1Scope 1.1This guide is intended to assist primarily in the identification of risks considered unique, less obvious, or particularly important or significant to hydrolysable absorbable polymeric materials, devices, or device components intended for implantation in the human body with optional provision of some additional analysis, estimation, evaluation of those risks included, where appropriate. 1.1.1This 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, -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, enzymatically induced degradation). 1.2This guide assists the user in recognizing that all absorbable polymers have specific raw material characteristics that can be affected by further processing that can ultimately impact their degradation and biological performance characteristics. 1.3This guide applies to both completely absorbable implants and absorbable implant components of an otherwise non-absorbable device 1.4The risks described herein are intended to be considered within a risk assessment as outlined in other documents, such as ISO 14971, ISO 10993-1, etc. 1.5This standard includes both unique information and direction to other standards where appropriate pre-existing guidance exists. 1.6This standard is intended to assist in the identification of unique and important risks present in all aspects of implantable device manufacturing, which includes 1.6.1raw materials 1.6.2processing 1.6.3chemical characterization 1.6.4physical characterization 1.6.5mechanical characterization 1.6.6sterilization 1.6.7degradation characterization 1.6.8biocompatibility testing 1.6.9shelf-life determination 1.6.10preclinical and clinical study design 1.6.11post-commercialization risks 1.7This guide is not intended to be considered all inclusive, since some absorbable unique aspects may have not yet been known, identified, or may be dependent upon or made more pronounced by a specific device design. 1.7.1These polymeric material-oriented guidelines do not necessarily reflect the total needs for any particular implant application (for example, orthopedic, cardiovascular, sutures, and dermal fillers), which likely require additional and potentially essential application-specific requirements and evaluations. 1.8The risks described in this guide may also be applicable to absorbable ceramics or absorbable metals, but evaluation methods specific for these types of materials will not be covered. 1.9This 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, semi-crystalline, cross-linked, and all other absorbable polymer systems. 1.10This guide will reference and generally describe various means to assess absorbable materials, components, and devices. The user will need 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. 1.11 Adherence to all aspects of these guidelines is not mandatory, in that the described considerations, assessments, and tests listed within this guide are not necessarily relevant for all absorbable implant systems and applications. 1.12 Risks associated with absorbables and bioactive agents (drug delivery) 1.12.1Absorbable 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 agents composition, loading, release kinetics, safety, and efficacy. 1.13 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 composites other component(s).
risk assessment; risk identification; implant; hydrolysis; hydrolyzable; hydrolysable; absorbable; bioabsorbable; resorbable; bioresorbable; biodegradable;
Numerous standards exist for implantable absorbable polymeric materials and general absorbable device guidance can be found in ASTM F2902. However, little guidance exists that underscores the risks involved in the numerous steps needed to successfully bring a reliable implantable absorbable implant device to market, which range from raw material quality to clinical implant design and post-market surveillance. This standard, which will cite existing standards whenever possible, is intended to uniquely provide a general overview of the steps to market and any related non-obvious or critical risks that may be unique to implants composed of absorbable materials.
The title and scope are in draft form and are under development within this