ASTM F1088-23 PDF

Scope: 1.1 This specification covers chemical and crystallographic requirements for beta-tricalcium phosphate (β-TCP) raw materials intended for use in medical device applications. For a material to be identified as medical-grade beta-tricalcium phosphate, it must conform to this specification (see Appendix X1). 1.2 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. 1.3 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.

ASTM F1088-23 Referenced Document

ANSI/ISO/ASQ 9001 Quality management systems - Requirements
ASTM F748 Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
ASTM F981 Standard Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and Bone

2023 ASTM F1088-23 Standard Specification for Medical-Grade Beta-Tricalcium Phosphate Raw Material for Implantable Medical Devices
2018 ASTM F1088-18 Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation
2010 ASTM F1088-04a(2010) Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation
2004 ASTM F1088-04ae1 Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation
2004 ASTM F1088-04a Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation
2004 ASTM F1088-04 Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation
1992 ASTM F1088-87(1992)e1 Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation