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ASTM F 2150 : 2013 : REDLINE

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Standard Guide for Characterization and Testing of Biomaterial Scaffolds Used in Tissue-Engineered Medical Products
Available format(s)

PDF

Superseded date

08-27-2020

Language(s)

English

Published date

10-01-2013

CONTAINED IN VOL. 13.01, 2015 Describes the characterization of the compositional and structural aspects of biomaterial scaffolds used to develop and manufacture tissue-engineered medical products (TEMPs).

1.1This guide is a resource of currently available test methods for the characterization of the compositional and structural aspects of biomaterial scaffolds used to develop and manufacture tissue-engineered medical products (TEMPs).

1.2The test methods contained herein guide characterization of the bulk physical, chemical, mechanical, and surface properties of a scaffold construct. Such properties may be important for the success of a TEMP, especially if they affect cell retention, activity and organization, the delivery of bioactive agents, or the biocompatibility and bioactivity within the final product.

1.3This guide may be used in the selection of appropriate test methods for the generation of an original equipment manufacture (OEM) specification. This guide also may be used to characterize the scaffold component of a finished medical product.

1.4This guide is intended to be utilized in conjunction with appropriate characterization(s) and evaluation(s) of any raw or starting material(s) utilized in the fabrication of the scaffold, such as described in Guide F2027.

1.5This guide addresses natural, synthetic, or combination scaffold materials with or without bioactive agents or biological activity. This guide does not address the characterization or release profiles of any biomolecules, cells, drugs, or bioactive agents that are used in combination with the scaffold. A determination of the suitability of a particular starting material and/or finished scaffold structure to a specific cell type and/or tissue engineering application is essential, but will require additional in vitro and/or in vivo evaluations considered to be outside the scope of this guide.

1.6This 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.

Committee
F 04
DocumentType
Redline
Pages
14
PublisherName
American Society for Testing and Materials
Status
Superseded
SupersededBy

ASTM F 2998 : 2014 Guide for Using Fluorescence Microscopy to Quantify the Spread Area of Fixed Cells (Withdrawn 2023)
DD ISO/TS 10993-19:2006 Biological evaluation of medical devices Physico-chemical, morphological and topographical characterization of materials
ISO 13019:2018 Tissue-engineered medical products — Quantification of sulfated glycosaminoglycans (sGAG) for evaluation of chondrogenesis
ASTM F 2903 : 2011 Standard Guide for Tissue Engineered Medical Products (TEMPs) for Reinforcement of Tendon and Ligament Surgical Repair (Withdrawn 2020)
ASTM F 2900 : 2011 Standard Guide for Characterization of Hydrogels used in Regenerative Medicine (Withdrawn 2020)
ASTM F 3163 : 2016 Standard Guide for Classification of Cellular and/or Tissue-Based Products (CTPs) for Skin Wounds
ASTM F 2211 : 2013 Standard Classification for Tissue Engineered Medical Products (TEMPs)
ASTM F 2603 : 2006 Standard Guide for Interpreting Images of Polymeric Tissue Scaffolds
ASTM F 2027 : 2016 : REDLINE Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products
ASTM F 2721 : 2009 : R2014 Standard Guide for Pre-clinical <emph type="bdit">in vivo</emph> Evaluation in Critical Size Segmental Bone Defects
17/30319534 DC : 0 BS ISO 13019 - TISSUE-ENGINEERED MEDICAL PRODUCTS - QUANTIFICATION OF SULPHATED GLYCOSAMINOGLYCANS (SGAG) FOR EVALUATION OF CHONDROGENESIS
ANSI/AAMI/ISO TIR10993-19:2006 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 19: PHYSICOCHEMICAL, MORPHOLOGICAL, AND TOPOGRAPHICAL CHARACTERIZATION OF MATERIALS
ASTM F 3225 : 2017 Standard Guide for Characterization and Assessment of Vascular Graft Tissue Engineered Medical Products (TEMPs)
ASTM F 2603 : 2006 : R2012 Standard Guide for Interpreting Images of Polymeric Tissue Scaffolds
ASTM F 2451 : 2005 : R2010 Standard Guide for <i>in vivo</i> Assessment of Implantable Devices Intended to Repair or Regenerate Articular Cartilage (Withdrawn 2019)
ASTM F 2883 : 2011 Standard Guide for Characterization of Ceramic and Mineral Based Scaffolds used for Tissue-Engineered Medical Products (TEMPs) and as Device for Surgical Implant Applications (Withdrawn 2020)
ASTM F 2451 : 2005 Standard Guide for <i>in vivo</i> Assessment of Implantable Devices Intended to Repair or Regenerate Articular Cartilage
ASTM F 2721 : 2009 Standard Guide for Pre-clinical <span class="bdit">in vivo</span> Evaluation in Critical Size Segmental Bone Defects
ASTM F 3223 : 2017 Standard Guide for Characterization and Assessment of Tissue Engineered Medical Products (TEMPs) for Knee Meniscus Surgical Repair and/or Reconstruction
ISO/TS 10993-19:2006 Biological evaluation of medical devices Part 19: Physico-chemical, morphological and topographical characterization of materials
ASTM F 2884 : 2012 Standard Guide for Pre-clinical <emph type="bdit">in vivo</emph> Evaluation of Spinal Fusion (Withdrawn 2021)

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ASTM F 2791 : 2015 : REDLINE Standard Guide for Assessment of Surface Texture of Non-Porous Biomaterials in Two Dimensions
ASTM D 3418 : 2015 : REDLINE Standard Test Method for Transition Temperatures and Enthalpies of Fusion and Crystallization of Polymers by Differential Scanning Calorimetry
ASTM F 2312 : 2011 : REDLINE Standard Terminology Relating to Tissue Engineered Medical Products
ASTM D 4001 : 2013 : REDLINE Standard Test Method for Determination of Weight-Average Molecular Weight of Polymers By Light Scattering
ASTM E 177 : 2014 : REDLINE Standard Practice for Use of the Terms Precision and Bias in ASTM Test Methods
ASQ Q9000:2005 Quality Management Systems - Fundamentals And Vocabulary
ASTM F 1983 : 2014 : REDLINE Standard Practice for Assessment of Selected Tissue Effects of Absorbable Biomaterials for Implant Applications
ISO 80000-9:2009 Quantities and units Part 9: Physical chemistry and molecular physics
ISO 10993-13:2010 Biological evaluation of medical devices Part 13: Identification and quantification of degradation products from polymeric medical devices
ASTM F 2900 : 2011 Standard Guide for Characterization of Hydrogels used in Regenerative Medicine (Withdrawn 2020)
ISO 1133-1:2011 Plastics Determination of the melt mass-flow rate (MFR) and melt volume-flow rate (MVR) of thermoplastics Part 1: Standard method
ASTM F 2212 : 2011 : REDLINE Standard Guide for Characterization of Type I Collagen as Starting Material for Surgical Implants and Substrates for Tissue Engineered Medical Products (TEMPs)
AAMI STBK9 3 : 2001 STERILIZATION - PART 3: INDUSTRIAL PROCESS CONTROL
ASTM E 1078 : 2014 : REDLINE Standard Guide for Specimen Preparation and Mounting in Surface Analysis
BS EN 12442-3:2000 Animal tissues and their derivatives utilized in the manufacture of medical devices Validation of the elimination and/or inactivation of viruses and transmissible agents
BS EN 12442-2:2000 Animal tissues and their derivatives utilized in the manufacture of medical devices Controls on sourcing, collection and handling
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ASTM F 2809 : 2010 Standard Terminology Relating to Medical and Surgical Materials and Devices (Withdrawn 2019)
ASTM D 1238 : 2013 : REDLINE Standard Test Method for Melt Flow Rates of Thermoplastics by Extrusion Plastometer
CFR 21(PTS800-1299) : 0 FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 800-1299
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AAMI STBK9 1 : 2001 STERILIZATION - PART 1: STERILIZATION IN HEALTH CARE FACILITIES
ASTM F 1635 : 2016 : REDLINE Standard Test Method for <emph type="bdit">in vitro</emph> Degradation Testing of Hydrolytically Degradable Polymer Resins and Fabricated Forms for Surgical Implants
ASTM F 2027 : 2016 : REDLINE Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products
ISO 10993-14:2001 Biological evaluation of medical devices Part 14: Identification and quantification of degradation products from ceramics
ISO 11357-2:2013 Plastics Differential scanning calorimetry (DSC) Part 2: Determination of glass transition temperature and glass transition step height
ASTM E 1142 : 2015 : REDLINE Standard Terminology Relating to Thermophysical Properties
ASTM D 6474 : 2012 : REDLINE Standard Test Method for Determining Molecular Weight Distribution and Molecular Weight Averages of Polyolefins by High Temperature Gel Permeation Chromatography
ASTM E 1829 : 2014 : REDLINE Standard Guide for Handling Specimens Prior to Surface Analysis
ASTM D 790 : 2017 : REDLINE Standard Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials
ASTM F 748 : 2016 : REDLINE Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
CFR 21(PTS1-99) : 0 FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 1-99
ANSI/ISO/ASQ Q9001:2008 Quality Management Systems - Requirements
ASTM D 648 : 2016 Standard Test Method for Deflection Temperature of Plastics Under Flexural Load in the Edgewise Position
ISO 10993-9:2009 Biological evaluation of medical devices Part 9: Framework for identification and quantification of potential degradation products
AAMI STBK9 2 : 2001 STERILIZATION - PART 2: STERILIZATION EQUIPMENT
ASTM D 3039/D3039M : 2017 : REDLINE Standard Test Method for Tensile Properties of Polymer Matrix Composite Materials
BS EN 12442-1:2000 Animal tissues and their derivatives utilized in the manufacture of medical devices Analysis and management of risk
ASTM F 1980 : 2016 : REDLINE Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
ASTM D 1621 : 2016 : REDLINE Standard Test Method for Compressive Properties of Rigid Cellular Plastics
ASTM E 473 : 2016-05 TERMINOLOGY RELATING TO THERMAL ANALYSIS AND RHEOLOGY
ASTM D 695 : 2015 : REDLINE Standard Test Method for Compressive Properties of Rigid Plastics
ASTM D 6539 : 2013 : REDLINE Standard Test Method for Measurement of the Permeability of Unsaturated Porous Materials by Flowing Air
ASTM D 570 : 1998 : R2018 Standard Test Method for Water Absorption of Plastics
ISO 11357-1:2016 Plastics — Differential scanning calorimetry (DSC) — Part 1: General principles
ASTM D 2990 : 2017 : REDLINE Standard Test Methods for Tensile, Compressive, and Flexural Creep and Creep-Rupture of Plastics
ASTM D 638 : 2014 : REDLINE Standard Test Method for Tensile Properties of Plastics
ASTM E 128 : 1999 Standard Test Method for Maximum Pore Diameter and Permeability of Rigid Porous Filters for Laboratory Use
ASTM F 1249 : 2013 : REDLINE Standard Test Method for Water Vapor Transmission Rate Through Plastic Film and Sheeting Using a Modulated Infrared Sensor
ASTM F 2883 : 2011 Standard Guide for Characterization of Ceramic and Mineral Based Scaffolds used for Tissue-Engineered Medical Products (TEMPs) and as Device for Surgical Implant Applications (Withdrawn 2020)
ASTM G 120 : 2015 : REDLINE Standard Practice for Determination of Soluble Residual Contamination by Soxhlet Extraction

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