ASTM F2181-2008 Standard Specification for Wrought Seamless Stainless Steel Tubing for Surgical Implants.pdf

1、Designation: F 2181 08Standard Specification forWrought Seamless Stainless Steel Tubing for SurgicalImplants1This standard is issued under the fixed designation F 2181; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of la

2、st revision. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon () indicates an editorial change since the last revision or reapproval.1. Scope*1.1 This specification covers the requirements for fivecompositions of wrought seamless stainless steel tubing for themanuf

3、acture of surgical implants. Material shall conform to theapplicable requirements of Specifications F 138, F 1314,F 1586, F 2229,orF 2581. This specification addresses thoseproduct variables that differentiate wrought seamless tubingfrom the bar and wire product forms covered in these specifi-cation

4、s.1.2 This specification applies to cold finished, straightlength tubing from 0.125 to 1.315 in. (3.18 to 33.4 mm)nominal outside diameter (OD) and 0.018 in. (0.46 mm) andgreater nominal wall thickness.1.3 The specifications in 2.1 will be referred to as theASTMmaterial standard(s) in this specifica

5、tion.1.4 The values stated in inch-pound units are to be regardedas standard. The values given in parentheses are mathematicalconversions to SI units that are provided for information onlyand are not considered standard.2. Referenced Documents2.1 ASTM Material Standards:2F 138 Specification for Wrou

6、ght 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for SurgicalImplants (UNS S31673)F 1314 Specification for Wrought Nitrogen Strengthened 22Chromium 13 Nickel 5 Manganese 2.5 MolybdenumStainless Steel Alloy Bar and Wire for Surgical Implants(UNS S20910)F 1586 Specification for Wroug

7、ht Nitrogen Strengthened21Chromium10Nickel3Manganese2.5MolybdenumStainless Steel Alloy Bar for Surgical Implants (UNSS31675)F 2229 Specification for Wrought, Nitrogen Strengthened23Manganese-21Chromium-1Molybdenum Low-NickelStainless Steel Alloy Bar and Wire for Surgical Implants(UNS S29108)F 2257 S

8、pecification for Wrought Seamless or Welded andDrawn 18 Chromium-14Nickel-2.5Molybdenum StainlessSteel Small Diameter Tubing for Surgical Implants (UNSS31673)F 2581 Specification for Wrought Nitrogen Strengthened11Manganese-17Chromium-3Molybdenum Low-NickelStainless Steel Alloy Bar and Wire for Surg

9、ical Implants(UNS S29225)2.2 ASTM Tubing Standards:A 262 Practices for Detecting Susceptibility to IntergranularAttack in Austenitic Stainless SteelsA 269 Specification for Seamless and Welded AusteniticStainless Steel Tubing for General ServiceA 632 Specification for Seamless and Welded AusteniticS

10、tainless Steel Tubing (Small-Diameter) for General Ser-viceE29 Practice for Using Significant Digits in Test Data toDetermine Conformance with Specifications2.3 ISO Standards:3ISO 5832-1 Implants for SurgeryMetallic MaterialsPart 1: Wrought Stainless SteelISO 5832-9 Implants for SurgeryMetallic Mate

11、rialsPart 9: Wrought High Nitrogen Stainless SteelISO 9001 Quality Management SystemRequirements2.4 American Society for Quality Standard:4ASQ C1 Specification of General Requirements for a Qual-ity Program2.5 ASME Standard:5ASME Y14.5.1M Mathematical Definition of Dimension-ing and Tolerancing Prin

12、ciples3. Terminology3.1 Definitions of Terms Specific to This Standard:1This specification is under the jurisdiction of ASTM Committee F04 onMedical and Surgical Materials and Devices and is the direct responsibility ofSubcommittee F04.12 on Metallurgical Materials.Current edition approved May 1, 20

13、08. Published June 2008. Originallyapproved in 2002. Last previous edition approved 2002 as F 2181 02a.2For referenced 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

14、 Document Summary page onthe ASTM website.3Available from American National Standards Institute (ANSI), 25 W. 43rd St.,4th Floor, New York, NY 10036, http:/www.ansi.org.4Available from American Society for Quality (ASQ), 600 N. Plankinton Ave.,Milwaukee, WI 53203, http:/www.asq.org.5Available from A

15、merican Society of Mechanical Engineers (ASME), ASMEInternational Headquarters, Three Park Ave., New York, NY 10016-5990, http:/www.asme.org.1*A Summary of Changes section appears at the end of this standard.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 1942

16、8-2959, United States.3.1.1 individual wall thickness measurementany one ofthe wall thickness measurements taken around the circumfer-ence on any one transverse cross section of a single sample ofthe tube.3.1.2 lot, nthe total number of mill products producedfrom the same melt heat under the same co

17、nditions at essen-tially the same time.3.1.3 lot average concentricitythe arithmetic average ofthe sample concentricities measured on a statistically represen-tative number of samples from the lot.3.1.4 lot average wall thicknessthe arithmetic average ofthe sample average wall thicknesses measured o

18、n a statisticallyrepresentative number of samples from the lot.3.1.5 nominal outside diameter (OD)the outside diameterspecified by the purchaser without regard to tolerance.3.1.6 nominal wall thicknessthe wall thickness specifiedby the purchaser without regard to tolerance.3.1.7 sample average wall

19、thicknessthe arithmetic aver-age of all individual wall thickness measurements measuredaround the circumference on any one transverse cross sectionof a single sample of tube.3.1.8 sample concentricitytwo times the offset betweenthe centers of the two circles representing the outside diameter(OD) and

20、 the inside diameter (ID) of the tube.3.1.8.1 DiscussionFor the purposes of this specification,the sample minimum wall and the sample maximum wallmeasured on any one transverse cross section of a singlesample shall be used to calculate concentricity. Also forpurposes of this specification, sample co

21、ncentricity shall beexpressed as a percent and shall be calculated using thefollowing equation:sample concentricity percent 5 2 3SA 2 BA 1 BD3 100where:A = sample maximum wall, andB = sample minimum wall.3.1.9 sample maximum wall thicknessthe largest indi-vidual wall thickness measurement taken arou

22、nd the circum-ference on any one transverse cross section of a single sampleof tube.3.1.9.1 DiscussionIn practice, the sample maximum wallthickness may be the largest of no less than four individual wallthickness measurements taken at uniformly spaced locationsaround the circumference of a single sa

23、mple of the tube.3.1.10 sample minimum wall thicknessthe smallest indi-vidual wall thickness measurement taken around the circum-ference on any one transverse cross section of a single sampleof tube.3.1.10.1 DiscussionIn practice, the sample minimum wallthickness may be the smallest of no less than

24、four individualwall thickness measurements taken at uniformly spaced loca-tions around the circumference of a single sample of the tube.4. General Requirements for Delivery4.1 In addition to the requirements of this specification, allapplicable requirements of the appropriate ASTM materialstandard s

25、hall apply.4.2 In addition to the requirements of this specification, allapplicable seamless tubing requirements of SpecificationA 269 or Specification A 632 shall apply. Flare testing is notapplicable.4.3 In the event that a conflict exists between this specifi-cation and those listed in Section 2,

26、 or in the event that aconflict exists between those specifications listed in 2.1 andthose listed in 2.2 and 2.3, the following order of precedenceapplies: (1) this specification, (2) the ASTM material standardreferenced on the purchase order, and (3) all other referencedspecifications.5. Ordering I

27、nformation5.1 Inquiries and orders for material under this specificationshould include the following information:5.1.1 Quantity (weight, total length or number of pieces),5.1.2 This ASTM designation and date of issue,5.1.3 The appropriate ASTM material standard and date ofissue,5.1.4 Applicable dime

28、nsions including OD and ID, OD andwall or ID and wall, length (exact, random, multiples) orengineering drawing reference number,5.1.5 Dimensional tolerances (see Table 1 and Table 2),5.1.6 Condition (see 6.2),5.1.7 Surface finish (see 6.3),5.1.8 Special requirements or supplements, if any, and5.1.9

29、Certification requirements.6. Materials and Manufacture6.1 Method of Manufacture:6.1.1 Tubing shall be made by a seamless process in whichthe tube periphery is continuous at all stages of the process.6.2 Condition:6.2.1 Tubing shall be furnished, as specified, in the an-nealed, cold worked, medium h

30、ard, hard or extra hard condi-tion as defined in the appropriate ASTM material standard.6.3 Surface Finish:6.3.1 The tubing outer surface shall be furnished with apickled, cold drawn, bright annealed, ground, or polishedfinish. Outer surface roughness shall be 30 in. (0.75 m) Ramaximum.6.3.2 The tub

31、ing inner surface shall be furnished with apickled, cold drawn, bright annealed, or abrasive conditionedfinish. Inner surface roughness shall be 60 in. (1.5 m) Ramaximum.TABLE 1 Permissible Variation in OD DimensionsNominal OD,in. (mm)Permissible Variation from NominalAStandard Tolerance,in. (mm)12

32、Standard Tolerance,Bin. (mm)0.125 to 0.500 excl.(3.2 to 12.7)60.002 (0.051) 60.001 (0.025)0.500 to 1.00 excl.(12.7 to 25.4)60.003 (0.076) 60.0015 (0.038)1.00 to 1.315 incl.(25.4 to 33.4)60.004 (0.102) 60.002 (0.051)AUnless otherwise specified, size tolerances are plus and minus as shown inthe table.

33、 When required by the purchaser, tolerances may be specified all plusand nothing minus, or all minus and nothing plus, or any combination of plus andminus if the total spread in size tolerance is not less than the total spread shownin the table.B 12 standard tolerance may be used when specifying tub

34、ing for use onmachining centers with tight collet clearance.F21810826.3.3 The method used to determine surface roughness shallbe agreed upon between the purchaser and supplier.7. Chemical Composition, Metallurgical Requirements,and Mechanical Properties7.1 The chemical composition, metallurgical req

35、uirements,and mechanical properties of the finished tube shall conform tothe requirements of the appropriate ASTM material standard.7.2 In the event that both tensile properties and hardness arespecified on the purchase order, tensile properties shall be usedto accept or reject the tubing. Hardness

36、shall be reported forinformation only.8. Permissible Variation in Dimensions8.1 OD and ID:8.1.1 The permissible variations of OD and ID from thenominal dimension on the purchase order, or engineeringdrawing are listed in Tables 1 and 2.8.2 Wall Thickness:8.2.1 The range of total wall variation (incl

37、uding concen-tricity and average wall variation) shall not exceed 14 %(67 %) of nominal wall thickness.8.2.2 Concentricity shall not exceed 10 % (65 %) of aver-age wall thickness for tubing with nominal wall thicknessgreater than or equal to 10 % of the nominal OD dimension.For tubing with nominal w

38、all thickness less than 10 % of thenominal OD dimension, concentricity shall be negotiatedbetween purchaser and supplier.8.2.3 Wall thickness shall be measured directly with amicrometer or linear variable displacement transducer (LVDT),coordinate measuring machine (CMM), or by optical measure-ment o

39、n a transverse metallographic cross section or otherappropriate method. The method of wall thickness measure-ment shall be agreed upon between purchaser and supplier.8.3 Length:8.3.1 For exact length orders up to and including 24 ft (7300mm), the length tolerance shall be plus or minus18 in. (3 mm).

40、8.3.2 On random length orders, a maximum and minimumlength shall be specified by the purchaser. Up to 5 % of theorder may ship short of the minimum length specified. Nolength shall be less than 5 ft (1500 mm) unless agreed uponbetween purchaser and supplier.8.4 Straightness:8.4.1 The deviation from

41、straightness shall not exceed 0.012inch per foot (0.25 mm per 300 mm) of tube length.9. Permissible Outer and Inner Surface Imperfections9.1 For tubes with wall thickness greater than or equal to0.060 in. (1.5 mm) and less than 0.250 in. (6.4 mm), neitherouter nor inner surface imperfections shall e

42、xceed 0.003 in.(0.08 mm) in depth. For tubes with wall thickness greater thanor equal to 0.250 in. (6.4 mm), neither outer nor inner surfaceimperfections shall exceed 0.005 in. (0.13 mm) in depth. Fortubes with wall thickness less than 0.060 in. (1.5 mm), outerand inner surface imperfection depth sh

43、all be agreed uponbetween purchaser and supplier.9.2 The method of inspecting for these imperfections shallbe negotiated between the purchaser and supplier.9.3 Outer surface imperfections may be removed by grind-ing or polishing providing that the resultant wall thickness doesnot violate the minimum

44、 wall thickness. The ground orpolished surface shall meet the surface finish requirements of6.3.1.10. Special Tests10.1 The material shall conform to the special test require-ments of the appropriate ASTM material standard.10.2 When required by the appropriate ASTM materialstandard, both OD and ID s

45、urfaces of the finished tube shall becapable of passing the intergranular corrosion susceptibilitytest in accordance with Practice E of Practices A 262.11. Significance of Numerical Limits11.1 The following applies to all specified numerical limitsin this specification. To determine conformance to t

46、hese limits,an observed or calculated value shall be rounded to the nearestunit in the last right hand digit used in expressing thespecification limit, in accordance with the rounding method ofPractice E29.12. Certification12.1 The supplier shall provide certification that the mate-rial meets the re

47、quirements of this specification.Areport of thetest results shall be furnished to the purchaser at the time ofshipment.13. Quality Program Requirements13.1 The producer shall maintain a quality program such asdefined in ASQ C1, ISO 9001, or similar.14. Keywords14.1 metals (for surgical implant); sea

48、mless tubing; stain-less steel; surgical applications tubing; surgical implantsTABLE 2 Permissible Variation in ID DimensionsNominal ID,in. (mm)Permissible Variationfrom Nominal, in. (mm)AUp to 0.500 excl. (3.18 to 12.7) 60.002 (0.051)0.500 to 1.00 excl. (12.7 to 25.4) 60.003 (0.076)1.00 (and over)

49、(25.4) 60.004 (0.102)AUnless otherwise specified, size tolerances are plus and minus as shown inthe table. When required by the purchaser, tolerances may be specified all plusand nothing minus, or all minus and nothing plus, or any combination of plus andminus if the total spread in size tolerance is not less than the total spread shownin the table.F2181083APPENDIXES(Nonmandatory Information)X1. RATIONALEX1.1 The primary reason for this specification is to estab-lish a tubular product standard for Specifications F 138,F 1314, F 1586, F 2229, and