1、Designation: F1441 03 (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 n
2、umber 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 intra
3、operatively 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 spe
4、cification.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
5、 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 r
6、egulatorylimitations 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
7、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Methodsfor Materials and DevicesF1251 Terminology Relating to Polymeric Biomaterials inMedical and Surgical Devices (Withdrawn 2012)3F2038 Guide for Silicone Elastomers, Gels, and Foams Us
8、edin 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, Pa
9、rt 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 Device
10、sValidation andRoutine Control of Ethylene Oxide Sterilization6ANSI/AAMI/ISO 11137 Sterilization of Health CareProductsRequirements for Validation and Routine andRoutine ControlRadiation Sterilization6ANSI/AAMI/ISO 11134 Sterilization of Health CareProductsRequirements for Validation and RoutineCont
11、rolIndustrial 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
12、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
13、 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.o
14、rg.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 Twi
15、nbrook 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, 10
16、0 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States13.1.1 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.
17、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 hypodermic needle pene
18、tration through the port.3.1.4 silicone elastomeran elastomer containing cross-linked silicone polymer and fumed amorphous (non-crystalline) silica as a reinforcing filler.3.1.5 reinforced silicone elastomera composite of siliconeelastomer and an embedded textile made from polyethyleneterephthalate
19、(such as Dacron (trademark) fibers.3.1.6 shella silicone elastomer continuous layer or mem-brane container (sac) which encloses a lumen of a soft tissueexpander.3.1.7 patch or basea piece of silicone elastomer or rein-forced silicone elastomer, which covers and seals the holewhich results from the m
20、anufacturing process of shell fabrica-tion.3.1.8 lumena cavity within a shell and patch or base,accessible by an injection port, to facilitate the addition ofsaline to adjust the volume of the soft tissue expander.3.1.9 tubing length adapterthe tissue expander compo-nent used to connect more than on
21、e piece of remote porttubing.3.1.10 tubing/shell junctionthe junction of the remote porttubing to the shell of the tissue expander.3.1.11 fused or adhered joints (seams)sites in the shell orother parts of the tissue expander device where materials havebeen joined (fused or bonded) together, with or
22、withoutadhesive, as part of the manufacturing process.3.1.12 orientation meansany mark or palpable portion ofa soft tissue expander to assist the surgeon in positioning.3.1.13 salineonly sodium chloride for injection (USP) isrecommended for filling lumens of soft tissue expanders.3.2 For other terms
23、 used in this specification see Terminol-ogy F1251.4. Classification4.1 Type I: Chronic Tissue Expansion DeviceA soft tissueexpander device intended to be inflated postoperatively.4.2 Type II: Immediate Tissue Expansion DeviceA softtissue expander device only intended for intraoperative use.4.3 Type
24、 III: Combination Expander/Mammary DeviceAspecific type of soft tissue expander device intended to beimplanted for postoperative expansion of the breast and furtherindicated for long term implantation as a breast prosthesis.4.3.1 Gel/SalineExpansion indications for devices of thistype shall confirm
25、to this specification in addition to Specifi-cation F703, as applicable.4.3.2 Saline OnlyExpansion indications for devices of thistype shall confirm to this specification in addition to Specifi-cation F2051, as applicable.5. Significance and Use5.1 This specification contains requirements based on s
26、tate-of-art science and technology as applicable to various consid-erations that have been identified as important to ensurereasonable safety and efficacy as it relates to the biocompat-ibility and the mechanical integrity of the device componentsin soft tissue expander devices.5.1.1 This specificat
27、ion is not intended to limit the scienceand technology that may be considered and applied to ensureperformance characteristics of subject device in intendedapplications. When new information becomes available orchanges in state-of-art science and technology occur andrelevance to subject devices has
28、been established by validscience, it is intended that this specification will be revised inaccordance with ASTM guidelines.6. Volume and Dimensions6.1 Volumes of DevicesThe designed or minimum andmaximum recommended volume of saline fill shall be listed ininstructions for use.6.2 DimensionsThe range
29、s of shapes, volumes, base sizes,and anterior projections are determined by the manufacturer.Pertinent information shall be contained in the package insert.7. Fixation Sites7.1 The presence of fixation sites on any type of soft tissueexpander device is optional. When used, the size and locationsof f
30、ixation sites shall be clearly stated in instructions for use.8. Orientation Means8.1 Orientation means are optional features of subject de-vices. When orientation means are claimed, the location andrecommended techniques for use shall be clearly described ininstructions for use.9. Test Methods and
31、Requirements9.1 Biocompatibility:9.1.1 Practice F748New or existing materials shall be incompliance with Practice F748 or other accepted standardssuch as ANSI/AAMI/ISO 10993-1. Assays recommended byPractice F748 include Cell Culture Cytotoxicity Assays, Short-Term Intramuscular Implantation Assay, S
32、hort-Term Subcuta-neous Assay, Carcinogenicity, Long-Term Implant Test, Sys-temic Injection (Acute Toxicity) Assay, Sensitization Assay,Mutagenicity, and Pyrogenicity.9.1.2 Soft Tissue Expander DevicesTest specimens forchronic implantation assays (carcinogenicity and long termimplant tests) shall be
33、 fabricated from the same combination ofsilicone elastomer and by the same or similar procedures andconditions used in fabricating devices. The thickness of shell inspecimens shall be typical of thickness used in devices.F1441 03 (2014)29.1.3 Prior Biocompatibility AssaysWhen prior biocom-patibility
34、 data are available for silicone elastomer in clinicaluse for tissue expansion, even if not done by the exactprotocols described in more standards, such data may satisfyall or part of the specific biocompatibility requirements ofPractice F748 or equivalent methodology.9.2 Physical Properties:9.2.1 T
35、issue expander or component designs, or both, shalldemonstrate an acceptable response to the following tests.Devices for testing should be selected from standard produc-tion batches which have gone through all manufacturingprocesses, including sterilization. Unless otherwise specified,the standard t
36、emperature for testing shall be 23 6 2C (73.4 63.6F). Condition the test specimens for at least 3 h when thetest temperature is not 23 6 2C. If the material is affected bymoisture, maintain the relative humidity at 50 6 5 % andcondition the specimen for at least 24 h prior to testing. Whentesting at
37、 any other temperature is required, use one of thetemperatures specified in Practice D1349.9.2.2 ShellCut the test specimens from units made bystandard production processes including sterilization. Cleanwith appropriate (polar, for example, 2-propanol, or nonpolar,for example, 1,1,1-trichloroethane)
38、 solvent if necessary.9.2.2.1 Tensile SetAt 300 % elongation, stress the testspecimens for 3 min. Remove the load, then allow 3 min forrelaxation. Test the set in accordance with Test Methods D412with the exception of sample thickness and cycle time. Maxi-mum set shall be less than 10 %.9.2.2.2 Brea
39、king ForceTest ultimate breaking force intension in accordance with Test Methods D412 Die C with theexception of sample thickness. Ultimate breaking force intension shall be no less than 11.12 N (2.5 lb).9.2.3 Tubing Shell JunctionThe tubing/shell junction ofType I tissue expanders shall not fail wh
40、en tested under thefollowing conditions:9.2.3.1 Tubing Greater Than 2.3 mm (0.090 in.) in OuterDiameterThe tubing/shell junction shall not fail whenstressed to 6.672-N (1.5-lb) tension.9.2.3.2 Tubing Less Than or Equal to 2.3 mm (0.090 in.) inOuter DiameterThe tubing/shell junction shall not fail wh
41、enstressed to 2.224-N (0.5-lb) tension.9.2.4 Injection Port CompetenceThere shall be no Type Itissue expander port leakage observed when an injection port istested under the following conditions. Apply 120-mm Hgintraluminal pressure to the port using water or test media withdemonstrated equivalence.
42、 Using the prescribed gauge hypo-dermic needle, puncture the port 5 consecutive times within 1mm2at a site near the center of the port. The port is consideredleaking and fails the test if beads of fluid on the port surface arenot static after 30 s.9.2.4.1 21 Gage PortAn injection port may be labelle
43、d a21 G port only if it passes the injection port competence testwhen tested with a 21 G hypodermic needle.9.2.4.2 23 Gage PortAn injection port may be labelled a23 G port only if it passes the injection port competence testwhen tested with a 23 G hypodermic needle.9.2.4.3 25 Gage PortAn injection p
44、ort may be labelled a25 G port only if it passes the injection port competence testwhen tested with a 25 G hypodermic needle.9.2.5 OverexpansionThere shall be no leakage or devicerupture when the tissue expander is expanded (using water atambient conditions) to 200 % of its maximum recommendedinflat
45、ion volume and kept at that volume for a minimum of 10min.FIG. 1 Testing Fused or Adhered JointsF1441 03 (2014)39.2.6 Tubing Length Adapter StrengthTwo pieces of re-mote port tubing attached by means of the tubing lengthadapter shall not separate when a 152.4-mm (6-in.) testspecimen is stressed at 1
46、0 % elongation. Tubing length adaptershall not be ligated in this test method.9.2.7 Needle Stop PenetrationMount a 38.1-mm (1.5-in.)21-gage hypodermic needle to a syringe. Insert the needle intothe injection port, perpendicular to the needle stop.Apply forcealong the axis of the needle, to push it i
47、nto the needle stop. Theneedle must fail without penetrating the needle stop.9.2.8 Fused or Adhered JointsRequirements for adheredor fused materials shall be critical to their integrity.9.2.8.1 Critical Fused or Adhered JointsAdhered or fusedjoints or seams that are critical to the integrity of the
48、deviceenvelope shall not fail when the shell adjacent to the joint isstressed to 200 % elongation for 10 s (see Fig. 1).9.2.8.2 Non-Critical Fused or Adhered JointsAdhered orfused joints or seams that are bonded to the device envelope,but are not critical to the envelope integrity (fixations, suture
49、tabs, orientation bars, and so forth) shall not fail when the shelladjacent to the joint is stressed to 100 % elongation for 10 s(see Fig. 1).10. Sterilization10.1 The units may be supplied pre-sterilized in accordancewith current AMI and PDA procedures and good manufactur-ing practices (GMP) established by the FDA.810.2 If user sterilization of the device is intended, validatedinstruction for cleaning and sterilization shall be supplied withthe package insert.11. Packaging, Labelling, and Package Inserts11.1 PackagingThe d
