1、Designation: F 665 98 (Reapproved 2003)Standard 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
2、 year of last 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 classification provides guidance to engineers andusers in the selection of practical vinyl chloride pla
3、stics 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 compositio
4、n of vinyl chloride 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
5、particular 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 adjustme
6、nt of 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 ma
7、nufacturers 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 vin
8、yl chloride 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
9、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:D 149 Test Method for Dielectric Breakdown Voltage andDielectric Strength of Solid
10、 Electrical Insulating Materialsat Commercial Power Frequencies2D 150 Test Methods for ac Loss Characteristics and Permit-tivity (Dielectric Constant) of Solid Electrical InsulatingMaterials2D 257 Test Methods for dc Resistance or Conductance ofInsulating Materials2D 543 Test Method for Resistance o
11、f Plastics to ChemicalReagents3D 570 Test Method for Water Absorption of Plastics3D 792 Test Methods for Density and Specific Gravity (Rela-tive Density) of Plastics by Displacement3D 882 Test Methods for Tensile Properties of Thin PlasticSheeting3D 955 Test Method of Measuring Shrinkage from MoldDi
12、mensions of Molded Plastics3D 1898 Practice for Sampling of Plastics4D 2124 Method for Analysis of Components in Poly(VinylChloride) Compounds Using an Infrared Spectrophoto-metric Technique3D 2240 Test Method for Rubber PropertyDurometerHardness5F 748 Practoce for Selecting Generic Biological Test
13、Meth-ods for Materials and Devices62.2 Other Standards:Title 21 Code of Federal Regulations73. Terminology3.1 Definitions:3.1.1 fillera relatively inert material added to a plastic tomodify its strength, permanence, working properties, or otherqualities, or to lower costs.1This classification is und
14、er the jurisdiction of ASTM Committee F04 onMedical and Surgical Materials and Devicesand is the direct responsibility ofSubcommittee F04.11on Polymeric Materials.Current edition approved Apr. 10, 2003. Published May 2003. Originallyapproved in 1980. Last previous edition approved in 1998 as F 665 9
15、8.2Annual Book of ASTM Standards, Vol 10.01.3Annual Book of ASTM Standards, Vol 08.01.4Discontinued; See 1997 Annual Book of ASTM Standards, Vol 08.01.5Annual Book of ASTM Standards, Vol 09.01.6Annual Book of ASTM Standards, Vol 13.01.7Available from Superintendent of Documents, U.S. Government Prin
16、tingOffice, Washington, DC 20402.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.3.1.2 plasticizera substance incorporated in a material toincrease its workability, flexibility, or distensibility.3.1.3 stabilizera substance added to
17、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 chloride being the comonomer of thehighest concentration by
18、 mass.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 pace wi
19、th 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 suitability
20、.5.1 A letter/number system shall be used that will giveguidance to the engineer/user as to the nature of the formula-tion. A general knowledge of the types of additives employedwill aid in the evaluation of a particular formulations utility ina medical application.5.2 HomopolymerBy definition, only
21、 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 thecopolymer, use the prefix (A) followed by the number desig-nation for the copolymer. In the event that more than oneco
22、polymer is present, separate the individual number designa-tions by a comma.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
23、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
24、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
25、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
26、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
27、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 number designations, orboth, by a comma.Letter Metal in Soap AcceptorA noneB bariumC calciumD cadmiumE magnesiumF leadG
28、 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, separate ea
29、ch number by a comma.Number Filler1 none2 clay3 mica4 talc5 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 prefix
30、 (E)followed by the number. In the event that more than one isused, separate each number by a comma.F 665 98 (2003)2Number Colorant1 none2 titanium dioxide3 ultramarine blue4 phthalocyanines5 benzidines6 quinacridones7 oxynaphthoic reds8 FD vinyl chloride plas-tics8The boldface numbers in parenthese
31、s refer to the list of references at the end ofthis standard.F 665 98 (2003)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 test methods a
32、nd 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 perspective is de
33、pendent on the specific application.The biologic tests appropriate for the specific site, such asrecommended in Practice F 748 should be used as 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 clin
34、ical 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.REFERENCES(1) The United States Pharmacopeia, XXIII, 1995.AS
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36、ntirely 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 withdrawn. Your comments are invited either for revision of this standard or for additional standards
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38、 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).F 665 98 (2003)4
