ASTM F2312-11 (2020) pdf free.Standard Terminology Relating to Tissue Engineered Medical Products.
This terminology defines basic terms and presents therelationships of the scientific fields related to Tissue Engineered Medical Products (TEMPs).Committee F04 has defined these terms for the specific purpose of unifying thelanguage used in standards for TEMPs.The terms and relationships defined here are limited toTEMPs.They do not apply to any medical products of humanorigin regulated by the U.S. Food and Drug Administrationunder 21 CFR Parts 16 and 1270 and 21 CFR Parts 207,807,and 1271.
The terms and nomenclature presented in this standardare for the specific purposes of unifying the language used inTEMP standards and are not intended for labeling of regulatedmedical products.
This standard does not purport to address all of thesafety concerns,if any, associated with its use. It is theresponsibility of the user of this standard to establish appropriate safety， health,and environmental practices and deter-mine the applicability of regulatory limitations prior to use.1.5 This international standard was developed in accor-dance with internationally recognized principles on standard-ization established in the Decision on Principles for theDevelopment of International Standards，Guides and Recom-mendations issued by the World Trade Organization TechnicalBarriers to Trade (TBT) Committee.
3.1 The need for standards regardingTEMPs has alsoprompted a need for definitions.This terminology sets forthdefinitions of the most commonly used terms and specifies therelationship among the sciences and components applied intissue engineering to develop TEMPs.Use of these terms andan understanding of these relationships will unify the ASTMTEMPs standards with a common language such that the usersof these standards can understand and interpret the standardsmore precisely.Terms specific to a TEMP standard will also bedefined within the respective standard as appropriate.
Terms are defined with a broad scopeto encompass these new products known as TEMPs. Forinstance, the definition for somatic cell therapy as stated in the“Guidance for Human Somatic Cell Therapy and GeneTherapy” (1)3is recognized in this terminology.However,forthe purposes of TEMPs that contain cells，we have added thedefinition of”cell”which is much broader and not limited tothe use of living cells.
The users of this terminol-ogy should note that terms used regarding the clinical effects ofTEMPs, for instance, “modify or modification”of the patient’scondition，may also be interpreted to “enhance，augment,transform,alter，improve,or supplement.”Similarly,”repairmay also serve to mean”restore.”
The diagram in Fig. 1 shows the relationships ofcomponents of TEMPs and of the fields of science (forexample, technologies and principles) used in tissue engineer-ing to create TEMPs.Certain TEMPs may be tissue engineeredor produced in vitro by using specific components and sciencesto create an off-the-shelf TEMP for the users.Other TEMPsmay by design require the users to place the components insidethe patient,(that is,in vivo) to rely upon the patient’sregenerative potential to achieve the product’s primary intended purpose. The expectation of a TEMP used for therapeu-tic 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 aTEMP may be used for human and nonhuman applications.ASTM F2312 pdf download.