11.100.99 标准查询与下载

GSO ASTM F2211:2023 组织工程医疗产品 (TEMP) 的标准分类

  Scope is not provided for this standard

Standard Classification for Tissue-Engineered Medical Products (TEMPs)

GSO ASTM F2459:2022 从金属医疗成分中提取残留物并通过重量分析进行定量的标准测试方法

1.1 This test method covers the quantitative assessment of the amount of residue obtained from metallic medical components when extracted with aqueous or organic solvents. 1.2 This test method does not advocate an acceptable level of cleanliness. It identifies two techniques to quantify extractable residue on metallic medical components. In addition, it is recognized that this test method may not be the only method to determine and quantify extractables. 1.3 Although these methods may give the investigator a means to compare the relative levels of component cleanliness, it is recognized that some forms of component residue may not be accounted for by these methods. 1.4 The applicability of these general gravimetric methods have been demonstrated by many literature reports; however, the specific suitability for applications to all-metal medical components will be validated by an Interlaboratory Study (ILS) conducted according to Practice E691. 1.5 This test method is not intended to evaluate the residue level in medical components that have been cleaned for reuse. This test method is also not intended to extract residue for use in biocompatibility testing. NOTE 1—For extraction of samples intended for the biological evaluation of devices or materials, refer to ISO 10993–12. 1.6 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

Standard Test Method for Extracting Residue from Metallic Medical Components and Quantifying via Gravimetric Analysis

GSO ASTM F2884:2021 脊柱融合临床前体内评估标准指南

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Standard Guide for Pre-clinical in vivo Evaluation of Spinal Fusion

GSO ASTM F639:2021 医疗应用聚乙烯塑料标准规范

This specification covers the properties for polyethylene plastics for use in medical device applications involving human tissue contact devices, short term indwellings, and fluid transfer devices. Biocompatibility tests must be conducted on the final products as the biocompatibility of these materials as a class has not been established. Plyethylene plastics should consist of basic polymers with ethylene as essentially the sole monomer. The compound may contain optional adjuvant substances required in polymer production or fabrication. The final compound should yield a consistent absorption spectrum characteristic of the established formulation. The polyethylene plastics should be tested using the specified physical test procedures for density, melt flow, tensile properties, compressive properties, stiffness, flexural fatigue, and other flexural properties.

Standard Specification for Polyethylene Plastics for Medical Applications

GSO ASTM F997:2021 医疗应用聚碳酸酯树脂的标准规范

This specification covers the general, physical property, and biocompatibility requirements, and the associated test methods for establishing a reasonable level of confidence concerning the performance of unfilled thermoplastic polycarbonate resin for use in the manufacture of medical devices or the components thereof.

Standard Specification for Polycarbonate Resin for Medical Applications

GSO ASTM E1048:2021 涂有抗凝剂的颜色编码移液管或容器的标准规范

This specification establishes a color-coding system to identify the anticoagulants used in coating pipets or containers not exceeding 1 mL in volume. Its purpose is to ensure that if a color code is used with an anticoagulant, all manufacturers will be encouraged, though not required, to use the same code.

Standard Specification for Color-Coding Pipets or Containers Coated With Anticoagulants

GSO ASTM F619:2021 医用塑料提取的标准实施规程

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Standard Practice for Extraction of Medical Plastics

GSO ISO 7405:2016 牙科 牙科用医疗器械生物相容性评估

This International Standard specifies test methods for the evaluation of biological effects of medical devices used in dentistry. It includes testing of pharmacological agents that are an integral part of the device under test. This International Standard does not cover testing of materials and devices that do not come into direct or indirect contact with the patient's body.

Dentistry -- Evaluation of biocompatibility of medical devices used in dentistry

DIN EN ISO 22442-2:2016 医疗设备用动物组织及其衍生物.第2部分:来源、采集和处理控制(ISO 22442-2-2015).德文版本EN ISO 22442-2-2015

Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2015); German version EN ISO 22442-2:2015

DIN EN ISO 22442-1:2016 医疗设备用动物组织及其衍生物.第1部分:风险管理的应用(ISO 22442-1-2015).德文版本EN ISO 22442-1-2015

Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2015); German version EN ISO 22442-1:2015

BS ISO 18385:2016 法医用生物材料的收集, 存储和分析产品中人类DNA污染风险最小化. 要求

Minimizing the risk of human DNA contamination in products used to collect, store and analyze biological material for forensic purposes. Requirements

BS EN ISO 22442-1:2015 医疗设备用动物组织及其衍生物.风险管理的应用

Medical devices utilizing animal tissues and their derivatives. Application of risk management

EN ISO 22442-1:2015 医疗设备用动物组织及其衍生物.第1部分:风险管理应用(ISO 22442-1:2015)

Dieser Teil von ISO 22442 bezieht sich auf Medizinprodukte, mit Ausnahme von in-vitro-Diagnostika, hergestellt unter Verwendung von Materialien tierischen Ursprungs, die nicht lebensfähig sind oder abgetötet wurden. Er ergibt in Verbindung mit ISO 14971 ein Verfahren zur Identifizierung der Gefahren und gefährlichen Situationen im Zusammenhang mit diesen Produkten, zur Abschätzung und Beurteilung der sich ergebenden Risiken, zur Kontrolle dieser Risiken und zur Überwachung der Wirksamkeit dieser Kontrolle. Zusätzlich umschreibt er den Entscheidungsprozess für die Annehmbarkeit des Restrisikos, indem das Restrisiko, wie in ISO 14971 definiert, abgewägt und der erwartete medizinische Nutzen, verglichen mit verfügbaren Alternativen, einander gegenübergestellt wird. Dieser Teil von ISO 22442 legt Anforderungen und Anleitungen für das Risikomanagement in Bezug auf typische Gefährdungen durch Medizinprodukte fest, die unter Verwendung tierischer Gewebe und deren Derivate hergestellt wurden, z. B. a) Verunreinigungen durch Bakterien, Schimmelpilze oder Hefepilze; b) Verunreinigungen durch Viren; c) Verunreinigungen durch Erreger, die übertragbare spongiforme Enzephalopathie (en: Transmissible Spongiform Encephalopathy, TSE) hervorrufen; d) für ungewünschte pyrogene, immunologische oder toxikologische Reaktionen verantwortliches Material. Bei Parasiten und anderen nicht klassifizierten pathogenen Einheiten können ähnliche Prinzipien gelten. Dieser Teil von ISO 22442 legt keine Anforderungen für die Akzeptanz fest, weil diese von einer Vielzahl von Faktoren bestimmt und in einer solchen Internationalen Norm nicht festgelegt werden können. Ausgenommen sind bestimmte Derivate, die in Anhang C erwähnt werden. Anhang C legt Grade für die Annehmbarkeit von TSE-Risiken bei Talg-Derivaten, Kohle aus tierischem Ausgangsmaterial, Milch und Milch-Derivaten, Derivaten von Wolle und Aminosäuren fest. Dieser Teil von ISO 22442 legt kein Qualitätsmanagementsystem zur Kontrolle aller Produktionsschritte eines Medizinproduktes fest. Dieser Teil von ISO 22442 gilt nicht für die Verwendung von menschlichen Geweben in Medizinprodukten. ANMERKUNG 1 Es ist keine Anforderung dieses Teils von ISO 22442, ein vollständiges Qualitätsmanagementsystem für die Herstellung zu nutzen. Es wird jedoch auf Internationale Normen für Qualitätsmanagementsysteme (siehe ISO 13485) zur Kontrolle aller Schritte der Produktion und Wiederaufarbeitung von Medizinprodukten hingewiesen. ANMERKUNG 2 Eine Anleitung zur Anwendung dieses Teils von ISO 22442 ist in Anhang A gegeben.

Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2015)

EN ISO 22442-2:2015 医疗设备用动物组织及其衍生物.第2部分:资源控制,采集和处理（ISO 22442-2:2015）

In diesem Teil von ISO 22442 werden die Anforderungen an die Kontrolle der Beschaffung, Materialgewinnung und Handhabung (einschließlich Lagerung und Transport) von Tieren und Geweben festgelegt, die zur Herstellung von Medizinprodukten eingesetzt werden, mit Ausnahme von in-vitro-Diagnostika, unter Verwendung von Materialien tierischen Ursprungs. Er kommt dort zum Einsatz, wo es der Risikomanagementprozess nach ISO 22442-1 vorschreibt. ANMERKUNG 1 Die selektive Beschaffung wird beim Risikomanagement in Bezug auf übertragbare spongiforme Enzephalopathie (TSE) als besonders wichtig angesehen. Die Hersteller sollten für die Validierung der Eliminierung und/oder Inaktivierung von Viren und TSE-Erregern ISO 22442-3 beachten. Dieser Teil von ISO 22442 behandelt nicht die Verwendung menschlichen Gewebes in Medizinprodukten. Dieser Teil von ISO 22442 legt kein Qualitätsmanagementsystem zur Kontrolle aller Produktionsschritte eines Medizinproduktes fest. Es ist keine Anforderung dieses Teils von ISO 22442, ein vollständiges Qualitätsmanagementsystem für die Herstellung zu haben, aber er spezifiziert Anforderungen für einige der Elemente eines Qualitätsmanagementsystems. Es wird auf die Normen für Qualitätsmanagementsysteme (siehe ISO 13485) zur Kontrolle aller Schritte der Produktion oder Wiederaufarbeitung von Medizinprodukten hingewiesen. Die Elemente des Qualitätsmanagementsystems, welche von diesem Teil von ISO 22442 gefordert werden, können einen Teil eines Qualitätsmanagementsystems in Übereinstimmung mit ISO 13485 darstellen. ANMERKUNG 2 Für die Anwendung von ISO 22442 ist es generell zweckmäßig, den Anforderungen und Empfehlungen, die in allen drei Teilen der Norm enthalten sind, gebührende Betrachtung zukommen zu lassen.

Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing@ collection and handling

ASTM F2952-14 用于测定多孔组织支架平均达西渗透系数的标准指南

4.1 This document describes the basic principles that need to be followed to obtain a mean value of the Darcy permeability coefficient for structures that consist of a series of interconnected voids or pores. The coefficient is a measure of the permeability of the structure to fluid flowing through it that is driven by a pressure gradient created across it. 4.2 The technique is not sensitive to the presence of closed or blind-end pores (Fig. 1). 4.3 Values of the permeability coefficient can be used to compare the consistency of manufactured samples or to determine what the effect of changing one or more manufacturing settings has on permeability. They can also be used to assess the homogeneity and anisotropy of tissue scaffolds. Variability in the permeability coefficient can be also be indicative of: 4.3.1 Internal damage within the sample e.g., cracking or permanent deformation. 4.3.2 The presence of large voids, including trapped air bubbles, within the structure. 4.3.3 Surface effects such as a skin formed during manufacture. 4.3.4 Variable sample geometry. 4.4 This test method is based on the assumption that the flow rate through a given sample subjected to an applied pressure gradient is constant with time.Note 1—If a steady state flow condition isn’t reached, then this could be due to structural damage (i.e., crack formation or the porous structure deformed as a result of the force being placed upon it by the fluid flowing through it). Sample deformation in the form of stretching (bowing) can also occur for less resilient structures as a result of high fluid flow rates. This topic is discussed in more detail in Section 7. 4.5 Care should be taken to ensure that hydrophobic materials are fully wetted out when using water or other aqueous-based liquids as permeants. 4.6 Conventionally, the pressure differential created across a sample is measured as a function of both increasing and decreasing flow rates. An alternative approach, which may be practically easier to create, is to apply a range of different pressure differentials across the sample and measure the resultant flow of fluid through it. The hysteresis that occurs during a complete cycle of increasing flow rate followed by a progressive decrease in flow rate can provide an excellent measure of the behavioural consistency of the matrix. Significant hysteresis in the measured pressure differential during increasing and decreasing flow rates can indicate the existence of induced damage in the structure, the fact that the material is behaving viscoelastically or suffering from permanent plastic deformation. Some guidance on how to identify which of these factors are responsible for hysteresis is provided in Section 7. 4.7 It is assumed that Darcy’s law is valid. This can be established by plotting the volume flow through the specimen against the differential pressure drop across the specimen. This plot should be linear for Darcy’s law to apply and a least squares fit to the data should pass through the origin. It is not uncommon......

Standard Guide for Determining the Mean Darcy Permeability Coefficient for a Porous Tissue Scaffold

ASTM F3089-14 可聚合的基于胶原蛋白的产品和相关胶原细胞交互作用的特性描述和标准化的标准指南

4.1 The objective of this document is to provide guidance in the production, characterization, testing, and standardization of: (a) collagen polymers as a starting material for surgical implants, substrates for tissue-engineered medical products (TEMPs), vehicles for therapeutic cells and molecules, and 3D in-vitro tissue systems for basic research, drug development, and toxicity testing; and (b) self-assembled collagen-based materials produced with collagen polymer formulations. This guide can be used as an aid in the selection, characterization, and standardization of the appropriate collagen polymer starting material as well as associated self-assembled collagen-based products for a specific use. Not all tests or parameters are applicable to all uses of collagen. 4.2 The collagen covered by this guide may be used in a broad range of applications, forms, or medical products, for example (but not limited to) wound and hemostatic dressings, surgical implants or injectables, hybrid medical devices, tissue-engineered medical products (TEMPs), injectable or implantable delivery vehicles for therapeutic cells, molecules, and drugs, and 3D in-vitro tissue systems or models for basic research, drug development, and toxicity testing. The practical application of the collagen polymers and associated self-assembled collagen-based materials should be based, among other factors, on biocompatibility, application-specific performance measures, as well as chemical, physical, and biological test data. Recommendations in this guide should not be interpreted as a guarantee of success for any research or medical application. 4.3 The following general areas should be considered when determining if the collagen supplied satisfies requirements for use in the above mentioned medical and research applications: source of collagen polymer, impurities profile, and comprehensive chemical, physical, and biological characterization and testing. 4.4 The following documents or other relevant guidances from appropriate regulatory bodies relating to the production, regulation, and regulatory approval of devices, biologics, drugs, and combination products should be considered when determining if the collagen supplied satisfies requirements for use in medical and research products, including TEMPs, therapeutic delivery vehicles, and 3D in-vitro tissue systems: FDA CFR: 21 CFR 3: Product Jurisdiction: 8199;8199;8199;http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/ 8199;8199;8199;8199;CFRSearch.cfm?CFRPart=3 21 CFR 58: Good Laboratory Practice for Nonclinical Laboratory Studies: 8199;8199;8199;http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/ 8199;8199;8199;8199;CFRSearch.cfm?CFRPart=58

Standard Guide for Characterization and Standardization of Polymerizable Collagen-Based Products and Associated Collagen-Cell Interactions

ASTM F3088-14 使用离心法量化测量/研究细胞材料粘合剂的相互作用的标准试验方法

4.1 This test method describes a cell adhesion method that can be used to provide a detachment percent at a given RCF for cells that have adhered to a substrate, typically for a short time. The information generated by this test method can be used to obtain a semi-quantitative measurement of the adhesion of cells to either an uncoated or pre-coated substrate, when compared to a reference (adherent) cell type on the same substrate. As described in Reyes and Garcia (2003), it is recommended that the 50 % point be used for either ligand concentration or RCF for the most robust measurement of adhesion strength. The adhesion may vary due to changes in the phenotype of the cells or as a result of the specific properties of the surface. The substrate may include tissue culture-treated polystyrene, biomaterials or bioactive surfaces. If the substrate is a hydrogel, care must be taken to avoid cohesive failure in the hydrogel (that is, detached cells have pulled away fragments of gel). The coating may consist of (but is not limited to) the following: natural or synthetic biomaterials, hydrogels, components of extracellular matrix (ECM), ligands, adhesion or bioactive molecules, genes or gene products. Cell concentration is also critical, as use of too high a concentration of cells may result in cells detaching as a sheet, rather than as individual cells. This centrifugation approach, once validated, may be applicable for quality control (QC) and product development. However, until the method is correlated to other measures of cell attachment, the current method should be run in parallel with other known measures of cell adhesion. 4.2 This test method does not cover test methods to quantitate changes in gene expression, or changes in biomarkers, as identified by immunostaining. This test method additionally does not cover quantitative image analysis techniques. In some cases the change in adhesive properties may reflect on the degree of differentiation or de-differentiation of the cells. However, it is worth noting that adhesive interactions do not necessarily reflect the differentiation state of a particular cell type, although in many instances they do. (See X1.3 for application to the Adhesion of Chondrocytes.) 1.1 This test method covers a centrifugation cell adhesion assay that can be used to detect changes in adhesive characteristics of cells with passage or treatments. This approach measures the force required to detach cells from a substrate. Adhesion, among many variables, may vary due to changes in the phenotype of the cells. 1.2 This test method does not cover methods to verify the uniformity of coating of surfaces, nor does it cover methods for characterizing surfaces. 1.3 The cells may include adult, progenitor or stem cells from any species. The types of cells may include chondrocytes, fibroblasts, osteoblast, islet cells, or other relevant adherent cell types. 1.4 This test method does not cover methods for isolating or harvesting of cells. This test method does not cover test methods to quantitate changes in gene expression, or changes in biomarker type or concentration, as identified by immunostaining. Nor does this test method cover quantitative image analysis techniques. 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 limitations prior to use.

Standard Test Method for Use of a Centrifugation Method to Quantify/Study Cell-Material Adhesive Interactions

ASTM F2459-12 医疗部件提取残余物并经由化学分离测重法确定数量的标准试验方法

This test method is suitable for determination of the extractable residue in metallic medical components. Extractable residue includes aqueous and non-aqueous residue, as well as non-soluble residue. This test method recommends the use of a sonication technique to extract residue from the medical component. Other techniques, such as solvent reflux extraction, could be used but have been shown to be less efficient in some tests, as discussed in X1.2. This test method is not applicable for evaluating the extractable residue for the reuse of a single-use component (SUD).1.1 This test method covers the quantitative assessment of the amount of residue obtained from metallic medical components when extracted with aqueous or organic solvents. 1.2 This test method does not advocate an acceptable level of cleanliness. It identifies one technique to quantify extractable residue on metallic medical components. In addition, it is recognized that this test method may not be the only method to determine and quantify extractables. 1.3 Although these methods may give the investigator a means to compare the relative levels of component cleanliness, it is recognized that some forms of component residue may not be accounted for by these methods. 1.4 The applicability of these general gravimetric methods have been demonstrated by many literature reports; however, the specific suitability for applications to all-metal medical components will be validated by an Interlaboratory Study (ILS) conducted according to Practice E691. 1.5 This test method is not intended to evaluate the residue level in medical components that have been cleaned for reuse. This test method is also not intended to extract residue for use in biocompatibility testing. Note 18212;For extraction of samples intended for the biological evaluation of devices or materials, refer to ISO 10993–12. 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 may involve hazardous or environmentally-restricted 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 and health practices and determine the applicability of regulatory limitations prior to use.

Standard Test Method for Extracting Residue from Metallic Medical Components and Quantifying via Gravimetric Analysis

ASTM F2884-12 临床前体外评价脊柱融合的标准指南

This guide is aimed at providing a range of in vivo models to aid in preclinical research and development of tissue-engineered medical products (TEMPs) intended for the clinical repair or regeneration of bone in the spine. This guide includes a description of the animal models, surgical considerations, and tissue processing as well as the qualitative and quantitative analysis of tissue specimens. The user is encouraged to utilize appropriate ASTM and other guidelines to conduct cytotoxicity and biocompatibility tests on materials, TEMPs, or both, prior to assessment of the in vivo models described herein. It is recommended that safety testing be in accordance with the provisions of the FDA Good Laboratory Practices Regulations 21 CFR 58. Safety and effectiveness studies to support regulatory submissions (for example, Investigational Device Exemption (IDE), Premarket Approval (PMA), 510K, Investigational New Drug (IND), or Biologics License Application (BLA) submissions in the U.S.) should conform to appropriate guidelines of the regulatory bodies for development of medical devices, biologics, or drugs. Animal model outcomes are not necessarily predictive of human results and should, therefore, be interpreted cautiously with respect to potential applicability to human conditions.1.1 This guide covers general guidelines for the pre-clinical in vivo assessment of tissue-engineered medical products (TEMPs) intended to repair or regenerate bone in an interbody and/or posterolateral spinal environment. TEMPs included in this guide may be composed of, but are not limited to, natural or synthetic biomaterials or composites thereof, and may contain cells or biologically active agents such as growth factors, synthetic peptides, plasmids, or cDNA. The models described in this document represent a stringent test of a material’s ability to induce and/or augment bone growth in the spinal environment. 1.2 While clinically TEMPs may be combined with hardware for initial stabilization or other purposes, the focus of this guide is on the appropriateness of the animal model chosen and evaluation of the TEMP induced repair and as such does not focus on issues of hardware. 1.3 Guidelines include a description and rationale of various animal models for the in vivo assessment of the TEMP. The animal models utilize a range of species including rat (murine), rabbit (lapine), dog (canine), goat (caprine), pig (porcine), sheep (ovine), and non-human primate (primates). Outcome measures include in vivo assessments based on radiographic, histologic, CT imaging as well as subsequent in vitro assessments of the repair, including histologic analyses and mechanical testing. All methods are described briefly and referenced. The user should refer to specific test methods for additional detail. 1.4 This guide is not intended to include the testing of raw materials, preparation of biomaterials, sterilization, or packaging of the product. ASTM standards for these steps are available in Referenced Documents (Section 2). 1.5 The use of any of the methods included in this guide may not produce a result that is consistent with clinical performance in one or more specific applications. 1.6 Other pre-clinical methods may also be appropriate and this guide is not meant to exclude such methods. The material must be suitable for its intended purpose. Additional biological testing in this regard would be required. 1.7 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.8 The values state......

Standard Guide for Pre-clinical in vivo Evaluation of Spinal Fusion

ASTM F2903-11 腱和韧带外科修复加固用组织工程医疗产品(TEMPs)的标准指南

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......

Standard Guide for Tissue Engineered Medical Products (TEMPs) for Reinforcement of Tendon and Ligament Surgical Repair