Standard Specification for Soft-Tissue Expander Devices

Importancia y uso:

5.1 This specification contains requirements based on state-of-the-art science and technology as applicable to various considerations that have been identified as important to ensure reasonable safety and efficacy as it relates to the biocompatibility and the mechanical integrity of the device components in soft-tissue expander devices.

5.1.1 This specification is not intended to limit the science and technology that may be considered and applied to ensure performance characteristics of subject devices in intended applications. When new information becomes available or changes in state-of-the-art science and technology occur and relevance to subject devices has been established by valid science, it is intended that this specification will be revised in accordance with ASTM guidelines.

Subcomité:

F04.32

Volúmen:

13.01

Número ICS:

85.100 (Equipment for the paper industry)

Palabras clave:

elastomer; expander; implant; implant material; medical device; plastic surgery; soft tissue expander;