ASTM F1441-2003(2009) Standard Specification for Soft-Tissue Expander Devices《人体软组织扩张器具的标准规范》.pdf

1、Designation: F 1441 03 (Reapproved 2009)Standard Specification forSoft-Tissue Expander Devices1This standard is issued under the fixed designation F 1441; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of last revision. A

2、 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 int

3、raoperatively 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 s

4、pecification.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 a

5、nd 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

6、regulatorylimitations prior to use.2. Referenced Documents2.1 ASTM Standards:2D 412 Test Methods for Vulcanized Rubber and Thermo-plastic ElastomersTensionD 624 Test Method for Tear Strength of ConventionalVulcanized Rubber and Thermoplastic ElastomersD 1349 Practice for RubberStandard Temperatures

7、forTestingF 703 Specification for Implantable Breast ProsthesesF 748 Practice for Selecting Generic Biological Test Meth-ods for Materials and DevicesF 1251 Terminology Relating to Polymeric Biomaterials inMedical and Surgical DevicesF 2038 Guide for Silicone Elastomers, Gels, and FoamsUsed in Medic

8、al Applications Part IFormulations andUncured MaterialsF 2042 Guide for Silicone Elastomers, Gels, and FoamsUsed in Medical Applications Part IICrosslinking andFabricationF 2051 Specification for Implantable Saline Filled BreastProsthesis2.2 Other Documents:Federal Register, Title 21, Part 8203USP (

9、United States Pharmacopoeia)4Association for the Advance of Medical Instrumentation:ANSI/AAMI/ISO 10993-1 Biological Testing of Medicaland Dental Materials and DevicesPart 1: Guidance onSelection of Tests5ANSI/AAMI/ST50 Dry Heat (Heated Air) Sterilizers5ANSI/AAMI/ISO 11135 Medical DevicesValidation

10、andRoutine Control of Ethylene Oxide Sterilization5ANSI/AAMI/ISO 11137 Sterilization of Health CareProductsRequirements for Validation and Routine andRoutine ControlRadiation Sterilization5ANSI/AAMI/ISO 11134 Sterilization of Health CareProductsRequirements for Validation and RoutineControlIndustria

11、l Moist Heat Sterilization5Parenteral Drug Association 1981 Technical Report No. 3,Validation of Dry Heat Processes Used for Sterilizationand Depyrogenation63. Terminology3.1 Definitions:1This specification is under the jurisdiction of ASTM Committee F04 onMedical and Surgical Materials and Devices

12、and is the direct responsibility ofSubcommittee F04.32 on Plastic and Reconstructive Surgery.Current edition approved April 1, 2009. Published April 2009. Originallyapproved in 1992. Last previous edition approved in 2003 as F 1441 03.2For referenced ASTM standards, visit the ASTM website, www.astm.

13、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.3Available from U.S. Government Printing Office Superintendent of Documents,732 N. Capitol St., NW, Mail Stop: SDE, Washington

14、, DC 20401, http:/www.access.gpo.gov.4United States Pharmacopeia, Vol XXI, Mack Publishing Company, Easton,PA 1989. Available from Pharmacopeia Convention, Inc., 12601 TwinbrookParkway, Rockville, NC 00852.5Available from American National Standards Institute (ANSI), 25 W. 43rd St.,4th Floor, New Yo

15、rk, NY 10036, http:/www.ansi.org.6Available from the Parenteral Drug Association, 3 Bethesda Medical Center,Suite 1500, Bethesda, MD 20814.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.3.1.1 injection portthe port through which an

16、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

17、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 penetration through the port.3.1.4 silicone elastomeran elastomer containing cross-linked silicone polymer and fumed amorphous (non-

18、crystalline) silica as a reinforcing filler.3.1.5 reinforced silicone elastomera composite of siliconeelastomer and an embedded textile made from polyethyleneterephthalate (such as Dacron (trademark) fibers.3.1.6 shella silicone elastomer continuous layer or mem-brane container (sac) which encloses

19、a lumen of a soft tissueexpander.3.1.7 patch or basea piece of silicone elastomer orreinforced silicone elastomer, which covers and seals the holewhich results from the manufacturing process of shell fabrica-tion.3.1.8 lumena cavity within a shell and patch or base,accessible by an injection port, t

20、o 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 one piece of remote porttubing.3.1.10 tubing/shell junctionthe junction of the remoteport tubing to the shell of the tissue expander

21、.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 withoutadhesive, as part of the manufacturing process.3.1.12 orientation meansany mark or palpable portion ofa soft tissue expande

22、r 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 used in this specification see Terminol-ogy F 1251.4. Classification4.1 Type I: Chronic Tissue Expansion DeviceA soft tissueexpan

23、der 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 III: Combination Expander/Mammary DeviceAspecific type of soft tissue expander device intended to beimplanted for postoperative

24、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 to this specification in addition to Specifi-cation F 703, as applicable.4.3.2 Saline OnlyExpansion indications for devices ofthi

25、s type shall confirm to this specification in addition toSpecification F 2051, as applicable.5. Significance and Use5.1 This specification contains requirements based on state-of-art science and technology as applicable to various consid-erations that have been identified as important to ensurereaso

26、nable 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 specification is not intended to limit the scienceand technology that may be considered and applied to ensureperformance characteristics of

27、 subject device in intendedapplications. When new information becomes available orchanges in state-of-art science and technology occur andrelevance to subject devices has been established by validscience, it is intended that this specification will be revised inaccordance with ASTM guidelines.6. Vol

28、ume and Dimensions6.1 Volumes of DevicesThe designed or minimum andmaximum recommended volume of saline fill shall be listed ininstructions for use.6.2 DimensionsThe ranges of shapes, volumes, basesizes, and anterior projections are determined by the manufac-turer. Pertinent information shall be con

29、tained in the packageinsert.7. Fixation Sites7.1 The presence of fixation sites on any type of soft tissueexpander device is optional. When used, the size and locationsof fixation sites shall be clearly stated in instructions for use.8. Orientation Means8.1 Orientation means are optional features of

30、 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 Requirements9.1 Biocompatibility:9.1.1 Practice F 748New or existing materials shall be incompliance with Practice F 748 or othe

31、r accepted standardssuch as ANSI/AAMI/ISO 10993-1. Assays recommended byPractice F 748 include Cell Culture CytotoxicityAssays, Short-Term Intramuscular Implantation Assay, Short-Term Subcuta-neous Assay, Carcinogenicity, Long-Term Implant Test, Sys-temic Injection (Acute Toxicity) Assay, Sensitizat

32、ion Assay,Mutagenicity, and Pyrogenicity.9.1.2 Soft Tissue Expander DevicesTest specimens forchronic implantation assays (carcinogenicity and long termimplant tests) shall be fabricated from the same combination ofsilicone elastomer and by the same or similar procedures andconditions used in fabrica

33、ting devices. The thickness of shell inspecimens shall be typical of thickness used in devices.9.1.3 Prior Biocompatibility AssaysWhen prior biocom-patibility data are available for silicone elastomer in clinicaluse for tissue expansion, even if not done by the exactprotocols described in more stand

34、ards, such data may satisfyall or part of the specific biocompatibility requirements ofPractice F 748 or equivalent methodology.F 1441 03 (2009)29.2 Physical Properties:9.2.1 Tissue expander or component designs, or both, shalldemonstrate an acceptable response to the following tests.Devices for tes

35、ting should be selected from standard produc-tion batches which have gone through all manufacturingprocesses, including sterilization. Unless otherwise specified,the standard temperature for testing shall be 23 6 2C (73.4 63.6F). Condition the test specimens for at least 3 h when thetest temperature

36、 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 any other temperature is required, use one of thetemperatures specified in Practice D 1349.9.2.2 ShellCut the test specimen

37、s from units made bystandard production processes including sterilization. Cleanwith appropriate (polar, for example, 2-propanol, or nonpolar,for example, 1,1,1-trichloroethane) solvent if necessary.9.2.2.1 Tensile SetAt 300 % elongation, stress the testspecimens for 3 min. Remove the load, then all

38、ow 3 min forrelaxation. Test the set in accordance with Test Methods D 412with the exception of sample thickness and cycle time. Maxi-mum set shall be less than 10 %.9.2.2.2 Breaking ForceTest ultimate breaking force intension in accordance with Test Methods D 412 Die C with theexception of sample t

39、hickness. 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 when tested under thefollowing conditions:9.2.3.1 Tubing Greater Than 2.3 mm (0.090 in.) in OuterDiameterThe tubing/shell j

40、unction 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 whenstressed to 2.224-N (0.5-lb) tension.9.2.4 Injection Port CompetenceThere shall be no Type Itissue expander port leakag

41、e 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. Using the prescribed gauge hypo-dermic needle, puncture the port 5 consecutive times within 1mm2at a site near the cente

42、r 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 labelled a21 G port only if it passes the injection port competence testwhen tested with a 21 G hypodermic needle.9.2.4.2 23 Gag

43、e 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 port may be labelled a25 G port only if it passes the injection port competence testwhen tested with a 25 G hypodermic nee

44、dle.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 recommendedinflation volume and kept at that volume for a minimum of 10min.9.2.6 Tubing Length Adapter StrengthTwo pieces of re-mote port

45、tubing attached by means of the tubing lengthadapter shall not separate when a 152.4-mm (6-in.) testspecimen is stressed at 10 % elongation. Tubing length adaptershall not be ligated in this test method.FIG. 1 Testing Fused or Adhered JointsF 1441 03 (2009)39.2.7 Needle Stop PenetrationMount a 38.1-

46、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 into the needle stop. Theneedle must fail without penetrating the needle stop.9.2.8 Fused or Adhered JointsRequirements f

47、or 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 deviceenvelope shall not fail when the shell adjacent to the joint isstressed to 200 % elongation for 10 s (see Fig. 1).

48、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, suturetabs, orientation bars, and so forth) shall not fail when the shelladjacent to the joint is stressed to 100 % elongation

49、 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.710.2 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 devices shall be packaged to protectthem from damage, including maintenance of sterilization ofpre-sterilized devices, du