ASTM F1441-92(2002)
Historical Standard: ASTM F1441-92(2002) Standard Specification for Soft-Tissue Expander Devices
SUPERSEDED (see Active link, below)
ASTM F1441
1. Scope
1.1 This specification covers the requirements for inflatable tissue expansion devices to be used intraoperatively or implanted for typically less than 6 months and then removed.
1.2 Limitations 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.
1.3 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 portion, Section 7, of this specification. This standard does not purport to address all of the safety problems, 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.
ASTM Standards
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
Keywords
elastomer; expander; implant; implant material; medical device; plastic surgery; soft tissue expander; Expander devices; Orthopaedic medical devices--specifications; Soft tissue implant materials;
ICS Code
ICS Number Code 85.100 (Equipment for the paper industry)
DOI: 10.1520/F1441-92R02
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