ASTM F2312-04
(Terminology)Standard Terminology Relating to Tissue Engineered Medical Products
Standard Terminology Relating to Tissue Engineered Medical Products
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.
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:F2312–04
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 TEMPs standards with a common language such that the users
of these standards can understand and interpret the standards
1.1 This terminology defines basic terms and presents the
more precisely.Terms specific to aTEMPstandard will also be
relationships of the scientific fields related to Tissue Engi-
defined within the respective standard as appropriate.
neered Medical Products (TEMPs). Committee F04 has de-
3.2 Defining Terms—Terms are defined with a broad scope
fined these terms for the specific purpose of unifying the
to encompass these new products known as TEMPs. For
language used in standards for TEMPs.
instance, the definition for somatic cell therapy as stated in the
1.2 The terms and relationships defined here are limited to
“Guidance for Human Somatic Cell Therapy and Gene
TEMPs. They do not apply to any medical products of human
3
Therapy” (4) is recognized in this terminology. However, for
origin regulated by the U.S. Food and Drug Administration
the purposes of TEMPs that contain cells, we have added the
under 21 CFR Parts 16 and 1270 and 21 CFR Parts 207, 807,
definition of “cell” which is much broader and not limited to
and 1271.
the use of living cells.
1.3 The terms and nomenclature presented in this standard
3.3 Clinical Effects of TEMPs—The users of this terminol-
are for the specific purposes of unifying the language used in
ogyshouldnotethattermsusedregardingtheclinicaleffectsof
TEMPstandards and are not intended for labeling of regulated
TEMPs, for instance, “modify or modification” of the patient’s
medical products.
condition, may also be interpreted to “enhance, augment,
1.4 This standard does not purport to address all of the
transform, alter, improve, or supplement.” Similarly, “repair”
safety concerns, if any, associated with its use. It is the
may also serve to mean “restore.”
responsibility of the user of this standard to establish appro-
3.4 The diagram in Fig. 1 shows the relationships of
priate safety and health practices and determine the applica-
components of TEMPs and of the fields of science (for
bility of regulatory limitations prior to use.
example, technologies and principles) used in tissue engineer-
2. Referenced Documents ing to createTEMPs. CertainTEMPs may be tissue engineered
2
or produced in vitro by using specific components and sciences
2.1 Government Documents:
to create an off-the-shelf TEMP for the users. Other TEMPs
21 CFR Parts 16 and 1270, Human Tissues, Intended for
may by design require the users to place the components inside
Transplantation (July 29, 1997)
the patient, (that is, in vivo) to rely upon the patient’s
21 CFR Parts 207, 807, and 1271, Human Cells, Tissues,
regenerative potential to achieve the product’s primary in-
and Cellular and Tissue-Based Products; Establishment
tended purpose.The expectation of aTEMPused for therapeu-
Registration and Listing (January 19, 2001)
tic clinical applications is to have a therapeutic effect, specifi-
3. Significance and Use
cally to repair, modify or regenerate the recipient’s cells,
tissues, and organs or their structure and function. Such a
3.1 The need for standards regarding TEMPs has also
TEMPmay be used for human and non-human applications. In
prompted a need for definitions. This terminology sets forth
other applications, a TEMP may be used in diagnostic clinical
definitions of the most commonly used terms and specifies the
applications, or both, to achieve an investigative outcome of
relationship among the sciences and components applied in
the function of the cells, tissues, and organs.
tissue engineering to develop TEMPs. Use of these terms and
an understanding of these relationships will unify the ASTM
4. Terminology
adventitious agents, n—an unintentionally introduced micro-
1
biological or other infectious contaminant. In the production
ThisterminologyisunderthejurisdictionofASTMCommitteeF04onMedical
and Surgical Materials and Devices and is the direct responsibility of Subcommittee of TEMPs, these agents may be unintentionally introduced
F04.41 on Classification and Terminology for TEMPs.
into the process stream or the final product, or both.
Current edition approved Nov. 1, 2004. Published December 2004. Originally
approved in 2003. Last previous edition approved in 2003 as F2312 – 03. DOI:
10.1520/F2312-04.
2 3
AvailablefromU.S.GovernmentPrintingOfficeSuperintendentofDocuments, The boldface number
...
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