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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 ). Examples of TEMPs are listed in Classification .
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.
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.
2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
F1635 Test Method for in vitro Degradation Testing of Hydrolytically Degradable Polymer Resins and Fabricated Forms for Surgical Implants
F2150 Guide for Characterization and Testing of Biomaterial Scaffolds Used in Tissue-Engineered Medical Products
F2210 Guide for Processing Cells, Tissues, and Organs for Use in Tissue Engineered Medical Products
F2211 Classification for Tissue Engineered Medical Products (TEMPs)
F2212 Guide for Characterization of Type I Collagen as Starting Material for Surgical Implants and Substrates for Tissue Engineered Medical Products (TEMPs)
F2312 Terminology Relating to Tissue Engineered Medical Products
F2382 Test Method for Assessment of Circulating Blood-Contacting Medical Device Materials on Partial Thromboplastin Time (PTT)
F2739 Guide for Quantifying Cell Viability within Biomaterial Scaffolds
ICS Number Code 11.040.40 (Implants for surgery, prosthetics and orthotics)
UNSPSC Code 42296006(Vascular graft)
|Link to Active (This link will always route to the current Active version of the standard.)|
ASTM F3225-17, Standard Guide for Characterization and Assessment of Vascular Graft Tissue Engineered Medical Products (TEMPs), ASTM International, West Conshohocken, PA, 2017, www.astm.orgBack to Top