ASTM F 1088 : 2023
Current
The latest, up-to-date edition.
Standard Specification for Medical-Grade Beta-Tricalcium Phosphate Raw Material for Implantable Medical Devices
Hardcopy , PDF
English
24-04-2023
Important note : Users cannot be edited or removed once added to your Multi user PDF.| Committee |
F 04
|
| DocumentType |
Standard
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| Pages |
4
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| PublisherName |
American Society for Testing and Materials
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| Status |
Current
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| Supersedes |
1.1This 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).
1.2This 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.
1.3This 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.
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| ASTM F 981 : 2004 : R2016 | Standard Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and Insertion into Bone |
| ASTM F 981 : 2023 | Standard Practice for Assessment of Muscle and Bone Tissue Responses to Long-Term Implantable Materials Used in Medical Devices |
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