1、Designation: F997 10Standard Specification forPolycarbonate Resin for Medical Applications1This standard is issued under the fixed designation F997; the number immediately following the designation indicates the year of originaladoption or, in the case of revision, the year of last revision. A numbe
2、r in parentheses indicates the year of last reapproval. A superscriptepsilon () indicates an editorial change since the last revision or reapproval.1. Scope1.1 This specification covers polycarbonate resin and pro-vides requirements and associated test methods for this ther-moplastic when it is to b
3、e used in the manufacture of medicaldevices or components of medical devices.1.2 As with any material, some characteristics may bealtered by the processing techniques (such as molding, extru-sion, machining, assembly, sterilization, and so forth) requiredfor the production of a specific part or devi
4、ce. Therefore,properties of fabricated forms of this resin should be evaluatedusing those test methods that are appropriate to assure safetyand efficacy.1.3 The properties included in this specification are thoseapplicable for polycarbonate only. The biocompatibility ofplastic compounds made up of p
5、olycarbonate resin containingcolorants, fillers, processing aids, or other additives, as well aspolymer blends which contain polycarbonate, should not beassumed. The biocompatibility of these modified polycarbon-ates must be established by testing the final (end-use) compo-sitions using the appropri
6、ate methods of evaluation. In addi-tion, the biocompatibility of the material depends to a largedegree on the nature of the end-use application. It is, therefore,necessary to specify a set of biocompatibility test methods foreach new and distinct application.1.4 This standard does not purport to add
7、ress 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:2D256 Test Met
8、hods for Determining the Izod PendulumImpact Resistance of PlasticsD570 Test Method for Water Absorption of PlasticsD638 Test Method for Tensile Properties of PlasticsD648 Test Method for Deflection Temperature of PlasticsUnder Flexural Load in the Edgewise PositionD790 Test Methods for Flexural Pro
9、perties of Unreinforcedand Reinforced Plastics and Electrical Insulating MaterialsD792 Test Methods for Density and Specific Gravity (Rela-tive Density) of Plastics by DisplacementD883 Terminology Relating to PlasticsD955 Test Method of Measuring Shrinkage from MoldDimensions of ThermoplasticsD1003
10、Test Method for Haze and Luminous Transmittanceof Transparent PlasticsD1238 Test Method for Melt Flow Rates of Thermoplasticsby Extrusion PlastometerD1600 Terminology for Abbreviated Terms Relating toPlasticsD1898 Practice for Sampling of Plastics3D3892 Practice for Packaging/Packing of PlasticsD393
11、5 Specification for Polycarbonate (PC) Unfilled andReinforced MaterialF748 Practice for Selecting Generic Biological Test Meth-ods for Materials and Devices2.2 Underwriters Laboratories Document:UL Standard 94 Tests and Flammability of Plastic Materialsfor Parts in Devices and Appliances42.3 Code of
12、 Federal Regulations:Title 21 CFR Subpart 177.158052.4 ISO Standard:ISO 10993 Biological Evaluation of Medical Devices63. Significance and Use3.1 This specification is designed to recommend physical,chemical, and biological test methods to establish a reasonablelevel of confidence concerning the per
13、formance of unfilledpolycarbonate resins for use in medical devices. The propertieslisted should be considered in selecting material according tothe specific end-use requirements.1This specification is under the jurisdiction of ASTM Committee F04 onMedical and Surgical Materials and Devices and is t
14、he direct responsibility ofSubcommittee F04.11 on Polymeric Materials.Current edition approved Jan. 1, 2010. Published January 2010. Originallyapproved in 1986. Last previous edition approved in 2003 as F997 98a(2003).DOI: 10.1520/F0997-10.2For referenced ASTM standards, visit the ASTM website, www.
15、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.3Withdrawn.4Available from Underwriters Laboratories (UL), 333 Pfingsten Rd., North-brook, IL 60062-2096, http:/.5Availab
16、le from Standardization Documents Order Desk, Bldg. 4 Section D, 700Robbins Ave., Philadelphia, PA 191115094, Attn: NPODS.6Available from American National Standards Institute (ANSI), 25 W. 43rd St.,4th Floor, New York, NY 10036, http:/www.ansi.org.1Copyright ASTM International, 100 Barr Harbor Driv
17、e, PO Box C700, West Conshohocken, PA 19428-2959, United States.4. Classification4.1 Types of polycarbonate plastics, molding, and extrusiongrades are described in Specification D3935.5. General Requirements5.1 Polycarbonate resin may be processed by most tech-niques available for thermoplastic poly
18、mers. Medical devicesand components of medical devices made of polycarbonatemay be sterilized. Methods used successfully include steam,ethylene oxide, and irradiation. Repeated sterilization mayweaken parts molded of any plastic material. The number oftimes a given part may be sterilized safely with
19、out fear ofsubsequent breakage depends on a number of factors, forexample, the design of the part, the method of manufacture, themethod of sterilization, the application or use of the part.Therefore, it is imperative that the manufacturer test the part todetermine the maximum number of sterilization
20、 cycles towhich it can be safely subjected. The function of the partshould be very carefully evaluated if repeated sterilization isdesired.5.2 Polycarbonate resin is the thermoplastic carbonic-acidpolyester of bisphenol-A (BPA), or 4,48-isopropylidenediphenol, or as defined in Terminology D883.5.3 P
21、olycarbonate resins used in medical applications maycomply with the Food and Drug Administration (FDA) Regu-lation 21 CFR 177.1580 which covers both wet and dry foodcontact applications.5.4 The formulated compound may contain optional adju-vant substances required in the production of the polymer or
22、 inthe fabrication or intended use of the end product. Thebiocompatibility of these adjuvant substances shall be estab-lished on the finished product in accordance with Practice F748or ISO 10993.6. Physical Properties6.1 The physical properties of polycarbonate may be deter-mined by the following: T
23、est Methods D256, Test MethodD570, Test Method D638, Test Method D648, Test MethodsD790, Test Methods D792, Terminology D883, Test MethodD955, Test Method D1003, Test Method D1238, TerminologyD1600, and UL Standard 94.7. Biocompatibility7.1 Biocompatibility shall be determined in accordance withPrac
24、tice F748 or ISO 10993, unless otherwise agreed upon bythe supplier and consumer.7.1.1 Biocompatibility testing should be performed onspecimens that have been processed and sterilized per themethods intended for the final device.7.1.2 Residual BPAhas been implicated as a potential healthrisk. At pre
25、sent, there is no censensus on the allowable amountof BPA for medical devices, but it is suggested that steps betaken to control and minimize it. For applications in whichbiocompatibility testing would not be appropriate or would notdiscover potentially harmful levels of BPA, the concentrationof res
26、idual BPA should be determined by a validated analyticaltechnique.8. Sampling8.1 The material should be sampled in accordance withstandard sampling procedures, such as those described inPractice D1898, or other sampling techniques unless otherwiseagreed upon between consumer and supplier.9. Packagin
27、g and Labeling9.1 Packaging material shall meet the standards set forth inPractice D3892, unless otherwise agreed upon by packager andconsumer.10. Keywords10.1 plastics (thermoplastic); plastic surgical devices/applications; polycarbonate (PC) plastics; polymers-surgicalapplications; resins-polycarb
28、onate; sealsAPPENDIXES(Nonmandatory Information)X1. RATIONALEX1.1 This specification was established to provide guid-ance in the testing of polycarbonate resins intended for use inmedical device applications. It recommends test methods forthe measurement of chemical, physical, and mechanical prop-er
29、ties of unfilled resins. Tests should be selected according toend-use applications. It is intended that biocompatibility beestablished on the finished product by the appropriate proce-dures, after it has gone through all processing steps and after alladjuvant substances have been incorporated.F997 1
30、02X2. BIOCOMPATIBILITYX2.1 No known surgical implant material has ever beenshown to be completely free of adverse reactions in the humanbody. However, long-term clinical experience of use of specificformulations and grades of this material referred to in thisspecification has shown that an acceptabl
31、e level of biologicalresponse can be expected, if the material is used in appropriateapplications.ASTM International takes no position respecting the validity of any patent rights asserted in connection with any item mentionedin this standard. Users of this standard are expressly advised that determ
32、ination of the validity of any such patent rights, and the riskof infringement of such rights, are entirely their own responsibility.This standard is subject to revision at any time by the responsible technical committee and must be reviewed every five years andif not revised, either reapproved or w
33、ithdrawn. Your comments are invited either for revision of this standard or for additional standardsand should be addressed to ASTM International Headquarters. Your comments will receive careful consideration at a meeting of theresponsible technical committee, which you may attend. If you feel that
34、your comments have not received a fair hearing you shouldmake your views known to the ASTM Committee on Standards, at the address shown below.This standard is copyrighted by ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959,United States. Individual reprints (s
35、ingle or multiple copies) of this standard may be obtained by contacting ASTM at the aboveaddress or at 610-832-9585 (phone), 610-832-9555 (fax), or serviceastm.org (e-mail); or through the ASTM website(www.astm.org). Permission rights to photocopy the standard may also be secured from the ASTM website (www.astm.org/COPYRIGHT/).F997 103
