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[Determination of standards for hydroxyapatite as bone substitute].
1Feldmühle Aktiengesellschaft, Plochingen.
Biomedizinische Technik. Biomedical Engineering
|September 1, 1990
Summary
Hydroxyapatite ceramic surgical implants meet ASTM F 1185-88 standards for quality control. Broader clinical application requires public health department approval beyond material specifications.
Area of Science:
- Biomaterials Science
- Orthopedic Materials
- Ceramic Engineering
Context:
- Hydroxyapatite ceramic is utilized for surgical implants.
- Material specifications are crucial for medical device development.
- ASTM F 1185-88 provides a benchmark for hydroxyapatite ceramic quality.
Purpose:
- To outline the importance of ASTM F 1185-88 standards for hydroxyapatite ceramic.
- To highlight the role of quality control in manufacturing surgical implant materials.
- To discuss the regulatory pathway for broader clinical application of implantable biomaterials.
Summary:
- Hydroxyapatite ceramic intended for surgical implants must adhere to the ASTM F 1185-88 standard.
- This standard establishes essential quality control specifications for manufacturers.
- While the standard provides a foundation for clinical use, public health department approval is necessary for widespread adoption.
Impact:
- Ensures a baseline level of quality and safety for hydroxyapatite ceramic implants.
- Facilitates the development and adoption of advanced orthopedic materials.
- Clarifies the regulatory requirements for bringing new biomaterials to market.