1、Designation: F 665 09Standard Classification forVinyl Chloride Plastics Used in Biomedical Application1This standard is issued under the fixed designation F 665; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of last revi
2、sion. A 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 classification provides guidance to engineers andusers in the selection of practical vinyl chloride plastics formedical ap
3、plications and further provides a method for speci-fying these materials by use of a simple line call-out designa-tion. This classification excludes vinyl chloride plastics used inlong-term implants.1.2 Use is made of a classification scheme based on thepremise that the composition of vinyl chloride
4、 plastics, copoly-mers, fillers, plasticizers, stabilizers, and other additives inthese systems can be arranged into characteristic materialdesignations.1.3 In all cases where the provisions of this classificationsystem would conflict with those of the detailed specificationfor a particular device,
5、the latter shall take precedence.NOTE 1For cases in which the vinyl chloride plastic may be used forpurposes where the requirements are too specific to be completelydescribed by this classification system, it is advisable for the purchaser toconsult the supplier to secure adjustment of the propertie
6、s to suit the actualconditions to which the device is to be subjected.1.4 The biocompatibility of vinyl chloride plastics as a classof materials has not been established. Since many composi-tions and formulations fall under this class, it is essential thatthe fabricators/device manufacturers assure
7、the safety andefficacy of the specific composition or formulation, in itsintended application, using state-of-the-art test methods.1.5 This classification is to assist the interface between thematerial supplier and the device manufacturer (fabricator) whopurchases a formulated vinyl chloride plastic
8、 for a component.For those device manufacturers (fabricators) who do their ownformulating, compounding, extrusion, molding, and so forth,this classification does not apply.1.6 This standard does not purport to address all of thesafety concerns, if any, associated with its use. It is theresponsibilit
9、y 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:2D 149 Test Method for Dielectric Breakdown Voltage andDielectric Strength of Solid Electrical Insula
10、ting Materialsat Commercial Power FrequenciesD 150 Test Methods for AC Loss Characteristics and Per-mittivity (Dielectric Constant) of Solid Electrical Insula-tionD 257 Test Methods for DC Resistance or Conductance ofInsulating MaterialsD 543 Practices for Evaluating the Resistance of Plastics toChe
11、mical ReagentsD 570 Test Method for Water Absorption of PlasticsD 792 Test Methods for Density and Specific Gravity (Rela-tive Density) of Plastics by DisplacementD 882 Test Method for Tensile Properties of Thin PlasticSheetingD 955 Test Method of Measuring Shrinkage from MoldDimensions of Thermopla
12、sticsD 2124 Test Method for Analysis of Components in Poly-(Vinyl Chloride) Compounds Using an Infrared Spectro-photometric TechniqueD 2240 Test Method for Rubber PropertyDurometerHardnessF 748 Practice for Selecting Generic Biological Test Meth-ods for Materials and DevicesF 1251 Terminology Relati
13、ng to Polymeric Biomaterials inMedical and Surgical Devices2.2 Other Standards:21 CFR Code of Federal Regulations32.3 ISO Standard:ISO 10993 Biological Evaluation of Medical Devices43. Terminology3.1 Definitions:1This classification is under the jurisdiction of ASTM Committee F04 onMedical and Surgi
14、cal Materials and Devices and is the direct responsibility ofSubcommittee F04.11 on Polymeric Materials.Current edition approved Aug. 1, 2009. Published September 2009. Originallyapproved in 1980. Last previous edition approved in 2003 as F 665 98(2003).2For referenced ASTM standards, visit the ASTM
15、 website, www.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.3Available from Superintendent of Documents, U.S. Government PrintingOffice, Washington, DC 20402.4Availabl
16、e 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 Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.3.1.1 fillera relatively inert material added to a plastic tomodify
17、 its strength, permanence, working properties, or otherqualities, or to lower costs.3.1.2 plasticizera substance incorporated into a materialto increase its workability, flexibility, or distensibility.3.1.3 stabilizera substance added to a plastic that willretard the deterioration of the plastic due
18、 to the effects of heat,light, or oxidation.3.1.4 vinyl chloride plasticsplastics based on polymers ofvinyl chloride or copolymers of vinyl chloride with othermonomers, the vinyl chloride being the comonomer of thehighest concentration by mass.3.2 See Terminology F 1251 for additional terms relevant
19、 topolymers.4. Significance and Use4.1 This classification was developed to permit the additionof descriptive symbols and values for further new formulationswith improved properties without complete reorganization ofthe standard and to facilitate the incorporation of future newtest methods to keep p
20、ace with changing industry require-ments.5. Formulation DesignationNOTE 2No judgment is made by ASTM as to the suitability ofpossible compounds classified by the following system to any specificbiomedical use. Knowledge of formulation composition will only aid inevaluation of a composition for suita
21、bility.5.1 A letter/number system that will give guidance to theengineer/user as to the nature of the formulation shall be used.A general knowledge of the types of additives employed willaid in the evaluation of a particular formulations utility in amedical application.5.2 HomopolymerBy definition,
22、only one homopolymeris covered by this classification: poly(vinyl chloride).5.3 CopolymerThe following is a representative list ofmajor copolymers of poly(vinyl chloride). To specify a copoly-mer, use the prefix (A) followed by the number designation forthe copolymer. In the event that more than one
23、 copolymer ispresent, separate the individual number designations by acomma.Number Designation Copolymer1 none2 vinyl acetate3 vinylidene chloride4 maleic ester5 vinyl ether6 propylene7 ethylene999 other5.4 PlasticizerThe following is a representative list ofprimary monomeric and polymeric plasticiz
24、ers with corre-sponding number designation and a list of secondary plasticiz-ers with their corresponding letter designation. To specify theplasticizer system, use the prefix letter (B) followed by thesecondary plasticizer number. In the event that there is morethan one primary or secondary plastici
25、zer, or both, separate theindividual letter or number designations, or both, by a comma.Letter Designation Secondary PlasticizerA noneB alkyl epoxy stearatesC epoxidized tall oilD epoxidized soybean oilE epoxidized linseed oilF epoxidized sunflower oilZ otherNumber Primary Plasticizer1 none2 adipic
26、acid derivatives3 azelaic acid derivatives4 benzoic acid derivatives5 citric acid derivatives6 isophthalic acid derivatives7 myristic acid derivatives8 phosphoric acid derivatives9 phthalic acid derivatives10 sebacic acid derivatives11 terephthalic acid derivatives12 polyethers13 polyethylene glycol
27、s14 polyesters999 other5.5 StabilizersStabilization systems are usually composedof metal soap acceptors and auxiliary organic stabilizers. Themetal soap acceptors are characterized by the metal(s) present.The following is a representative list of stabilizers. Thedesignation is obtained by using the
28、prefix (C) followed by theletter for the metal, followed by the number for the chelatorF665092used. In the event that more than one in each category ispresent, separate multiple letter or number designations, orboth, by a comma.Letter Metal in Soap AcceptorA noneB bariumC calciumD cadmiumE magnesium
29、F leadG strontiumH tinI zincZ otherNumber Auxiliary Organic Stabilizer1 none2 organophospite999 other5.6 FillersThe following is a representative list of fillers.The designation is obtained by using the prefix (D) followed bythe number of the filler used. In the event that more than oneis used, sepa
30、rate each number by a comma.Number Filler1 none2 clay3 mica4tal5 diatomaceous earth6 titanium dioxide7 calcium carbonate8 carbon black9 conductive carbon black10 barium sulfate11 Bi2O3999 other5.7 ColorantsThe following is a representative list ofcolorants. The designation is obtained by using the p
31、refix (E)followed by the number. In the event that more than one isused, separate each number by a comma.Number Colorant1 none2 titanium dioxide3 ultramarine blue4 phthalocyanines5 benzidines6 quinacridones7 oxynaphthoic reds8 FD vinyl chlorideplasticsAPPENDIXES(Nonmandatory Information)X1. RATIONAL
32、EX1.1 This classification provides definitions and a standarddescription for vinyl chloride plastics for biomedical applica-tions. The guide enumerates relevant test methods and de-scribes generic criteria which should assist in developing morespecific specifications for implantable devices containi
33、ng vinylchloride plastics with values and limits covering end-useapplications.X2. BIOCOMPATIBILITYX2.1 The suitability of these materials from a humanimplant perspective is dependent on the specific application.The biologic tests appropriate for the specific site, such asrecommended in Practice F 74
34、8 and ISO 10993 should be usedas a guideline.X2.2 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 specificcompositions and formulations of this material class referred toin this standa
35、rd has shown that an acceptable 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
36、 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 must be reviewed every five years andif not r
37、evised, 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 theresponsible technical committee, which you
38、 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 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 (fax), or serviceastm.org (e-mail); or through the ASTM website(www.astm.org).F665094
