ASTM F1441-03(2022)

Annotation of standard text ASTM F1441-03(2022) :

This specification covers the requirements for single use saline inflatable, smooth and textured tissue expansion devices to be used intraoperatively or implanted for typically less than 6 months and then removed. This specification applies only to soft-tissue expander devices fabricated with elastomer shells. It does not necessarily cover any custom fabricated soft tissue expander device manufactured to any other specification. The device shall be classified as: Type I; Type II; and Type III. Biocompatibility, tensile set, breaking force, tubing shell junction, injection port competence, overexpansion, tubing length adapter strength, needle stop penetration, and fused or adhered joints tests shall be performed to conform with the specified requirements.


Keywords:
elastomer, expander, implant, implant material, medical device, plastic surgery, soft tissue expander,, ICS Number Code 85.100 (Equipment for the paper industry)