ASTM F3515-21

Standard Guide for Characterization and Testing of Porcine Fibrinogen as a Starting Material for Use in Biomedical and Tissue-Engineered Medical Product Applications

SIGNIFICANCE AND USE
5.1 The purpose of this guide is to provide guidance on characterization of the properties of porcine fibrinogen as a starting material for surgical implants and as a matrix for tissue-engineered medical products (TEMPs). This guide contains a set of physical and chemical parameters directly related to the function of porcine fibrinogen. This guide can be used to help select and characterize appropriate fibrinogen starting materials for specific purposes. Not all tests or parameters are suitable for all uses of fibrinogen.  
5.2 Fibrinogen described in this guide may be used in various types of medical products including, but not limited to, implants, tissue-engineered medical products (TEMPs), and cell, drug, or DNA delivery vectors. The recommendations in this guide shall not be construed to guarantee the successful clinical application of any tissue-engineered medical product.  
5.3 In determining whether fibrinogen meets the requirements for use in a TEMP, the relevant regulatory authorities or other appropriate guidelines relating to the production, regulation, and approval of TEMP products shall be taken into account (Guide E1298, Practice F981, Practice F1983).
SCOPE
1.1 This guide covers the evaluation of porcine fibrinogen suitable for use in biomedical or pharmaceutical applications including, but not limited to, tissue-engineered medical products (TEMPs).  
1.2 This guide addresses key parameters relevant for functionality, characterization, and purity of porcine fibrinogen.  
1.3 As with any material, some characteristics of porcine fibrinogen may be altered by processing techniques, such as electrospinning (1)2 and sterilization, required for the production of a specific formulation or device. Therefore, properties of fabricated forms of this protein should be evaluated using test methods that are appropriate to ensure safety and efficacy and are not addressed in this guide.  
1.4 The primary focus of this document is fibrinogen derived from porcine blood, which is similar to human fibrinogen. The biggest advantage that pigs have over other species (such as cattle, sheep, goats, elk, and deer) is that they are less likely to transmit transmissible spongiform encephalitis (TSE) (ISO 22442-1 Annex D; WHO Guidelines, 2003; WHO Guidelines, 2006; WHO Guidelines, 2010). The document may also discuss fibrinogen from other sources when useful information is available. Fibrin is also discussed in some sections.  
1.5 Units—The values stated in SI units are to be regarded as the standard. No other units of measurement are included in this 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 this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.7 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.

General Information

• Status: Published
• Publication Date: 31-Jul-2021
• ICS: 11.100.20 - Biological evaluation of medical devices
• Technical Committee: F04 - Medical and Surgical Materials and Devices
• Drafting Committee: F04.42 - Biomaterials and Biomolecules for TEMPs

Standards Content (Sample)

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.
Designation: F3515 − 21
Standard Guide for
Characterization and Testing of Porcine Fibrinogen as a
Starting Material for Use in Biomedical and Tissue-
1
Engineered Medical Product Applications
This standard is issued under the fixed designation F3515; 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 1.7 This international standard was developed in accor-
dance with internationally recognized principles on standard-
1.1 This guide covers the evaluation of porcine fibrinogen
ization established in the Decision on Principles for the
suitable for use in biomedical or pharmaceutical applications
Development of International Standards, Guides and Recom-
including, but not limited to, tissue-engineered medical prod-
mendations issued by the World Trade Organization Technical
ucts (TEMPs).
Barriers to Trade (TBT) Committee.
1.2 This guide addresses key parameters relevant for
functionality, characterization, and purity of porcine fibrino-
2. Referenced Documents
gen.
3
2.1 ASTM Standards:
1.3 As with any material, some characteristics of porcine
E1298 Guide for Determination of Purity, Impurities, and
fibrinogen may be altered by processing techniques, such as
Contaminants in Biological Drug Products (Withdrawn
2
4
electrospinning (1) and sterilization, required for the produc-
2014)
tion of a specific formulation or device. Therefore, properties
F981 Practice for Assessment of Compatibility of Biomate-
of fabricated forms of this protein should be evaluated using
rials for Surgical Implants with Respect to Effect of
test methods that are appropriate to ensure safety and efficacy
Materials on Muscle and Insertion into Bone
and are not addressed in this guide.
F1983 Practice forAssessment of Selected Tissue Effects of
1.4 The primary focus of this document is fibrinogen Absorbable Biomaterials for Implant Applications
F2212 Guide for Characterization of Type I Collagen as
derived from porcine blood, which is similar to human fibrino-
gen. The biggest advantage that pigs have over other species Starting Material for Surgical Implants and Substrates for
(such as cattle, sheep, goats, elk, and deer) is that they are less Tissue Engineered Medical Products (TEMPs)
likely to transmit transmissible spongiform encephalitis (TSE) F3163 Guide for Classification of Cellular and/or Tissue-
(ISO 22442-1 Annex D; WHO Guidelines, 2003; WHO Based Products (CTPs) for Skin Wounds
5
Guidelines,2006;WHOGuidelines,2010).Thedocumentmay
2.2 ISO Standards:
also discuss fibrinogen from other sources when useful infor-
ISO10993-1 Biologicalevaluationofmedicaldevices—Part
mation is available. Fibrin is also discussed in some sections.
1: Evaluation and testing with a risk management process
1.5 Units—The values stated in SI units are to be regarded ISO 11137-1:2006 Sterilization of health care products—
Radiation—Part 1: Requirements for validation and rou-
as the standard. No other units of measurement are included in
this standard. tine control of a sterilization process for medical devices
ISO 11737-1:2006 Sterilization of health care products—
1.6 This standard does not purport to address all of the
Microbiological methods—Part 1: Determination of a
safety concerns, if any, associated with its use. It is the
population of microorganisms on products
responsibility of the user of this standard to establish appro-
ISO 11737-2:1998 Sterilization of health care products—
priate safety, health, and environmental practices and deter-
mine the applicability of regulatory limitations prior to use.
3
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
1
This guide is under the jurisdiction of ASTM Committee F04 on Medical and contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
Surgical Materials and Devices and is the direct responsibility of Subcommittee Standards volume information, refer to the standard’s Document Summary page on
F04.42 on Biomaterials and Biomolecules for TEMPs. the ASTM website.
4
Current edition approved Aug. 1, 2021. Published August 2021. DOI: 10.1520/ The last approved version of this historical standard is referenced on
F3515-21. www.astm.org.
2 5
The boldface numbers in parentheses refer to a list of references at the end of Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
this standard. 4th Floor, New York, NY 10036, http://www.ansi.org.
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