| ASTM F881-94 (Reapproved 2014) Standard Specification for Silicone Elastomer Facial Implants |
| Recognition Date | 2015-08-14 |
| Recognition List | 040 |
| Recognition Number | 6-185 |
| Extent | Complete standard |
| Standards Orgs | ASTM ASTM International http://www.astm.org/ |
| STG | General Plastic Surgery/General Hospital |
| FDA Tech | Sambasiva Arepalli FDA/OMPT/CDRH/ODE/DSD/PRSB2/ 301-796-6434 sambasiva.arepalli@fda.hhs.gov |
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
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.
| Regulation Number | Device Name | Device Class | Product Code |
| §878.3680 | Prosthesis, Nose, Internal | Class 2 | FZE |
| §878.3590 | Prosthesis, Ear, Internal | Class 2 | FZD |
| §878.3550 | Prosthesis, Chin, Internal | Class 2 | FWP |
| §878.3300 | Mesh, Surgical, Polymeric | Class 2 | FTL |
| §878.3550 | Implant, Malar | Class 2 | LZK |
| There is no relevant guidance developed at this time. |