ASTM F881-94(2006) PDF

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. 1.3 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 F881-94(2006) Referenced Document

ASTM D2240 Standard Test Method for Properties of Rubber &8212; Durometer Hardness*， 2024-04-22 Update
ASTM D412 Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers8212;Tension
ASTM D624 Standard Test Method for Tear Strength of Conventional Vulcanized Rubber and Thermoplastic Elastomers*， 2024-04-22 Update
ASTM F1251 Standard Terminology Relating to Polymeric Biomaterials in Medical and Surgical Devices
ASTM F604 Specification for Silicone Elastomers Used in Medical Applications (Withdrawn 2001)*， 2017-08-16 Update
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

2022 ASTM F881-94(2022) Standard Specification for Silicone Elastomer Facial Implants
1994 ASTM F881-94(2014) Standard Specification for Silicone Elastomer Facial Implants
2006 ASTM F881-94(2006) Standard Specification for Silicone Elastomer Facial Implants
2000 ASTM F881-94(2000) Standard Specification for Silicone Elastomer Facial Implants