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Description of ASTM-F881 2006ASTM F881 - 94(2006)Standard Specification for Silicone Elastomer Facial ImplantsActive Standard ASTM F881 | Developed by Subcommittee: F04.32 Book of Standards Volume: 13.01 ASTM F881Abstract This specification covers the requirements for silicone elastomer implants used in facial surgery, that is, chin, nasal, malar, and ear implants. The primary material of construction shall be fully vulcanized silicone elastomer. Implants may have orientation means or sites of attached fixation materials, or both. Different tests shall be conducted in order to determine the following properties of elastomers: elongation at failure, tensile strength, modulus, and tear. This abstract is a brief summary of the referenced standard. It is informational only and not an official part of the standard; the full text of the standard itself must be referred to for its use and application. ASTM does not give any warranty express or implied or make any representation that the contents of this abstract are accurate, complete or up to date. 1. Scope 1.1 This specification covers the requirements for silicone elastomer implants used in facial surgery (that is, chin, nasal, malar, and ear implants). 1.2 Limitations 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. The 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 and health practices and determine the applicability of regulatory limitations prior to use.
ASTM Standards D412 Test Methods for Vulcanized Rubber and Thermoplastic Elastomers--Tension D624 Test Method for Tear Strength of Conventional Vulcanized Rubber and Thermoplastic Elastomers D2240 Test Method for Rubber Property--Durometer Hardness F604 Specification for Silicone Elastomers Used in Medical Applications F748 Practice for Selecting Generic Biological Test Methods for Materials and Devices F981 Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and Bone F1251 Terminology Relating to Polymeric Biomaterials in Medical and Surgical Devices Other Documents DowCorningCorporate Test Method--CTM 0930--Adhesion--OneHundred Eighty Degree Shear--Thin Elastometric Substrates Available from Dow Corning Corp., P.O. Box 994, Midland, MI 48686-0994.ICS Code ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics) DOI: 10.1520/F0881-94R06 ASTM International is a member of CrossRef. ASTM F881This book also exists in the following packages...Subscription InformationMADCAD.com ASTM Standards subscriptions are annual and access is unlimited concurrency based (number of people that can access the subscription at any given time) from single office location. For pricing on multiple office location ASTM Standards Subscriptions, please contact us at info@madcad.com or +1 800.798.9296.
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About ASTMASTM International, formerly known as the American Society for Testing and Materials (ASTM), is a globally recognized leader in the development and delivery of international voluntary consensus standards. Today, some 12,000 ASTM standards are used around the world to improve product quality, enhance safety, facilitate market access and trade, and build consumer confidence. ASTM’s leadership in international standards development is driven by the contributions of its members: more than 30,000 of the world’s top technical experts and business professionals representing 150 countries. Working in an open and transparent process and using ASTM’s advanced electronic infrastructure, ASTM members deliver the test methods, specifications, guides, and practices that support industries and governments worldwide. |
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