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ASTM F2884-12

(Guide)

Standard Guide for Pre-clinical in vivo Evaluation of Spinal Fusion (Withdrawn 2021)

Standard Guide for Pre-clinical <emph type="bdit">in vivo</emph> Evaluation of Spinal Fusion (Withdrawn 2021)

SIGNIFICANCE 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 (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.
SCOPE
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 stated in inch-pound units are to be regarded as standard. The values given in parentheses are mathematical conversions to SI units that are provided for information only and are not considered standard.

General Information

Status
Historical
Publication Date
31-Mar-2012
ICS
11.100.99 - Other standards related to laboratory medicine
Technical Committee
F04 - Medical and Surgical Materials and Devices
Drafting Committee
F04.44 - Assessment for TEMPs
Current Stage
Ref Project

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ASTM F2884-12 - Standard Guide for Pre-clinical <emph type="bdit">in vivo</emph> Evaluation of Spinal Fusion (Withdrawn 2021)ASTM F2884-12 - Standard Guide for Pre-clinical <emph type="bdit">in vivo</emph> Evaluation of Spinal Fusion (Withdrawn 2021)
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ASTM F2884-12 - Standard Guide for Pre-clinical <emph type="bdit">in vivo</emph> Evaluation of Spinal Fusion (Withdrawn 2021)
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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: F2884 − 12
Standard Guide for
1
Pre-clinical in vivo Evaluation of Spinal Fusion
This standard is issued under the fixed designation F2884; 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 must be suitable for its intended purpose.Additional biological
testing in this regard would be required.
1.1 This guide covers general guidelines for the pre-clinical
in vivo assessment of tissue-engineered medical products 1.7 The values stated in SI units are to be regarded as
(TEMPs) intended to repair or regenerate bone in an interbody standard. No other units of measurement are included in this
and/or posterolateral spinal environment. TEMPs included in standard.
this guide may be composed of, but are not limited to, natural
1.8 The values stated in inch-pound units are to be regarded
or synthetic biomaterials or composites thereof, and may
as standard. The values given in parentheses are mathematical
contain cells or biologically active agents such as growth
conversions to SI units that are provided for information only
factors, synthetic peptides, plasmids, or cDNA. The models
and are not considered standard.
described in this document represent a stringent test of a
material’s ability to induce and/or augment bone growth in the
2. Referenced Documents
spinal environment.
2
2.1 ASTM Standards:
1.2 While clinically TEMPs may be combined with hard-
F561 Practice for Retrieval and Analysis of Medical
ware for initial stabilization or other purposes, the focus of this
Devices, and Associated Tissues and Fluids
guideisontheappropriatenessoftheanimalmodelchosenand
F565 PracticeforCareandHandlingofOrthopedicImplants
evaluation of the TEMP induced repair and as such does not
and Instruments
focus on issues of hardware.
F895 TestMethodforAgarDiffusionCellCultureScreening
for Cytotoxicity
1.3 Guidelinesincludeadescriptionandrationaleofvarious
F981 Practice for Assessment of Compatibility of Biomate-
animal models for the in vivo assessment of the TEMP. The
rials for Surgical Implants with Respect to Effect of
animalmodelsutilizearangeofspeciesincludingrat(murine),
Materials on Muscle and Bone
rabbit (lapine), dog (canine), goat (caprine), pig (porcine),
F1983 Practice for Assessment of Compatibility of
sheep (ovine), and non-human primate (primates). Outcome
Absorbable/Resorbable Biomaterials for ImplantApplica-
measures include in vivo assessments based on radiographic,
tions
histologic, CT imaging as well as subsequent in vitro assess-
F2150 Guide for Characterization and Testing of Biomate-
ments of the repair, including histologic analyses and mechani-
rial Scaffolds Used in Tissue-Engineered Medical Prod-
cal testing. All methods are described briefly and referenced.
ucts
The user should refer to specific test methods for additional
detail.
2.2 Other Standards
ISO 10993 Biological Evaluation of Medical TEMPs—Part
1.4 This guide is not intended to include the testing of raw
3
5: Tests for in vitro Cytotoxicity
materials, preparation of biomaterials, sterilization, or packag-
21 CFR Part 58 Good Laboratory Practice for Nonclinical
ing of the product. ASTM standards for these steps are
4
Laboratory Studies
available in Referenced Documents (Section 2).
21 CFR 610.12 General Biological Product Standards –
1.5 The use of any of the methods included in this guide 4
Sterility
may not produce a result that is consistent with clinical
performance in one or more specific applications.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
1.6 Other pre-clinical methods may also be appropriate and
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
this guide is not meant to exclude such methods. The material
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website.
1 3
This guide is under the jurisdiction of ASTM Committee F04 on Medical and Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
Surgical Materials and Devices and is the direct responsibility of Subcommittee 4th Floor, New York, NY 10036, http://www.ansi.org.
4
F04.44 on Assessment for TEMPs. AvailablefromU.S.GovernmentPrintingOfficeSuperintendentofDocuments,
Current edition approved April 1, 2012. Published April 2012. DOI: 10.1520/ 732 N. Capitol St., NW, Mail Stop: SDE, Washington, DC 20401, http://
F2884–12. www.access.gpo.gov.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
F2884 − 12
3. Terminology 3.1.11
...

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Standard Guide for  in vivo Evaluation of Osteoinductive Potential for Materials Containing Demineralized Bone (DBM)

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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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4.1 The objective of this guide is to provide guidance in the characterization of Type I collagen as a starting material for surgical implants and substrates for tissue engineered medical products (TEMPs). This guide contains a listing of physical and chemical parameters that are directly related to the function of collagen. This guide can be used as an aid in the selection and characterization of the appropriate collagen starting material for the 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) 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.  
4.4 The following documents or other appropriate guidances from appropriate regulatory bodies relating to the production, regulation, and regulatory approval of TEMPs products should be considered when determining if the collagen supplied satisfies requirements for use in TEMPs:    
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 F719-20e1(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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