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This specification covers requirements and corresponding test methods for acrylic resins supplied in virgin form (typically pellets, powder, or granules) for medical implant applications. The co-polymers are limited to random co-polymers, which shall contain poly(methyl methacrylate) (PMMA) as the primary ingredient and are intended for use in manufacturing implantable medical devices or components of medical devices. They shall undergo appropriate testing to ensure safety and efficacy as agreed upon between the supplier, purchaser, and regulating bodies.This specification includes chemical and mechanical properties that are applicable for both unfilled acrylic polymers and for formulated resins containing barium sulfate. It also covers sampling, appearance, certification, and assessment of selected tissue effects of implant devices made using acrylic polymers.1.1 This specification covers acrylic resins supplied in virgin form (typically pellets, powder, or granules) for medical implant applications. The co-polymers are limited to random co-polymers. This specification provides requirements and associated test methods for this thermoplastic when it is intended for use in manufacturing implantable medical devices or components of medical devices.1.1.1 While a variety of co-monomers may be used, the composition of the resin shall contain poly(methyl methacrylate) (PMMA) as its primary ingredient. Classification D788 defines an acrylic molding compound as “having at least 70% of the polymer polymerized from methyl methacrylate.” The terms PMMA and acrylic as used herein refer generically to both the homopolymer and to co-polymers as defined above.1.2 As with any material, some characteristics may be altered by the processing techniques (such as molding, extrusion, machining, sterilization, and so forth) required for the production of a specific part or device. Therefore, properties of fabricated forms of this resin should be evaluated using test methods that are appropriate to ensure safety and efficacy as agreed upon between the supplier, purchaser, and regulating bodies.1.3 This specification allows for designation of acrylic resins for all medical implant applications. The actual extent of performance and suitability for a specific application shall be evaluated by the medical device manufacturer and regulating bodies.1.4 The properties included in this specification are those applicable for both unfilled acrylic polymers and for formulated resins containing barium sulfate. Indicated properties (Table 1 and Table X3.1) are for unfilled injection molded forms. Forms containing fillers other than barium sulfate, colorants, polymer blends that contain PMMA, or reclaimed materials are not covered by this specification.1.5 Compliance with this specification does not obviate the need for functional testing of any device fabricated from the resin to demonstrate effectiveness in its intended application.1.6 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.1.7 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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3.1 For any given ceramic composition, one or more of the properties covered herein may be of more importance for a given insulating application than the other properties. Thus, it may be appropriate that selected properties be specified for testing these ceramic materials.3.2 Pertinent statements of the significance of individual properties may be found in the sections pertaining to such properties.1.1 These test methods outline procedures for testing samples of vitrified ceramic materials that are to be used as electrical insulation. Where specified limits are mentioned herein, they shall not be interpreted as specification limits for completed insulators.1.2 These test methods are intended to apply to unglazed specimens, but they may be equally suited for testing glazed specimens. The report section shall indicate whether glazed or unglazed specimens were tested.1.3 The test methods appear as follows:Section Test Method RelatedStandard(s)6      Compressive Strength      C77313      Dielectric Strength      D618, D1498      Elastic Properties      C62315      Electrical Resistivity      D618, D257, D18297      Flexural Strength      C674, F4179      Hardness      C730, E185      Porosity      C37314      Relative Permittivity and Dissipation          Factor      D150, D2149, D25204      Specific Gravity      C20, C329, F7710      Thermal Conductivity      C177, C40812      Thermal Expansion      C539, E28811      Thermal Shock Resistance  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. Specific warning statements are given in 11.3, 13.5, and 15.3.1.5 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 a 100 % middle distillate fuel oil with no residual fuel oil contamination for use in military marine (non-aviation gas turbine engines, compression ignition/diesel engines, and other non-automotive applications) and emergency generator applications (military or commercial). Specimens shall be suitably sampled and tested, and accordingly conform to specified values of the following requirements: ash content; carbon residue (10 % distillation residue); cetane number or index; cloud point; copper corrosion rating; density; 90 % distillation point; flash point; storage stability; sulfur content; kinematic viscosity; and water and sediment content.1.1 This specification covers a 100 % middle distillate fuel oil with no residual fuel oil contamination for use in military marine applications (non-aviation gas turbine engines, compression ignition/diesel engines, and other non-automotive applications), and emergency generator applications (military or commercial).1.2 This specification, unless otherwise provided by agreement between the purchaser and the supplier, prescribes the required properties of middle distillate fuel at the time and place of delivery. Nothing in this specification shall preclude observance of federal, state, or local regulations that may be more restrictive.1.3 During handling and use of all middle distillate fuels, the generation and dissipation of static electricity can create fire and explosion hazards. For more information on this subject see Guide D 4865.1.4 The values stated in SI units are to be regarded as 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 and health practices and determine the applicability of regulatory requirements prior to use.

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3.1 The purpose of this standard is to facilitate communication and promote common understanding within the professionals in radiation processing research and industry.3.2 Unambiguous communication of concepts is crucial taking into account the relevant implications that may arise from misunderstandings with regard to equipment and materials involved in the standards dealing with any subject regarding radiation processing activities. Concepts dealing with dosimetry related to radiation processing and procedures for preparation, testing, and using dosimetry systems to determine the absorbed dose are present in all standards developed by E61 and ISO/TC85/WG3 and need to be designated by common terms and described by harmonized definitions in order to avoid misunderstandings.1.1 This terminology standard lists terms and definitions related to radiation processing concepts, especially radiation dose measurements. Use of this standard, and the common terminology, will foster clearer communication, and remove ambiguity.1.2 The use of ionizing radiation for the treatment of commercial products such as the sterilization of medical devices, the reduction of microbial contamination in food or the modification of polymers is referred to as radiation processing. The types of radiation used may be gamma radiation (typically from cobalt-60 sources), X-radiation or accelerated electrons.1.3 This standard provides terms and definitions for dosimetry for radiation processing concepts dealing with procedures related to operational qualification, performance qualification, and routine processing that may influence absorbed dose in the products, and types of dosimetry systems that may be used during calibration or on a routine basis as part of quality assurance in commercial radiation processing of products.1.4 When selecting terms and definitions, special care has been taken to include the terms that need to be defined, that is to say, either because the definitions are essential to the correct understanding of the corresponding concepts or because some specific ambiguities need to be addressed.1.5 The “Discussion” appended to certain definitions offers clarification or examples to facilitate understanding of the concepts described. In certain cases, miscellaneous information is also included, for example, the units in which a quantity is normally measured, recommended parameter values, references, etc.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.

定价: 590元 / 折扣价: 502 加购物车

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