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Significance and Use
4.2 This guide includes brief descriptions of various intended uses, processing conditions, assessments, and both qualitative and quantitative analyses for raw materials to finished product components.
4.3 The user is encouraged to utilize appropriate ASTM and other standards to conduct the physical, chemical, mechanical, biocompatibility, and preclinical tests on absorbable materials, device components, or devices prior to assessment in an in vivo model.
4.4 Whenever an absorbable material is mixed or coated with other substances (bioactive, polymeric, or otherwise), the physical and degradation properties of the resulting composite may differ significantly from the base polymer. Thus, unless prior experience can justify otherwise, performance characterizations described herein should be conducted on the composite construct rather than on individual components.
4.6 Studies to support regulatory approval for clinical or commercial use, or both, should conform to appropriate nationally adopted directives or guidelines, or both, for the development of medical devices [for example, CE approval; US-FDA Investigational Device Exemption (IDE), Pre- Market Approval (PMA), or 510K submission].
4.7 Assessments based upon data from physical, chemical, mechanical, biocompatibility, and preclinical testing models are highly valuable but carry inherent limitations. Thus, the clinical relevance of each assessment needs to be carefully considered and the user is cautioned that pre-clinical evaluations may not be predictive of human clinical performance.
1.1 This guide describes general guidelines for the chemical, physical, mechanical, biocompatibility, and preclinical assessments of implantable synthetic polymeric absorbable devices. This guide also describes evaluation methods that are potentially useful and should be considered when assessing absorbable implants or implant components.
1.2 The described evaluations may assist a manufacturer in establishing the safety and effectiveness of an absorbable implant device. This listing of assessment methods may also be utilized to assist in establishing substantial equivalence to an existing commercially marketed device. However, these polymeric material-oriented guidelines do not necessarily reflect the total needs for any particular implant application (for example, orthopedic, cardiovascular), which may require additional and potentially essential application-specific evaluations.
1.3 This guide is intended to cover all forms of absorbable polymeric components and devices, including solid (for example, injection-molded) and porous (for example, fibrous) forms. This guide is also intended to cover devices fabricated from amorphous and/or semi-crystalline absorbable polymer systems.
1.4 This guide has been generated with principal emphasis on the evaluation of devices formed from synthetic polymers that degrade in vivo primarily through hydrolysis (for example, α-hydroxy-polyesters). Evaluation methods suggested herein may or may not be applicable to implants formed from materials that, upon implantation, are substantially degraded through other mechanisms (for example, enzymatic action).
1.5 This guide references and generally describes various means to assess absorbable materials, components, and devices. The user needs to refer to specific test methods for additional details. Additionally, some of the recommended test methods may require modification to address the properties of a particular device, construct, or application.
1.6 Adherence to all aspects of these guidelines is not mandatory, in that assessments and tests listed within this guide are not necessarily relevant for all absorbable implant systems and applications.
1.7 Absorbable polymers used as a matrix to control the in vivo release of bioactive agents (drugs, antimicrobials, and so forth) may be evaluated according to many of the methods described herein. However, additional test methods not covered by this guide will likely be needed to evaluate a bioactive agent’s composition, loading, release kinetics, safety, and efficacy.
1.8 Composites of absorbable polymers with ceramics and/or metals may be evaluated according to many of the methods described herein. However, additional test methods not covered by this guide will likely be needed to evaluate the composite’s other component(s).
2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
D570 Test Method for Water Absorption of Plastics
D638 Test Method for Tensile Properties of Plastics
D695 Test Method for Compressive Properties of Rigid Plastics
D792 Test Methods for Density and Specific Gravity (Relative Density) of Plastics by Displacement
D1042 Test Method for Linear Dimensional Changes of Plastics Caused by Exposure to Heat and Moisture
D2990 Test Methods for Tensile, Compressive, and Flexural Creep and Creep-Rupture of Plastics
D2991 Test Method for Stress-Relaxation of Plastics
D3079 Test Method for Water Vapor Transmission of Flexible Heat-Sealed Packages for Dry Products
D3418 Test Method for Transition Temperatures and Enthalpies of Fusion and Crystallization of Polymers by Differential Scanning Calorimetry
D4404 Test Method for Determination of Pore Volume and Pore Volume Distribution of Soil and Rock by Mercury Intrusion Porosimetry
D5296 Test Method for Molecular Weight Averages and Molecular Weight Distribution of Polystyrene by High Performance Size-Exclusion Chromatography
E96/E96M Test Methods for Water Vapor Transmission of Materials
E128 Test Method for Maximum Pore Diameter and Permeability of Rigid Porous Filters for Laboratory Use
E398 Test Method for Water Vapor Transmission Rate of Sheet Materials Using Dynamic Relative Humidity Measurement
E467 Practice for Verification of Constant Amplitude Dynamic Forces in an Axial Fatigue Testing System
E793 Test Method for Enthalpies of Fusion and Crystallization by Differential Scanning Calorimetry
E794 Test Method for Melting And Crystallization Temperatures By Thermal Analysis
E1356 Test Method for Assignment of the Glass Transition Temperatures by Differential Scanning Calorimetry
E1441 Guide for Computed Tomography (CT) Imaging
E1570 Practice for Computed Tomographic (CT) Examination
E2207 Practice for Strain-Controlled Axial-Torsional Fatigue Testing with Thin-Walled Tubular Specimens
F99 Guide for Writing a Specification for Flexible Barrier Rollstock Materials
F316 Test Methods for Pore Size Characteristics of Membrane Filters by Bubble Point and Mean Flow Pore Test
F748 Practice for Selecting Generic Biological Test Methods for Materials and Devices
F1249 Test Method for Water Vapor Transmission Rate Through Plastic Film and Sheeting Using a Modulated Infrared Sensor
F1635 Test Method for in vitro Degradation Testing of Hydrolytically Degradable Polymer Resins and Fabricated Forms for Surgical Implants
F1925 Specification for Semi-Crystalline Poly(lactide) Polymer and Copolymer Resins for Surgical Implants
F1980 Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
F1983 Practice for Assessment of Compatibility of Absorbable/Resorbable Biomaterials for Implant Applications
F2097 Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products
F2210 Guide for Processing Cells, Tissues, and Organs for Use in Tissue Engineered Medical Products
F2313 Specification for Poly(glycolide) and Poly(glycolide-co-lactide) Resins for Surgical Implants with Mole Fractions Greater Than or Equal to 70 % Glycolide
F2450 Guide for Assessing Microstructure of Polymeric Scaffolds for Use in Tissue-Engineered Medical Products
F2477 Test Methods for in vitro Pulsatile Durability Testing of Vascular Stents
F2502 Specification and Test Methods for Absorbable Plates and Screws for Internal Fixation Implants
F2559 Guide for Writing a Specification for Sterilizable Peel Pouches
F2579 Specification for Amorphous Poly(lactide) and Poly(lactide-co-glycolide) Resins for Surgical Implants
F2791 Guide for Assessment of Surface Texture of Non-Porous Biomaterials in Two Dimensions
ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)