ASTM F601-2003(2008) Standard Practice for Fluorescent Penetrant Inspection of Metallic Surgical Implants《金属外科植入物荧光渗透剂检测的标准实施规范》.pdf

1、Designation: F 601 03 (Reapproved 2008)Standard Practice forFluorescent Penetrant Inspection of Metallic SurgicalImplants1This standard is issued under the fixed designation F 601; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, th

2、e 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. Scope*1.1 This practice is intended as a guide for fluorescentpenetrant inspection of metallic surgical implants.1.2

3、 This standard does not purport to address all of thesafety concerns, if any, associated with its use. It 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 Docu

4、ments2.1 ASTM Standards:2D95 Test Method for Water in Petroleum Products andBituminous Materials by DistillationE 165 Test Method for Liquid Penetrant ExaminationE 433 Reference Photographs for Liquid Penetrant Inspec-tion2.2 ASNT Recommended Practice:3Recommended Practice No. SNT-TC-1A2.3 SAE Stand

5、ard:4AMS 2644 Inspection Material, Penetrant3. Significance and Use3.1 This practice is intended to confirm the method ofobtaining and evaluating the fluorescent penetrant indicationson metallic surgical implants.3.2 The product acceptance and rejection criteria will be asagreed upon between the pur

6、chaser and the supplier.4. Fluorescent Penetrant Method4.1 Perform fluorescent penetrant inspection of metallicsurgical implants in accordance with Practice E 165, MethodA.4.2 The penetrant system used shall conform to a minimumof Sensitivity Level 3, in accordance with the latest revision ofAMS 264

7、4.4.3 All penetrant materials shall be compatible with eachother.5. Penetrant Method Materials Control5.1 The penetrant method materials deteriorate in usefulnessthrough contamination and age. The following controls shouldbe used to evaluate the materials usefulness unless thesuppliers requirements

8、are more stringent:5.1.1 Penetrants:5.1.1.1 Water ContentWhere there is a possibility ofwater contamination to penetrant materials, the water contentshould be determined by Test Method D95. The water contentshall not exceed 10 %. The frequency of testing shall be at leastonce every 30 days for open

9、containers.5.1.1.2 Fluorescent BrightnessFluorescent brightnessshould be determined at least once every 30 days or before useby comparison of samples of the working penetrant to a sampleof new penetrant under black light. No visible difference shallbe allowed.5.1.2 Developer:5.1.2.1 DryThe developer

10、 should be dry and fluffy. De-velopers showing evidence of fluorescence when compared tonew developer shall not be used.5.1.2.2 WetA method should be employed to ensureadequate suspension of the wet developer prior to use. Thespecific gravity of the developer should be from 1.018 to 1.034.This metho

11、d does not apply to nonaqueous solvent developerdue to the volatile nature of the product.1This practice is under the jurisdiction ofASTM Committee F04 on Medical andSurgical Materials and Devices and is the direct responsibility of SubcommitteeF04.12 on Metallurgical Materials.Current edition appro

12、ved Feb. 1, 2008. Published May 2008. Originallyapproved in 1978. Last previous edition approved in 2003 as F 601 03.2For 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

13、 the standards Document Summary page onthe ASTM website.3Available fromAmerican Society for Nondestructive Testing (ASNT), P.O. Box28518, 1711 Arlingate Ln., Columbus, OH 43228-0518, http:/www.asnt.org.4Available from Society of Automotive Engineers (SAE), 400 CommonwealthDr., Warrendale, PA 15096-0

14、001, http:/www.sae.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 19428-2959, United States.5.1.3 Black LightsBlack lights used for fluorescent pen-etrant inspection should be checked for

15、black light output (witha filter) for a minimum of 800 W/cm2at a distance of 381 mm(15 in.) from the lamp face. This measurement could bedetermined by using a calibrated black light meter. Thefrequency of testing shall be at least once every 7 days orbefore use.6. Evaluation6.1 A general method of e

16、valuating fluorescent penetrantindications is encompassed in Reference Photographs E 433.7. Personnel Certification7.1 The personnel performing fluorescent penetrant inspec-tion under this practice shall be certified in accordance withASNT Recommended Practice No. SNT-TC-1A or recognizednational equ

17、ivalent.8. Keywords8.1 fluorescent; penetrant inspection; testing methods; sur-gical implantsAPPENDIX(Nonmandatory Information)X1. RATIONALEX1.1 A method of nondestructive inspection, known asfluorescent penetrant inspection, is employed as a qualitycontrol tool for surgical devices. This method of

18、inspection isnot only used by the manufacturers, but by their suppliers andalso independent testing laboratories. This method has beenused for over twenty years for the nondestructive examinationof surgical implants and devices. Fluorescent penetrant inspec-tion provides a sensitive method of detect

19、ing surface imper-fections such as scratches, cracks, surface porosity, and weld-ing joint imperfections.X1.2 Fluorescent penetrant inspection uses specially for-mulated penetrating oil, manufactured by many sources, whichalso has a fluorescent dye as part of its formula. The method ofinspection all

20、ows for the fluorescent penetrating oil to entersurface discontinuities; a subsequent process removes all othersurface remnants of the penetrating oil, thus leaving thefluorescent material only in surface discontinuities. A final“developer” is applied to bring out the penetrating oil from thediscont

21、inuities. Then an ultra violet light (black light) is used toinspect the part for the presence of the fluorescent material.This method allows for highly sensitive examination of smalldiscontinuities that normally would not be visible by unaidedvisual inspection.X1.3 Due to a variety of specification

22、s being applied to theinspection of surgical implants and devices, a task force wasformed under Committee F04 to standardize methods forfluorescent penetrant inspection of metallic surgical implants;the result was Practice F 601. The task force, comprised of alarge cross section of manufacturers, te

23、sting experts, govern-ment representatives, and other interested parties, developed auniversally accepted practice for surgical implants and devices.X1.4 This is a standard practice and is only intended toconfirm the standardized method of obtaining and evaluatingthe fluorescent penetrant indication

24、s, as well as the evaluationof the materials used in the testing method. This practice is notintended to set acceptance standards; this type of specificationwould be extremely difficult due to such variables as surfacefinish (that is, mechanically polished, vapor blasted, electropolished, and so for

25、th); manufacturing method (that is,wrought, forged, cast, and so forth); as well as other variablesin surface texture.SUMMARY OF CHANGESCommittee F04 has identified the location of selected changes to this standard since the last issue (F 601 98)that may impact the use of this standard. (Approved Se

26、pt. 10, 2003.)(1) Changed MIL-I-25135 to AMS 2644 in paragraphs 2.3 and4.2. MIL-I-25135E, Notice 1, 13 March 1998 states, “Futureacquisitions for this material should refer to SAE AMS 2644.”(2) Added Summary of Changes section.F 601 03 (2008)2ASTM International takes no position respecting the valid

27、ity 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 responsibility.This standard is subje

28、ct 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 International Headquart

29、ers. 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 shown below.This standard

30、 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 601 03 (2008)3