ASTM_F_703_-_07.pdf

Designation:F70307Standard Specification forImplantable Breast Prostheses1This standard is issued under the fixed designation F703;the number immediately following the designation indicates the year of originaladoption or,in the case of revision,the year of last revision.Anumber in parentheses indicates the year of last reapproval.Asuperscriptepsilon()indicates an editorial change since the last revision or reapproval.1.Scope1.1 This specification covers the requirements for siliconegel-filled and saline-inflatable silicone gel-filled implantablebreast prostheses intended for use in surgical reconstruction,augmentation,or replacement of the breast.1.2 LimitationsThis specification does not cover customfabricated implantable breast prostheses.1.3 Single-use saline-inflatable,smooth,and textured sili-cone shell implantable breast prostheses are addressed inSpecification F2051.1.4 The values stated in SI units are to be regarded as thestandard.The inch-pound units given in parentheses are forinformation only.1.5 This standard does not purport to address all of thesafety concerns,if any,associated with its use.It is theresponsibility of the user of this standard to establish appro-priate safety and health practices and determine the applica-bility of regulatory limitations prior to use.2.Referenced Documents2.1 ASTM Standards:2D412 Test Methods for Vulcanized Rubber and Thermoplas-tic ElastomersTensionD1349 Practice for RubberStandard Conditions for Test-ingF748 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Methodsfor Materials and DevicesF1251 Terminology Relating to Polymeric Biomaterials inMedical and Surgical Devices(Withdrawn 2012)3F2038 Guide for Silicone Elastomers,Gels,and Foams Usedin Medical Applications Part IFormulations and Un-cured MaterialsF2042 Guide for Silicone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:Saline,Silicone Gel,and Alternative Breast ImplantsGuidance for Industry and FDA Staff,November 17,20064ISO/AAMI/ANSI 10993-1 Biological Evaluation of MedicalDevicesPart 1:Evaluation and Testing53.Terminology3.1 Definitions:3.1.1 barrier coat,na silicone elastomer layer that is partof the shell of a silicone gel implantable breast prosthesis thatretards silicone bleed.3.1.2 fixation site,nan area of the shell of an implantablebreast prosthesis containing material that allows tissue in-growth.3.1.3 fused or adhered joints(seams),n sites in the shellor other parts of an implantable breast prosthesis wherematerials have been joined(fused or bonded)together,with orwithout an adhesive,as part of the manufacturing process.3.1.4 gel bleed,ndiffusion of liquid silicone componentsof silicone gel through the shell of an implantable breastprosthesis.3.1.5gel-filled breast prosthesis,nimplantable breastprosthesis designed and provided with a pre-filled,fixedvolume of silicone gel.3.1.5.1 Type I breast prosthesis,nimplantable breast pros-thesis containing a single lumen containing a fixed amount ofsilicone gel.(1)DiscussionThe lumen of a Type I breast prostheses isnot accessible for volume adjustments of any kind.3.1.5.2 Type II breast prosthesis,nimplantable breastprosthesis comprised of two complete lumens,one inside theother.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 April 1,2007.Published May 2007.Originallyapproved in 1981.Last previous edition approved in 2002 as F703 96(2002)1.DOI:10.1520/F0703-07.2For 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.Department of Health and Human Services,Food andDrug Administration(FDA),5600 Fishers Ln.,Rockville,MD 20857,http:/www.fda.gov/cdrh/ode/guidance/1239.5Available from American National Standards Institute(ANSI),25 W.43rd St.,4th Floor,New York,NY 10036,http:/www.ansi.org.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1(1)DiscussionThe inner lumen of a Type II implantablebreast prosthesis contains a fixed amount of silicone gel and isnot accessible for volume adjustments of any kind.The outerlumen is provided with a valve to facilitate filling the voidbetween the inner and outer lumens with saline to adjust thetotal volume of the prosthesis,at the time of use.The valvesystem may also be designed to facilitate post-operative salinevolume adjustment by following the instructions provided inthe product literature.3.1.5.3 Type III breast prosthesis,nimplantable breastprosthesis comprised of two complete lu