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Description of ASTM-F2451 2010ASTM F2451 - 05(2010)Standard Guide for in vivo Assessment of Implantable Devices Intended to Repair or Regenerate Articular CartilageActive Standard ASTM F2451 | Developed by Subcommittee: F04.44 Book of Standards Volume: 13.01 ASTM F2451Significance and Use This guide is aimed at providing a range of in vivo models to aid in preclinical research and development of tissue engineered medical products intended for the clinical repair or regeneration of articular cartilage. 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 or devices, 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 IDE (Investigational Device Exemption), PMA (Premarket Approval), or 510K submissions should conform to appropriate FDA guidelines for development of medical devices. 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. Scope 1.1 This guide covers general guidelines for the in vivo assessment of implantable devices intended to repair or regenerate articular cartilage. Devices included in this guide may be composed of natural or synthetic biomaterials (biocompatible and biodegradable) or composites thereof and may contain cells or biologically active agents such as growth factors, synthetic peptides, plasmids, or cDNA. 1.2 Guidelines include a description and rationale of various animal models utilizing a range of species such as rabbit (lupine), dog (canine), pig (porcine), goat (caprine), sheep (ovine), and horse (equine). Outcome measures based on histologic, biochemical, and mechanical analyses are briefly described and referenced. The user should refer to specific test methods for additional detail. 1.3 This guide is not intended to include the testing of raw materials, preparation of biomaterials, sterilization, or packaging of product. ASTM standards for these steps are available in Reference Documents. 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 and health practices and determine the applicability of regulatory requirements prior to use.
ASTM Standards F561 Practice for Retrieval and Analysis of Medical Devices, and Associated Tissues and Fluids F565 Practice for Care and Handling of Orthopedic Implants and Instruments F895 Test Method for Agar Diffusion Cell Culture Screening for Cytotoxicity F981 Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and Bone F1983 Practice for Assessment of Compatibility of Absorbable/Resorbable Biomaterials for Implant Applications F2150 Guide for Characterization and Testing of Biomaterial Scaffolds Used in Tissue-Engineered Medical Products Other Documents 21CFRPart58 Good Laboratory Practice for Nonclinical Laboratory Studies Available from U.S. Government Printing Office Superintendent of Documents, 732 N. Capitol St., NW, Mail Stop: SDE, Washington, DC 20401.Keywords animal models; biomaterials; cartilage; cartilage regeneration; cartilage repair; defect generation; devices; implants; in vivo; mechanical testing; synthetic biomaterials; TEMPs; Biomaterials; Cartilage; Implantable surgical materials/applications; Medical devices/equipment; TEMPs (tissue engineered medical products); Tissue repair/regeneration; ICS Code ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics) DOI: 10.1520/F2451-05R10 ASTM International is a member of CrossRef. ASTM F2451This book also exists in the following packages...Subscription InformationMADCAD.com ASTM Standards subscriptions are annual and access is unlimited concurrency based (number of people that can access the subscription at any given time) from single office location. For pricing on multiple office location ASTM Standards Subscriptions, please contact us at info@madcad.com or +1 800.798.9296.
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About ASTMASTM International, formerly known as the American Society for Testing and Materials (ASTM), is a globally recognized leader in the development and delivery of international voluntary consensus standards. Today, some 12,000 ASTM standards are used around the world to improve product quality, enhance safety, facilitate market access and trade, and build consumer confidence. ASTM’s leadership in international standards development is driven by the contributions of its members: more than 30,000 of the world’s top technical experts and business professionals representing 150 countries. Working in an open and transparent process and using ASTM’s advanced electronic infrastructure, ASTM members deliver the test methods, specifications, guides, and practices that support industries and governments worldwide. |
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