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ASTM F2383-11

(Guide)

Standard Guide for Assessment of Adventitious Agents in Tissue Engineered Medical Products (TEMPs) (Withdrawn 2020)

Standard Guide for Assessment of Adventitious Agents in Tissue Engineered Medical Products (TEMPs) (Withdrawn 2020)

SIGNIFICANCE AND USE
TEMPs may be composed of biological products (for example, human cells, organs, tissues, derivatives, and processed biologics), biomaterials (for example, substrates and scaffolds composed of polymers or collagen), and biomolecules (for example, recombinant proteins, alginates, and hyaluronates) (see Terminology F2312). Those TEMPs that contain human viable cells, organs, or tissues differ in terms of adventitious agent safety from other TEMPs because of the need to preserve viability of the organ, tissue, or cellular components. The need for preservation of viability limits processing options for the reduction or elimination of adventitious agents. Examples of TEMPs are listed in Classification F2211.
To ensure production and use of TEMPs with minimal risks associated with microorganisms and other adventitious agents, a multi-tiered approach is required. Donor testing, as well as testing of components and raw materials by sufficiently sensitive assays that are state of the art is usually necessary. Compliance with good manufacturing practices (GMPs) and good tissue practices (GTPs), where applicable, is required (21 CFR 210, 211, 820, 1270, and 1271). Although some of the components of the TEMPs may be processed to remove potential microbiological contaminants, viable tissues and cellular components are generally unable to withstand rigorous processing without losing functionality. For those TEMPs containing tissues or cells for which banking is not possible, even greater reliance on donor screening, component testing, and manufacturing controls is required. When more upfront testing is possible, there is generally greater confidence in the safety of the final product. Process validation can enhance confidence in the ability of the TEMPs' producer to minimize risks from adventitious agents.
Throughout this guide, the reader is referred to other documents that may provide specific information that can be applied in the manufacture and testing of TEMPs. Although ...
SCOPE
1.1 This guide is intended as a resource for individuals and organizations involved in the production, delivery, and regulation of tissue engineered medical products (TEMPs). The safety from contamination by potentially infectious adventitious agents is important in the development of all TEMPs as well as their components. This guide addresses how to assess safety risks associated with adventitious agents and their byproducts. These agents currently include bacteria, fungi, mycoplasma, viruses, endotoxins, transmissible spongiform encephalopathies (TSEs), and parasitic organisms. This guide does not address TEMPs with live animal cells, tissues or organs, or human cells, including stem cells, grown on any animal feeder cells. Also excluded is patient follow-up testing.
1.2 This guide 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. This guide does apply to cellular therapies regulated under the PHS (Public Health Service) act.
1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
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 to determine the applicability of regulatory limitations prior to use.
WITHDRAWN RATIONALE
This guide was intended as a resource for individuals and organizations involved in the production, delivery, and regulation of tissue engineered medical products (TEMPs).
Formerly under the jurisdiction of Committee F04 on Medical and Surgical Materials and Devices, this guide was withdrawn in January 2020 in accordance with section 10.6.3 of the Regulations Governing ASTM Technical Committees, which requires that standards shall be upd...

General Information

Status
Withdrawn
Publication Date
28-Feb-2011
Withdrawal Date
13-Jan-2020
ICS
11.100.99 - Other standards related to laboratory medicine
Technical Committee
F04 - Medical and Surgical Materials and Devices
Drafting Committee
F04.45 - Adventitious Agents Safety
Current Stage
Ref Project

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ASTM F2383-11 - Standard Guide for Assessment of Adventitious Agents in Tissue Engineered Medical Products (TEMPs) (Withdrawn 2020)ASTM F2383-11 - Standard Guide for Assessment of Adventitious Agents in Tissue Engineered Medical Products (TEMPs) (Withdrawn 2020)
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ASTM F2383-11 - Standard Guide for Assessment of Adventitious Agents in Tissue Engineered Medical Products (TEMPs) (Withdrawn 2020)
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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: F2383 − 11
Standard Guide for
Assessment of Adventitious Agents in Tissue Engineered
1
Medical Products (TEMPs)
This standard is issued under the fixed designation F2383; 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 F2210 Guide for Processing Cells, Tissues, and Organs for
Use in Tissue Engineered Medical Products
1.1 This guide is intended as a resource for individuals and
F2211 Classification for Tissue Engineered Medical Prod-
organizations involved in the production, delivery, and regula-
ucts (TEMPs)
tion of tissue engineered medical products (TEMPs). The
F2312 Terminology Relating to Tissue Engineered Medical
safety from contamination by potentially infectious adventi-
Products
tious agents is important in the development of all TEMPs as
F2386 Guide for Preservation of Tissue Engineered Medical
well as their components. This guide addresses how to assess
Products (TEMPs)
safety risks associated with adventitious agents and their
2.2 ANSI/AAMI Standard:
byproducts. These agents currently include bacteria, fungi,
ST72 Bacterial Endotoxin—Test Methodologies, Routine
mycoplasma, viruses, endotoxins, transmissible spongiform
3
Monitoring and Alternatives to Batch Testing
encephalopathies (TSEs), and parasitic organisms. This guide
4
2.3 Federal Regulations:
does not address TEMPs with live animal cells, tissues or
9 CFR Animals and Animal Products
organs, or human cells, including stem cells, grown on any
21 CFR 210 Current Good Manufacturing Practice in
animal feeder cells.Also excluded is patient follow-up testing.
Manufacturing,Processing,Packing,orHoldingofDrugs,
1.2 This guide does not apply to any medical products of
General
human origin regulated by the U.S. Food and Drug Adminis-
21 CFR 211 Current Good Manufacturing Practice for Fin-
trationunder21CFRParts16and1270and21CFRParts207,
ished Pharmaceuticals
807 and 1271. This guide does apply to cellular therapies
21 CFR 610.12 General Biological Products Standards—
regulated under the PHS (Public Health Service) act.
Sterility
1.3 The values stated in SI units are to be regarded as 21CFR610.13(b) GeneralBiologicalProductsStandards—
standard. No other units of measurement are included in this
Purity Test for Pyrogenic Substances
standard. 21 CFR 820 Quality System Regulation
21 CFR 1270 Human Tissue Intended for Transplantation
1.4 This standard does not purport to address all of the
21 CFR 1271 Human Cells, Tissues, and Cellular and
safety concerns, if any, associated with its use. It is the
Tissue-Based Products
responsibility of the user of this standard to establish appro-
2.4 MDA Standard:
priate safety and health practices and to determine the
Code of Practice for the Production of Human-Derived
applicability of regulatory limitations prior to use.
5
Therapeutic Products
2. Referenced Documents
2.5 U. S. Pharmacopeia Document:
6
2
United States Pharmacopeia (USP), Edition XXIV (24)
2.1 ASTM Standards:
E1873 Guide for Detection of Nucleic Acid Sequences by
3. Terminology
the Polymerase Chain Reaction Technique
3.1 Definitions:
1
This guide is under the jurisdiction of ASTM Committee F04 on Medical and
3
Surgical Materials and Devices and is the direct responsibility of Subcommittee Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
F04.45 on Adventitious Agents Safety. 4th Floor, New York, NY 10036, http://www.ansi.org.
4
Current edition approved March 1, 2011. Published March 2011. Originally AvailablefromU.S.GovernmentPrintingOfficeSuperintendentofDocuments,
approved in 2005. Last previous edition approved in 2005 as F2383 – 05. DOI: 732 N. Capitol St., NW, Mail Stop: SDE, Washington, DC 20401, http://
10.1520/F2383-11. www.access.gpo.gov.
2 5
For referenced ASTM standards, visit the ASTM website, www.astm.org, or Available from Medicines and Healthcare Products Regulatory Agency
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM (MHRA), Hannibal House, Elephant & Castle, London SE1 6TQ, U.K.
6
Standards volume information, refer to the standard’s Document Summary page on Available from U.S. Pharmacopeia (USP), 12601Twinbrook Pkwy., Rockville,
the ASTM website. MD 20852-1790, http://www.usp.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
F2383 − 11
3.1.1 adventitiousagents,n—unintentionallyintroducedmi- the Production of Human-Derived Therapeutic Products pro-
crobiological or other infectious contaminant. In the produc- vides informa
...

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1.4 Measures of permeability should not be considered as definitive metrics of the structure of porous tissue scaffolds and should complement measures obtained by other investigative techniques, for example, scanning electron microscopy, gas flow porometry, and micro-computer X-ray tomography (Guides F2450, F2603, and F3259).  
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SCOPE
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4.1 The objective of this guide is to provide guidance in the characterization of Type I collagen as a starting material for surgical implants and substrates for tissue engineered medical products (TEMPs). This guide contains a listing of physical and chemical parameters that are directly related to the function of collagen. This guide can be used as an aid in the selection and characterization of the appropriate collagen starting material for the specific use. Not all tests or parameters are applicable to all uses of collagen.  
4.2 The collagen covered by this guide may be used in a broad range of applications, forms, or medical products, for example (but not limited to) medical devices, tissue engineered medical products (TEMPs) or cell, drug, or DNA delivery devices for implantation. The use of collagen in a practical application should be based, among other factors, on biocompatibility and physical test data. Recommendations in this guide should not be interpreted as a guarantee of clinical success in any tissue engineered medical product or drug delivery application.  
4.3 The following general areas should be considered when determining if the collagen supplied satisfies requirements for use in TEMPs. These are source of collagen, chemical and physical characterization and testing, and impurities profile.  
4.4 The following documents or other appropriate guidances from appropriate regulatory bodies relating to the production, regulation, and regulatory approval of TEMPs products should be considered when determining if the collagen supplied satisfies requirements for use in TEMPs:    
FDA CFR:  
21 CFR 3: Product Jurisdiction:  
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/
CFRSearch.cfm?CFRPart=3    
21 CFR 58: Good Laboratory Practice for Nonclinical Laboratory Studies:  
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/
CFRSearch.cfm?CFRPart=58    
FDA/CDRH CFR and Guidances:  
21 CFR Part 803: Medical Device ...
SCOPE
1.1 This guide for characterizing collagen-containing biomaterials is intended to provide characteristics, properties, and test methods for use by producers, manufacturers, and researchers to more clearly identify the specific collagen materials used. With greater than 20 types of collagen and the different properties of each, a single document would be cumbersome. This guide will focus on the characterization of Type I collagen, which is the most abundant collagen in mammals, especially in skin and bone. Collagen isolated from these sources may contain other types of collagen, for example, Type III and Type V. This guide does not provide specific parameters for any collagen product or mix of products or the acceptability of those products for the intended use. The collagen may be from any source including, but not limited to, animal or cadaveric sources, human cell culture, or recombinant sources. The biological, immunological, or toxicological properties of the collagen may vary, depending on the source material. The properties of the collagen prepared from each of the above sources must be thoroughly investigated, as the changes in the collagen properties as a function of source materials is not thoroughly understood. This guide is intended to focus on purified Type I collagen as a starting material for surgical implants and substrates for tissue engineered medical products (TEMPs); some methods may not be applicable for gelatin or tissue implants. This guide may serve as a template for characterization of other types of collagen.  
1.2 The biological response to collagen in soft tissue has been well documented by a history of clinical use (1, 2)2 and laboratory studies (3-6). Biocompatibility and appropriateness of use for a specific application(s) is the responsibility of the product manufacturer.  
1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this...

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ASTM
ASTM F619-20(Practice)
Standard Practice for Extraction of Materials Used in Medical Devices

SIGNIFICANCE AND USE
5.1 These extraction procedures are the initial part of several test procedures used in the biocompatibility screening of plastics or other materials used in medical devices.  
5.2 The limitations of the results obtained from this practice should be recognized. The choices of the extraction vehicle, duration of immersion, and temperature of the test are necessarily arbitrary. The specification of these conditions provides a basis for standardization and serves as a guide to investigators wishing to compare the relative resistance of various plastics or other materials to extraction vehicles.  
5.3 Correlation of test results with the actual performance or serviceability of materials is necessarily dependent upon the similarity between the testing and end-use conditions (see 12.1.2 and Note 7).  
5.4 Caution should be exercised in the understanding and intent of this practice as follows:  
5.4.1 No allowance or distinction is made for variables such as end-use application and duration of use. Decisions on selection of tests to be done should be made based on Practice F748.  
5.4.2 This practice was originally designed for use with nonporous, solid materials. Its application for other materials, such as those that are porous, absorptive (for example, sponge-like materials that are capable of absorbing liquid), or resorptive, should be considered with caution. Consideration should be given to altering the specified material-to-liquid ratio to allow additional liquid to fully hydrate the material and additional liquid or other methods to fully submerge the test specimen. Additional procedures that fully remove the extract liquid from the test specimen, such as pressure or physically squeezing the material, should also be considered as appropriate. Although no definitions are given in this practice for the following terms, such items as extraction vehicle surface tension at the specified extraction condition and test specimen physical structure should be taken into ...
SCOPE
1.1 This practice covers methods of extraction of medical plastics and may be applicable to other materials. This practice identifies a method for obtaining “extract liquid” for use in determining the biological response in preclinical testing. Further testing of the “extract liquid” is specified in other ASTM standards. The extract may undergo chemical analysis as part of the preclinical evaluation of the biological response, and the material after extraction may also be examined.  
1.2 This practice may be used for, but is not limited to, the following areas: partial evaluation of raw materials, auditing materials within the manufacturing process, and testing final products. This practice may also be used as a reference method for the measurement of extractables in plastics used in medical devices. In general, it is the responsibility of the user of the standard to determine if the methods described in this standard are appropriate for the materials in their device.  
1.3 This practice was initially developed for extraction of medical plastics not intended to undergo degradation or absorption during normal medical device usage. When applied to the extraction of absorbable materials, additional considerations may be necessary in the selection of extraction procedures and fluids.  
1.4 For assessment of compatibility of the Single-use System material with the cell culture medium or the manufacturing processes used for cell-based therapeutics, vaccines, cell-based diagnostics, or other biopharmaceutical products, the user should refer to Guide E3231.  
1.5 The values stated in SI units are to be regarded as standard. The values given in parentheses are mathematical conversions to inch-pound units that are provided for information only and are not considered standard.  
1.6 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 thi...

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ASTM
ASTM F719-20(Practice)
Standard Practice for Testing Materials in Rabbits for Primary Skin Irritation

SIGNIFICANCE AND USE
4.1 Materials that are to be in contact with the skin should not cause irritation to the skin. Since it is probably the substances leached from a material that cause the irritation, this practice provides for direct material-skin contact testing or for skin exposure to the liquid extract of the test material. The rationale for this rabbit test is that it is a comparatively quick and sensitive method which, through use over the years, has become a generally accepted method. Additionally, the albino rabbit allows for easy visualization of erythema and edema, which are the cardinal signs of skin irritation.
SCOPE
1.1 This practice covers a procedure by which the irritancy of a material may be assessed through contact with abraded and intact skin of rabbits.  
1.2 The results of this practice depend upon the effectiveness with which contact between the skin and the test material is established and maintained. Because of the operator technique included in performing this test, it is important that the test be performed by personnel with appropriate training.  
1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.4 This standard may involve hazardous materials, operations, and equipment. 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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