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

1、Designation: F 1441 03Standard 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 number in parenth

2、eses indicates the year of last reapproval. Asuperscript epsilon (e) 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

3、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.

4、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 p

5、ortion, 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 regulatorylimitat

6、ions prior to use.2. Referenced Documents2.1 ASTM Standards:D 412 Test Methods for Vulcanized Rubber and Thermo-plastic ElastomersTension2D 624 Test Method for Tear Strength of ConventionalVulcanized Rubber and Thermoplastic Elastomers2D 1349 Practice for RubberStandard Temperatures forTesting2F 703

7、 Specification for Implantable Breast Prostheses3F 748 Practice for Selecting Generic Biological Test Meth-ods for Materials and Devices3F 1251 Terminology Relating to Polymeric Biomaterials inMedical and Surgical Devices3F 2038 Guide for Silicone Elastomers, Gels and FoamsUsed in Medical Applicatio

8、ns Part IFormulations andUncured Materials3F 2042 Guide for Silicone Elastomers, Gels, and FoamsUsed in Medical Application Part IICrosslinking andFabrication3F 2051 Specification for Implantable Saline Filled BreastProsthesis32.2 Other Documents:Federal Register, Title 21, Part 8204USP (United Stat

9、es 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/ST50-1995, Dry Heat (Heated Air) Steriliz-ers6ANSI/AAMI/ISO 11135-1994, Medical DevicesValidati

10、on and Routine Control of Ethylene Oxide Steril-ization6ANSI/AAMI/ISO 11137-1994, Sterilization of Health CareProductsRequirements for Validation and Routine andRoutine ControlRadiation Sterilization6ANSI/AAMI/ISO 11134-1993, Sterilization of Health CareProductsRequirements for Validation and Routin

11、eControlIndustrial Moist Heat Sterilization6Parenteral Drug Association, 1981 Technical Report No. 3,Validation of Dry Heat Processes Used for Sterilizationand Depyrogenation73. Terminology3.1 Definitions:3.1.1 injection portthe port through which an injection toinflate or deflate the variable volum

12、e device is made.3.1.1.1 remote porta port that is remote from the shell andattached to the shell by means of tubing.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

13、Reconstructive Surgery.Current edition approved Apr. 10, 2003. Published May 2003. Originallyapproved in 1992. Last previous edition approved in 2002 as F 1441 92 (2002).2Annual Book of ASTM Standards, Vol 09.01.3Annual Book of ASTM Standards, Vol 13.01.4Available from U.S. Government Printing Offic

14、e Superintendent of Documents,732 N. Capitol St., NW, Mail Stop: SDE, Washington, DC 20401.5United States Pharmacopeia, Vol XXI, Mack Publishing Company, Easton, PA1989. Available from Pharmacopeia Convention, Inc., 12601 Twinbrook Parkway,Rockville, NC 00852.6Available from American National Standa

15、rds Institute (ANSI), 25 W. 43rd St.,4th Floor, New York, NY 10036.7Available 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.3.1.1.2 self

16、-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 penetratio

17、n 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 (such

18、as Dacront) 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 orreinforced silicone elastomer, which covers and seals the holewhich results from the manufacturing proce

19、ss 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 one piece of remote

20、porttubing.3.1.10 tubing/shell junctionthe junction of the remoteport tubing 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 withoutadhesive, a

21、s 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 used in this spec

22、ification see Terminol-ogy F 1251.4. 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 III: Combination

23、 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 to this specifica

24、tion in addition to Specifi-cation F 703, as applicable.4.3.2 Saline OnlyExpansion indications for devices ofthis 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 scien

25、ce 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 specification is not intend

26、ed 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 been established

27、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 ranges of shapes, volu

28、mes, basesizes, and anterior projections are determined by the manufac-turer. Pertinent information shall be contained 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 sh

29、all 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 Requirements9.1

30、Biocompatibility:9.1.1 Practice F 748New or existing materials shall be incompliance with Practice F 748 or other accepted standardssuch as ANSI/AAMI/ISO 10993-1. Assays recommended byPractice F 748 include Cell Culture Cytotoxicity Assays, Short-Term Intramuscular Implantation Assay, Short-Term Sub

31、cuta-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 fabricated f

32、rom 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.9.1.3 Prior Biocompatibility AssaysWhen prior biocom-patibility data are available for silic

33、one 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 F 748 or equivalent methodology.9.2 Physical Properties:9.2.1 Tissue expander or component

34、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 manufacturingF1441032processes, including sterilization. Unless otherwise specified,the standard temperature for testi

35、ng 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 any other temperatu

36、re is required, use one of thetemperatures specified in Practice D 1349.9.2.2 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) solvent if necessa

37、ry.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 D 412with the exception of sample thickness and cycle time. Maxi-mum set shall be less than 10 %.9.2.2.2 Breaking ForceTest ult

38、imate breaking force intension in accordance with Test Methods D 412 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 when tested under t

39、hefollowing 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 whenstressed to 2.2

40、24-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. Using the prescr

41、ibed 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 labelled a21 G port only

42、 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 port may be labell

43、ed 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 recommendedinflation volume and ke

44、pt at that volume for a minimum of 10min.9.2.6 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 10 % elongation. Tubing length adaptershall not be ligated in this test

45、method.9.2.7 Needle Stop PenetrationMount a 38.1-mm (1.5-in.)21-gage hypodermic needle to a syringe. Insert the needle8intothe injection port, perpendicular to the needle stop. Apply force8The Precision Glide hypodermic needle, available from Becton Dickinson, OneBecton Drive, Franklin Lakes, NJ 074

46、17, or its equivalent, has been foundsatisfactory for this purpose.FIG. 1 Testing Fused or Adhered JointsF1441033along 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 for adheredor fused materi

47、als 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).9.2.8.2 Non-Critical Fuse

48、d 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 for 10 s(see Fig. 1).10.

49、 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.910.2 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, during the customary conditions ofp