ASTM_F_1441_-_03_2014.pdf

Designation:F144103(Reapproved 2014)Standard Specification forSoft-Tissue Expander Devices1This standard is issued under the fixed designation F1441;the number immediately following the designation indicates the year oforiginal adoption or,in the case of revision,the year of last revision.A number in parentheses indicates the year of last reapproval.Asuperscript epsilon()indicates an editorial change since the last revision or reapproval.1.Scope1.1 This specification covers the requirements for single usesaline inflatable,smooth and textured tissue expansion devicesto be used intraoperatively or implanted for typically less than6 months and then removed.1.2 Limitations:1.2.1 This specification applies only to soft-tissue expanderdevices fabricated with elastomer shells.It does not necessarilycover any custom fabricated soft tissue expander devicemanufactured 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 asstandard,values in parentheses are for information only.1.4 The following statement pertains only to the test meth-ods and requirements portion,Section 9,of this specification.This standard does not purport to address all of the safetyconcerns,if any,associated with its use.It is the responsibilityof the user of this standard to establish appropriate safety andhealth practices and determine the applicability of regulatorylimitations prior to use.2.Referenced Documents2.1 ASTM Standards:2D412 Test Methods for Vulcanized Rubber and Thermoplas-tic ElastomersTensionD624 Test Method for Tear Strength of Conventional Vul-canized Rubber and Thermoplastic ElastomersD1349 Practice for RubberStandard Conditions for Test-ingF703 Specification for Implantable Breast ProsthesesF748 Practice for Selecting Generic Biological Test Methodsfor Materials and DevicesF1251 Terminology Relating to Polymeric Biomaterials inMedical and Surgical Devices(Withdrawn 2012)3F2038 Guide for Silicone Elastomers,Gels,and Foams Usedin Medical Applications Part IFormulations and Un-cured MaterialsF2042 Guide for Silicone Elastomers,Gels,and Foams Usedin Medical Applications Part IICrosslinking and Fabri-cationF2051 Specification for Implantable Saline Filled BreastProsthesis2.2 Other Documents:Federal Register,Title 21,Part 8204USP(United States Pharmacopoeia)5Association for the Advance of Medical Instrumentation:ANSI/AAMI/ISO 10993-1 Biological Testing of Medicaland Dental Materials and DevicesPart 1:Guidance onSelection of Tests6ANSI/AAMI/ST50 Dry Heat(Heated Air)Sterilizers6ANSI/AAMI/ISO 11135 Medical DevicesValidation andRoutine Control of Ethylene Oxide Sterilization6ANSI/AAMI/ISO 11137Sterilization of Health CareProductsRequirements for Validation and Routine andRoutine ControlRadiation Sterilization6ANSI/AAMI/ISO 11134Sterilization of Health CareProductsRequirements for Validation and RoutineControlIndustrial Moist Heat Sterilization6Parenteral Drug Association 1981 Technical Report No.3,Validation of Dry Heat Processes Used for Sterilizationand Depyrogenation73.Terminology3.1 Definitions:1This specification is under the jurisdiction of ASTM Committee F04 onMedical and Surgical Materials and Devices and is the direct responsibility ofSubcommittee F04.32 on Plastic and Reconstructive Surgery.Current edition approved Oct.1,2014.Published November 2014.Originallyapproved in 1992.Last previous edition approved in 2009 as F1441 03(2009).DOI:10.1520/F1441-03R14.2For referenced ASTM standards,visit the ASTM website,www.astm.org,orcontact ASTM Customer Service at serviceastm.org.For Annual Book of ASTMStandards volume information,refer to the standards Document Summary page onthe ASTM website.3The last approved version of this historical standard is referenced onwww.astm.org.4Available from U.S.Government Printing Office Superintendent of Documents,732 N.Capitol St.,NW,Mail Stop:SDE,Washington,DC 20401,http:/www.access.gpo.gov.5United States Pharmacopeia,Vol XXI,Mack Publishing Company,Easton,PA1989.Available from Pharmacopeia Convention,Inc.,12601 Twinbrook Parkway,Rockville,NC 00852.6Available from American National Standards Institute(ANSI),25 W.43rd St.,4th Floor,New York,NY 10036,http:/www.ansi.org.7Available from the Parenteral Drug Association,3 Bethesda Medical Center,Suite 1500,Bethesda,MD 20814.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 3.1.1 injection portthe port through which an injection toinflate or deflate the variable volume device is made.3.1.1.1 remote porta port that is remote from the shell andattached to the shell by means of tubing.3.1.1.2 self-contained(integrated)porta port that is inte-gral to the device shell.3.1.2 injection surfacethe area of the injection port rec-ommended by the manufacturer for needle insertion to inflateor deflate the device.3.1.3 needle stopthe injection port component used tolimit hypo