ASTM F997-1998a(2003) Standard Specification for Polycarbonate Resin for Medical Applications《医疗设备用聚碳酸酯树脂标准规范》.pdf

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1、Designation: F 997 98a (Reapproved 2003)Standard Specification forPolycarbonate Resin for Medical Applications1This standard is issued under the fixed designation F 997; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of l

2、ast revision. A number in parentheses 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 polycarbonate resin and pro-vides requirements and associated test methods for this ther-mop

3、lastic when it is to be 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

4、 specific part or device. 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

5、compounds made up of polycarbonate 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-siti

6、ons using the appropriate 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 d

7、oes 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 St

8、andards:D 256 Test Methods for Determining Izod Pendulum Im-pact Resistance of Plastics2D 570 Test Method for Water Absorption of Plastics2D 638 Test Method for Tensile Properties of Plastics2D 648 Test Method for Deflection Temperature of PlasticsUnder Flexural Load in the Edgewise Position2D 790 T

9、est Methods for Flexural Properties of Unreinforcedand Reinforced Plastics and Electrical Insulating Materi-als2D 792 Test Methods for Specific Gravity (Relative Density)and Density of Plastics by Displacement2D 883 Terminology Relating to Plastics2D 955 Test Method of Measuring Shrinkage From MoldD

10、imensions of Molded Plastics2D 1003 Test Method for Haze and Luminous Transmittanceof Transparent Plastics2D 1238 Test Method for Flow Rates of Thermoplastics byExtrusion Plastometer2D 1600 Terminology for Abbreviated Terms Relating toPlastics2D 1898 Practice for Sampling of Plastics3D 3892 Practice

11、 for Packaging/Packing of Plastics4D 3935 Specification for Polycarbonate (PC) Unfilled andReinforced Material4F 748 Practice for Selecting Generic Biological Test Meth-ods for Materials and Devices52.2 Underwriters Laboratories Document:UL Standard 94 Tests and Flammability of Plastic Materialsfor

12、Parts in Devices and Appliances62.3 Code of Federal Regulations:Title 21 CFR Subpart 177.158073. Significance and Use3.1 This specification is designed to recommend physical,chemical, and biological test methods to establish a reasonablelevel of confidence concerning the performance of unfilledpolyc

13、arbonate resins for use in medical devices. The propertieslisted should be considered in selecting material according tothe specific end-use requirements.4. Classification4.1 Types of polycarbonate plastics, molding, and extrusiongrades are described in Specification D 3935.1This specification is un

14、der the jurisdiction of ASTM Committee F04 onMedical and Surgical Materials and Devices and is the direct responsibility ofSubcommittee F04.11 on Polymeric Materials.Current edition approved Apr. 10, 2003. Published May 2003. Originallyapproved in 1986. Last previous edition approved in 1998 as F 99

15、7 98ae1.2Annual Book of ASTM Standards, Vol 08.01.3Discontinued; See 1997 Annual Book of ASTM Standards, Vol 08.01.4Annual Book of ASTM Standards, Vol 08.02.5Annual Book of ASTM Standards, Vol 13.01.6Available from Underwriters Laboratories, Publication Stock, 333 PfingstenRd., Northbrook, IL 60062.

16、7Available from Standardization Documents Order Desk, Bldg. 4 Section D, 700Robbins Ave., Philadelphia, PA 191115094, Attn: NPODS.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.5. General Requirements5.1 Polycarbonate resin may be p

17、rocessed by most tech-niques available for thermoplastic polymers. 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.

18、The number oftimes a given part may be sterilized safely without 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

19、test the part todetermine the maximum number of sterilization 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-is

20、opropylidenediphenol, or as defined in Terminology D 883.5.3 Polycarbonate 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 adj

21、u-vant substances required in the production of the polymer or 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 PracticeF 748.6. Physical Properties6.1 The physical properties of po

22、lycarbonate may be deter-mined by the following: Test Methods D 256, Test MethodD 570, Test Method D 638, Test Method D 648, Test MethodsD 790, Test Methods D 792, Terminology D 883, Test MethodD 955, Test Method D 1003, Test Method D 1238, Terminol-ogy D 1600, and UL Standard 94.7. Biocompatibility

23、7.1 Biocompatibility shall be determined in accordance withPractice F 748, unless otherwise agreed upon by packager andconsumer.8. Sampling8.1 The material should be sampled in accordance withstandard sampling procedures, such as those described inPractice D 1898, or other sampling techniques unless

24、 otherwiseagreed upon between consumer and supplier.9. Packaging and Labeling9.1 Packaging material shall meet the standards set forth inPractice D 3892, unless otherwise agreed upon by packagerand consumer.10. Keywords10.1 plastics (thermoplastic); plastic surgical devices/applications; polycarbona

25、te (PC) plastics; polymers-surgicalapplications; resins-polycarbonate; 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

26、forthe measurement of chemical, physical, and mechanical prop-erties 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 step

27、s and after alladjuvant substances have been incorporated.X2. 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 refe

28、rred to in thisspecification has shown that an acceptable level of biologicalresponse can be expected, if the material is used in appropriateapplications.F 997 98a (2003)2ASTM International takes no position respecting the validity of any patent rights asserted in connection with any item mentionedi

29、n this standard. Users of this standard are expressly advised that determination 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 mu

30、st be reviewed every five years andif not revised, either reapproved or withdrawn. 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 th

31、eresponsible technical committee, which you may attend. If you feel that 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 C70

32、0, West Conshohocken, PA 19428-2959,United States. Individual reprints (single 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).F 997 98a (2003)3