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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.
This abstract is a brief summary of the referenced standard. It is informational only and not an official part of the standard; the full text of the standard itself must be referred to for its use and application. ASTM does not give any warranty express or implied or make any representation that the contents of this abstract are accurate, complete or up to date.
Significance and Use
This specification contains requirements based on state-of-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.
This specification is not intended to limit the science and technology that may be considered and applied to ensure performance characteristics of subject device in intended applications. When new information becomes available or changes in state-of-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.
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 6 months and then removed.
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 and health practices and determine the applicability of regulatory limitations prior to use.
2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
D412 Test Methods for Vulcanized Rubber and Thermoplastic Elastomers--Tension
D624 Test Method for Tear Strength of Conventional Vulcanized Rubber and Thermoplastic Elastomers
D1349 Practice for Rubber--Standard Temperatures for Testing
F703 Specification for Implantable Breast Prostheses
F748 Practice for Selecting Generic Biological Test Methods for Materials and Devices
F1251 Terminology Relating to Polymeric Biomaterials in Medical and Surgical Devices
F2038 Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part I--Formulations and Uncured Materials
F2042 Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part II--Crosslinking and Fabrication
F2051 Specification for Implantable Saline Filled Breast Prosthesis
ICS Number Code 85.100 (Equipment for the paper industry)
UNSPSC Code 42322200(Soft tissue fixation products )