1、Designation: F 601 03Standard 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, the year of last rev
2、ision. 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 This standard doe
3、s 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 Documents2.1 ASTM Stan
4、dards:D 95 Test Method for Water in Petroleum Products andBituminous Materials by Distillation2E 165 Test Method for Liquid Penetrant Examination3E 433 Reference Photographs for Liquid Penetrant Inspec-tion32.2 ASNT Recommended Practice:4Recommended Practice No. SNT-TC-1A2.3 SAE Standard:5AMS 2644 I
5、nspection 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 purchaser and the
6、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 2644.4.3 All penet
7、rant 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 are more string
8、ent: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 D 95. The water contentshall not exceed 10 %. The frequency of testing shall be at leastonce every 30 days for open containers.5.1
9、.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 should be dry
10、 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 method does not app
11、ly to nonaqueous solvent developerdue to the volatile nature of the product.5.1.3 Black LightsBlack lights used for fluorescent pen-etrant inspection should be checked for 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
12、 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 evaluating fluorescent penetrantindications is encompassed in Reference Photographs E 433.1This practice is under the jurisdictio
13、n of ASTM Committee F04 on Medical andSurgical Materials and Devices and is the direct responsibility of SubcommitteeF04.12 on Metallurgical Materials.Current edition approved Sept. 10, 2003. Published October 2003. Originallyapproved in 1978. Last previous edition approved in 1998 as F 601 98.2Annu
14、al Book of ASTM Standards, Vol 05.01.3Annual Book of ASTM Standards, Vol 03.03.4Available from American Society for Non-Destructive Testing, 3200 RiversideDr., Columbus, OH 43221.5Available from Society of Automotive Engineers (SAE), 400 CommonwealthDr., Warrendale, PA 15096-0001.1*A Summary of Chan
15、ges 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.7. Personnel Certification7.1 The personnel performing fluorescent penetrant inspec-tion under this practice shall be certified in accorda
16、nce withASNT Recommended Practice No. SNT-TC-1A or recognizednational equivalent.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, i
17、s employed as a qualitycontrol tool for surgical devices. This method of 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
18、. Fluorescent penetrant inspec-tion provides a sensitive method of detecting 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
19、has a fluorescent dye as part of its formula. The method ofinspection allows 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 fin
20、al“developer” is applied to bring out the penetrating oil from thediscontinuities. 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 v
21、isible by unaidedvisual inspection.X1.3 Due to a variety of specifications 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 60
22、1. The task force, comprised of alarge cross section of manufacturers, testing 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 standardiz
23、ed method of obtaining and evaluatingthe fluorescent penetrant indications, 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 (t
24、hat is, mechanically polished, vapor blasted, electropolished, and so forth); 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 la
25、st issue (F 601 98)that may impact the use of this standard. (Approved Sept. 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.
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27、 entirely 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 standar
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29、ee 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).F601032
