ASTM F2312-03

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.
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.

General Information

• Status: Historical
• Publication Date: 09-Sep-2003
• ICS: 01.040.11 - Health care technology (Vocabularies)
• ICS: 11.120.99 - Other standards related to pharmaceutics
• Technical Committee: F04 - Medical and Surgical Materials and Devices
• Drafting Committee: F04.41 - Classification and Terminology for TEMPs

Relations

• Replaced By: ASTM F2312-04 - Standard Terminology Relating to Tissue Engineered Medical Products
• Effective Date: 01-Nov-2004
• Referred By: ASTM F3504-21 - Standard Practice for Quantifying Cell Proliferation in 3D Scaffolds by a Nondestructive Method
• Effective Date: 10-Sep-2003
• Referred By: ASTM F3142-16 - Standard Guide for Evaluation of <emph type="bdit">in vitro</emph> Release of Biomolecules from Biomaterials Scaffolds for TEMPs
• Effective Date: 10-Sep-2003
• Referred By: ASTM F3225-17(2022) - Standard Guide for Characterization and Assessment of Vascular Graft Tissue Engineered Medical Products (TEMPs)
• Effective Date: 10-Sep-2003
• Referred By: ASTM F3368-19 - Standard Guide for Cell Potency Assays for Cell Therapy and Tissue Engineered Products
• Effective Date: 10-Sep-2003
• Referred By: ASTM F3163-22 - Standard Guide for Categories and Terminology of Cellular and/or Tissue-Based Products (CTPs) for Skin Wounds
• Effective Date: 10-Sep-2003
• Referred By: ASTM F3369-19e1 - Standard Guide for Assessing the Skeletal Myoblast Phenotype
• Effective Date: 10-Sep-2003
• Referred By: ASTM F2997-21 - Standard Practice for Quantification of Calcium Deposits in Osteogenic Culture of Progenitor Cells Using Fluorescent Image Analysis
• Effective Date: 10-Sep-2003
• Referred By: ASTM F3223-17 - Standard Guide for Characterization and Assessment of Tissue Engineered Medical Products (TEMPs) for Knee Meniscus Surgical Repair and/or Reconstruction
• Effective Date: 10-Sep-2003
• Referred By: ASTM F3224-17 - Standard Test Method for Evaluating Growth of Engineered Cartilage Tissue using Magnetic Resonance Imaging
• Effective Date: 10-Sep-2003
• Referred By: ASTM F3209-16 - Standard Guide for Autologous Platelet-Rich Plasma for Use in Tissue Engineering and Cell Therapy
• Effective Date: 10-Sep-2003
• Referred By: ASTM F2315-18 - Standard Guide for Immobilization or Encapsulation of Living Cells or Tissue in Alginate Gels
• Effective Date: 10-Sep-2003
• Referred By: ASTM F2664-19e1 - Standard Guide for Assessing the Attachment of Cells to Biomaterial Surfaces by Physical Methods
• Effective Date: 10-Sep-2003
• Referred By: ASTM F2150-19 - Standard Guide for Characterization and Testing of Biomaterial Scaffolds Used in Regenerative Medicine and Tissue-Engineered Medical Products
• Effective Date: 10-Sep-2003
• Referred By: ASTM F3274-21 - Standard Guide for Testing and Characterization of Alginate Foam Scaffolds Used in Tissue-Engineered Medical Products (TEMPs)
• Effective Date: 10-Sep-2003

Standards Content (Sample)

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:F2312–03
Standard Terminology Relating to
1
Tissue Engineered Medical Products
This standard is issued under the fixed designation F 2312; 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 (e) indicates an editorial change since the last revision or reapproval.
1. Scope 3. Significance and Use
1.1 This terminology defines basic terms and presents the 3.1 The need for standards regarding TEMPs has also
relationships of the scientific fields related to Tissue Engi- prompted a need for definitions. This terminology sets forth
neered Medical Products (TEMPs). Committee F04 has de- definitions of the most commonly used terms and specifies the
fined these terms for the specific purpose of unifying the relationship among the sciences and components applied in
language used in standards for TEMPs. tissue engineering to develop TEMPs. Use of these terms and
1.2 The terms and relationships defined here are limited to an understanding of these relationships will unify the ASTM
TEMPs. They do not apply to any medical products of human TEMPs standards with a common language such that the users
origin regulated by the U.S. Food and Drug Administration of these standards can understand and interpret the standards
under 21 CFR Parts 16 and 1270 and 21 CFR Parts 207, 807, more precisely.Terms specific to aTEMPstandard will also be
and 1271. defined within the respective standard as appropriate.
1.3 The terms and nomenclature presented in this standard 3.2 Defining Terms—Terms are defined with a broad scope
are for the specific purposes of unifying the language used in to encompass these new products known as TEMPs. For
TEMPstandards and are not intended for labeling of regulated instance, the definition for somatic cell therapy as stated in the
medical products. “Guidance for Human Somatic Cell Therapy and Gene
4
1.4 This standard does not purport to address all of the Therapy” (5) is recognized in this terminology. However, for
safety concerns, if any, associated with its use. It is the the purposes of TEMPs that contain cells, we have added the
responsibility of the user of this standard to establish appro- definition of “cell” which is much broader and not limited to
priate safety and health practices and determine the applica- the use of living cells.
bility of regulatory limitations prior to use. 3.3 Clinical Effects of TEMPs—The users of this terminol-
ogyshouldnotethattermsusedregardingtheclinicaleffectsof
2. Referenced Documents
TEMPs, for instance, “modify or modification” of the patient’s
2
2.1 ASTM Standards: condition, may also be interpreted to “enhance, augment,
F 2027 Guide for Characterization and Testing of Substrate
transform, alter, improve, or supplement.” Similarly, “repair”
Materials for Tissue-Engineered Medical Products may also serve to mean “restore.”
F 2311 Guide for Classification of Therapeutic Skin Substi-
3.4 The diagram in Fig. 1 shows the relationships of
tutes components of TEMPs and of the fields of science (for
3
2.2 Government Documents:
example, technologies and principles) used in tissue engineer-
21 CFR Parts 16 and 1270, Human Tissues, Intended for ing to createTEMPs. CertainTEMPs may be tissue engineered
Transplantation (July 29, 1997)
or produced in vitro by using specific components and sciences
21 CFR Parts 207, 807, and 1271, Human Cells, Tissues, to create an off-the-shelf TEMP for the users. Other TEMPs
and Cellular and Tissue-Based Products; Establishment
may by design require the users to place the components inside
Registration and Listing (January 19, 2001) the patient, (that is, in vivo) to rely upon the patient’s
regenerative potential to achieve the product’s primary in-
tended purpose. The expectation of a TEMPused for therapeu-
1
ThisterminologyisunderthejurisdictionofASTMCommitteeF04onMedical
tic clinical applications is to have a therapeutic effect, specifi-
and Surgical Materials and Devices and is the direct responsibility of Subcommittee
cally to repair, modify or regenerate the recipient’s cells,
F04.41 on Classification and Terminology for TEMPs.
Current edition approved Sept. 10, 2003. Published November 2003. tissues, and organs or their structure and function. Such a
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
TEMPmay be used for human and non-human applications. In
contactASTM Customer Service at [e-mail]. ForAnnual Book ofASTM
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website.
3 4
AvailablefromU.S.GovernmentPrintingOfficeSuperintendentofDocuments, The boldface numbers in parentheses refer to this list of references at the end
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