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ASTM F3225-17

(Guide)

Standard Guide for Characterization and Assessment of Vascular Graft Tissue Engineered Medical Products (TEMPs)

Standard Guide for Characterization and Assessment of Vascular Graft Tissue Engineered Medical Products (TEMPs)

SIGNIFICANCE AND USE
4.1 A common therapy to mitigate the pathological effects of blood vessel occlusion or aneurysm-related vascular wall weakening is to reroute blood flow around the diseased vascular regions. Autologous and non-autologous grafts are often used as vascular substitutes surgically to achieve this therapeutic intervention. Vascular graft TEMPs may also be used for these purposes. They may also be used to create or revise arteriovenous shunts.  
4.2 Coronary, carotid, renal, common iliac, external iliac, superficial femoral, and popliteal arteries are examples of vascular sites commonly requiring bypass surgery.  
4.3 TEMPs may be composed of biological products (for example, cells, organs, and tissues), biomaterials (for example, substrates and scaffolds composed of polymers or collagen), biomolecules (for example, recombinant proteins, native/biological proteins, amino acids, peptides, fatty acids, sugars and other macromolecules) and various combinations thereof (see Terminology F2312). Examples of TEMPs are listed in Classification F2211.  
4.4 TEMPs may be used with the intent of facilitating the surgical outcome by improving the biological repair and/or reconstruction, by accommodating the mechanical loads at the repair site, or by a combination of these mechanisms.  
4.5 Clinical evidence of improved surgical outcomes may include patency, reduced incidence of revision surgery, reduced rate of implant infection, and improved functionality after surgery.
SCOPE
1.1 This guide is intended as a resource for individuals and organizations involved in the development, production, delivery, and regulation of tissue engineered medical products (TEMPs) intended for use in the surgical repair, replacement, shunting and/or bypass of blood vessels. This guide is intended for use related to the in vitro assessment of TEMP vascular grafts. In vitro cellular characterization and in vivo testing are not within scope for this standard guide.  
1.2 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.  
1.3 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
Historical
Publication Date
14-Nov-2017
ICS
11.040.40 - Implants for surgery, prosthetics and orthotics
Technical Committee
F04 - Medical and Surgical Materials and Devices
Drafting Committee
F04.44 - Assessment for TEMPs
Current Stage
Ref Project

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ASTM F3225-17 - Standard Guide for Characterization and Assessment of Vascular Graft Tissue Engineered Medical Products (TEMPs)ASTM F3225-17 - Standard Guide for Characterization and Assessment of Vascular Graft Tissue Engineered Medical Products (TEMPs)
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ASTM F3225-17 - Standard Guide for Characterization and Assessment of Vascular Graft Tissue Engineered Medical Products (TEMPs)
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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: F3225 − 17
Standard Guide for
Characterization and Assessment of Vascular Graft Tissue
1
Engineered Medical Products (TEMPs)
This standard is issued under the fixed designation F3225; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope F2211Classification for Tissue Engineered Medical Prod-
ucts (TEMPs)
1.1 This guide is intended as a resource for individuals and
F2212Guide for Characterization of Type I Collagen as
organizations involved in the development, production,
Starting Material for Surgical Implants and Substrates for
delivery, and regulation of tissue engineered medical products
Tissue Engineered Medical Products (TEMPs)
(TEMPs) intended for use in the surgical repair, replacement,
F2312Terminology Relating to Tissue Engineered Medical
shuntingand/orbypassofbloodvessels.Thisguideisintended
Products
for use related to the in vitro assessment of TEMP vascular
F2382Test Method for Assessment of Circulating Blood-
grafts. In vitro cellular characterization and in vivo testing are
Contacting Medical Device Materials on Partial Throm-
not within scope for this standard guide.
boplastin Time (PTT)
1.2 This standard does not purport to address all of the
F2739Guide for Quantifying Cell Viability within Bioma-
safety concerns, if any, associated with its use. It is the
terial Scaffolds
responsibility of the user of this standard to establish appro-
STP 997-EBCompositional Analysis by Thermogravimetry
priate safety, health, and environmental practices and deter-
4
2.2 US FDA Regulations and Guidance Documents:
mine the applicability of regulatory limitations prior to use.
21 CFR 610.12General Biological Products Standards—
1.3 This international standard was developed in accor-
Sterility
dance with internationally recognized principles on standard-
21 CFR 1270Human Tissue Intended for Transplantation
ization established in the Decision on Principles for the
21 CFR 1271Human Cells, Tissues, and Cellular and
Development of International Standards, Guides and Recom-
Tissue-Based Products
mendations issued by the World Trade Organization Technical
FDA Guidance for Industry:Pyrogen and Endotoxins Test-
Barriers to Trade (TBT) Committee.
ing: Questions and Answers
Guidance for Industry:Eligibility Determination for Donors
2. Referenced Documents
of Human Cells, Tissues, and Cellular and Tissue-Based
2
2.1 ASTM Standards:
Products (HCT/Ps)
F1635Test Method for in vitro Degradation Testing of
FDA Guidance for Industry:Container and Closure System
HydrolyticallyDegradablePolymerResinsandFabricated
Integrity Testing in Lieu of Sterility Testing as a Compo-
Forms for Surgical Implants
nent of the Stability Protocol for Sterile Products
F2150Guide for Characterization and Testing of Biomate-
Guidance for Industry and Food and Drug Administration
rial Scaffolds Used in Tissue-Engineered Medical Prod-
Staff:Use of International Standard ISO-10993-1, Bio-
ucts
logical Evaluation of Medical Devices—Part 1: Evalua-
F2210Guide for Processing Cells, Tissues, and Organs for
tion and testing within a risk management process
Use in Tissue Engineered Medical Products (Withdrawn
5
3 2.3 ISO Standards:
2015)
ISO 7198 Cardiovascular implants and extracorporeal
systems—Vascular prostheses—Tubular vascular grafts
1
This guide is under the jurisdiction ofASTM Committee F04 on Medical and
and vascular patches
Surgical Materials and Devices and is the direct responsibility of Subcommittee
ISO 10993Biological evaluation of medical devices
F04.44 on Assessment for TEMPs.
Current edition approved Nov. 15, 2017. Published December 2017. DOI:
10.1520/F3225–17.
2 4
For referenced ASTM standards, visit the ASTM website, www.astm.org, or Available from U.S. Government Printing Office, Superintendent of
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM Documents, 732 N. Capitol St., NW, Washington, DC 20401-0001, http://
Standardsvolume information,referto thestandard’sDocumentSummary page on www.access.gpo.gov.
5
the ASTM website. Available from International Organization for Standardization (ISO), ISO
3
The last approved version of this historical standard is referenced on Central Secretariat, BIBC II, Chemin de Blandonnet 8, CP 401, 1214 Vernier,
www.astm.org. Geneva, Switzerland, http://www.iso.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
F3225 − 17
ISO 11135Sterilization of health-care products—Ethylene documents are continually produced, and existing document
...

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A1.1 Significance and Use
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1.2.5 Annex A5—Specifications for Type HA and Type HB Metallic Bone Screws.  
1.2.6 Annex A6—Specifications for Type HC and Type HD Metallic Bone Screws.  
1.2.7 Annex A7—Specifications for Metallic Bone Screw Drive Connections.  
1.3 This specification is based, in part, upon ISO 5835, ISO 6475, and ISO 9268.  
1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.5 Multiple test methods are included in this standard. However, the user is not necessarily obligated to test using all of the described methods. Instead, the user should only select, with justification, test methods that are appropriate for a particular device design. This may only be a subset of the herein described test methods.  
1.6 This standard may involve the use of 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.  
1.7 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.

  • Technical specification
    22 pages
    English language
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  • Technical specification
    22 pages
    English language
    sale 15% off