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ASTM F2883-11

(Guide)

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Based Scaffolds used for Tissue-Engineered Medical Products (TEMPs) and as Device for Surgical Implant Applications (Withdrawn 2020)

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Based Scaffolds used for Tissue-Engineered Medical Products (TEMPs) and as Device for Surgical Implant Applications (Withdrawn 2020)

SIGNIFICANCE AND USE
Scaffolds may be composed of purely mineral or ceramic materials, or they may be composed of a composite material with its main phase being a mineral or ceramic. Scaffolds may be porous or non-porous, mechanically rigid or compliant, and degradable or non-degradable. The scaffold may or may not have undergone a surface treatment.
SCOPE
1.1 This guidance document covers the chemical, physical, biological, and mechanical characterization requirements for biocompatible mineral- and ceramic-based scaffolds used solely as device or to manufacture tissue-engineered medical products (TEMPs). In this guide, the pure device or the TEMPs product will be referred to as scaffold.
1.2 The test methods contained herein provide guidance on the characterization of the bulk physical, chemical, mechanical, and surface properties of a scaffold construct. These properties may be important for the performance of the scaffold, especially if they affect cell behavior, adhesion, proliferation and differentiation. In addition, these properties may affect the delivery of bioactive agents, the biocompatibility and the bioactivity of the final product.  
1.3 This document may be used as guidance in the selection of test methods for the comprehensive characterization of a raw materials, granules, pre-shaped blocks, or an original equipment manufacture (OEM) specification. This guide may also be used to characterize the scaffold component of a finished medical product.  
1.4 While a variety of materials can be used to manufacture such scaffolds, the composition of the final scaffold shall contain mineral or ceramic components as its main ingredients.
1.5 This guide assumes that the scaffold is homogeneous in nature. Chemical or physical inhomogeneity or mechanical anisotropy of the scaffold shall be declared in the manufacturer’s material and scaffold specification.
1.6 This guide addresses neither the biocompatibility of the scaffold, nor the characterization or release profiles of any biomolecules, cells, drugs, or bioactive agents that are used in combination with the scaffold.  
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 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.
WITHDRAWN RATIONALE
This guidance document covered the chemical, physical, biological, and mechanical characterization requirements for biocompatible mineral- and ceramic-based scaffolds used solely as device or to manufacture tissue-engineered medical products (TEMPs).
Formerly under the jurisdiction of Committee F04 on Medical and Surgical Materials and Devices, this guide was withdrawn in January 2020 in accordance with section 10.6.3 of the Regulations Governing ASTM Technical Committees, which requires that standards shall be updated by the end of the eighth year since the last approval date.

General Information

Status
Withdrawn
Publication Date
30-Nov-2011
Withdrawal Date
14-Jan-2020
ICS
11.100.99 - Other standards related to laboratory medicine
Technical Committee
F04 - Medical and Surgical Materials and Devices
Drafting Committee
F04.42 - Biomaterials and Biomolecules for TEMPs
Current Stage
Ref Project

Relations

Referred By
ASTM F2150-19 - Standard Guide for Characterization and Testing of Biomaterial Scaffolds Used in Regenerative Medicine and Tissue-Engineered Medical Products
Effective Date
01-Dec-2011

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ASTM F2883-11 - 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 F2883-11 - 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)
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ASTM F2883-11 - 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)
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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation: F2883 − 11
Standard Guide for
Characterization of Ceramic and Mineral Based Scaffolds
used for Tissue-Engineered Medical Products (TEMPs) and
1
as Device for Surgical Implant Applications
This standard is issued under the fixed designation F2883; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope 1.7 The values stated in SI units are to be regarded as
standard. No other units of measurement are included in this
1.1 This guidance document covers the chemical, physical,
standard.
biological, and mechanical characterization requirements for
1.8 This standard does not purport to address all of the
biocompatible mineral- and ceramic-based scaffolds used
safety concerns, if any, associated with its use. It is the
solely as device or to manufacture tissue-engineered medical
responsibility of the user of this standard to establish appro-
products(TEMPs).Inthisguide,thepuredeviceortheTEMPs
priate safety and health practices and determine the applica-
product will be referred to as scaffold.
bility of regulatory limitations prior to use.
1.2 The test methods contained herein provide guidance on
the characterization of the bulk physical, chemical,
2. Referenced Documents
mechanical, and surface properties of a scaffold construct.
2
2.1 ASTM Standards:
These properties may be important for the performance of the
C373 Test Method for Water Absorption, Bulk Density,
scaffold, especially if they affect cell behavior, adhesion,
Apparent Porosity, andApparent Specific Gravity of Fired
proliferation and differentiation. In addition, these properties
Whiteware Products
may affect the delivery of bioactive agents, the biocompatibil-
C693 Test Method for Density of Glass by Buoyancy
ity and the bioactivity of the final product.
C729 Test Method for Density of Glass by the Sink-Float
1.3 This document may be used as guidance in the selection Comparator
oftestmethodsforthecomprehensivecharacterizationofaraw C830 Test Methods for Apparent Porosity, Liquid
materials, granules, pre-shaped blocks, or an original equip- Absorption, Apparent Specific Gravity, and Bulk Density
ment manufacture (OEM) specification. This guide may also of Refractory Shapes by Vacuum Pressure
be used to characterize the scaffold component of a finished C1198 Test Method for Dynamic Young’s Modulus, Shear
medical product. Modulus, and Poisson’s Ratio for Advanced Ceramics by
Sonic Resonance
1.4 While a variety of materials can be used to manufacture
C1274 Test Method forAdvanced Ceramic Specific Surface
such scaffolds, the composition of the final scaffold shall
Area by Physical Adsorption
containmineralorceramiccomponentsasitsmainingredients.
C1424 Test Method for Monotonic Compressive Strength of
1.5 This guide assumes that the scaffold is homogeneous in Advanced Ceramics at Ambient Temperature
nature. Chemical or physical inhomogeneity or mechanical D695 Test Method for Compressive Properties of Rigid
anisotropy of the scaffold shall be declared in the manufactur- Plastics
er’s material and scaffold specification. D1621 Test Method for Compressive Properties of Rigid
Cellular Plastics
1.6 This guide addresses neither the biocompatibility of the
D4404 Test Method for Determination of Pore Volume and
scaffold, nor the characterization or release profiles of any
Pore Volume Distribution of Soil and Rock by Mercury
biomolecules, cells, drugs, or bioactive agents that are used in
Intrusion Porosimetry
combination with the scaffold.
D6226 Test Method for Open Cell Content of Rigid Cellular
Plastics
1
This guide is under the jurisdiction of ASTM Committee F04 on Medical and
2
Surgical Materials and Devices and is the direct responsibility of Subcommittee For referenced ASTM standards, visit the ASTM website, www.astm.org, or
F04.42 on Biomaterials and Biomolecules for TEMPs. contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Current edition approved Dec. 1, 2011. Published January 2012. DOI: 10.1520/ Standards volume information, refer to the standard’s Document Summary page on
F2883–11. the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
F2883 − 11
D6420 Test Method for Determination of Gaseous Organic F2150 Guide for Characterization and Testing of Biomate-
Compounds by Direct Interface Gas Chromatography- rial Scaffolds Used in Tissue-Engineered Medical Prod-
ucts
Mass Spectrometry
F2450 Guide for Assessing Microstructure of Polymeric
E128 Test Method for Maximum Pore Diameter
...

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4.1 The objective of this document is to provide guidance in the production, characterization, testing, and standardization of: (1) polymerizable collagen starting materials; and (2) collagen polymeric materials produced with polymerizable collagen formulations, used for surgical implants, substrates for TEMPs, vehicles for therapeutic cells and molecules, and 3D in-vitro tissue systems for basic research, drug development, and toxicity testing. This guide can be used as an aid in the selection, characterization, and standardization of the appropriate polymerizable collagen starting formulations as well as collagen polymeric materials prepared from polymerizable collagens for a specific use. Not all tests or parameters are applicable to all uses of collagen and users are expected to select and justify a subset of the tests for characterization purposes.  
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4.2 The categories outlined in this classification are intended to list, identify, and group the areas pertinent to tissue-engineered medical products. This classification will be used by the Tissue-Engineered Medical Products subcommittees for the organization of the development of standards for the field of tissue engineering, TEMPs, and protocols for their use. The development of products from the new tissue engineering technologies necessitates creation and implementation of new standards (1).5  
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1.1 This classification outlines the aspects of tissue-engineered medical products that will be developed as standards. This classification excludes traditional transplantation of organs and tissues as well as transplantation of living cells alone as cellular therapies.  
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4.1 This guide covers animal implantation methods and analysis of the explanted DBM-containing material to determine whether a material or substance possesses osteoinductive potential, as defined by its ability to cause bone to form in vivo at a site that would otherwise not support bone formation, that is, heterotopically in a skeletal muscle implant site. For in vitro evaluation see Test Method F2131 for in vitro assessment of rhBMP 2.  
4.2 The test methods described here may be suitable for defining product specifications, cGMP lot release testing, research evaluation, regulatory submission, and so forth, but a positive outcome should not be presumed to indicate that the product will be osteoinductive in a human clinical application. At present, the only direct assays to assess new bone formation are in vivo, since the property of bone conduction or induction can only be assessed in a heterotopic or orthotopic site in a living animal. When these products are implanted in an orthotopic site, osteogenic factors already present at the implantation site may contribute to and enhance bone formation in conjunction with the osteoconductive nature of the product. Thus, orthotopic implantation of products may result in bone formation by acting on existing bone-forming cells and not by causing mesenchymal stem cells to become osteochondroprogenitor cells. In contrast, when these products are implanted in a heterotopic site, no native osteogenic factors are present to contribute to or enhance bone formation. Thus, heterotopic implantation of products will only result in new bone formation by causing mesenchymal stem cells to become osteochondroprogenitor cells. In vitro assays have been described and some believe they may correlate to the results obtained from in vivo assays. However such in vitro assays measure only some of the biochemical marker(s) associated with in vivo bone formation and are therefore only indirect assays for osteoinductive activity or the capacity t...
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Standard Guide for Characterization of Type I Collagen as Starting Material for Surgical Implants and Substrates for Tissue Engineered Medical Products (TEMPs)

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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) medical devices, tissue engineered medical products (TEMPs) or cell, drug, or DNA delivery devices for implantation. The use of collagen in a practical application should be based, among other factors, on biocompatibility and physical test data. Recommendations in this guide should not be interpreted as a guarantee of clinical success in any tissue engineered medical product or drug delivery application.  
4.3 The following general areas should be considered when determining if the collagen supplied satisfies requirements for use in TEMPs. These are source of collagen, chemical and physical characterization and testing, and impurities profile.  
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FDA CFR:  
21 CFR 3: Product Jurisdiction:  
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/
CFRSearch.cfm?CFRPart=3    
21 CFR 58: Good Laboratory Practice for Nonclinical Laboratory Studies:  
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/
CFRSearch.cfm?CFRPart=58    
FDA/CDRH CFR and Guidances:  
21 CFR Part 803: Medical Device ...
SCOPE
1.1 This guide for characterizing collagen-containing biomaterials is intended to provide characteristics, properties, and test methods for use by producers, manufacturers, and researchers to more clearly identify the specific collagen materials used. With greater than 20 types of collagen and the different properties of each, a single document would be cumbersome. This guide will focus on the characterization of Type I collagen, which is the most abundant collagen in mammals, especially in skin and bone. Collagen isolated from these sources may contain other types of collagen, for example, Type III and Type V. This guide does not provide specific parameters for any collagen product or mix of products or the acceptability of those products for the intended use. The collagen may be from any source including, but not limited to, animal or cadaveric sources, human cell culture, or recombinant sources. The biological, immunological, or toxicological properties of the collagen may vary, depending on the source material. The properties of the collagen prepared from each of the above sources must be thoroughly investigated, as the changes in the collagen properties as a function of source materials is not thoroughly understood. This guide is intended to focus on purified Type I collagen as a starting material for surgical implants and substrates for tissue engineered medical products (TEMPs); some methods may not be applicable for gelatin or tissue implants. This guide may serve as a template for characterization of other types of collagen.  
1.2 The biological response to collagen in soft tissue has been well documented by a history of clinical use (1, 2)2 and laboratory studies (3-6). Biocompatibility and appropriateness of use for a specific application(s) is the responsibility of the product manufacturer.  
1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this...

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ASTM
ASTM F619-20(Practice)
Standard Practice for Extraction of Materials Used in Medical Devices

SIGNIFICANCE AND USE
5.1 These extraction procedures are the initial part of several test procedures used in the biocompatibility screening of plastics or other materials used in medical devices.  
5.2 The limitations of the results obtained from this practice should be recognized. The choices of the extraction vehicle, duration of immersion, and temperature of the test are necessarily arbitrary. The specification of these conditions provides a basis for standardization and serves as a guide to investigators wishing to compare the relative resistance of various plastics or other materials to extraction vehicles.  
5.3 Correlation of test results with the actual performance or serviceability of materials is necessarily dependent upon the similarity between the testing and end-use conditions (see 12.1.2 and Note 7).  
5.4 Caution should be exercised in the understanding and intent of this practice as follows:  
5.4.1 No allowance or distinction is made for variables such as end-use application and duration of use. Decisions on selection of tests to be done should be made based on Practice F748.  
5.4.2 This practice was originally designed for use with nonporous, solid materials. Its application for other materials, such as those that are porous, absorptive (for example, sponge-like materials that are capable of absorbing liquid), or resorptive, should be considered with caution. Consideration should be given to altering the specified material-to-liquid ratio to allow additional liquid to fully hydrate the material and additional liquid or other methods to fully submerge the test specimen. Additional procedures that fully remove the extract liquid from the test specimen, such as pressure or physically squeezing the material, should also be considered as appropriate. Although no definitions are given in this practice for the following terms, such items as extraction vehicle surface tension at the specified extraction condition and test specimen physical structure should be taken into ...
SCOPE
1.1 This practice covers methods of extraction of medical plastics and may be applicable to other materials. This practice identifies a method for obtaining “extract liquid” for use in determining the biological response in preclinical testing. Further testing of the “extract liquid” is specified in other ASTM standards. The extract may undergo chemical analysis as part of the preclinical evaluation of the biological response, and the material after extraction may also be examined.  
1.2 This practice may be used for, but is not limited to, the following areas: partial evaluation of raw materials, auditing materials within the manufacturing process, and testing final products. This practice may also be used as a reference method for the measurement of extractables in plastics used in medical devices. In general, it is the responsibility of the user of the standard to determine if the methods described in this standard are appropriate for the materials in their device.  
1.3 This practice was initially developed for extraction of medical plastics not intended to undergo degradation or absorption during normal medical device usage. When applied to the extraction of absorbable materials, additional considerations may be necessary in the selection of extraction procedures and fluids.  
1.4 For assessment of compatibility of the Single-use System material with the cell culture medium or the manufacturing processes used for cell-based therapeutics, vaccines, cell-based diagnostics, or other biopharmaceutical products, the user should refer to Guide E3231.  
1.5 The values stated in SI units are to be regarded as standard. The values given in parentheses are mathematical conversions to inch-pound units that are provided for information only and are not considered 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 thi...

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ASTM
ASTM F719-20(Practice)
Standard Practice for Testing Materials in Rabbits for Primary Skin Irritation

SIGNIFICANCE AND USE
4.1 Materials that are to be in contact with the skin should not cause irritation to the skin. Since it is probably the substances leached from a material that cause the irritation, this practice provides for direct material-skin contact testing or for skin exposure to the liquid extract of the test material. The rationale for this rabbit test is that it is a comparatively quick and sensitive method which, through use over the years, has become a generally accepted method. Additionally, the albino rabbit allows for easy visualization of erythema and edema, which are the cardinal signs of skin irritation.
SCOPE
1.1 This practice covers a procedure by which the irritancy of a material may be assessed through contact with abraded and intact skin of rabbits.  
1.2 The results of this practice depend upon the effectiveness with which contact between the skin and the test material is established and maintained. Because of the operator technique included in performing this test, it is important that the test be performed by personnel with appropriate training.  
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 may involve hazardous 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, 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.

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