1、Designation:F 1341 99Standard Specification forUnalloyed Titanium Wire UNS R50250,1UNS R50400,1UNSR50550,1UNS R50700,1for Surgical Implant Applications2This standard is issued under the fixed designation F 1341;the number immediately following the designation indicates the year oforiginal adoption o
2、r,in the case of revision,the 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 specification covers the chemical,mechanical,andmetallurgical requirements for
3、four grades of unalloyed tita-nium wire used for the manufacture of surgical implants.1.2 The values stated in inch-pound units are to be regardedas the standard.The values given in parentheses are forinformation only.2.Referenced Documents2.1 ASTM Standards:E 8 Test Methods for Tension Testing of M
4、etallic Materials3E 120 Test Methods for Chemical Analysis of Titanium andTitanium Alloys4E 527 Practice for Numbering Metals and Alloys(UNS)5E 1409 Test Method for Determinitation of Oxygen inTitanium Alloys by the Inert Gas Fusion Technique4E 1447 Test Method for Determination of Hydrogen inTitani
5、um and Titanium Alloys by the Inert Gas FusionThermal Conductivity Method6F 67 Specification for Unalloyed Titanium for SurgicalImplant Applications7F 981 Practice for Assessment of Compatibility of Bioma-terials for Surgical Implants with Respect to Effect ofMaterials on Muscle and Bone72.2Aerospac
6、e Material Specification:AMS 2249 Chemical Check Analysis Limits,Titanium andTitanium Alloys82.3American Society for Quality(ASQ)Standard:C1Specifications of General Requirements for a QualityProgram92.4Society of Automotive Engineers Standard:SAE J1086 Practice for Numbering Metals and Alloys(UNS)8
7、3.Product Classification3.1 WireRound product with a diameter equal to or lessthan 0.3125 in.(7.94 mm).Flat and special shape wire with amajor dimension equal to or less than 0.3125 in.(7.94 mm)may also be ordered as agreed upon between the supplier andthe purchaser.4.Ordering Information4.1 Inquiri
8、es and orders for material under this specificationshall include the following information:4.1.1 Quantity(weight or number of pieces),4.1.2 Grade(1,2,3,or 4),4.1.3 ASTM designation,4.1.4 Form(wire),4.1.5 Condition(5.1),4.1.6 Mechanical Properties(if applicable,for special con-ditions),4.1.7 Finish(5
9、.2),4.1.8 Applicable dimensions including size,thickness,width,spool size,coil diameter,and length(exact,random,multiples)or print number,and4.1.9 Special Tests,if any.5.Manufacture5.1 ConditionMaterial shall be furnished in the annealedor cold worked condition.5.2 FinishTypes of finish available fo
10、r wire products arebright annealed,pickled,cold drawn,cold rolled,ground,ground and polished,or as specified in the purchase order.6.Chemical Composition6.1 The heat analysis shall conform to the requirements asto chemical composition prescribed in Table 1.Ingot analysismay be used for reporting all
11、 chemical requirements excepthydrogen,samples of which shall be taken from the finishedproduct.The supplier shall not ship material that is outside thelimits specified in Table 1 for the applicable grade.6.1.1 Requirement for the major and minor elemental con-stituents are listed in Table 1.Also lis
12、ted are important residualelements.Analysis for elements not listed in Table 1 is notrequired to verify compliance with this specification.1New designation established in accordance with E 527 and SAE J1086.2This specification is under the jurisdiction of ASTM Committee F-04 onMedical and Surgical M
13、aterials and Devices and is the direct responsibility ofSubcommittee F04.12 on Resources.Current edition approved May 10,1999.Published August 1999.Originallypublished as F 1341-92.Last previous edition F 1341-92.3Annual Book of ASTM Standards,Vol 03.01.4Annual Book of ASTM Standards,Vol 03.05.5Annu
14、al Book of ASTM Standards,Vol 01.01.6Annual Book of ASTM Standards,Vol 03.06.7Annual Book of ASTM Standards,Vol 13.01.8Available from Society of Automotive Engineers,400 Commonwealth Drive,Warrendale,PA 15096.9Available from American Society for Quality,1611 E.Wisconsin Ave.,Milwaukee,WI 53203.1Copy
15、right ASTM,100 Barr Harbor Drive,West Conshohocken,PA 19428-2959,United States.6.2 Product Analysis Product analysis tolerances do notbroaden the specified heat analysis requirements but covervariations between laboratories in the measurement of chemi-cal content.Product analysis limits shall be as
16、specified inTable 2.6.2.1 The product analysis is either for the purpose ofverifying the composition of a heat or lot or to determinevariations in the composition within the heat.6.2.2 Acceptance or rejection of a heat or lot of materialmay be made by the purchaser on the basis of this checkanalysis.6.3 For referee purposes,Test Methods E 120,E 1409,andE 1447 shall apply.6.3.1 Samples for chemical analysis shall be representativeof the material being tested.PrecautionExtreme care mustbe taken in