1、Designation: F601 13Standard Practice forFluorescent Penetrant Inspection of Metallic SurgicalImplants1This standard is issued under the fixed designation F601; the number immediately following the designation indicates the year of originaladoption or, in the case of revision, the year of last revis
2、ion. A number in parentheses indicates the year of last reapproval. A superscriptepsilon () 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 does n
3、ot 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 Standar
4、ds:2D95 Test Method for Water in Petroleum Products andBituminous Materials by DistillationE165 Practice for Liquid Penetrant Examination for GeneralIndustryE1135 Test Method for Comparing the Brightness of Fluo-rescent PenetrantsE1417 Practice for Liquid Penetrant Testing2.2 ASNT Recommended Practi
5、ce:3Recommended Practice No. SNT-TC-1A2.3 SAE Standard: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 rejec
6、tion criteria will be asagreed upon between the purchaser and the supplier.4. Fluorescent Penetrant Method4.1 Perform fluorescent penetrant inspection of metallicsurgical implants in accordance with Practice E165, Method A.4.2 The penetrant system used shall conform to a minimumof Sensitivity Level
7、3, in accordance with the latest revision ofAMS 2644.4.3 All penetrant materials shall be compatible with eachother.5. Preparation for Testing5.1 Pre- and post-cleaning requirements are to be agreedupon between the purchaser and supplier.6. Penetrant Method Materials Control6.1 The penetrant method
8、materials deteriorate in usefulnessthrough contamination and age. The following controls shall beused to evaluate the materials usefulness unless the suppliersrequirements are more stringent:6.1.1 Penetrants:6.1.1.1 Water Content of Non-Water-Based Water-WashablePenetrantsWater content of non-water-
9、based Method A pen-etrants shall be checked monthly in accordance with TestMethod D95. If the water content of the in-use penetrantexceeds 5 %, the penetrant shall either be discarded orsufficient unused penetrant added to reduce the water content tobelow 5 %.6.1.1.2 Penetrant BrightnessBrightness t
10、ests of in-usefluorescent penetrants shall be conducted quarterly. Tests shallbe in accordance with Test Method E1135 with a representativesample of the unused penetrant serving as the reference.Brightness values less than 90 % of the unused penetrantbrightness are unsatisfactory and the in-use pene
11、trants shall bediscarded or otherwise corrected, as appropriate.6.1.2 Developer:6.1.2.1 The following forms of developers are allowed foruse with Type 1 Method A penetrants:Form A: Dry developers.Form C: Water suspendable developers.Form D: Nonaqueous developers for Type 1 penetrants.6.1.2.2 The par
12、ameters for controlling the application andrequired tests frequencies of developers are located in PracticeE1417 and Practice E1417, Table 1.1This practice is under the jurisdiction ofASTM Committee F04 on Medical andSurgical Materials and Devices and is the direct responsibility of SubcommitteeF04.
13、12 on Metallurgical Materials.Current edition approved Dec. 1, 2013. Published January 2014. Originallyapproved in 1978. Last previous edition approved in 2008 as F601 03 (2008).DOI: 10.1520/F0601-13.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Servic
14、e at serviceastm.org. For Annual Book of ASTMStandards volume information, refer to 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
15、 Society of Automotive Engineers (SAE), 400 CommonwealthDr., Warrendale, PA 15096-0001, http:/www.sae.org.*A Summary of Changes section appears at the end of this standardCopyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States16.1.3 Black Lig
16、htsPortable, hand-held, permanentlymounted or fixed black lights used to inspect parts shall bechecked for intensity daily or prior to use, and after bulbreplacement, using a calibrated black light meter. The mini-mum acceptable intensity is 1000 W/cm2(10 W/m2)at15in.(38.1 cm) from the front of the
17、filter to the face of the sensor.Black lights shall be checked weekly for cleanliness andintegrity and shall be cleaned, repaired, or replaced as appro-priate.6.1.4 Ambient Light IntensityAmbient visible light back-ground shall not exceed 2 fc (21.5 lx) at the examinationsurface and shall be checked
18、 using a calibrated light meterquarterly or when any changes or construction, or both, aremade in the inspection area.6.1.5 Penetrant System PerformanceThe penetrant sys-tems overall performance shall be checked daily as specifiedin Practice E1417, paragraph 7.8.3.6.1.6 Additional Required TestsThe
19、following tests shallbe preformed in accordance with Practice E1417:6.1.6.1 Wash water temperature and temperature check atthe start of every working shift, and6.1.6.2 Daily checks for penetrant contamination and in-spection area cleanliness.7. Evaluation7.1 The product acceptance and rejection crit
20、eria shall be asagreed upon between the purchaser and supplier.8. Personnel Certification8.1 The personnel performing fluorescent penetrant inspec-tion under this practice shall be certified in accordance withASNT Recommended Practice No. SNT-TC-1A or recognizednational equivalent.9. Keywords9.1 flu
21、orescent; 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 inspection isnot only used
22、 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 detecting surface imper-fections
23、 such as scratches, cracks, surface porosity, and weld-ing joint imperfections.X1.2 Fluorescent penetrant inspection uses specially formu-lated penetrating oil, manufactured by many sources, whichalso has a fluorescent dye as part of its formula. The method ofinspection allows for the fluorescent pe
24、netrating 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 thediscontinuities. Then an ultra vi
25、olet 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 specifications being applied to theinsp
26、ection 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 F601. The task force, comprised of alarge cross section of manufacturers, testing experts, govern-ment
27、representatives, and other interested parties, developed auniversally accepted practice for surgical implants and devices.X1.4 This is a standard practiceand is only intended toconfirm the standardized method of obtaining and evaluatingthe fluorescent penetrant indications, as well as the evaluation
28、of 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, grit or vapor blasted,electro polished, and so forth); manufacturing m
29、ethod (that is,wrought, forged, cast, and so forth); as well as other variablesin surface texture.F601 132SUMMARY OF CHANGESCommittee F04 has identified the location of selected changes to this standard since the last issue, F601 03(2008), that may impact the use of this standard. (Approved Dec. 1,
30、2013)(1) Reference to Test Method E1135 and Practice E1417 wereadded to the standard.(2) Section 6 (formerly Section 5) was revised to eliminate theconflicts between this practice and Practices E165 and E1417.ASTM International takes no position respecting the validity of any patent rights asserted
31、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 subject to revision at any time by the
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33、reful 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 is copyrighted by ASTM Internatio
34、nal, 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). Permission rights to photocopy the standard may also be secured from the ASTM website (www.astm.org/COPYRIGHT/).F601 133
