ASTM_F_601_-_13.pdf

Designation:F60113Standard 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 revision.Anumber in parentheses indicates the year of last reapproval.Asuperscriptepsilon()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 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 Standards: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 Practice: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 rejection 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,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 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 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-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 tests 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 penetrants 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 parameters 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 SubcommitteeF04.12 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 Service 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 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 States1 6.1.3 Black LightsPortable,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)at 15 in.(38.1 cm)from the front of the 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 examinationsur