5.1 Thermal analysis provides a rapid method for measuring transitions due to morphological or chemical changes in a polymer as it is heated/cooled at a controlled rate through a specified temperature range. Change in specific heat capacity, heat flow and temperature values are determined for these transitions. Differential scanning calorimetry is used to assist in identifying specific polymers, polymer alloys, and certain polymer additives, which exhibit thermal transitions. Chemical reactions that cause or affect certain transitions have been measured with the aid of this technique; such reactions include oxidation, curing of thermosetting resins, and thermal decomposition.5.2 This test method is useful for specification acceptance, process control, and research.1.1 This test method covers determination of transition temperatures and enthalpies of fusion and crystallization of polymers by differential scanning calorimetry.NOTE 1: True heats of fusion are to be determined in conjunction with structure investigation, and frequently, specialized crystallization techniques are needed.1.2 This test method is applicable to polymers in granular form or to any fabricated shape from which it is possible to cut appropriate specimens.1.3 The normal operating temperature range is from the cryogenic region to 600°C. Certain equipment allows the temperature range to be extended.1.4 The values stated in SI units are the standard.NOTE 2: This test method does not apply to all types of polymers as written (see 6.8).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.NOTE 3: This standard is similar but not equivalent to ISO 11357-1, -2, -3. The ISO procedures provide additional information not supplied by this test method.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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4.1 With the need to calculate free formaldehyde levels in emulsion polymers, it is necessary to make the determination without upsetting any equilibria that might generate or deplete formaldehyde. This test method provides a means for determining ppm levels of free formaldehyde in emulsion polymers without upsetting existing equilibria.1.1 This test method is used for the determination of free formaldehyde (HCHO) in emulsion polymers without upsetting existing formaldehyde equilibria. The procedure has been evaluated using acrylic, acrylonitrile-butadiene, carboxylated styrene-butadiene and polyvinyl acetate emulsion polymers. This test method may also be applicable for emulsion polymers of other compositions. The established working range of this test method is from 0.05 to 15 ppm formaldehyde. Emulsion polymers must be diluted to meet the working range.1.2 This test method minimizes changes in free formaldehyde concentration that can result from changes in the physical or chemical properties of an emulsion polymer.1.3 There are no known limitations to this test method when used in the manner described. The emulsion polymer test specimen must be prepared with a diluent that has a pH similar to that of the emulsion. Use of an inappropriate pH may upset formaldehyde equilibria and result in incorrect formaldehyde levels.1.4 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 specification covers chopped carbon-fiber reinforced (CFR) polyetheretherketone (PEEK) polymer in pellets, filaments used in additive manufacturing, or fabricated forms. It provides requirements and associated test methods for these thermoplastic composites when they are to be used in the manufacture of intracorporeal devices such as surgical implants or components of surgical or dental devices.1.2 The properties included in this specification are those applicable for chopped CFR-PEEK compounds and fabricated forms only. Materials or forms containing colorants, fillers other than carbon fibers, processing aids, or other additives, as well as polymer blends which contain PEEK, or reclaimed materials, are not covered by this specification.1.2.1 This standard does not include continuous carbon-fiber reinforced PEEK composites, which are fabricated using a different process than chopped CFR-PEEK.1.2.2 This standard can include CFR-PEEK compounds that are fabricated with the use of coupling (sizing) agents. However, when coupling agents are used to improve wetting of the carbon fibers, the biological risk assessments and biocompatibility testing should consider these coupling agents.1.3 This specification is designed to recommend physical, chemical, and biological test methods to establish a reasonable level of confidence concerning the performance of CFR-PEEK polymers for use in medical implant devices.1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.1.5 When evaluating material in accordance with this specification, hazardous materials, operations, and equipment may be involved.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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4.1 Mechanical properties of PEEK polymers, such as stiffness or yield strength, are influenced by the level of crystallinity.5 The reported crystallinity index determined by this test method has been correlated with percent crystallinity in PEEK polymers by wide-angle X-ray scattering (WAXS) experiments.2, 34.2 This test method may be useful for both process development, process control, product development, and research.1.1 This test method describes the collection of absorption spectra of polyetheretherketone (PEEK) polymer in filled and unfilled grades, as supplied by a vendor, and the subsequent calculation of the percent crystallinity. The material is evaluated by infrared spectroscopy. The intensity (height) of the absorbance peaks is related to the amount of crystalline regions present in the material.1.2 This test method can be used for PEEK consolidated forms, such as injection molded parts, as long as the samples are optically flat and smooth.1.3 The applicability of the infrared method to industrial and medical grade PEEK materials has been demonstrated by scientific studies.2, 3 Percentage of crystallinity is related to R-FTIR measurement by calibration through wide-angle x-ray scattering (WAXS) crystallinity measurements.2, 3 It is anticipated that this test method, involving the peak heights near 1305 cm-1 and 1280 cm-1, will be evaluated in an Interlaboratory Study (ILS) conducted according to Test Method E691.1.4 This test method does not suggest a desired range of crystallinity for specific applications.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 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.1.7 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 specification covers polyaryletherketone (PAEK) polymers in virgin forms as supplied by a vendor (pellets, powder, and so forth). It provides requirements and associated test methods for these thermoplastics when they are to be used in the manufacture of intracorporeal devices such as surgical implants or components of surgical or dental devices. The described PAEK polymers are pure semicrystalline homopolymers consisting of phenylene rings connected by ether and carbonyl groups. The tensile strength, elongation, and impact strength shall be tested to meet the requirements prescribed.1.1 This specification covers polyaryletherketone (PAEK) polymers in virgin forms as supplied by a vendor (pellets, powder, and so forth). It provides requirements and associated test methods for these thermoplastics when they are to be used in the manufacture of intracorporeal devices such as surgical implants or components of surgical or dental devices.1.2 As with any material, some characteristics may be altered by the processing techniques (molding, extrusion, machining, assembly, sterilization, and so forth) required for the production of a specific part or device. Therefore, properties of fabricated forms of these polymers should be evaluated using test methods that are appropriate to ensure safety and efficacy as agreed upon by the vendor, purchaser, and regulating bodies.1.3 The properties included in this specification are those applicable for PAEK polymers only. Fabricated forms, material or forms containing colorants, fillers, processing aids, or other additives, as well as polymer blends that contain PAEK, are not covered by this specification.1.4 This specification is designed to recommend physical, chemical, and biological test methods to establish a reasonable level of confidence concerning the performance of unfilled PAEK polymers for use in medical devices. The properties listed should be considered in selecting material according to the specific end-use requirements.1.5 When evaluating material to this specification hazardous materials, operations, and equipment may be involved. 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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1.1 This test method covers determination of the solubility of resins and polymers in terms of the region of solubility parameter and hydrogen bonding of solvents in which complete solution occurs. In some cases dipole moment of the solvents may also be required to delineate more exactly the boundaries of solubility. 1.2 This test method is applicable only if the test solutions are of sufficient clarity and freedom from color to allow accurate visual judgement of complete solubility and of low enough viscosity for solution to take place. 1.3 This standard does not purport to address all of the safety problems 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. For a specific hazard statement see Note in 6.2.

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4.1 The knowledge of dilute solution viscosity serves as an additional tool in characterizing ethylene polymers. Viscosity data alone is potentially a limited value in predicting the processing behavior of the polymer. However, when used in conjunction with other flow and physical property values, the solution viscosity of ethylene polymers contributes to characterizing the material.4.2 Satisfactory correlation between solution viscosity and certain other properties is possible from polymers of a single manufacturing process. The solution viscosity test is not sensitive to some molecular configurational patterns that occur among polymers from different manufacturing processes. Hence, its correlation with other properties of polymers produced by different processes, by even one manufacturer, is limited without structural characterization.4.3 The viscosity of polymer solutions has the potential to be drastically affected by the presence of known or unknown additives in the sample. The use of solution viscosity data where ethylene polymers are known or suspected to contain colorants, carbon black, low molecular weight hydrocarbons, fillers, or other additives needs to be considered.4.4 The measurement of dilute solution viscosity of ethylene polymers presents problems not ordinarily encountered in viscosimetry. Ethylene polymers are not soluble at room temperature in any known solvent. Some of the higher density materials are insoluble below 100°C. Extreme care must be exercised in transferring the solution to the viscometer for the test if the correct solution concentration is to be maintained. This test has no significance unless the sample is completely soluble.4.5 The solution viscosity is a function of the root-mean-square size of the polymer molecules in solution. It is known that the solvent selected and the temperature of the determination have an effect on the root-mean-square size of the particles. Hence, where a viscometer, solvent, or temperature other than specified in this standard is used, the data is likely not comparable to that obtained by this procedure.1.1 This test method covers the determination of the dilute solution viscosity of ethylene polymers at 135°C. It is applicable to a reasonably wide spectrum of ethylene polymers having densities from 0.910 to 0.970 g/cm2. Directions are given for the determination of relative viscosity (viscosity ratio), inherent viscosity (logarithmic viscosity number), and intrinsic viscosity (limiting viscosity number).1.2 The values as stated in SI units are to be regarded as the 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.1.3.1 Warning—Mercury has been designated by many regulatory agencies as a hazardous material that can cause serious medical issues. Mercury, or its vapor, has been demonstrated to be hazardous to health and corrosive to materials. Caution should be taken when handling mercury and mercury containing products. See the applicable product Safety Data Sheet (SDS) for additional information. Users should be aware that selling mercury and/or mercury containing products into your state or country may be prohibited by law.NOTE 1: This standard is equivalent to ISO 1628-3.NOTE 2: Appendix X1 – Appendix X3 contain material from the previous version of Test Method D1601 and are included for information only.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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1.1 This classification system covers liquid crystal polymeric (LCP) materials suitable for injection molding and extrusion. This classification system allows the use of liquid crystal polymers that are recycled, reconstituted, recycled-regrind, recovered, or reprocessed, or a combination thereof, provided that the requirements as stated in this classification system are met. It is the responsibility of the supplier and the buyer of liquid crystal polymers that are recycled, reconstituted, recycled-regrind, recovered, or reprocessed, or a combination thereof, to ensure compliance.1.2 The properties included in this classification system are those required to identify the compositions covered. Other requirements necessary to identify particular characteristics important to specialized applications are allowed. These shall be agreed upon between the user and the supplier, by using suffixes as given in Section 5.1.3 This classification system and subsequent line callout (specification) are intended to be a means of calling out plastic materials used in the fabrication of end-use items or parts. It is not intended for the selection of materials. Material selection can be made by those having expertise in the plastics field after careful consideration of the design and the performance required of the part, the environment to which it will be exposed, the fabrication process to be employed, the costs involved, and the inherent properties of the material other than those covered by this classification system.1.4 The values stated in SI units are to be regarded as standard.1.5 The following precautionary caveat pertains only to the test method portion, Section 11, of this classification system: 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: There is no known ISO equivalent to this standard.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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This specification covers virgin polyetherketoneketone (PEKK) polymer resin as supplied by a vendor (for example, in pellets, powder, and fabricated forms). It provides requirements and associated test methods for these thermoplastics when they are to be used in the manufacture of intracorporeal devices such as surgical implants or components of surgical or dental devices. As with any material, some characteristics may be altered by the processing techniques (for example, molding, extrusion, machining, assembly, and sterilization) required for the production of a specific part or device. Therefore, properties of fabricated forms of these polymers should be evaluated using test methods which are appropriate to ensure safety and efficacy as agreed upon by the vendor, purchaser, and regulating bodies. This specification is designed to recommend physical, chemical, and biological test methods to establish a reasonable level of confidence concerning the performance of virgin PEKK polymers for use in medical implant devices. It lists the properties that should be considered in selecting material(s) in accordance with the specific end-use requirements. This specification also addresses classification, properties, sampling, and biocompatibility.1.1 This specification covers virgin polyetherketoneketone (PEKK) polymer resin as supplied by a vendor (for example, in pellets, powder, and fabricated forms). It provides requirements and associated test methods for these thermoplastics when they are to be used in the manufacture of intracorporeal devices such as surgical implants or components of surgical or dental devices.1.2 As with any material, some characteristics may be altered by the processing techniques (for example, molding, extrusion, machining, assembly, and sterilization) required for the production of a specific part or device. Therefore, properties of fabricated forms of these polymers should be evaluated using test methods which are appropriate to ensure safety and efficacy as agreed upon by the vendor, purchaser, and regulating bodies. With reduced crystallinity, certain polymers have been shown to be more susceptible to environmental stress cracking. Depending upon the implant application, the end user should characterize the material for environmental stress cracking resistance.1.3 The properties included in this specification are those applicable for PEKK polymers only. Indicated properties are for fabricated forms. Fabricated forms and materials containing colorants, fillers, processing aids, or other additives, as well as polymer blends which contain PEKK, or reclaimed materials are not covered by this specification.1.4 This specification is designed to recommend physical, chemical, and biological test methods to establish a reasonable level of confidence concerning the performance of virgin PEKK polymers for use in medical implant devices. The properties listed should be considered in selecting material(s) in accordance with the specific end-use requirements.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 When evaluating material in accordance with this specification, hazardous materials, operations, and equipment may be involved. 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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5.1 Identification of specific acrylic polymers in emulsion paints is often difficult or impossible by infrared alone. This is particularly true when the acrylic is present in a small amount as a comonomer with vinyl acetate, or when blended with alkyds or other ester systems. If identification of an acrylic component is required in such a system, it may often be accomplished by gas-liquid chromatographic analysis of the pyrolyzed paint film. The presence of a number of other polymers may often also be confirmed by pyrolysis since they produce characteristic and reproducible pyrograms.5.2 The pyrograms obtained from unknown samples vary in complexity according to the sample composition. It is necessary to establish the presence or absence of as many components as possible from a study of the infrared spectra obtained in the first part of this practice. The gas-liquid chromatography results may then be used to help identify any unknown components present and to confirm identifications made by infrared.1.1 This practice describes a procedure for the qualitative identification in emulsion paints of most types of polymers present as major components of the paint vehicle. Limitations are discussed in Sections 5 and 10.1.2 The values stated in SI units are to be regarded as the standard. The values given in parentheses are for information only.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 In form-fill operations, sealed areas of packages are frequently subject to disruptive forces while still hot. If the hot seals have inadequate resistance to these forces, breakage can occur during the packaging process. These test methods measure hot seal strength and can be used to characterize and rank materials in their ability to perform in commercial applications where this quality is critical.1.1 These two test methods cover laboratory measurement of the strength of heatseals formed between thermoplastic surfaces of flexible webs, immediately after a seal has been made and before it cools to ambient temperature (hot tack strength).1.2 These test methods are restricted to instrumented hot tack testing, requiring a testing machine that automatically heatseals a specimen and immediately determines strength of the hot seal at a precisely measured time after conclusion of the sealing cycle. An additional prerequisite is that the operator shall have no influence on the test after the sealing sequence has begun. These test methods do not cover non-instrumented manual procedures employing springs, levers, pulleys and weights, where test results can be influenced by operator technique.1.3 Two variations of the instrumented hot tack test are described in these test methods, differing primarily in two respects: (a) rate of grip separation during testing of the sealed specimen, and (b) whether the testing machine generates the cooling curve of the material under test, or instead makes a measurement of the maximum force observed following a set delay time. Both test methods may be used to test all materials within the scope of these test methods and within the range and capacity of the machine employed. They are described in Section 4.1.4 SI units are preferred and shall be used in referee decisions. Values stated herein in inch-pound units are to be regarded separately and may not be exact equivalents to SI units. 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. The operator of the equipment is to be aware of pinch points as the seal jaws come together to make a seal, hot surfaces of the jaws, and sharp instruments used to cut specimens. It is recommended that the operator review safety precautions from the equipment supplier.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 The determination of dilute solution viscosity provides one item of information towards the molecular characterization of polymers. When viscosity data are used in conjunction with other molecular parameters, the properties of polymers depending on their molecular structure may be predicted.5.2 Viscosity is dependent on molecular weight distribution, so with certain restrictions, satisfactory correlations can be obtained between dilute-solution viscosity and molecular parameters such as molecular weight or chain length. The most limiting restrictions that must be observed are as follows:5.2.1 It must be known that the polymers used to establish the correlations and those to which they are applied do not consist of or contain branched species. Basically a measure of molecular size and not molecular weight, the dilute solution viscosity can be correlated appropriately with molecular weight or chain length only if there is a unique relationship between the mass and the size of the dissolved polymer molecules. This is the case for linear, but not for most branched, polymers.5.2.2 For reasons similar to those outlined in 5.2.1, it must be required that the polymers to which the correlations are applied have the same chemical composition as those used in establishing the relationships.5.3 For polymers meeting the restrictions of 5.2, empirical relationships can be developed between the dilute solution viscosity of a polymer and its hydrodynamic volume or average chain dimension (radius of gyration or end-to-end distance). Such relationships depend upon any variables influencing this molecular size of the dissolved polymer. The most important of these variables are solvent type and temperature. Thus, the solution viscosity of a given polymer specimen depends on the choice of these variables, and they must always be specified with the viscosity for complete identification.5.4 The solution viscosity of a polymer of sufficiently high molecular weight may depend on rate of shear in the viscometer, and the viscosity of a polyelectrolyte (polymer containing ionizable chemical groupings) will depend on the composition and ionic strength of the solvent. Special precautions beyond the scope of this practice are required when measuring such polymers.5.5 Finally, the viscosity of polymer solutions may be affected drastically by the presence of recognized or unrecognized additives in the sample, including but not limited to colorants, fillers, or low-molecular-weight species.1.1 This practice covers the determination of the dilute solution viscosity of polymers. There are several ASTM standards (Test Methods D789, D1243, D1601, and D4603, and Practice D3591) that describe dilute solution viscosity procedures for specific polymers, such as nylon, poly(vinyl chloride), polyethylene, and poly(ethylene terephthalate). This practice is written to augment these standards when problems arise with which the specific procedure is not concerned, or when no standard is available for the polymer under investigation.1.2 This practice is applicable to all polymers that dissolve completely without chemical reaction or degradation to form solutions that are stable with time at a temperature between ambient and 150°C. Results are usually expressed as relative viscosity (viscosity ratio), inherent viscosity (logarithmic viscosity number), or intrinsic viscosity (limiting viscosity number) (see 3.1).1.3 For polyamides, relative viscosity values by this procedure are not equivalent to those determined by Test Methods D789.1.4 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.NOTE 1: This standard and ISO 1628, “Plastics—Determination of Viscosity Number and Limiting Viscosity Number,” are technically equivalent.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 Dilute solution viscosity values for vinyl chloride polymers are related to the average molecular size of that portion of the polymer that dissolves in the solvent.1.1 This test method covers the determination of the dilute solution viscosity of vinyl chloride polymers in cyclohexanone. The viscosity is expressed in terms of inherent viscosity (logarithmic viscosity number). The test method is limited to those materials that give clear, uniform solutions at the test dilution.NOTE 1: Other expressions for viscosity may be used as described in the Appendix, but any change from the test method as specified shall be stated in the report.1.2 The values stated in SI units are to be regarded as the 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 2: This standard and ISO 1628-2 address the same subject matter, but differ in technical content.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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