance.1.2 Inclusions: 1.2.1 This guide describes objective, quantifiable, and reproducible methods for evaluating the cleaning characteristics of a brush part under prescribed laboratory conditions, with test methods that simulate the cleaning challenge of a defined target area(s) of a medical device. This also makes possible the comparison of one design of a brush part to another.1.2.2 In this guide, a brush part is one that is intended to be moved within a tube.1.2.3 Tubes used for testing described in this guide are cylindrical and uniform in diameter. The test methods describe may not apply to non-cylindrical tubes.1.2.4 By use of this guide, medical device manufacturers can characterize the brush part designed for cleaning their device.1.2.5 By use of this guide, manufacturers of cleaning brushes can evaluate and characterize the cleaning performance of their brushes for the target area(s) of medical device(s), including allowing a comparison with existing brush part designs offered on the market. Further, they are able to evaluate modifications to designs and construction that might improve performance.1.2.6 This information can also be shared with the users of the brushes (medical device reprocessors) to help them evaluate the performance of commercially available brushes.1.3 Exclusions: 1.3.1 This guide does not assess potential damage that may be inflicted by the brush. For instance, brushes with rigid bristles (for example, stainless steel or other metals) or other abrasive materials are more likely to damage medical devices than brushes with flexible bristles (for example, nylon) or more pliable materials. Potential damage from more abrasive materials should be assessed.1.3.2 This guide does not specify acceptance criteria, and the results will be dependent on the specific parameters (for example, test soil, drying time, channel inside diameter and material, and so forth) that are tested.1.3.3 This guide is not intended to constitute all steps required to conduct validation of cleaning instructions for a medical device, including the use of brushes for this purpose, but provides methods that may be part of a broader protocol to conduct a complete cleaning instructions validation.1.3.4 If a brush is intended to clean a specific device(s), cleaning validation shall include testing with that device(s).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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1.1 This practice describes a model for designing and validating performance-based, ISO 17025-compliant, standard test methods for the instrumental chemical analysis of metals, ores, and related materials. The principles in this practice can also be applied to the development of test methods used to determine the composition of other materials.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 requirements prior to use.

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This consumer safety performance specification establishes performance requirements, test methods, and marking requirements to promote the safe use of cribs in commercial environments such as hotels, rentals, motels, day care centers and the like. Crib static load, threshold test, and drop side dynamic test shall be performed in accordance to the requirements specified.1.1 This consumer safety performance specification establishes performance requirements, test methods, and marking requirements to promote the safe use of cribs in commercial environments such as hotels, rentals, motels, and child care centers and the like.1.2 This consumer safety performance specification subsumes the federal and ASTM standards which are in existence for these types of product when those products are used in non-commercial applications.1.3 This consumer safety performance specification includes products intended to provide a safe sleeping environment such as full size cribs, non-full size cribs, and play yards and includes both rigid and mesh sided units. The term “crib” as used in this standard includes all of these items.1.4 Products such as bassinets and cradles are specifically excluded from this consumer safety performance specification.1.5 No commercial crib produced after the approval date of this consumer safety performance specification shall, either by label or other means indicate compliance with this specification unless it conforms to all applicable requirements contained herein, before and after all testing.1.6 The values stated in inch-pound units are to be regarded as standard. The values given in parentheses are mathematical conversions to SI units that are provided for information only and are not considered standard.1.7 The following precautionary caveat pertains only to the test methods portion, Section 6, 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 This guide provides two test methods for evaluating the performance characteristics of a brush part designed to clean external surface(s) of a medical device by utilizing force testers.5.1.1 The first test method utilizes a force tester to measure the force required to actuate a brush part across a surface. This is an indicator of the friction a brush exerts on a surface, a parameter of cleaning effectiveness.5.1.2 The second test method measures the removal of soil from a surface by a brush part actuated across the surface. This is a further indicator of the effectiveness of a brush part to loosen and remove soil from a surface.5.2 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 designs1.1 This guide describes methods for characterizing the efficacy, under prescribed laboratory conditions, of a brush part designed to clean the external surface of a medical device. The method utilizes force testers to mechanically actuate a brush part across a surface at a constant rate and constant pressure. In the first method, the force required to actuate across the surface is measured. In the next method, which utilizes the same force testers and protocol (actuation motion), the brush part is actuated on a soiled surface and the amount of soil removed is measured, as another indicator of performance.1.2 Brushes designed to clean medical devices after clinical use play an important role in the effective reprocessing of those medical devices.1.3 Inclusions: 1.3.1 This guide describes objective, quantifiable, and reproducible methods for evaluating the cleaning characteristics of a brush part, under prescribed laboratory conditions, with a test method that simulates the cleaning challenge of a defined target area(s) of a medical device. This also makes it possible to compare one brush part design to another.1.3.2 By use of this guide, manufacturers of cleaning brushes will be able to evaluate and characterize the cleaning performance of their brushes for the target area(s) of medical device(s) and evaluate modifications to design and construction that might improve performance.1.3.3 By use of this guide, this information can also be shared with the users of the brushes (medical device reprocessors) to help them evaluate the performance of commercially available brushes.1.4 Exclusions: 1.4.1 This guide is not intended to be used for brushes designed to clean medical devices using rotational motion.1.4.2 This guide does not assess potential damage that may be inflicted by the brush, or degradation of the brush that may occur during repeated use. Brushes with rigid bristles (for example, stainless steel or other metals) are predicted to be more likely to damage medical devices than brushes with flexible bristles (for example, nylon); damage from rigid-bristled brushes should be assessed. Assessing repeated use would require a greatly increased number of test repetitions than what is described in this guide.1.4.3 This guide does not specify acceptance criteria, and the results will be dependent on the specific parameters that are tested (for example, test soil, drying time, surface area, and materials, etc.) that are tested.1.4.4 This guide is not intended to constitute all steps required to conduct validation of cleaning instructions for a medical device, including use of brushes for this purpose, but provides methods that may be part of a broader protocol to conduct a complete cleaning instructions validation. Separate medical device cleaning instruction validation studies must be conducted.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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