ASTM F601-2018 Standard Practice for Fluorescent Penetrant Inspection of Metallic Surgical Implants.pdf

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1、Designation: F601 13F601 18Standard 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 las

2、t 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 fluorescent penetrant inspection of metallic surgical implants.1.2 This standard do

3、es not purport to address all of the safety concerns, if any, associated with its use. It is the responsibilityof the user of this standard to establish appropriate safety safety, health, and healthenvironmental practices and determine theapplicability of regulatory limitations prior to use.1.3 This

4、 international standard was developed in accordance with internationally recognized principles on standardizationestablished in the Decision on Principles for the Development of International Standards, Guides and Recommendations issuedby the World Trade Organization Technical Barriers to Trade (TBT

5、) Committee.2. Referenced Documents2.1 ASTM Standards:2D95 Test Method for Water in Petroleum Products and Bituminous Materials by DistillationE165E165/E165M Practice for Liquid Penetrant Examination for General IndustryE1135 Test Method for Comparing the Brightness of Fluorescent PenetrantsE1417E14

6、17/E1417M Practice for Liquid Penetrant Testing2.2 ASNT Recommended Practice:Documents:3Recommended Practice No. SNT-TC-1ACP-189 Standard for Qualification and Certification of Nondestructive Testing Personnel2.3 SAE Standard:4AMS 2644 Inspection Material, Penetrant2.4 ISO Document:5ISO 9712 Non-des

7、tructive Testing Qualification and Certification of NDT Personnel2.5 NAS Document:6NAS-410 Certification and Qualification of Nondestructive Test Personnel3. Significance and Use3.1 This practice is intended to confirm the method of obtaining and evaluating the fluorescent penetrant indications on m

8、etallicsurgical implants.3.2 The product acceptance and rejection criteria will be as agreed upon between the purchaser and the supplier.4. Fluorescent Penetrant Method4.1 Perform fluorescent penetrant inspection of metallic surgical implants in accordance with Practice E165E165/E165M,Method A.1 Thi

9、s practice is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of Subcommittee F04.12on Metallurgical Materials.Current edition approved Dec. 1, 2013April 1, 2018. Published January 2014May 2018. Originally approved in 1978.

10、Last previous edition approved in 20082013 asF601 03 (2008).F601 13. DOI: 10.1520/F0601-13.10.1520/F0601-18.2 For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM Customer Service at serviceastm.org. For Annual Book of ASTM Standardsvolume information, refer to the stand

11、ards Document Summary page on the ASTM website.3 Available from American Society for Nondestructive Testing (ASNT), P.O. Box 28518, 1711 Arlingate Ln., Columbus, OH 43228-0518, http:/www.asnt.org.4 Available from Society of Automotive Engineers (SAE), 400 Commonwealth Dr., Warrendale, PA 15096-0001,

12、 http:/www.sae.org.5 Available from International Organization for Standardization (ISO), ISO Central Secretariat, BIBC II, Chemin de Blandonnet 8, CP 401, 1214 Vernier, Geneva,Switzerland, http:/www.iso.org.6 Available from Aerospace Industries Association (AIA/NAS), 1000 Wilson Boulevard, Suite 17

13、00, Arlington, VA 22209-3928.This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Becauseit may not be technically possible to adequately depict all changes accurately, ASTM recommends

14、 that users consult prior editions as appropriate. In all cases only the current versionof the standard as published by ASTM is to be considered the official document.*A Summary of Changes section appears at the end of this standardCopyright ASTM International, 100 Barr Harbor Drive, PO Box C700, We

15、st Conshohocken, PA 19428-2959. United States14.2 The penetrant system used shall conform to a minimum of Sensitivity Level 3, in accordance with the latest revision ofAMS2644.4.3 All penetrant materials shall be compatible with each other.other, and approved in accordance with AMS-2644.5. Preparati

16、on for Testing5.1 Pre- and post-cleaning requirements are to be agreed upon between the purchaser and supplier.5.2 If sand/grit blasting is used for pre-cleaning, take care to ensure that defects are not masked or peened over.6. Penetrant Method Materials Control6.1 The penetrant method materials de

17、teriorate in usefulness through contamination and age. The following controls shall beused to evaluate the materials usefulness unless the suppliers requirements are more stringent:6.1.1 Penetrants:6.1.1.1 Water Content of Non-Water-Based Water-Washable PenetrantsWater content of non-water-based Met

18、hod Apenetrants shall be checked monthly in accordance with Test Method D95. If the water content of the in-use penetrant exceeds 5%, the penetrant shall either be discarded or sufficient unused penetrant added to reduce the water content to below 5 %.6.1.1.2 Penetrant BrightnessBrightness tests of

19、in-use fluorescent penetrants shall be conducted quarterly. Tests shall be inaccordance with Test Method E1135 with a representative sample of the unused penetrant serving as the reference. Brightnessvalues less than 90 % of the unused penetrant brightness are unsatisfactory and the in-use penetrant

20、s shall be discarded or otherwisecorrected, as appropriate.6.1.2 Developer:6.1.2.1 The following forms of developers are allowed for use 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 paramet

21、ers for controlling the application and required tests frequencies of developers are located in PracticeE1417E1417/E1417M and Practice E1417E1417/E1417M, Table 1.6.1.3 Black LightsPortable, hand-held, permanently mounted or fixed black lights used to inspect parts shall be checked forintensity daily

22、 or prior to use, and after bulb replacement, using a calibrated black light meter. UV-A radiometer. The minimumacceptable 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 lightsshall be checked weekly for cleanliness and integrity a

23、nd shall be cleaned, repaired, or replaced as appropriate.6.1.4 Ambient Light IntensityAmbient visible light background shall not exceed 2 fc (21.5 lx) at the examination surface andshall be checked using a calibrated light meter quarterly or when any changes or construction, or both, are made in th

24、e inspectionarea.6.1.5 Penetrant System PerformanceThe penetrant systems overall performance shall be checked daily as specified inPractice E1417E1417/E1417M, paragraph 7.8.3.6.1.6 Additional Required TestsThe following tests shall be preformedperformed in accordance with Practice E1417E1417/E1417M:

25、6.1.6.1 Wash water temperature and temperature check at the start of every working shift, and6.1.6.2 Daily checks for penetrant contamination and inspection area cleanliness.7. Evaluation7.1 The product acceptance and rejection criteria shall be as agreed upon between the purchaser and supplier.7.2

26、Indication verifications are allowed, as agreed between purchaser and supplier.8. Personnel Certification8.1 The personnel performing fluorescent penetrant inspection under this practice shall be certifiedPersonnel performingexaminations to this standard shall be qualified in accordance with ASNT Re

27、commended Practice No. SNT-TC-1A or recognizednational equivalent.a nationally or internationally recognized NDT personnel qualification practice or standard such asANSI/ASNT-CP-189, SNT-TC-1A, NAS-410, ISO 9712 or a similar document and certified by the employer or certifying agency,as applicable.

28、The practice or standard used and its applicable revision shall be identified in the contractual agreement betweenthe using parties.9. Keywords9.1 fluorescent; penetrant inspection; testing methods; surgical implantsF601 182APPENDIX(Nonmandatory Information)X1. RATIONALEX1.1 A method of nondestructi

29、ve inspection, known as fluorescent penetrant inspection, is employed as a quality control tool forsurgical devices. This method of inspection is not only used by the manufacturers, but by their suppliers and also independenttesting laboratories. This method has been used for over twenty years for t

30、he nondestructive examination of surgical implants anddevices. Fluorescent penetrant inspection provides a sensitive method of detecting surface imperfections such as scratches, cracks,surface porosity, and welding joint imperfections.X1.2 Fluorescent penetrant inspection uses specially formulated p

31、enetrating oil, manufactured by many sources, which also hasa fluorescent dye as part of its formula. The method of inspection allows for the fluorescent penetrating oil to enter surfacediscontinuities; a subsequent process removes all other surface remnants of the penetrating oil, thus leaving the

32、fluorescent materialonly in surface discontinuities.Afinal “developer” is applied to bring out the penetrating oil from the discontinuities. Then an ultraviolet light (black light) (UV-A) is used to inspect the part for the presence of the fluorescent material. This method allows forhighly sensitive

33、 examination of small discontinuities that normally would not be visible by unaided visual inspection.X1.3 Due to a variety of specifications being applied to the inspection of surgical implants and devices, a task force was formedunder Committee F04 to standardize methods for fluorescent penetrant

34、inspection of metallic surgical implants; the result wasPractice F601. The task force, comprised of a large cross section of manufacturers, testing experts, government representatives,and other interested parties, developed a universally accepted practice for surgical implants and devices.X1.4 This

35、is a standard practiceand is only intended to confirm the standardized method of obtaining and evaluating thefluorescent penetrant indications, as well as the evaluation of the materials used in the testing method. This practice is not intendedto set acceptance standards; this type of specification

36、would be extremely difficult due to such variables as surface finish (that is,mechanically polished, grit or vapor blasted, electro polished, and so forth); manufacturing method (that is, wrought, forged, cast,and so forth); as well as other variables in surface texture.SUMMARY OF CHANGESCommittee F

37、04 has identified the location of selected changes to this standard since the last issue, F601 03(2008)F601 13, that may impact the use of this standard. (Approved Dec. 1, 2013)April 1, 2018.)(1) Five year review.(2) Section 2: Updated applicable standards.(3) Section 4: Updated E-Specs and add AMS

38、reference.(4) ReferenceSection 5to Test Method: Added pre-cleaning E1135 and Practicecaution to be E1417 were added to thestandard.taken.(5) Section 6 (formerly Section 5) was revised to eliminate the conflicts between this practice and Practices: Updated applicablestandards, corrected typo and adde

39、d E165 and UV-A radiometer.E1417.(6) Section 7: Added bleed-back allowance.(7) Section 8: Updated to be in agreement with Committee E07.F601 183ASTM International takes no position respecting the validity of any patent rights asserted in connection with any item mentionedin this standard. Users of t

40、his 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 responsible technical committee and must be reviewed every five y

41、ears 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 Headquarters. Your comments will receive careful consideration at a meeting of theresponsible technical commi

42、ttee, 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 International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 194

43、28-2959,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 Copyright Clearance Center, 222Rosewood Drive, Danvers, MA 01923, Tel: (978) 646-2600; http:/ 184