Author: Publisher:
ISBN:
Category :
Languages : en
Pages : 0
Book Description
Standard Guide for Characterization and Assessment of Vascular Graft Tissue Engineered Medical Products TEMPs
Tissue Engineered Medical Products (TEMPs)
Author: Eliane SchuttePublisher: ASTM International
ISBN: 0803134711
Category : Biomedical materials
Languages : en
Pages : 267
Book Description
Written by an international group of industry experts, regulators, and academics, this new ASTM publication provides the latest data on tissue engineering and the standards available for manufacturing TEMPs. Twenty-three peer-reviewed papers cover current technology, existing standards, development of new standards, and international standards used by regulatory bodies.
Development of Standards for the Characterization of Natural Materials Used in Tissue Engineered Medical Products (TEMPs)
Author: DS. KaplanPublisher:
ISBN:
Category : Biomedical materials
Languages : en
Pages : 4
Book Description
ASTM Committee on F4 Medical and Surgical Materials and Devices, Division IV, Tissue Engineered Medical Products (TEMPs), Biomaterials and Biomolecules for TEMPs Subcommittee (F4.42) has been developing standards for characterizing natural materials used in TEMPs. Natural materials include alginate, chitosan, collagen and hyaluronate. These materials support cell growth and differentiation on TEMPs substrates and scaffolds. Natural materials have been used in a variety of applications, including encapsulation, cell seeding, development of "memory" biomaterials, as well as degradable scaffolds, growth factor/nucleic acid delivery vehicles, and as a carrier to improve product handling characteristics. These materials have typically been very poorly characterized as to their chemical, physical and biological properties. This has resulted in variability in the products produced from these starting materials. The development of Standard Guides and Test Methods for characterizing natural materials is anticipated to reduce the variability of these starting materials and to aid in the assessment of the safety of the subsequent TEMPs.
Standard Guide for Assessment of Adventitious Agents in Tissue Engineered Medical Products TEMPs
Author: Standard Guide for Characterization and Testing of Substrate Materials for Tissue-Engineered Medical Products
Author: Standard Guide for Processing Cells, Tissues and Organs for Use in Tissue Engineered Medical Products
Author: ASTM Committee F-4 on Medical and Surgical Materials and Devices. Subcommittee F04.43 on Cells and Tissue Engineered Constructs for TEMPsPublisher:
ISBN:
Category : Artificial organs
Languages : en
Pages : 6
Book Description
Design, Synthesis, and Characterization of a Tissue Engineered Small Caliber Vascular Graft
Author: Ericka PrechtelPublisher:
ISBN:
Category : Biomedical engineering
Languages : en
Pages : 122
Book Description
NIST and Standards for Tissue Engineered Medical Products
Author: JA. TeskPublisher:
ISBN:
Category : Bioinformatics
Languages : en
Pages : 7
Book Description
On June 13-14, 2001, the National Institute of Standards and Technology (NIST) convened a workshop of high level representatives from industry, federal agencies, and standards organizations to identify standards-related needs of the biomedical materials and devices industry. There were individual breakout sessions on standards for: Biomaterials, Therapeutic and Drug Delivery Devices, Auditory Diagnostic and Prosthetic Devices, Manufacturing of Prostheses, and Tissue Engineered Medical Products (TEMPs). Cross-cutting issues of Harmonization of Standards, Data, and Sterilization were also addressed. The session on Standards for TEMPs placed its most significant needs on the development of test methods and materials characterization. Action items for NIST to consider were separated into those relative to the Food and Drug Administration (FDA) approval process and those relative to industry needs not directly related to the FDA approval process. This paper summarizes the needs identified for TEMPs and the status of NIST-related activities.
Author: 
Author: Paul Howard Rigby