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5.1 Vinyl chloride-containing polymers are widely used to package a variety of materials, including foods.5.2 Vinyl chloride monomer has been shown to be a human carcinogen. Threshold toxicity value has not been established.5.3 Plastic manufacturers, food packagers, government agencies, etc. have a need to know the residual vinyl chloride monomer content of vinyl chloride-containing polymers.1.1 This test method is suitable for determining the residual vinyl chloride monomer (RVM) content of homopolymer and copolymers of vinyl chloride down to a concentration of ∼5 µg/kg (ppb).1.2 This test method is applicable to any polymer form, such as resin, compound, film, bottle wall, etc. that can be dissolved in a suitable solvent.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. Specific hazard statements are given in Section 9 and Note 10.NOTE 1: This standard is equivalent to ISO 6401.1.4 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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This document specifies the features of laser-based powder bed fusion of polymers (LB-PBF-P) and provides detailed design recommendations. Some of the fundamental principles are also applicable to other additive manufacturing (AM) processes, provided that due consideration is given to process-specific features. This document also provides a state-of-the-art review of design guidelines associated with the use of powder bed fusion (PBF) by bringing together relevant knowledge about this process and by extending the scope of ISO/ASTM 52910.

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1.1 This document provides guidance and recommendations for the qualification of polymeric materials intended for laser-based powder bed fusion of polymers (PBF-LB/P). The parameters and recommendations presented in this document relate mainly to the material polyamide 12 (PA12), but references are also made to polyamide 11 (PA11). The parameters and recommendations set forth herein cannot be applicable to other polymeric materials.1.2 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 document specifies the features of MEX/P and provides detailed design recommendations.1.2 Some of the fundamental principles are also applicable to other AM processes, provided that due consideration is given to process-specific features.1.3 This document also provides a state of the art review of design guidelines associated with the MEX/P by bringing together relevant knowledge about this process and by supplementing the scope of ISO/ASTM 52910.1.4 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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This specification covers polyetheretherketone (PEEK) polymer in virgin forms as 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 PEEK polymer in the scope of this specification is a pure semicrystalline homopolymer consisting of phenylene rings connected by ether (E) and carbonyl (or ketone, K) groups along the polymer chain. Its polymeric structure is defined by the repeating unit EEK. 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 shall be evaluated using appropriate test methods such as US Pharmacopeia test (infrared spectroscopy, viscosity measurements, and total heavy metal content (as lead)), and differential scanning calorimetry. Fabricated forms, material or forms containing colorants, fillers, processing aids, or other additives, as well as polymer blends which contain PEEK, or reclaimed materials, are not covered by this specification. The properties which shall be evaluated are the following: density, tensile strength, elongation, flexural strength, flexural modulus, and impact strength. The biocompatibility of PEEK polymers is also detailed.1.1 This specification covers polyetheretherketone (PEEK) polymer in virgin forms (for example, pellets, granules, powder, filaments used in additive manufacturing) 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 The properties included in this specification are those applicable for PEEK polymers only. Indicated properties are for fabricated forms. Materials or forms containing colorants, fillers, processing aids, or other additives, as well as polymer blends which contain PEEK, or reclaimed materials, are not covered by this specification.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 virgin 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. 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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2.1 This test method is generally accepted for the preparation of floor polish and floor polish polymers for the analysis of total zinc content. Knowing the total zinc content of a floor finish or polymer can aid in determining the proper disposal method of used or unwanted product.1.1 This laboratory test method covers the analysis of floor polishes and floor polish polymers for total zinc content.1.2 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 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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