ASTM F2211-04
(Classification)Standard Classification for Tissue Engineered Medical Products (TEMPs) (Withdrawn 2013)
Standard Classification for Tissue Engineered Medical Products (TEMPs) (Withdrawn 2013)
SIGNIFICANCE AND USE
This classification outlines aspects of TEMPs which includes their individual components.
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
Since interactions may occur among the components used in TEMPs, new standard descriptions, test methods, and practices are needed to aid the evaluation of these interactions. The degree of overall risk for any given TEMP is reflected by the number and types of tests required to demonstrate product safety and efficacy.
SCOPE
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.
1.2 This classification does not apply to any medical products of human origin regulated by the U.S. Food and Drug Administration under 21 CFR Parts 16 and 1270 and 21 CFR Parts 207, 807, and 1271.
1.3 This standard does not purport to address specific components coverd in other standards. Any safety areas associated with the medical product's use will not be addressed in this standard. 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 requirements prior to use.
WITHDRAWN RATIONALE
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.
Formerly under the jurisdiction of Committee F04 on Medical and Surgical Materials and Devices, this classification was withdrawn in January 2013 in accordance with section 10.5.3.1 of the Regulations Governing ASTM Technical Committees, which requires that standards shall be updated by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.
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Standards Content (Sample)
NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
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Designation:F2211 −04
StandardClassification for
1
Tissue Engineered Medical Products (TEMPs)
This standard is issued under the fixed designation F2211; 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 F2150 Guide for Characterization and Testing of Biomate-
rial Scaffolds Used in Tissue-Engineered Medical Prod-
1.1 This classification outlines the aspects of tissue engi-
ucts
neered medical products that will be developed as standards.
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2.2 Federal Documents:
This classification excludes traditional transplantation of or-
US FDA CFR 21, Part 3 [3.2(e)] Product Jurisdiction
gans and tissues as well as transplantation of living cells alone
21 CFR Parts 16 and 1270 Human Tissues, Intended for
as cellular therapies.
Transplantation
1.2 This classification does not apply to any medical prod-
21 CFR Parts 207, 807, and 1271 Human Cells,Tissues, and
ucts of human origin regulated by the U.S. Food and Drug
Cellular and Tissue-Based Products: Establishment Reg-
Administration under 21 CFR Parts 16 and 1270 and 21 CFR
istration and Listing
Parts 207, 807, and 1271.
2.3 ISO Standard:
1.3 This standard does not purport to address specific 4
ISO 10993 Biological Evaluation of Medical Devices
components coverd in other standards. Any safety areas asso-
ciated with the medical product’s use will not be addressed in
3. Terminology
this standard. This standard does not purport to address all of
3.1 tissue engineering, n—the application, in vivo and in
the safety concerns, if any, associated with its use. It is the
vitro, of scientific principles and technologies to form tissue
responsibility of the user of this standard to establish appro-
engineered medical products (TEMPs) used for medical treat-
priate safety and health practices and determine the applica-
ments and as diagnostics. The various technologies and prin-
bility of regulatory requirements prior to use.
ciples are common practices and methods in engineering and
biomedical sciences such as cell, gene, or drug therapy,
2. Referenced Documents
embryology or other forms of developmental biology, surgical
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2.1 ASTM Standards:
methodsandtechnologiesusedtocreatetraditionaldevicesand
F2027 Guide for Characterization and Testing of Raw or
biologics. Tissue engineering could be applied to create prod-
Starting Biomaterials for Tissue-Engineered Medical
ucts for non-human use as well.
Products
3.2 tissue engineered medical products (TEMPs),
F2064 Guide for Characterization and Testing of Alginates
n—medical products that repair, modify, or regenerate the
as Starting Materials Intended for Use in Biomedical and
recipients’ cells, tissues, and organs, or their structure and
Tissue-Engineered Medical Products Application
function, or combination thereof. TEMPs may achieve a
F2103 Guide for Characterization and Testing of Chitosan
therapeutic potential from cells, biomolecules, scaffolds, and
Salts as Starting Materials Intended for Use in Biomedical
other materials, and processed tissues and derivatives used in
and Tissue-Engineered Medical Product Applications
various combinations or alone. TEMPs are unique from con-
F2131 Test Method forIn Vitro Biological Activity of Re-
ventional organ transplants. TEMPs may be used in vivo or in
combinant Human Bone Morphogenetic Protein-2
vitro for disease, injury, elective surgery, and as a diagnostic.
(rhBMP-2) Using the W-20 Mouse Stromal Cell Line
3.3 For other definitions used in this classification, refer to
the terms developed by the subcommittee on tissue engineered
1 medical products terminology.
This classification is under the jurisdiction of ASTM Committee F04 on
Medical and Surgical Materials and Devicesand is the direct responsibility of
3.3.1 Discussion—ASTM Committee F04 is continuing to
Subcommittee F04.41 on Classification and Terminology for TEMPs.
refine definitions for tissue engineered medical products
Current edition approved Oct. 1, 2004. Published October 2004. Originally
approved in 2002. Last previous edition approved in 2002 as F2211 – 02. DOI:
10.1520/F2211-04.
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For referenced ASTM standards, visit the ASTM website, www.astm.org, or AvailablefromU.S.GovernmentPrintingOfficeSuperintendentofDocuments,
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM 732 N. Capitol St., NW, Mail Stop: SDE, Washington, DC 20401.
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