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ASTM F3384-21

(Specification)

Standard Specification for Polydioxanone Polymer Resins for Surgical Implants

Standard Specification for Polydioxanone Polymer Resins for Surgical Implants

SCOPE
1.1 This specification covers virgin polydioxanone homopolymer resins intended for use in surgical implants.  
1.2 Polydioxanone is commonly abbreviated as PDO, and is alternatively referred to as poly(para dioxanone) or poly(ρ-dioxanone) with the acronym PPD. Additionally, it may be referred to as PDS as it is the polymer of composition of PDS suture (Ethicon, Inc.), representing an early and widely used application of polydioxanone polymer.  
1.3 This specification covers virgin polydioxanone resins able to be fully solvated at 30 °C by fluorinated solvents such as hexafluoroisopropanol (HFIP) or hexafluoroacetone (HFA).  
1.4 Homopolymers of this composition are known to be semi-crystalline. Within this specification, semi-crystallinity within the resin is defined by the presence of a DSC (differential scanning calorimetry) crystalline endotherm peak upon annealing between 105 and 115 °C. While the presence of a crystalline endotherm indicates semi-crystallinity, the percentage and morphology of the crystalline phase are highly dependent on processing, and in particular on the thermal history of the material. Therefore, the thermal properties and percent crystallinity of the virgin polymer resin (with exception of melting temperature) are not necessarily indicative of final product quality.  
1.5 This specification addresses material characteristics of the virgin polydioxanone-based resins intended for use in surgical implants and does not apply to packaged and sterilized finished implants fabricated from these materials, nor does it address the characteristics of polydioxanone resins with compounded materials such as dyes, polymeric or ceramic compounds, or any other additives.  
1.6 As with any material, some characteristics may be altered by processing techniques (such as molding, extrusion, machining, assembly, sterilization, and so forth) required for the production of a specific part or device. Therefore, properties of fabricated forms of this resin should be evaluated independently using appropriate test methods to ensure safety and efficacy.  
1.7 Biocompatibility testing is not a requirement since this specification is not intended to cover fabricated devices. While biocompatibility testing of resin may provide an early indication of potential safety, biocompatibility analysis of the final finished device is required to determine safety and suitability for any implant device. Refer to Supplementary Requirement S1 of this standard and Guide F2902 for relevant biocompatibility information.  
1.8 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.9 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.  
1.10 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
30-Nov-2021
ICS
11.040.40 - Implants for surgery, prosthetics and orthotics
Technical Committee
F04 - Medical and Surgical Materials and Devices
Drafting Committee
F04.11 - Polymeric Materials
Current Stage
Ref Project

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ASTM F3384-21 - Standard Specification for Polydioxanone Polymer Resins for Surgical ImplantsASTM F3384-21 - Standard Specification for Polydioxanone Polymer Resins for Surgical Implants
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ASTM F3384-21 - Standard Specification for Polydioxanone Polymer Resins for Surgical Implants
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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:F3384 −21
Standard Specification for
1
Polydioxanone Polymer Resins for Surgical Implants
This standard is issued under the fixed designation F3384; 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 ties of fabricated forms of this resin should be evaluated
independently using appropriate test methods to ensure safety
1.1 Thisspecificationcoversvirginpolydioxanonehomopo-
and efficacy.
lymer resins intended for use in surgical implants.
1.7 Biocompatibility testing is not a requirement since this
1.2 Polydioxanone is commonly abbreviated as PDO, and is
specification is not intended to cover fabricated devices. While
alternatively referred to as poly(para dioxanone) or poly(ρ-
biocompatibility testing of resin may provide an early indica-
dioxanone) with the acronym PPD. Additionally, it may be
tion of potential safety, biocompatibility analysis of the final
referred to as PDS as it is the polymer of composition of PDS
finished device is required to determine safety and suitability
suture (Ethicon, Inc.), representing an early and widely used
for any implant device. Refer to Supplementary Requirement
application of polydioxanone polymer.
S1 of this standard and Guide F2902 for relevant biocompat-
1.3 This specification covers virgin polydioxanone resins ibility information.
able to be fully solvated at 30 °C by fluorinated solvents such
1.8 The values stated in SI units are to be regarded as
as hexafluoroisopropanol (HFIP) or hexafluoroacetone (HFA).
standard. No other units of measurement are included in this
standard.
1.4 Homopolymers of this composition are known to be
semi-crystalline. Within this specification, semi-crystallinity
1.9 This standard does not purport to address all of the
within the resin is defined by the presence of a DSC (differ-
safety concerns, if any, associated with its use. It is the
ential scanning calorimetry) crystalline endotherm peak upon
responsibility of the user of this standard to establish appro-
annealing between 105 and 115 °C. While the presence of a
priate safety, health, and environmental practices and deter-
crystalline endotherm indicates semi-crystallinity, the percent-
mine the applicability of regulatory limitations prior to use.
age and morphology of the crystalline phase are highly
1.10 This international standard was developed in accor-
dependent on processing, and in particular on the thermal
dance with internationally recognized principles on standard-
history of the material. Therefore, the thermal properties and
ization established in the Decision on Principles for the
percentcrystallinityofthevirginpolymerresin(withexception
Development of International Standards, Guides and Recom-
of melting temperature) are not necessarily indicative of final
mendations issued by the World Trade Organization Technical
product quality.
Barriers to Trade (TBT) Committee.
1.5 This specification addresses material characteristics of
2. Referenced Documents
the virgin polydioxanone-based resins intended for use in
2
2.1 ASTM Standards:
surgicalimplantsanddoesnotapplytopackagedandsterilized
D1505 Test Method for Density of Plastics by the Density-
finished implants fabricated from these materials, nor does it
Gradient Technique
address the characteristics of polydioxanone resins with com-
D2857 Practice for Dilute Solution Viscosity of Polymers
pounded materials such as dyes, polymeric or ceramic
D3418 Test Method for Transition Temperatures and En-
compounds, or any other additives.
thalpies of Fusion and Crystallization of Polymers by
1.6 As with any material, some characteristics may be
Differential Scanning Calorimetry
altered by processing techniques (such as molding, extrusion,
D4603 Test Method for Determining Inherent Viscosity of
machining, assembly, sterilization, and so forth) required for
Poly(Ethylene Terephthalate) (PET) by Glass Capillary
the production of a specific part or device. Therefore, proper-
Viscometer
D5296 Test Method for Molecular Weight Averages and
1
This specification is under the jurisdiction of ASTM Committee F04 on
2
Medical and Surgical Materials and Devices and is the direct responsibility of For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Subcommittee F04.11 on Polymeric Materials. contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Current edition approved Dec. 1, 2021. Published December 2021. DOI: Standards volume informatio
...

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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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1.2.6 Annex A6—Specifications for Type HC and Type HD Metallic Bone Screws.  
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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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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.  
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1.5 The values stated in SI units are to be regarded as the standard.  
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Standard Guide for Total Knee Replacement Loading Profiles

SIGNIFICANCE AND USE
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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).  
1.2 This document provides guidance for functional simulation that could be used to evaluate in vitro the durability of knee prosthetic devices under force control.  
1.3 Function simulation is defined as the reproduction of loads and motions that might be encountered in activities of daily living, but it does not necessarily cover every possible type of loading. Functional simulation differs from typical wear testing in that it attempts to exercise the prosthetic device through a variety of loading and motion conditions such as might be encountered in situ in the human body in order to reveal various damage modes and damage mechanisms that might be encountered throughout the life of the prosthetic device.  
1.4 Force control is defined as the mode of control of the test machine that accepts a force level as the set point input and which utilizes a force feedback signal in a control loop to achieve that set point input. For knee simulation, the flexion motion is placed under angular displacement control, internal and external rotation is placed under torque control, and axial load, anterior-posterior shear, and medial-lateral shear are placed under force control.  
1.5 This document establishes kinetic and kinematic test conditions for several activities of daily living, including walking, turning navigational movements, stair climbing, stair descent, and squatting. The kinetic and kinematic test conditions are expressed as reference waveforms used to drive the relevant simulator machine actuators. These waveforms represent motion, as in the case of flexion extension, or kinetic signals representing the forces and moments resulting from body dynamics, gravitation, and the active musculature acting across the knee.  
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 ...

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