4.1 Materials and devices that function at least in part by adhering to living tissues are finding increasing use in surgical procedures either as adjuncts to sutures and staples, or as frank replacements for those devices in a wide variety of medical procedures. While the nature and magnitude of the forces involved varies greatly with indication and with patient specific circumstances, all uses involve to some extent the ability of the material to resist imposed mechanical forces. Therefore, the mechanical properties of the materials, and in particular the adhesive properties, are important parameters in evaluating their fitness for use. In addition, the mechanical properties of a given adhesive composition can provide a useful means of determining product consistency for quality control, or as a means for determining the effects of various surface treatments on the substrate prior to use of the device.4.2 The complexity and variety of individual applications for tissue adhesive devices, even within a single indicated use (surgical procedure) is such that the results of a single-lap-shear test are not suitable for determining allowable design stresses without thorough analysis and understanding of the application and adhesive behaviors.4.3 This test method may be used for comparing adhesives or bonding processes for susceptibility to fatigue and environmental changes, but such comparisons must be made with great caution since different adhesives may respond differently to varying conditions.1.1 This test method is intended to provide a means for comparison of the adhesive strengths of tissue adhesives intended for use as surgical adhesives or sealants, or both, on soft tissue. With the appropriate choice of substrate, it may also be used for purposes of quality control in the manufacture of tissue adhesive based medical devices.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 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.

定价： 590元 / 折扣价： 502 元 加购物车

4.1 Materials and devices that function at least in part by adhering to living tissues are finding increasing use in surgical procedures either as adjuncts to sutures and staples, or as frank replacements for those devices in a wide variety of medical procedures. While the nature and magnitude of the forces involved varies greatly with indication and with patient specific circumstances, all uses involve to some extent the ability of the material to resist imposed mechanical forces. Therefore, the mechanical properties of the materials, and in particular the adhesive properties, are important parameters in evaluating their fitness for use. In addition, the mechanical properties of a given adhesive composition can provide a useful means of determining product consistency for quality control, or as a means for determining the effects of various surface treatments on the substrate prior to use of the device.4.2 The complexity and variety of individual applications for tissue adhesive devices, even within a single indicated use (surgical procedure) is such that the results of a T-Peel test are not suitable for determining allowable design stresses without thorough analysis and understanding of the application and adhesive behaviors.4.3 This test method may be used for comparing adhesives or bonding processes for susceptibility to fatigue and environmental changes, but such comparisons must be made with great caution since different adhesives may respond differently to varying conditions.1.1 This test method is intended to provide a means for comparison of the adhesive strengths of tissue adhesives intended for use as surgical adhesives or sealants, or both, on soft tissue. With the appropriate choice of substrate, it may also be used for purposes of quality control in the manufacture of tissue adhesive based medical devices.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 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.

定价： 590元 / 折扣价： 502 元 加购物车

4.1 This practice is a guideline for short-term and long-term assessment of skeletal muscle and bone tissue responses to long-term implant materials. For testing of final finished medical devices, the test article for implantation shall be as for intended use, including packaging and sterilization. The tissue responses to the test article are compared to the skeletal muscle and/or bone tissue response(s) elicited by control materials. The controls consistently demonstrate known cellular reaction and wound healing.1.1 This practice provides guidelines for biological assessment of tissue responses to nonabsorbable for medical device implants. It assesses the effects of the material that is implanted intramuscularly or intraosseously. The experimental protocol is not designed to provide a comprehensive assessment of the systemic toxicity, immune response, carcinogenicity, or mutagenicity of the material since other standards address these issues. It applies only to materials with projected applications in humans where the materials will reside in bone or skeletal muscle tissue in excess of 30 days. Applications in other organ systems or tissues may be inappropriate and are therefore excluded. Control materials are well recognized with a well-characterized long-term response and can include metals and any one of the metal alloys in Specification F67, F75, F90, F136, F138, or F562, high purity dense aluminum oxide as described in Specification F603, ultra high molecular weight polyethylene as stated in Specification F648, or USP polyethylene negative control.1.2 The values stated in SI units, including units officially accepted for use with SI, are to be regarded as standard. No other systems of measurement are included in this 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.1.4 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.

定价： 590元 / 折扣价： 502 元 加购物车

4.1 The utility, range, and efficacy of adhesives in clinical medicine are well documented in the literature. Whether being used as an adhesive, hemostatic, sealant, or carrier for drugs or growth factors, or both, the scope of adhesive use in clinical medicine continues to expand. There are several factors which are vital to the success and efficacy of a medical tissue adhesive including, (1) adequate tissue bonding strength, (2) tissue compatibility, (3) acceptable biodegradable properties when the adhesive is used internally, (4) availability, (5) ease of application, and (6) cost.4.2 Medical adhesives are currently used for a variety of applications and tissue types. Applications range from fixation of external tissues to internal application for use with either similar or dissimilar opposing surfaces. While the biological or chemical makeup, or both, of the adhesive may define its characteristics, additional mechanical factors including adhesive volume or method of application, or both, may also contribute significantly toward the performance of the adhesive. In an effort to fairly and adequately quantify adhesive bonding strength for medical adhesives, it is important to develop a consistent, reproducible testing standard for evaluative and comparative purposes. Due to the fact that the adhesives will be used on or in living tissues, a readily available biological testing surface is preferred.4.3 The data generated from a standardized testing method on biologic tissue may vary from that found in vivo, however, testing results should offer valuable information on the potential bonding capacity and for the preparation of subsequent in vivo experiments.4.4 The complexity and variety of individual applications for tissue adhesive devices, even within a single indicated use (surgical procedure), is such that the results of a tensile test are not suitable for determining allowable design stresses without thorough analysis and understanding of the application and adhesive behaviors.4.5 This test method may be used for comparing adhesives or bonding processes for susceptibility to fatigue and environmental changes, but such comparisons must be made with great caution since different adhesives may respond differently to varying conditions.1.1 This test method is intended to provide a means for comparison of the adhesive strengths of tissue adhesives intended for use as surgical adhesives or sealants, or both, on soft tissue. With the appropriate choice of substrate, it may also be used for purposes of quality control in the manufacture of tissue adhesive based medical devices.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 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.

定价： 590元 / 折扣价： 502 元 加购物车

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5.1 This practice is a guideline for a screening test of candidate materials or assessment of local tissue response to absorbable medical devices which are expected to undergo complete absorption within three years.5.2 This practice is similar to those for studies on candidate materials or medical devices that are not absorbable, such as those specified in Practices F763, F981, and F1408; however, analysis of the host response must take into account the effect of degradation and degradation products on the inflammatory response at the local tissue site and on subsequent healing of the implantation site, as well as the potential for adverse distal tissue effects.5.3 For testing of absorbable medical devices, the test article for implantation should be in the final finished form as for intended use, including packaging and sterilization (if applicable). Configurations specific to the animal study may be needed. The test article’s surface-area-to-body mass or mass-to-body mass ratios within the animal model should be established by calculating based on surface-area-to-body mass or mass-to-body mass ratios in humans during the device’s intended clinical use. Worst-case clinical dose should be considered in the study design. For implantation studies incorporating evaluation of both local tissue responses and systemic toxicity, exaggerated material surface area or mass-to-body mass ratios (for example, a 2X to 10X safety factor to assess implant safety for regulatory submissions) compared to clinical use (for example, largest device size, maximum number of devices) should be considered, unless otherwise justified. For example, implantation of exaggerated doses may not be feasible in the selected animal model. For some devices, additional animal group(s) for exaggerated conditions should be considered if dose response information is needed. Additionally, for some devices, exaggerated dose at a specific implantation site can also be used to evaluate local tissue responses.5.4 Materials that are designed for use in devices with in situ polymerization shall be introduced in a manner such that in situ polymerization occurs. Additional testing of individual precursor components or partially polymerized materials may be needed in some cases (for example, if testing of the final implant indicates an adverse response or incomplete polymerization).1.1 This practice provides experimental protocols for biological assays of tissue reactions to absorbable biomaterials for implant applications. This practice applies only to absorbable materials with projected clinical applications in which the materials will reside in bone or soft tissue longer than 30 days and less than three years. Other standards with designated implantation times are available to address shorter time periods. Careful consideration should be given to the appropriateness of this practice for slowly degrading materials that will remain for longer than three years. It is anticipated that the tissue response to degrading biomaterials will be different from the response to nonabsorbable materials. In many cases, a chronic inflammatory response may be observed during the degradation phase, but the local histology should return to normal after absorption; therefore, the minimal tissue response usually equated with biocompatibility may require long implantations.1.2 The time period for implant absorption can depend on variables of chemical composition, implant size, implant location, and animal models. Therefore, the selected time points for assessing tissue effects may be selected based on the rate of absorption.1.3 These protocols assess the effects of the material on the animal tissue in which it is implanted. They do not fully assess systemic toxicity, carcinogenicity, reproductive and development toxicity, or mutagenicity of the material. Other standards are available to address these issues.1.4 To maximize use of the animals in the study protocol, some aspects of systemic toxicity, including effects of degradation products on different organs and tissues downstream of or surrounding the target site, can be addressed with this practice.1.5 Because animal models are not identical to human biology, this practice cannot account for all potential biological hazards, for example the effect of the oligosaccharide a-Gal (Gala 1,3-Galb1-4GlcNAc-R), known as the “a-Gal” epitope present in xenogeneic materials on humans. See ISO 22442.1.6 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 元 加购物车

Injuries to tendons or ligaments are frequently treated by surgery to repair the damaged tissues and facilitate the healing process. The potential of TEMPs to enhance the outcomes (including function, pain, anatomy) of the surgical repair has been recognized.Examples of tissues that when injured may be appropriate for repair using TEMPs: rotator cuff with a partial or full tear; Achilles tendon; Achilles tendon after harvesting for anterior cruciate ligament repair; patella tendon; patella tendon after harvesting for anterior cruciate ligament repair; quadriceps tendon; posterior cruciate ligament; medial collateral ligaments; lateral collateral ligaments; flexor tendons.TEMPs may be used with the intent to improve the surgical outcome of tendon or ligament repair by (a) assuming some of the mechanical load experienced at the repair site to stabilize the surgical repair, (b) improving the natural biological healing process, or (c) a combination of these mechanisms.TEMPs should improve clinical outcome. This may be accomplished by reducing or eliminating pain, returning function, shortening the recovery time following surgery, facilitating early mobility, improving return of strength, improving mobility, or other clinically relevant parameters.The mechanism used by TEMPs to improve surgical repair should be understood and this conclusion should be supported by experimental results and should be supportive of the primary function of the TEMP.TEMPs with the primary function of mechanical reinforcement may also have a secondary, biological function.When the product is used to improve the body’s natural biological repair process of tendons or ligaments, the product should allow cell attachment, migration, infiltration, extracellular matrix deposition and organization, formation of tendon or ligament repair tissue, integration with adjacent tendon, ligament or bone, tendon-bone attachment, or more than one of these actions.When the TEMP is used to provide a mechanical support of the surgical repair of a tendon or ligament, the product may provide enhanced mechanical properties of the repaired construct immediately after the surgery. Ideally, TEMPs would have mechanical properties similar to the uninjured native tissue being repaired. After surgery, the TEMP should limit the amount of tendon/ligament separation from the bone, or separation of the fractured ends of the tendon or ligament, or reduce the number of patients that have these as outcomes of the surgery. The TEMP may allow functionality to return to the repaired tendon or ligament in a shorter time than without the use of the product.1.1 This guide is intended as a resource for individuals and organizations involved in the development, production, and delivery of tissue engineered medical products (TEMPs) intended to provide a mechanical (functional) reinforcement of the surgical repair of tendons and ligaments.1.2 Surgical repair can include procedures that repair tendon to tendon, tendon to bone, tendon to muscle, ligament to ligament, and ligament to bone. In the context of this guide, a tendon is a fibrous cord or band that connects a muscle to a bone or other structure and consists of both dense collagenous fibers and rows of elongated tendon cells. In contrast, a ligament is a band or sheet of fibrous tissue connecting two or more bones, or cartilagenous structures.1.3 Examples of TEMPs for use in reinforcement of tendon or ligament repairs include extracellular matrices (including allograft tissue, xenograft tissue, and tissue engineered extracellular matrix), polymeric matrices, membranes, or combinations of two or more of these, with or without cells and/or molecular mediators, where the function is to reinforce the surgical repair of tendon to tendon, tendon to bone, tendon to muscle, ligament to ligament, or ligament to bone.1.4 The products may be rapidly degrading, slowly degrading, or non-degrading.1.5 The guide is not intended to apply to TEMPs that have a primary function to induce a biological repair through cell or molecular action, although biologic activity may be a feature of the TEMPs. Examples of products or product concepts that are not included are (a) growth factors or cytokines applied to a biologic or synthetic scaffold, and (b) platelet-enriched plasma applied to or within a biologic or polymeric scaffold, where the primary function of the product is biologic.1.6 The guide is not intended to apply to TEMPs that have a primary function to induce a chemical repair. An example of a product or product concept that would not be included would be a polymeric matrix containing reagents that glue collagenous tissues together.1.7 The guide is not intended to apply to TEMPs that are designed to be used to achieve primary surgical repair of injured tendons and ligaments.1.8 The guide is not intended to apply to TEMPs that are designed to replace tendons or ligaments.1.9 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this 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 and health practices and determine the applicability of regulatory limitations prior to use.

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5.1 The test methods contained herein guide characterization of the structural, physical, chemical, mechanical, and biological properties of a fiber-based construct. Such properties may be important for the success of a TEMP, especially if they affect cell retention; activity and organization; tensile strength; the delivery of bioactive agents; or the biocompatibility and bioactivity of the construct.5.2 Tests described herein may be used for quality control during manufacturing or to assess how the product may perform its intended clinical function.5.3 Plans for product development, product characterization, and the regulatory pathway should be discussed with the appropriate regulatory body.1.1 This guide is a resource for the characterization of fiber-based constructs intended for use in a tissue-engineered medical product (TEMP). There are existing standards that broadly cover scaffolds in a more generalized fashion (Guides F2150, F2450, F2900, F2902, ISO 21560). This guide focuses specifically on fiber-based constructs.1.2 Fiber-based constructs may be fabricated by many different methods including, but not limited to the following: electrospinning, forcespinning, meltspinning, pneumatospinning, blowspinning, melt-electrowriting, melt extrusion, wet extrusion, fused deposition, liquid crystal deposition, electrochemical alignment, drawing, spinning, knitting, weaving, braiding, powder bed fusion (laser sintering), vat photopolymerization (stereolithography), binder jetting, directed energy deposition, self-assembly (for example, fibrillogenesis), and hybrid approaches. This document is intended to address fibers made by any of these methods, although electrospun fibers are addressed in greater detail in some sections.1.3 This guide will focus on constructs made of fibers wherein the average fiber diameter is within the range of approximately 100 nm to 100 µm.1.4 For the purposes of this standard, a “fiber-based construct” is defined as a construct composed of slender, elongated filaments.1.5 Units—The values stated in SI units are to be regarded as the 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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5.1 The purpose of this guide is to provide guidance on characterization of the properties of porcine fibrinogen as a starting material for surgical implants and as a matrix for tissue-engineered medical products (TEMPs). This guide contains a set of physical and chemical parameters directly related to the function of porcine fibrinogen. This guide can be used to help select and characterize appropriate fibrinogen starting materials for specific purposes. Not all tests or parameters are suitable for all uses of fibrinogen.5.2 Fibrinogen described in this guide may be used in various types of medical products including, but not limited to, implants, tissue-engineered medical products (TEMPs), and cell, drug, or DNA delivery vectors. The recommendations in this guide shall not be construed to guarantee the successful clinical application of any tissue-engineered medical product.5.3 In determining whether fibrinogen meets the requirements for use in a TEMP, the relevant regulatory authorities or other appropriate guidelines relating to the production, regulation, and approval of TEMP products shall be taken into account (Guide E1298, Practice F981, Practice F1983).1.1 This guide covers the evaluation of porcine fibrinogen suitable for use in biomedical or pharmaceutical applications including, but not limited to, tissue-engineered medical products (TEMPs).1.2 This guide addresses key parameters relevant for functionality, characterization, and purity of porcine fibrinogen.1.3 As with any material, some characteristics of porcine fibrinogen may be altered by processing techniques, such as electrospinning (1)2 and sterilization, required for the production of a specific formulation or device. Therefore, properties of fabricated forms of this protein should be evaluated using test methods that are appropriate to ensure safety and efficacy and are not addressed in this guide.1.4 The primary focus of this document is fibrinogen derived from porcine blood, which is similar to human fibrinogen. The biggest advantage that pigs have over other species (such as cattle, sheep, goats, elk, and deer) is that they are less likely to transmit transmissible spongiform encephalitis (TSE) (ISO 22442-1 Annex D; WHO Guidelines, 2003; WHO Guidelines, 2006; WHO Guidelines, 2010). The document may also discuss fibrinogen from other sources when useful information is available. Fibrin is also discussed in some sections.1.5 Units—The values stated in SI units are to be regarded as the 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.

定价： 590元 / 折扣价： 502 元 加购物车

4.1 This document provides guidance for users who wish to obtain quantifiable data from images of tissue scaffolds manufactured from polymers that include both high water content gels and woven textiles.4.2 Information derived from tissue scaffold images can be used to optimize the structural characteristics of the matrix for a particular application, to develop better manufacturing procedures or to provide a measure of quality assurance and product traceability. Fig. 1 provides a summary of the key stages of image capture and analysis.FIG. 1 Key Stages in Image Capture, Storage, and Analysis4.3 There is a synergy between the analysis of pores in tissue scaffolds and that of particles that is reflected in standards cited and in the analysis described in Section 9. Guide E1919 provides a compendium of standards for particle analysis that includes measurement techniques, data analytical and sampling methodologies.1.1 This guide covers the factors that need to be considered in obtaining and interpreting images of tissue scaffolds including technique selection, instrument resolution and image quality, quantification and sample preparation.1.2 The information in this guide is intended to be applicable to porous polymer-based tissue scaffolds, including naturally derived materials such as collagen. However, some materials (both synthetic and natural) may require unique or varied sample preparation methods that are not specifically covered in this guide.1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this 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.

定价： 590元 / 折扣价： 502 元 加购物车

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定价： 590元 / 折扣价： 502 元 加购物车

4.1 Autologous PRP and platelet gels are utilized in a wide range of orthopedic, sports medicine, regenerative medicine, and surgical applications (3-5). PRP and platelet gels are layered, sprayed, injected, molded, or packed, alone or in combination with graft material or TEMPs, into a variety of anatomical sites, tissues, and voids (3, 6). These platelet concentrates can provide an assortment of bioactive molecules, cells, and physical properties that are potentially attractive for promoting healing and other cell therapy applications (7). Unfortunately, the term “platelet-rich plasma” or “PRP,” which is ubiquitous in early and contemporary medical literature related to a variety of platelet concentrates, only unambiguously denotes one critical parameter of a platelet suspension—increased platelet concentration. Without further context, this common description of PRP offers no information about other important physical and cellular aspects of platelet concentrations. As scientific and clinical understanding of PRP and other cellular therapies increases standardization of nomenclature and terminology is critical for defining key properties, standardizing processing parameters and techniques, and developing repeatable assays for quality assurance and scientific evaluation (5, 8-13). This guide outlines basic guidelines to describe key properties of unique PRP and platelet gel formulations in a standardized fashion. Reliable, standardized descriptions can provide valuable context to PRP end users, such as clinicians seeking a PRP or platelet gel with certain biological attributes or scientific investigators seeking to duplicate a published formulation or to correlate a given PRP or platelet gel feature to other biological properties or outcomes.1.1 This guide defines terminology and identifies key fundamental properties of autologous platelet-rich plasma (PRP) and PRP-derived platelet gels intended to be used for tissue engineered medical products (TEMPS) or for cell therapy applications. This guide provides a common nomenclature and basis for describing notable properties and processing parameters for PRP and platelet gels that may have utility for manufacturers, researchers, and clinicians. Further discussion is also provided on certain aspects of PRP processing techniques, characterization, and quality assurance and how those considerations may impact key properties. The PRP characteristics outlined in this guide were selected based n a review of contemporary scientific and clinical literature but do not necessarily represent a comprehensive inventory; other significant unidentified properties may exist or be revealed by future scientific evaluation. This guide provides general recommendations for how to identify and cite relevant characteristics of PRP, based on broad utility; however, users of this standard should consult referenced documents for further information on the relative import or significance of any particular PRP characteristic in a particular context.1.2 The scope of this guide is confined to aspects of PRP and platelet gels derived and processed from autologous human peripheral blood. Platelet-rich plasma, as defined within the scope of this standard, may include leukocytes.1.3 The scope of this document is limited to guidance for PRP and platelet gels that are intended to be used for TEMPS or for cell therapy applications. Processing of PRP, other platelet concentrates or other blood components for direct intravenous transfusion is outside the scope of this guide. Apheresis platelets and other platelet concentrates utilized in transfusion medicine are outside the scope of this document. Production of PRP or platelet gels for diagnostic or research applications unrelated to PRP intended for TEMPS or cell therapy is also outside the scope of this guide. Fibrin gels devoid of platelets are also excluded from discussion within this document.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 and health practices and determine the applicability of regulatory limitations prior to use.

定价： 590元 / 折扣价： 502 元 加购物车

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3.1 The need for standards regarding TEMPs has also prompted a need for definitions. This terminology sets forth definitions of the most commonly used terms and specifies the relationship among the sciences and components applied in tissue engineering to develop TEMPs. Use of these terms and an understanding of these relationships will unify the ASTM TEMPs standards with a common language such that the users of these standards can understand and interpret the standards more precisely. Terms specific to a TEMP standard will also be defined within the respective standard as appropriate.3.2 Defining Terms—Terms are defined with a broad scope to encompass these new products known as TEMPs. For instance, the definition for somatic cell therapy as stated in the “Guidance for Human Somatic Cell Therapy and Gene Therapy” (1)3 is recognized in this terminology. However, for the purposes of TEMPs that contain cells, we have added the definition of “cell” which is much broader and not limited to the use of living cells.3.3 Clinical Effects of TEMPs—The users of this terminology should note that terms used regarding the clinical effects of TEMPs, for instance, “modify or modification” of the patient's condition, may also be interpreted to “enhance, augment, transform, alter, improve, or supplement.” Similarly, “repair” may also serve to mean “restore.”3.4 The diagram in Fig. 1 shows the relationships of components of TEMPs and of the fields of science (for example, technologies and principles) used in tissue engineering to create TEMPs. Certain TEMPs may be tissue engineered or produced in vitro by using specific components and sciences to create an off-the-shelf TEMP for the users. Other TEMPs may by design require the users to place the components inside the patient, (that is, in vivo) to rely upon the patient's regenerative potential to achieve the product's primary intended purpose. The expectation of a TEMP used for therapeutic clinical applications is to have a therapeutic effect, specifically to repair, modify or regenerate the recipient's cells, tissues, and organs or their structure and function. Such a TEMP may be used for human and non-human applications. In other applications, a TEMP may be used in diagnostic clinical applications, or both, to achieve an investigative outcome of the function of the cells, tissues, and organs.FIG. 1 Relationships of the Fields of Tissue Engineering to Tissue Engineered Medical Products1.1 This terminology defines basic terms and presents the relationships of the scientific fields related to Tissue Engineered Medical Products (TEMPs). Committee F04 has defined these terms for the specific purpose of unifying the language used in standards for TEMPs.1.2 The terms and relationships defined here are limited to TEMPs. They do not apply to any medical products of human origin regulated by the U.S. Food and Drug Administration under 21 CFR Parts 16 and 1270 and 21 CFR Parts 207, 807, and 1271.1.3 The terms and nomenclature presented in this standard are for the specific purposes of unifying the language used in TEMP standards and are not intended for labeling of regulated medical products.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.

定价： 590元 / 折扣价： 502 元 加购物车