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ASTM F3223-17

(Guide)

Standard Guide for Characterization and Assessment of Tissue Engineered Medical Products (TEMPs) for Knee Meniscus Surgical Repair and/or Reconstruction

Standard Guide for Characterization and Assessment of Tissue Engineered Medical Products (TEMPs) for Knee Meniscus Surgical Repair and/or Reconstruction

SIGNIFICANCE AND USE
5.1 Injuries to the knee meniscus are one of the most common orthopaedic problems. Meniscus injures include acute tears (such as occur in sports injuries), chronic degenerative tears, extrusion/subluxation, and/or degenerative dysfunction that occurs as part of the knee aging process or as a result of multiple meniscus surgeries. Knee arthroscopy for partial excision of the knee meniscus (partial meniscectomy) is the most commonly performed orthopaedic procedure.  
5.2 Complete or near complete excision of the meniscus in a young individual is associated with an early increased risk of knee osteoarthritis due to the loss of the meniscus chondroprotective effects. Lateral meniscal injuries tend to be more severe than medial injuries. Meniscus repair, augmentation, transplantation, and/or reconstruction is recommended in individuals to restore the chondroprotective effect of the meniscus, relieve pain, and prevent degenerative knee osteoarthritis. The potential of TEMPs to enhance the outcome of the surgical meniscus repair and/or reconstruction has been recognized.  
5.3 The knee joint and temporomandibular joint (TMJ) are examples of joints with meniscal structures.  
5.4 TEMPS may be used with the intent of enhancing the surgical outcome by improving the biological repair at the site of implantation, by providing mechanical function at a defect site, or by a combination of these mechanisms.  
5.5 Improving surgical outcome may include improving function relative to the pre-operative condition, shortening the recovery time after surgery, relieving pain, enabling return to normal daily activities, encouraging tissue growth into the defect site, restoring the mechanical function of the meniscus, delaying the progression of osteoarthritis, or any combination thereof.
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) and other tissues intended for use in the surgical repair, replacement, and/or reconstruction of the knee meniscus.  
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 and health 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
Published
Publication Date
28-Feb-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

Relations

Refers
ASTM F1635-16 - Standard Test Method for <emph type="bdit">in vitro</emph> Degradation Testing of Hydrolytically Degradable Polymer Resins and Fabricated Forms for Surgical Implants
Effective Date
01-Dec-2016
Refers
ASTM F2739-16 - Standard Guide for Quantifying Cell Viability within Biomaterial Scaffolds
Effective Date
01-Oct-2016
Refers
ASTM F2150-19 - Standard Guide for Characterization and Testing of Biomaterial Scaffolds Used in Regenerative Medicine and Tissue-Engineered Medical Products
Effective Date
01-Oct-2019
Refers
ASTM F2739-19 - Standard Guide for Quantifying Cell Viability and Related Attributes within Biomaterial Scaffolds
Effective Date
01-Sep-2019
Refers
ASTM F2312-11(2020) - Standard Terminology Relating to Tissue Engineered Medical Products
Effective Date
01-Feb-2020

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ASTM F3223-17 - Standard Guide for Characterization and Assessment of Tissue Engineered Medical Products (TEMPs) for Knee Meniscus Surgical Repair and/or ReconstructionASTM F3223-17 - Standard Guide for Characterization and Assessment of Tissue Engineered Medical Products (TEMPs) for Knee Meniscus Surgical Repair and/or Reconstruction
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ASTM F3223-17 - Standard Guide for Characterization and Assessment of Tissue Engineered Medical Products (TEMPs) for Knee Meniscus Surgical Repair and/or Reconstruction
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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: F3223 − 17
Standard Guide for
Characterization and Assessment of Tissue Engineered
Medical Products (TEMPs) for Knee Meniscus Surgical
1
Repair and/or Reconstruction
This standard is issued under the fixed designation F3223; 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 F2211 Classification for Tissue Engineered Medical Prod-
ucts (TEMPs)
1.1 This guide is intended as a resource for individuals and
F2212 Guide for Characterization of Type I Collagen as
organizations involved in the production, delivery, and regula-
Starting Material for Surgical Implants and Substrates for
tion of tissue engineered medical products (TEMPs) and other
Tissue Engineered Medical Products (TEMPs)
tissues intended for use in the surgical repair, replacement,
F2312 Terminology Relating to Tissue Engineered Medical
and/or reconstruction of the knee meniscus.
Products
1.2 This standard does not purport to address all of the
F2386 Guide for Preservation of Tissue Engineered Medical
safety concerns, if any, associated with its use. It is the
3
Products (TEMPs) (Withdrawn 2013)
responsibility of the user of this standard to establish appro-
F2739 Guide for Quantifying Cell Viability within Bioma-
priate safety and health practices and determine the applica-
terial Scaffolds
bility of regulatory limitations prior to use.
4
2.2 ISO Standards:
1.3 This international standard was developed in accor-
ISO 10993-1 Biological evaluation of medical devices
dance with internationally recognized principles on standard-
ISO 13022:2012 Medical products containing viable human
ization established in the Decision on Principles for the
cells—Application of risk management and requirements
Development of International Standards, Guides and Recom-
for processing practices
mendations issued by the World Trade Organization Technical
ISO 18362:2016 Manufacture of cell-based health care
Barriers to Trade (TBT) Committee.
products—Control of microbial risks during processing
5
2. Referenced Documents
2.3 Code of Federal Regulations
2
CFR 610.12 General Biological Products Standards—
2.1 ASTM Standards:
Sterility
D570 Test Method for Water Absorption of Plastics
CFR 820 Current Good Manufacturing Practice for Quality
F1635 Test Method forin vitro Degradation Testing of Hy-
System Regulation
drolytically Degradable Polymer Resins and Fabricated
CFR 1270 Current Good Manufacturing Practice for Human
Forms for Surgical Implants
Tissue Intended for Transplantation
F2150 Guide for Characterization and Testing of Biomate-
CFR 1271 Current Good Manufacturing Practice for Human
rial Scaffolds Used in Tissue-Engineered Medical Prod-
Cells, Tissues, and Cellular and Tissue-Based Products
ucts
F2210 Guide for Processing Cells, Tissues, and Organs for
3. Terminology
Use in Tissue Engineered Medical Products (Withdrawn
3
2015)
3.1 Unless provided otherwise in 3.2, terminology shall be
in conformance with Terminology F2312.
3.2 Definitions of Terms Specific to This Standard:
1
This test method is under the jurisdiction ofASTM Committee F04 on Medical
3.2.1 ECM, n—extracellular matrix.
and Surgical Materials and Devices and is the direct responsibility of Subcommittee
F04.44 on Assessment for TEMPs.
Current edition approved March 1, 2017. Published June 2017. DOI: 10.1520/
F3223-17.
2 4
For referenced ASTM standards, visit the ASTM website, www.astm.org, or Available from International Organization for Standardization (ISO), ISO
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM Central Secretariat, BIBC II, Chemin de Blandonnet 8, CP 401, 1214 Vernier,
Standards volume information, refer to the standard’s Document Summary page on Geneva, Switzerland, http://www.iso.org.
5
the ASTM website. Available from U.S. Government Printing Office, Superintendent of
3
The last approved version of this historical standard is referenced on Documents, 732 N. Capitol St., NW, Washington, DC 20401-0001, http://
www.astm.org. www.access.gpo.gov.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
F3223 − 17
3.2.2 osteoarthritis (OA), n—a disease of the entire joint knee osteoarthritis due to the loss of the meniscus chondropro-
involving the cartilage, joint lining, ligaments, and underlying tective effects. Lateral meniscal injuries tend to be more severe
bone.
...

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A1.1 Significance and Use
A1.1.1 This test method is used to measure the torsional yield strength, maximum torque, and breaking angle of the bone screw under standard conditions. The results obtained in this test method are not intended to predict the torque encountered while inserting or removing a bone screw in human or animal bone. This test method is intended only to measure the uniformity of the product tested or to compare the mechanical properties of different, yet similarly sized, products.
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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.  
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4.1 The purpose of this test guide is to provide load profile information on how one could test a total knee replacement in order to evaluate in vitro its function and wear during several types of knee motions as described in 4.2 and 4.3.  
4.2 This test guide may help characterize the magnitude and location of implant wear as an implant is repetitively moved according to specified load and displacement waveforms.  
4.3 This test guide may also help characterize the functional limitations of a total knee replacement as its motion is guided by these waveforms. These limitations may be observed as impingement, subluxation, or high loading in the soft tissue constraints, whether they are represented physically or virtually.  
4.4 The motions and load conditions in vivo will, in general, differ from the load and motions defined in this guide. The results obtained from this guide cannot be used to directly predict in vivo performance. However, this guide is designed to allow for comparisons in performance of different knee designs, when tested under similar conditions.
SCOPE
1.1 Motion path, load history, and loading modalities all contribute to the wear, degradation, and damage of implanted prosthetics. Simulating a variety of functional activities promises more realistic testing for wear and damage mode evaluation. Such activities are often called activities of daily living (ADLs). ADLs identified in the literature include walking, stair ascent and descent, sit-to-stand, stand-to-sit, squatting, kneeling, cross-legged sitting, into bath, out of bath, turning, and cutting motions (1-7).2 Activities other than walking gait often involve an extended range of motion and higher imposed loading conditions, which have the ability to cause damage and modes of failure other than normal wear (8-10).  
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1.6 This document does not address the assessment or measurement of damage modes, or wear or failure of the prosthetic device.  
1.7 This document is a guide. As defined by ASTM in their “Form and Style for ASTM Standards” book in section C15.2, “A standard guide is a compendium of information or series of options that does not recommend a specific course of action. Guides are intended ...

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ASTM F3047M-23(Guide)
Standard Guide for High Demand Hip Simulator Wear Testing of Hard-on-Hard Articulations

SIGNIFICANCE AND USE
5.1 The current hip simulator wear test standards (ISO 14242-1 or ISO 14242-3) stipulate only one load waveform and one set of articulation motions. There is a need for more versatile and rigorous wear test regimes, but the knowledge of what represents realistic high demand wear test features is limited. More research is clearly needed before a standard that defines what a representative high demand wear test should include can be written. The objective of this guide is to advise researchers on the possible high demand wear test features that should be included in evaluation of hard-on-hard articulations.  
5.2 This guide makes suggestions of what high demand test features may need to be added to an overall high demand wear test regime. The features described here are not meant to be all inclusive. Based on current knowledge they appear to be relevant to adverse conditions that can occur in clinical use.  
5.3 All the test features, both conventional and high demand, could have interactive effects on the wear of the components.
SCOPE
1.1 The objective of this guide is to advise researchers on the possible high demand wear test features that should be included in evaluation of hard-on-hard articulations. This guide makes suggestions for high demand test features that may need to be added to an overall wear test regime. Device articulating components manufactured from other metallic alloys, ceramics, or with coated or elementally modified surfaces without significant clinical use could possibly be evaluated with this guide. However, such materials may include risks and failure mechanisms that are not addressed in this guide.  
1.2 Hard-on-hard hip bearing systems include metal-on-metal (for example, Specifications F75, F799, and F1537; ISO 5832-4, ISO 5832-12), ceramic-on-ceramic (for example, ISO 6474-1, ISO 6474-2, ISO 13356), ceramic-on-metal, or any other bearing systems where both the head and cup components have high surface hardness. An argument has been made that the hard-on-hard THR articulation may be better for younger, more active patients. These younger patients may be more physically fit and expect to be able to perform more energetic activities. Consequently, new designs of hard-on-hard THR articulations may have some implantations subjected to more demanding and longer wear performance requirements.  
1.3 Total Hip Replacement (THR) with metal-on-metal articulations have been used clinically for more than 50 years (1, 2).2 Early designs had mixed clinical results. Eventually they were eclipsed by THR systems using metal-on-polyethylene articulations. In the 1990s the metal-on-metal articulation again became popular with more modern designs (3), including surface replacement.  
1.4 In the 1970s the first ceramic-on-ceramic THR articulations were used. In general, the early results were not satisfactory (4, 5). Improvement in alumina, and new designs in the 1990s improved the results for ceramic-on-ceramic articulations (6).  
1.5 The values stated in SI units are to be regarded as the 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.

  • Guide
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    English language
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  • Guide
    8 pages
    English language
    sale 15% off