ASTM F665-2009(2015) Standard Classification for Vinyl Chloride Plastics Used in Biomedical Application《生物医学用氯乙烯塑料的标准分类》.pdf

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1、Designation: F665 09 (Reapproved 2015)Standard Classification forVinyl Chloride Plastics Used in Biomedical Application1This standard is issued under the fixed designation F665; the number immediately following the designation indicates the year of originaladoption or, in the case of revision, the y

2、ear of last revision. A number in parentheses indicates the year of last reapproval. A superscriptepsilon () 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 plasti

3、cs formedical applications 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 o

4、f vinyl chloride plastics,copolymers, fillers, plasticizers, stabilizers, and other additivesin these 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 parti

5、cular device, 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

6、 the properties 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 manufac

7、turers assure 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 ch

8、loride plastic 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 th

9、eresponsibility 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:2D149 Test Method for Dielectric Breakdown Voltage andDielectric Strength of Solid Elec

10、trical Insulating Materialsat Commercial Power FrequenciesD150 Test Methods for AC Loss Characteristics and Permit-tivity (Dielectric Constant) of Solid Electrical InsulationD257 Test Methods for DC Resistance or Conductance ofInsulating MaterialsD543 Practices for Evaluating the Resistance of Plast

11、ics toChemical ReagentsD570 Test Method for Water Absorption of PlasticsD792 Test Methods for Density and Specific Gravity (Rela-tive Density) of Plastics by DisplacementD882 Test Method for Tensile Properties of Thin PlasticSheetingD955 Test Method of Measuring Shrinkage from MoldDimensions of Ther

12、moplasticsD2124 Test Method for Analysis of Components in Poly(Vi-nyl Chloride) Compounds Using an Infrared Spectropho-tometric TechniqueD2240 Test Method for Rubber PropertyDurometer Hard-nessF748 Practice for Selecting Generic Biological Test Methodsfor Materials and DevicesF1251 Terminology Relat

13、ing to Polymeric Biomaterials inMedical and Surgical Devices (Withdrawn 2012)32.2 Other Standards:21 CFR Code of Federal Regulations42.3 ISO Standard:ISO 10993 Biological Evaluation of Medical Devices53. Terminology3.1 Definitions:1This classification is under the jurisdiction of ASTM Committee F04

14、onMedical and Surgical Materials and Devicesand is the direct responsibility ofSubcommittee F04.11 on Polymeric Materials.Current edition approved March 1, 2015. Published May 2015. Originallyapproved in 1980. Last previous edition approved in 2009 as F665 09. DOI:10.1520/F0665-09R15.2For referenced

15、 ASTM standards, visit the ASTM 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.3The last approved version of this historical standard is referenced onwww.a

16、stm.org.4Available from Superintendent of Documents, U.S. Government PrintingOffice, Washington, DC 20402.5Available from American National Standards Institute (ANSI), 25 W. 43rd St.,4th Floor, New York, NY 10036, http:/www.ansi.org.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, W

17、est Conshohocken, PA 19428-2959. United States13.1.1 fillera relatively inert material added to a plastic tomodify 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

18、distensibility.3.1.3 stabilizera substance added to a plastic that willretard the deterioration of the plastic due 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 chlorid

19、e being the comonomer of thehighest concentration by mass.3.2 See Terminology F1251 for additional terms relevant topolymers.4. Significance and Use4.1 This classification was developed to permit the additionof descriptive symbols and values for further new formulationswith improved properties witho

20、ut complete reorganization ofthe standard and to facilitate the incorporation of future newtest methods to keep pace 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 s

21、pecificbiomedical use. Knowledge of formulation composition will only aid inevaluation of a composition for suitability.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 will

22、aid in the evaluation of a particular formulations utility in amedical application.5.2 HomopolymerBy definition, only one homopolymer iscovered by this classification: poly(vinyl chloride).5.3 CopolymerThe following is a representative list ofmajor copolymers of poly(vinyl chloride). To specify acop

23、olymer, use the prefix (A) followed by the number desig-nation for the copolymer. In the event that more than onecopolymer is present, separate the individual number designa-tions by a comma.Number Designation Copolymer1 none2 vinyl acetate3 vinylidene chloride4 maleic ester5 vinyl ether6 propylene7

24、 ethylene999 other5.4 PlasticizerThe following is a representative list ofprimary monomeric and polymeric plasticizers 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)

25、 followed by thesecondary plasticizer number. In the event that there is morethan one primary or secondary plasticizer, or both, separate theindividual letter or number designations, or both, by a comma.Letter Designation Secondary PlasticizerA noneB alkyl epoxy stearatesC epoxidized tall oilD epoxi

26、dized soybean oilE epoxidized linseed oilF epoxidized sunflower oilZ otherNumber Primary Plasticizer1 none2 adipic acid derivatives3 azelaic acid derivatives4 benzoic acid derivatives5 citric acid derivatives6 isophthalic acid derivatives7 myristic acid derivatives8 phosphoric acid derivatives9 phth

27、alic acid derivatives10 sebacic acid derivatives11 terephthalic acid derivatives12 polyethers13 polyethylene glycols14 polyesters999 other5.5 StabilizersStabilization systems are usually composedof metal soap acceptors and auxiliary organic stabilizers. Themetal soap acceptors are characterized by t

28、he metal(s) present.The following is a representative list of stabilizers. Thedesignation is obtained by using the prefix (C) followed by theletter for the metal, followed by the number for the chelatorused. In the event that more than one in each category ispresent, separate multiple letter or numb

29、er designations, orboth, by a comma.Letter Metal in Soap AcceptorA noneB bariumC calciumD cadmiumE magnesiumF 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

30、 using the prefix (D) followed bythe number of the filler used. In the event that more than oneis used, separate each number by a comma.Number Filler1 none2 clay3 mica4tal5 diatomaceous earth6 titanium dioxide7 calcium carbonate8 carbon black9 conductive carbon black10 barium sulfate11 Bi2O3F665 09

31、(2015)2999 other5.7 ColorantsThe following is a representative list ofcolorants. The designation is obtained by using the prefix (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 phthalocyanin

32、es5 benzidines6 quinacridones7 oxynaphthoic reds8 FD vinyl chloride plas-ticsF665 09 (2015)3APPENDIXES(Nonmandatory Information)X1. RATIONALEX1.1 This classification provides definitions and a standarddescription for vinyl chloride plastics for biomedical applica-tions. The guide enumerates relevant

33、 test methods and de-scribes generic criteria which should assist in developing morespecific specifications for implantable devices containing vinylchloride plastics with values and limits covering end-useapplications.X2. BIOCOMPATIBILITYX2.1 The suitability of these materials from a humanimplant pe

34、rspective is dependent on the specific application.The biologic tests appropriate for the specific site, such asrecommended in Practice F748 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 humanbo

35、dy. However, long-term clinical experience of use of specificcompositions and formulations of this material class referred toin this standard has shown that an acceptable level of biologicalresponse can be expected, if the material is used in appropriateapplications.ASTM International takes no posit

36、ion respecting 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 responsibilit

37、y.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 withdrawn. Your comments are invited either for revision of this standard or for additional standardsand should be addressed to ASTM

38、 International 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 s

39、hown 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). 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:/ 09 (2015)4