ASTM F1441-03R22
Standard Specification for Soft-Tissue Expander Devices
| Označení normy: | ASTM F1441-03R22 |
| Vydáno: | 01.10.2022 |
| Status: | Active |
| Počet stran: | 5 |
| Sekce: | 13.01 |
| Označení: | elastomer; expander; implant; implant material; medical device; plastic surgery; soft tissue expander; |
| ASTM označení: | ASTM F1441 |
| Nahrazuje: | F1441-03R14 |
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.
1.1 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 six months and then removed.
1.2 Limitations:
1.2.1 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.
1.2.2 This specification applies in part to combination “expander/mammary” devices as classified in Section 4.
1.3 The values stated in SI units are to be regarded as standard; values in parentheses are for information only.
1.4 The following statement pertains only to the test methods and requirements portion, Section 9, 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.