ASTM F 881 : 1994 : R2022
Current
The latest, up-to-date edition.
Standard Specification for Silicone Elastomer Facial Implants
Hardcopy , PDF
English
11-10-2022
Important note : All end users must be registered with an Account prior to user licenses being assigned.| Committee |
F 04
|
| DocumentType |
Standard
|
| Pages |
3
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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 the requirements for silicone elastomer implants used in facial surgery (that is, chin, nasal, malar, and ear implants).
1.2Limitations—This specification does not cover implants containing silicone gels or other gels or liquids. It does not necessarily cover any custom fabricated prosthesis manufactured to any other specification.
1.3The following safety hazards caveat pertains only to the mechanical testing and test methods portion, Section 7, of this specification: 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.
1.4This 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 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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