1. Scope

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 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 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/F1441-03

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