ASTM F2312-11
(Terminology)Standard Terminology Relating to Tissue Engineered Medical Products
Standard Terminology Relating to Tissue Engineered Medical Products
SIGNIFICANCE AND USE
The need for standards regarding TEMPs has also prompted a need for definitions. This terminology sets forth definitions of the most commonly used terms and specifies the relationship among the sciences and components applied in tissue engineering to develop TEMPs. Use of these terms and an understanding of these relationships will unify the ASTM TEMPs standards with a common language such that the users of these standards can understand and interpret the standards more precisely. Terms specific to a TEMP standard will also be defined within the respective standard as appropriate.
Defining Terms—Terms are defined with a broad scope to encompass these new products known as TEMPs. For instance, the definition for somatic cell therapy as stated in the “Guidance for Human Somatic Cell Therapy and Gene Therapy” (4) is recognized in this terminology. However, for the purposes of TEMPs that contain cells, we have added the definition of “cell” which is much broader and not limited to the use of living cells.
Clinical Effects of TEMPs—The users of this terminology should note that terms used regarding the clinical effects of TEMPs, for instance, “modify or modification” of the patient's condition, may also be interpreted to “enhance, augment, transform, alter, improve, or supplement.” Similarly, “repair” may also serve to mean “restore.”
SCOPE
1.1 This terminology defines basic terms and presents the relationships of the scientific fields related to Tissue Engineered Medical Products (TEMPs). Committee F04 has defined these terms for the specific purpose of unifying the language used in standards for TEMPs.
1.2 The terms and relationships defined here are limited to TEMPs. They do 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 The terms and nomenclature presented in this standard are for the specific purposes of unifying the language used in TEMP standards and are not intended for labeling of regulated medical products.
1.4 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.
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Designation: F2312 − 11
Standard Terminology Relating to
1
Tissue Engineered Medical Products
This standard is issued under the fixed designation F2312; 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 tissue engineering to develop TEMPs. Use of these terms and
an understanding of these relationships will unify the ASTM
1.1 This terminology defines basic terms and presents the
TEMPs standards with a common language such that the users
relationships of the scientific fields related to Tissue Engi-
of these standards can understand and interpret the standards
neered Medical Products (TEMPs). Committee F04 has de-
more precisely.Terms specific to aTEMPstandard will also be
fined these terms for the specific purpose of unifying the
defined within the respective standard as appropriate.
language used in standards for TEMPs.
1.2 The terms and relationships defined here are limited to
3.2 Defining Terms—Terms are defined with a broad scope
TEMPs. They do not apply to any medical products of human
to encompass these new products known as TEMPs. For
origin regulated by the U.S. Food and Drug Administration
instance, the definition for somatic cell therapy as stated in the
under 21 CFR Parts 16 and 1270 and 21 CFR Parts 207, 807,
“Guidance for Human Somatic Cell Therapy and Gene
3
and 1271.
Therapy” (1) is recognized in this terminology. However, for
1.3 The terms and nomenclature presented in this standard the purposes of TEMPs that contain cells, we have added the
are for the specific purposes of unifying the language used in definition of “cell” which is much broader and not limited to
TEMPstandards and are not intended for labeling of regulated
the use of living cells.
medical products.
3.3 Clinical Effects of TEMPs—The users of this terminol-
1.4 This standard does not purport to address all of the
ogyshouldnotethattermsusedregardingtheclinicaleffectsof
safety concerns, if any, associated with its use. It is the
TEMPs, for instance, “modify or modification” of the patient’s
responsibility of the user of this standard to establish appro-
condition, may also be interpreted to “enhance, augment,
priate safety and health practices and determine the applica-
transform, alter, improve, or supplement.” Similarly, “repair”
bility of regulatory limitations prior to use.
may also serve to mean “restore.”
2. Referenced Documents
3.4 The diagram in Fig. 1 shows the relationships of
2
2.1 Government Documents:
components of TEMPs and of the fields of science (for
21 CFR Parts 16 and 1270 Human Tissues, Intended for
example, technologies and principles) used in tissue engineer-
Transplantation (July 29, 1997)
ing to createTEMPs. CertainTEMPs may be tissue engineered
21 CFR Parts 207, 807, and 1271 Human Cells,Tissues, and
or produced in vitro by using specific components and sciences
Cellular and Tissue-Based Products; Establishment Reg-
to create an off-the-shelf TEMP for the users. Other TEMPs
istration and Listing (January 19, 2001)
may by design require the users to place the components inside
the patient, (that is, in vivo) to rely upon the patient’s
3. Significance and Use
regenerative potential to achieve the product’s primary in-
3.1 The need for standards regarding TEMPs has also
tended purpose. The expectation of a TEMPused for therapeu-
prompted a need for definitions. This terminology sets forth
tic clinical applications is to have a therapeutic effect, specifi-
definitions of the most commonly used terms and specifies the
cally to repair, modify or regenerate the recipient’s cells,
relationship among the sciences and components applied in
tissues, and organs or their structure and function. Such a
TEMPmay be used for human and non-human applications. In
1
ThisterminologyisunderthejurisdictionofASTMCommitteeF04onMedical other applications, a TEMP may be used in diagnostic clinical
and Surgical Materials and Devicesand is the direct responsibility of Subcommittee
applications, or both, to achieve an investigative outcome of
F04.41 on Classification and Terminology for TEMPs.
the function of the cells, tissues, and organs.
Current edition approved April 1, 2011. Published May 2011. Originally
approved in 2003. Last previous edition approved in 2010 as F2312 – 10. DOI:
10.1520/F2312-11.
2
AvailablefromU.S.GovernmentPrintingOfficeSuperintendentofDocuments,
3
732 N. Capitol St., NW, Mail Stop: SDE, Washington, DC 20401, http:// The boldface numbers in parentheses refer to the list of references at the end of
www.access.gpo.gov. this standard.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohoc
...
This document is not anASTM standard and is intended only to provide the user of anASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation:F2312–10 Designation:F2312–11
Standard Terminology Relating to
1
Tissue Engineered Medical Products
This standard is issued under the fixed designation F2312; 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
1.1 This terminology defines basic terms and presents the relationships of the scientific fields related to Tissue Engineered
Medical Products (TEMPs). Committee F04 has defined these terms for the specific purpose of unifying the language used in
standards for TEMPs.
1.2 The terms and relationships defined here are limited toTEMPs.They do 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 The terms and nomenclature presented in this standard are for the specific purposes of unifying the language used inTEMP
standards and are not intended for labeling of regulated medical products.
1.4 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.
2. Referenced Documents
2
2.1 Government Documents:
21 CFR Parts 16 and 1270,1270 Human Tissues, Intended for Transplantation (July 29, 1997)
21 CFR Parts 207, 807, and 1271, Human Cells, Tissues, and Cellular and Tissue-Based Products; Establishment Registration
and Listing (January 19, 2001)
3. Significance and Use
3.1 The need for standards regarding TEMPs has also prompted a need for definitions. This terminology sets forth definitions
of the most commonly used terms and specifies the relationship among the sciences and components applied in tissue engineering
to develop TEMPs. Use of these terms and an understanding of these relationships will unify the ASTM TEMPs standards with
acommonlanguagesuchthattheusersofthesestandardscanunderstandandinterpretthestandardsmoreprecisely.Termsspecific
to a TEMP standard will also be defined within the respective standard as appropriate.
3.2 Defining Terms—Terms are defined with a broad scope to encompass these new products known as TEMPs. For instance,
3
the definition for somatic cell therapy as stated in the “Guidance for Human Somatic Cell Therapy and Gene Therapy” (4) is
recognized in this terminology. However, for the purposes of TEMPs that contain cells, we have added the definition of “cell”
which is much broader and not limited to the use of living cells.
3.3 Clinical Effects of TEMPs—The users of this terminology should note that terms used regarding the clinical effects of
TEMPs,forinstance,“modifyormodification”ofthepatient’scondition,mayalsobeinterpretedto“enhance,augment,transform,
alter, improve, or supplement.” Similarly, “repair” may also serve to mean “restore.”
3.4 The diagram in Fig. 1 shows the relationships of components of TEMPs and of the fields of science (for example,
technologies and principles) used in tissue engineering to create TEMPs. Certain TEMPs may be tissue engineered or produced
in vitro by using specific components and sciences to create an off-the-shelf TEMP for the users. Other TEMPs may by design
require the users to place the components inside the patient, (that is, in vivo) to rely upon the patient’s regenerative potential to
achieve the product’s primary intended purpose. The expectation of a TEMP used for therapeutic clinical applications is to have
a therapeutic effect, specifically to repair, modify or regenerate the recipient’s cells, tissues, and organs or their structure and
function. Such a TEMP may be used for human and non-human applications. In other applications, a TEMP may be used in
diagnostic clinical applications, or both, to achieve an investigative outcome of the function of the cells, tissues, and organs.
1
This terminology is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of Subcommittee
F04.41 on Classification and Terminology for TEMPs.
Current edition approved JuneApril 1, 2010.2011. Published July 2010.May 2011. Originally approved in 2003. Last previous edition approved in 20042010 as
F2312 – 104. DOI: 10.1520/F2312-101.
2
Available from U.S. Government Printing O
...
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