1、Designation: F997 10F997 18Standard 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
2、number in parentheses indicates the year of last reapproval.Asuperscriptepsilon () indicates an editorial change since the last revision or reapproval.1. Scope1.1 This specification covers polycarbonate resin and provides requirements and associated test methods for this thermoplasticwhen it is to b
3、e used in the manufacture of medical devices or components of medical devices.1.2 As with any material, some characteristics may be altered by the processing techniques (such as molding, extrusion,machining, assembly, sterilization, and so forth) required for the production of a specific part or dev
4、ice. Therefore, properties offabricated forms of this resin should be evaluated using those test methods that are appropriate to assure safety and efficacy.1.3 The properties included in this specification are those applicable for polycarbonate only. The biocompatibility of plasticcompounds made up
5、of polycarbonate resin containing colorants, fillers, processing aids, or other additives, as well as polymerblends which contain polycarbonate, should not be assumed. The biocompatibility of these modified polycarbonates must beestablished by testing the final (end-use) compositions using the appro
6、priate methods of evaluation. In addition, thebiocompatibility of the material depends to a large degree on the nature of the end-use application. It is, therefore, necessary tospecify a set of biocompatibility test methods for each new and distinct application.1.4 This standard does not purport to
7、address all of the safety concerns, if any, associated with its use. It is the responsibilityof the user of this standard to establish appropriate safety safety, health, and healthenvironmental practices and determine theapplicability of regulatory limitations prior to use.1.5 This international sta
8、ndard was developed in accordance with internationally recognized principles on standardizationestablished in the Decision on Principles for the Development of International Standards, Guides and Recommendations issuedby the World Trade Organization Technical Barriers to Trade (TBT) Committee.2. Ref
9、erenced Documents2.1 ASTM Standards:2D256 Test Methods for Determining the Izod Pendulum Impact Resistance of PlasticsD570 Test Method for Water Absorption of PlasticsD638 Test Method for Tensile Properties of PlasticsD648 Test Method for Deflection Temperature of Plastics Under Flexural Load in the
10、 Edgewise PositionD790 Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating MaterialsD792 Test Methods for Density and Specific Gravity (Relative Density) of Plastics by DisplacementD883 Terminology Relating to PlasticsD955 Test Method of Measuring S
11、hrinkage from Mold Dimensions of ThermoplasticsD1003 Test Method for Haze and Luminous Transmittance of Transparent PlasticsD1238 Test Method for Melt Flow Rates of Thermoplastics by Extrusion PlastometerD1600 Terminology for Abbreviated Terms Relating to PlasticsD1898 Practice for Sampling of Plast
12、ics (Withdrawn 1998)3D3892 Practice for Packaging/Packing of PlasticsD3935 Classification System and Basis for Specification for Polycarbonate (PC) Unfilled and Reinforced MaterialF748 Practice for Selecting Generic Biological Test Methods for Materials and Devices1 This specification is under the j
13、urisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of SubcommitteeF04.11 on Polymeric Materials.Current edition approved Jan. 1, 2010Dec. 1, 2018. Published January 2010February 2019. Originally approved in 1986. Last previous edition app
14、roved in 20032010 asF997 98aF997 10.(2003). DOI: 10.1520/F0997-10. 10.1520/F0997-18.2 For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM Customer Service at serviceastm.org. For Annual Book of ASTM Standardsvolume information, refer to the standards Document Summary pa
15、ge on the ASTM website.This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Becauseit may not be technically possible to adequately depict all changes accurately, ASTM recommends that
16、users consult prior editions as appropriate. In all cases only the current versionof the standard as published by ASTM is to be considered the official document.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States12.2 Underwriters Laborato
17、ries Document:UL Standard 94 Tests andfor Flammability of Plastic Materials for Parts in Devices and Appliances32.3 Code of Federal Regulations:Title 21 CFR Subpart 177.1580 Polycarbonate Resins42.4 ISO Standard:ISO 1099310993-1 Biological Evaluation of Medical DevicesDevicesPart 1: Evaluation and t
18、esting within a risk managementprocess53. Significance and Use3.1 This specification is designed to recommend physical, chemical, and biological test methods to establish a reasonable levelof confidence concerning the performance of unfilled polycarbonate resins for use in medical devices. The prope
19、rties listed shouldbe considered in selecting material according to the specific end-use requirements.4. Classification4.1 Types of polycarbonate plastics, molding, and extrusion grades are described in Specification ASTM Standard D3935.5. General Requirements5.1 Polycarbonate resin may be processed
20、 by most techniques available for thermoplastic polymers. Medical devices andcomponents of medical devices made of polycarbonate may be sterilized. Methods used successfully include steam, ethylene oxide,and irradiation. Repeated sterilization may weaken parts molded ofmade from any plastic material
21、. The number of times a givenpart may be sterilized safely without fear of subsequent breakage depends on a number of factors, for example, the design of thepart, the method of manufacture, the method of sterilization, and the application or use of the part. Therefore, it is imperative thatthe manuf
22、acturer test the part to determine the maximum number of sterilization cycles to which it can be safely subjected. Thefunction of the part should be very carefully evaluated if repeated sterilization is desired.5.2 Polycarbonate resin is the thermoplastic carbonic-acid polyester of bisphenol-A (BPA)
23、, or 4,4-isopropylidenediphenol, oras defined in Terminology D883.5.3 Polycarbonate resins used in medical applications may comply with the Food and Drug Administration (FDA) Regulation21 CFR 177.1580 which covers both wet and dry for food contact applications.5.4 The formulated compound may contain
24、 optional adjuvant substances required in the production of the polymer or in thefabrication or intended use of the end product. The biocompatibility of these adjuvant substances shall be established on thefinished product in accordance with Practice F748 or ISO 10993.10993-1.6. Physical Properties6
25、.1 The physical properties of polycarbonate may be determined by the following: Test Methods D256, Test Method D570, TestMethod D638, Test Method D648, Test Methods D790, Test Methods D792, Terminology D883, Test Method D955, Test MethodD1003, Test Method D1238, Terminology D1600, and UL Standard 94
26、.7. Biocompatibility7.1 Biocompatibility shall be determined in accordance with Practice F748 or ISO 10993,10993-1, unless otherwise agreedupon by the supplier and consumer.7.1.1 Biocompatibility testing should be performed on specimens that have been processed and sterilized per the methodsintended
27、 for the final device.7.1.2 Residual BPA BPA can be released from polycarbonate products under certain conditions.6,7has been implicated as apotential health risk. At present, Release of BPA from polycarbonate can be through the surface hydrolysis mechanism.Furthermore, diffusion controlled residual
28、 release can also contribute to BPAlevels.While BPAhas been studied for possible healtheffects and is listed as a reproductive hazard, there is no censensus on current regulatory limit for the allowable amount of BPAfor medical devices,released from a medical device.8 but it is suggested that steps
29、be taken to control and minimize it. Forapplications in which biocompatibility testing would not be appropriate or would not discover potentially harmful levels of BPA,the concentration of residual As with any medical device material biocompatibility measurement, use conditions, and the natureand du
30、ration of contact should be taken into account. Proper techniques (for example, solvent choice, extraction conditions) based3 Available from Underwriters Laboratories (UL), 333 Pfingsten Rd., Northbrook, IL 60062-2096, http:/.4 Available from Standardization Documents Order Desk, Bldg. 4 Section D,
31、700 Robbins Ave., Philadelphia, PA 191115094, Attn: NPODS.5 Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036, http:/www.ansi.org.6 Release of Bisphenol A from PolycarbonateA Review, E.J. Hoekstra and C. Simoneau, Critical Reviews in Food Scie
32、nce and Nutrition, 53: 386-401 (2013).7 Physicochemical Processes Involved in Migration of Bisphenol A from Polycarbonate, P. Mercea, Journal of Applied Polymer Science, 112: 579-593 (2009).8 http:/www.factsaboutbpa.org from the ACC with references to FDA and other studies.F997 182on the specific en
33、d-use application should be used to investigate the release of BPA from the material; and the measuredconcentration of BPA should be determined by a using an appropriate, validated analytical technique.8. Sampling8.1 The material should be sampled in accordance with standard sampling procedures, suc
34、h as those described in PracticeASTM Standard D1898D3935, or other sampling techniques unless otherwise agreed upon between the consumer and supplier.9. Packaging and Labeling9.1 Packaging material shall meet the standards set forth in Practice D3892, unless otherwise agreed upon by the packager and
35、consumer.10. Keywords10.1 plastics (thermoplastic); plastic surgical devices/applications; polycarbonate (PC) plastics; polymers-surgical applications;resins-polycarbonate; sealsAPPENDIXES(Nonmandatory Information)X1. RATIONALEX1.1 This specification was established to provide guidance in the testin
36、g of polycarbonate resins intended for use in medicaldevice applications. It recommends test methods for the measurement of chemical, physical, and mechanical properties of unfilledresins. Tests should be selected according to end-use applications. It is intended that biocompatibility be established
37、 on the finishedproduct by the appropriate procedures, after it has gone through all processing steps and after all adjuvant substances have beenincorporated.X2. BIOCOMPATIBILITYX2.1 No known surgical implant material has ever been shown to be completely free of adverse reactions in the human body.H
38、owever, long-term clinical experience of use of specific formulations and grades of this material referred to in this specificationhas shown that an acceptable level of biological response can be expected, if the material is used in appropriate applications.ASTM International takes no position respe
39、cting the validity of any patent rights asserted in connection with any item mentionedin 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 st
40、andard 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 withdrawn.Your comments are invited either for revision of this standard or for additional standardsand should be addressed to ASTM Internati
41、onal Headquarters. Your comments will receive careful consideration at a meeting of theresponsible 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
42、.This standard is copyrighted by ASTM International, 100 Barr Harbor Drive, PO Box C700, 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 (f
43、ax), 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 Copyright Clearance Center, 222Rosewood Drive, Danvers, MA 01923, Tel: (978) 646-2600; http:/ The last approved version of this historical standard is referenced on www.astm.org.F997 183
