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ASTM F2903-11

(Guide)

Standard Guide for Tissue Engineered Medical Products (TEMPs) for Reinforcement of Tendon and Ligament Surgical Repair (Withdrawn 2020)

Standard Guide for Tissue Engineered Medical Products (TEMPs) for Reinforcement of Tendon and Ligament Surgical Repair (Withdrawn 2020)

SIGNIFICANCE AND USE
Injuries to tendons or ligaments are frequently treated by surgery to repair the damaged tissues and facilitate the healing process. The potential of TEMPs to enhance the outcomes (including function, pain, anatomy) of the surgical repair has been recognized.
Examples of tissues that when injured may be appropriate for repair using TEMPs: rotator cuff with a partial or full tear; Achilles tendon; Achilles tendon after harvesting for anterior cruciate ligament repair; patella tendon; patella tendon after harvesting for anterior cruciate ligament repair; quadriceps tendon; posterior cruciate ligament; medial collateral ligaments; lateral collateral ligaments; flexor tendons.  
TEMPs may be used with the intent to improve the surgical outcome of tendon or ligament repair by (a) assuming some of the mechanical load experienced at the repair site to stabilize the surgical repair, (b) improving the natural biological healing process, or (c) a combination of these mechanisms.  
TEMPs should improve clinical outcome. This may be accomplished by reducing or eliminating pain, returning function, shortening the recovery time following surgery, facilitating early mobility, improving return of strength, improving mobility, or other clinically relevant parameters.  
The mechanism used by TEMPs to improve surgical repair should be understood and this conclusion should be supported by experimental results and should be supportive of the primary function of the TEMP.  
TEMPs with the primary function of mechanical reinforcement may also have a secondary, biological function.  
When the product is used to improve the body’s natural biological repair process of tendons or ligaments, the product should allow cell attachment, migration, infiltration, extracellular matrix deposition and organization, formation of tendon or ligament repair tissue, integration with adjacent tendon, ligament or bone, tendon-bone attachment, or more than one of these actions.  
When the TEMP is used ...
SCOPE
1.1 This guide is intended as a resource for individuals and organizations involved in the development, production, and delivery of tissue engineered medical products (TEMPs) intended to provide a mechanical (functional) reinforcement of the surgical repair of tendons and ligaments.
1.2 Surgical repair can include procedures that repair tendon to tendon, tendon to bone, tendon to muscle, ligament to ligament, and ligament to bone. In the context of this guide, a tendon is a fibrous cord or band that connects a muscle to a bone or other structure and consists of both dense collagenous fibers and rows of elongated tendon cells. In contrast, a ligament is a band or sheet of fibrous tissue connecting two or more bones, or cartilagenous structures.
1.3 Examples of TEMPs for use in reinforcement of tendon or ligament repairs include extracellular matrices (including allograft tissue, xenograft tissue, and tissue engineered extracellular matrix), polymeric matrices, membranes, or combinations of two or more of these, with or without cells and/or molecular mediators, where the function is to reinforce the surgical repair of tendon to tendon, tendon to bone, tendon to muscle, ligament to ligament, or ligament to bone.
1.4 The products may be rapidly degrading, slowly degrading, or non-degrading.
1.5 The guide is not intended to apply to TEMPs that have a primary function to induce a biological repair through cell or molecular action, although biologic activity may be a feature of the TEMPs. Examples of products or product concepts that are not included are (a) growth factors or cytokines applied to a biologic or synthetic scaffold, and (b) platelet-enriched plasma applied to or within a biologic or polymeric scaffold, where the primary function of the product is biologic.
1.6 The guide is not intended to apply to TEMPs that have a primary function to induce a chemical repair. An example of a product or product concept t...

General Information

Status
Withdrawn
Publication Date
28-Feb-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
F04.44 - Assessment for TEMPs
Current Stage
Ref Project

Relations

Referred By
ASTM F3354-19 - Standard Guide for Evaluating Extracellular Matrix Decellularization Processes
Effective Date
01-Mar-2011

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ASTM F2903-11 - Standard Guide for Tissue Engineered Medical Products (TEMPs) for Reinforcement of Tendon and Ligament Surgical Repair (Withdrawn 2020)ASTM F2903-11 - Standard Guide for Tissue Engineered Medical Products (TEMPs) for Reinforcement of Tendon and Ligament Surgical Repair (Withdrawn 2020)
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ASTM F2903-11 - Standard Guide for Tissue Engineered Medical Products (TEMPs) for Reinforcement of Tendon and Ligament Surgical Repair (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: F2903 − 11
Standard Guide for
Tissue Engineered Medical Products (TEMPs) for
1
Reinforcement of Tendon and Ligament Surgical Repair
This standard is issued under the fixed designation F2903; 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 be a polymeric matrix containing reagents that glue collag-
enous tissues together.
1.1 This guide is intended as a resource for individuals and
organizations involved in the development, production, and 1.7 The guide is not intended to apply to TEMPs that are
delivery of tissue engineered medical products (TEMPs) in- designed to be used to achieve primary surgical repair of
tended to provide a mechanical (functional) reinforcement of injured tendons and ligaments.
the surgical repair of tendons and ligaments.
1.8 The guide is not intended to apply to TEMPs that are
1.2 Surgicalrepaircanincludeproceduresthatrepairtendon designed to replace tendons or ligaments.
to tendon, tendon to bone, tendon to muscle, ligament to
1.9 The values stated in SI units are to be regarded as
ligament, and ligament to bone. In the context of this guide, a
standard. No other units of measurement are included in this
tendon is a fibrous cord or band that connects a muscle to a
standard.
bone or other structure and consists of both dense collagenous
1.10 This standard does not purport to address all of the
fibers and rows of elongated tendon cells. In contrast, a
safety concerns, if any, associated with its use. It is the
ligament is a band or sheet of fibrous tissue connecting two or
responsibility of the user of this standard to establish appro-
more bones, or cartilagenous structures.
priate safety and health practices and determine the applica-
1.3 Examples of TEMPs for use in reinforcement of tendon
bility of regulatory limitations prior to use.
or ligament repairs include extracellular matrices (including
allograft tissue, xenograft tissue, and tissue engineered extra-
2. Referenced Documents
cellular matrix), polymeric matrices, membranes, or combina-
2
2.1 ASTM Standards:
tions of two or more of these, with or without cells and/or
D1004 Test Method for Tear Resistance (Graves Tear) of
molecular mediators, where the function is to reinforce the
Plastic Film and Sheeting
surgical repair of tendon to tendon, tendon to bone, tendon to
D2990 Test Methods for Tensile, Compressive, and Flexural
muscle, ligament to ligament, or ligament to bone.
Creep and Creep-Rupture of Plastics
1.4 The products may be rapidly degrading, slowly
D3786 Test Method for Bursting Strength of Textile
degrading, or non-degrading.
Fabrics—Diaphragm Bursting Strength Tester Method
D3787 Test Method for Bursting Strength of Textiles—
1.5 The guide is not intended to apply to TEMPs that have
Constant-Rate-of-Traverse (CRT) Ball Burst Test
a primary function to induce a biological repair through cell or
D5035 Test Method for Breaking Force and Elongation of
molecularaction,althoughbiologicactivitymaybeafeatureof
Textile Fabrics (Strip Method)
the TEMPs. Examples of products or product concepts that are
E139 Test Methods for Conducting Creep, Creep-Rupture,
not included are (a) growth factors or cytokines applied to a
and Stress-Rupture Tests of Metallic Materials
biologic or synthetic scaffold, and (b) platelet-enriched plasma
F1635 Test Method forin vitro Degradation Testing of Hy-
applied to or within a biologic or polymeric scaffold, where the
drolytically Degradable Polymer Resins and Fabricated
primary function of the product is biologic.
Forms for Surgical Implants
1.6 The guide is not intended to apply to TEMPs that have
F1978 Test Method for Measuring Abrasion Resistance of
a primary function to induce a chemical repair.An example of
Metallic Thermal Spray Coatings by Using the Taber
a product or product concept that would not be included would
Abraser
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
F04.44 on Assessment for TEMPs. contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Current edition approved March 1, 2011. Published April 2011. DOI: 10.1520/ Standards volume information, refer to the standard’s Document Summary page on
F2903–11. the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
F2903 − 11
F2150 Guide for Characterization and Testi
...

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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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SCOPE
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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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SIGNIFICANCE AND USE
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 F719-20(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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