ASTM F1983-23 PDF
Standard Practice for Assessment of Selected Tissue Effects of Absorbable Biomaterials for Implant Applications
Standard Practice for Assessment of Selected Tissue Effects of Absorbable Biomaterials for Implant Applications
- Статус документа:
- Действующий
- Формат:
- Электронный (PDF)
- Количество страниц:
- 7
- Дата публикации:
- 1 апреля 2023 г.
- Издание:
- F1983
- ICS:
- 11.040.40
SIGNIFICANCE AND USE 5.1 This practice is a guideline for a screening test of candidate materials or assessment of local tissue response to absorbable medical devices which are expected to undergo complete absorption within three years. 5.2 This practice is similar to those for studies on candidate materials or medical devices that are not absorbable, such as those specified in Practices F763, F981, and F1408; however, analysis of the host response must take into account the effect of degradation and degradation products on the inflammatory response at the local tissue site and on subsequent healing of the implantation site, as well as the potential for adverse distal tissue effects. 5.3 For testing of absorbable medical devices, the test article for implantation should be in the final finished form as for intended use, including packaging and sterilization (if applicable). Configurations specific to the animal study may be needed. The test article’s surface-area-to-body mass or mass-to-body mass ratios within the animal model should be established by calculating based on surface-area-to-body mass or mass-to-body mass ratios in humans during the device’s intended clinical use. Worst-case clinical dose should be considered in the study design. For implantation studies incorporating evaluation of both local tissue responses and systemic toxicity, exaggerated material surface area or mass-to-body mass ratios (for example, a 2X to 10X safety factor to assess implant safety for regulatory submissions) compared to clinical use (for example, largest device size, maximum number of devices) should be considered, unless otherwise justified. For example, implantation of exaggerated doses may not be feasible in the selected animal model. For some devices, additional animal group(s) for exaggerated conditions should be considered if dose response information is needed. Additionally, for some devices, exaggerated dose at a specific implantation site can also be used to evaluate local tissue res... SCOPE 1.1 This practice provides experimental protocols for biological assays of tissue reactions to absorbable biomaterials for implant applications. This practice applies only to absorbable materials with projected clinical applications in which the materials will reside in bone or soft tissue longer than 30 days and less than three years. Other standards with designated implantation times are available to address shorter time periods. Careful consideration should be given to the appropriateness of this practice for slowly degrading materials that will remain for longer than three years. It is anticipated that the tissue response to degrading biomaterials will be different from the response to nonabsorbable materials. In many cases, a chronic inflammatory response may be observed during the degradation phase, but the local histology should return to normal after absorption; therefore, the minimal tissue response usually equated with biocompatibility may require long implantations. 1.2 The time period for implant absorption can depend on variables of chemical composition, implant size, implant location, and animal models. Therefore, the selected time points for assessing tissue effects may be selected based on the rate of absorption. 1.3 These protocols assess the effects of the material on the animal tissue in which it is implanted. They do not fully assess systemic toxicity, carcinogenicity, reproductive and development toxicity, or mutagenicity of the material. Other standards are available to address these issues. 1.4 To maximize use of the animals in the study protocol, some aspects of systemic toxicity, including effects of degradation products on different organs and tissues downstream of or surrounding the target site, can be addressed with this practice. 1.5 Because animal models are not identical to human biology, this practice cannot account for all potential biological hazards, for example the effect o...
Abstract
Overview
ASTM F1983-23: Standard Practice for Assessment of Selected Tissue Effects of Absorbable Biomaterials for Implant Applications provides protocols for evaluating the biological tissue reactions to absorbable materials intended for long-term implantation. This ASTM standard is crucial for stakeholders in medical device development, regulatory affairs, and research as it outlines experimental approaches to assess local tissue response, degradation, and healing following implantation. The primary focus is on absorbable biomaterials with intended clinical residency in bone or soft tissue for periods ranging from over 30 days to less than three years.
Key Topics
- Absorbable Biomaterials: Materials expected to fully degrade in the body within a specified timeframe.
- Implantation Protocols: Detailed guidance on animal model selection, implant site choice, and handling of final finished form devices, including packaging and sterilization.
- Assessment Points: Recommendations on time points for evaluating tissue response, based on absorption rates influenced by the biomaterial's composition, size, and implantation site.
- Local and Systemic Effects: Emphasis on analyzing both localized tissue responses and, when appropriate, systemic effects from degradation products.
- Histological Evaluation: Standardized criteria for assessing acute and chronic inflammation, granulation tissue, necrosis, and foreign body reactions across multiple stages of material degradation.
- Controls and Study Design: Guidance on the selection of control materials, including requirements for sham surgeries and matched material-to-host ratios to ensure study validity.
Applications
ASTM F1983-23 is instrumental for:
- Medical Device Manufacturers: Assisting in the preclinical evaluation and safety assessment of absorbable implants such as sutures, meshes, and orthopedic devices.
- Regulatory Submissions: Supporting data packages for FDA and international regulatory bodies with validated protocols for animal testing of absorbable materials.
- Research and Development: Guiding researchers in designing animal studies that accurately represent clinical conditions, material absorption profiles, and tissue compatibility.
- Quality Assurance and Compliance: Ensuring consistent, reproducible methodologies for testing biocompatibility, reducing the risk of adverse tissue responses and improving patient safety.
- Comparative Studies: Enabling side-by-side assessments of different absorbable biomaterials or comparison with nonabsorbable standards to optimize material selection.
Related Standards
ASTM F1983-23 references and aligns with a range of international and ASTM standards for comprehensive biological evaluation:
- ASTM F763 - Short-Term Intramuscular Screening of Implantable Medical Device Materials
- ASTM F981 - Assessment of Compatibility of Biomaterials for Surgical Implants
- ASTM F1408 - Subcutaneous Screening Test for Implant Materials
- ISO 10993 series (notably Parts 6, 9, 11, 18, and 19) - Biological evaluation of medical devices including tests for local effects after implantation, and chemical characterization procedures
- ASTM F1635, F1903, F1904 - Degradation and biological response testing methods
- ISO/TS 17137 and ISO/TS 37137-1 - Requirements and guidance for absorbable device evaluation
Practical Value
Adhering to ASTM F1983-23 ensures manufacturers and researchers apply validated, internationally recognized procedures for assessing the safety and biocompatibility of absorbable implants. This standard promotes:
- Accurate Prediction of Tissue Response: Accounts for unique biological dynamics of degrading biomaterials.
- Risk Mitigation: Early detection of adverse local or systemic effects supports device safety and performance optimization.
- Regulatory Confidence: Using recognized procedures streamlines regulatory approval processes for new implantable medical devices.
Keywords: absorbable biomaterials, tissue response, implant applications, ASTM F1983-23, biocompatibility testing, medical device standards, degradation products, animal model studies
Технические детали
- Технический комитет
- F04 - Medical and Surgical Materials and Devices
- SKU
- ASTM F1983-23
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