ASTM F3212-2016 Standard Test Method for Coring Testing of Huber Needles《胡贝尔针取心试验的标准试验方法》.pdf

1、Designation: F3212 16Standard Test Method forCoring Testing of Huber Needles1This standard is issued under the fixed designation F3212; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of last revision. A number in parenthe

2、ses indicates the year of last reapproval. Asuperscript epsilon () indicates an editorial change since the last revision or reapproval.1. Scope1.1 This test method covers the qualitative measurement ofHuber-type needles potential to remove septum materialduring implantable port access (1)2.1.2 This

3、test method does not address other issues that mayinclude, but are not limited to, force measurement during theperforation/withdrawal, septum integrity, and any safety issues.1.3 This standard does not purport to address all of thesafety concerns, if any, associated with its use. It is theresponsibi

4、lity 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:3D2240 Test Method for Rubber PropertyDurometer Hard-ness3. Terminology3.1 Definitions of Terms Sp

5、ecific to This Standard:3.1.1 bevel, nthe slanted part of a needle that creates asharp pointed tip.3.1.2 cannula, nthe tubular part of a needle through whichfluids pass.3.1.3 core, na sliver of septum material that may beproduced when a needle perforates a septum.3.1.4 heel, nthe rear cutting edge o

6、f the needle bevel.3.1.5 Huber needle, na needle whose tip is angles suchthat the bevel opening is parallel to the main axis of thecannula. Its special shape slices rather than perforates theseptum, reducing the chance of leakage due to coring. It is alsoknown as a non-coring needed. See Fig. 1.3.1.

7、6 implantable port, na reservoir placed under the skin(and usually attached to a catheter) that is made to receive aneedle through a septum; it is often used to deliver medication.See Fig. 2.3.1.7 lumen, nthe inside surface of the cannula.3.1.8 septum, na feature of an implantable port that allowsre

8、peated access by a port-access needle, generally composed ofan elastomeric material. See Fig. 2, Item 1.3.1.9 stylet, na device, preferably metallic, inserted intothe lumen to remove a core.4. Summary of Test Method4.1 A silicone elastomeric disk (surrogate septum or justseptum thereafter) is clampe

9、d into a specifically designedseptum holder. The test operator accesses the septum with aHuber needle in accordance with the needle manufacturersinstructions for use, as if the septum was an implantable port.The lumen at the bevel is examined for the existence of a core,preferably before the needle

10、is withdrawn. This is categorizedas a pass/fail test. Existence of a core in the needles cannula isa failed result.5. Significance and Use5.1 This test method determines whether Huber needles aredesigned and manufactured such that they will not produce acore during simulated implantable port access.

11、5.2 If a needle produces a core during actual use, leaking ofthe implantable port may occur. Also, the core may be flushedinto the ports reservoir and subsequently into the patientsbody.6. Apparatus6.1 Clamping Test Fixture, a clamping device which canhold a septum with nominal dimensions of 0.70 in

12、. in diameterand 0.25 in. thick. The clamping device is such that it restrainsradial expansion of the septum under axial compression. Thecompression force is specified when the compression plates arein contact. The distance between the two compressive surfacesof the fixture plates after the clamping

13、 will be 0.213 in. whichresults in nominal 15 % compression. See Figs. 3-13.6.1.1 The clamping test fixture consists of 6 parts (See Figs.3-13.). The septum (Fig. 8) is placed on the opening of theseptum restrictor (Fig. 6). The septum restrictor with the1This test method is under the jurisdiction o

14、f ASTM Committee F04 on Medicaland Surgical Materials and Devices and is the direct responsibility of SubcommitteeF04.33 on Medical/Surgical Instruments.Current edition approved Oct. 1, 2016. Published October 2016. DOI: 10.1520/F3212-16.2The boldface numbers in parentheses refer to a list of refere

15、nces at the end ofthis standard.3For 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.Copyright ASTM International,

16、 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States1septum is held between two clamps (Fig. 4, Fig. 5 and Fig. 7)with three screws (Fig. 11 and Fig. 12). The screws must betightened completely. A polycarbonate cylinder (Fig. 9) holdsthe clamping setup at a height tha

17、t enables needle penetrationwhile protecting the tester from any potential needle sticks.Parts 6a, 6b, and 6c (Fig. 10) are three possible versions of theguide template.6.2 Septum (Fig. 8), a silicone disk 0.70 6 0.01 in. indiameter and 0.25 6 0.01 in. thick. The flat surfaces should besmooth with n

18、either tool marks nor voids visible to the nakedeye. The septum is made of molded LSR (silicone) elastomericmaterial with a durometer hardness of 55 6 5A (Test MethodD2240).FIG. 1 Example of a Huber Needle (partial section through cannula)FIG. 2 Example of an Implantable Port (section)F3212 1626.3 O

19、ptical Microscope, capable of an optical magnificationof at least 20 times.6.4 Stylet, a wire, not less than 70 % of inner diameter of thecannula, used to push through the needle to force out a possiblecore within the lumen.7. Test Specimens and Test Units7.1 Test specimens are production-equivalent

20、 Huber needlesin their original packaging.8. Procedure8.1 Remove the needle from its package (if applicable).Each needle should be tested only once.8.2 Clamp the septum into the test fixture (Fig. 11 and Fig.12) in accordance with 6.1.1.8.3 Fasten the test fixture on top of the cylinder and thenplac

21、e the guide template on top of the test fixture (Fig. 13).8.4 Insert the needle into the clamped septum along theouter edge of the circular opening of the guide template withthe bevel oriented in the circumferential direction (Fig. 14).Perforate the septum with only one needle at a time. Carefullyav

22、oid any previous penetration sites. Ensure that the needle ishandled and penetrates in accordance with the instructions foruse from the needle manufacturer except that the needle is to betested dry, even if the manufacturers instructions require thatFIG. 3 Clamping Test Fixture LayoutFIG. 4 Cross-se

23、ction of Clamping Device with SeptumF3212 163the needle to be flushed before use. Do not insert the needleinto the 0.125 in. diameter central area of the septum (2).8.5 Determine whether coring has occurred. The method todetermine whether a core is present may be developed by eachtesting facility, a

24、nd appropriately validated. The followingtechniques can potentially be used to identify a core:(a) Flip the clamping test fixture over to expose the bevel.Observe the cannula lumen at the bevel, area around thepenetration and under the penetration using an optical micro-scope with 20 times magnifica

25、tion for the presence of a core. Ifcoring has occurred, a sliver of the septum should be observedin the needle cannula. Use a stainless steel stylet, coil spring-type guide wire, or polyamide tubing to confirm the absence ofa core in the cannula lumen. Note existence or absence of acore or any forei

26、gn particles (Fig. 15 and Fig. 16).(b) For 90-degree bent needles, cut the needle to removethe bent part and be able to use a stylet in the straight part toremove the core.(c) Directly observe the inside of the lumen with a micro-scope by orienting the deflected tip of the needle with themicroscopes

27、 line-of-sight.(d) Attach a syringe to the needle and flush the needle withwater. Ensure that the discharged water passes through filterpaper to collect any existing core.8.6 Remove the needle from the septum and mark thelocation of the perforation with a permanent fine tip marker.8.7 Repeat steps 8

28、.1 8.6 for each needle tested by movingalong the circumference of the guide template. Replace the testfixture with a new septum once 12 needles have been tested orafter five cores are observed, whichever occurs first.9. Report9.1 Report the following information:9.1.1 Name of testing laboratory.9.1.

29、2 Name of person performing test.9.1.3 Date and time of testing and testing conditions.9.1.4 Identify septum holder used.9.1.5 Identify septum: materials, manufacturer, lot numberand actual hardness.9.1.6 Identify needle: manufacturer and/or supplier, model,size, lot number.9.1.7 Brief description o

30、f core identifying procedure andmagnification used.9.1.8 Existence or absence of core or other foreign particles.9.1.9 If a core is found, explain any specific observationsthat were made.9.1.10 Provide photographic documentation, if available.10. Precision and Bias10.1 The precision of this test met

31、hod is based on aninterlaboratory study of F3212, Standard Test Method forCoring Testing of Huber Needles, conducted in 2015. NineFIG. 5 Bottom ClampF3212 164laboratories participated in this study, with seven labs submit-ting suable data. Six labs received 100 individually identifiedHuber needles (

32、25 defective and 75 non-defective) and one labtested 125 needles (100 non-defective and 25 defective). Every“test result” reported represents an individual coring determi-nation. The details of this study are recorded in ASTMResearch Report No. RR:F04-1015.410.1.1 Intentionally defective Huber needl

33、es were properlyidentified 96.6 % of the time when the test method wasperformed as written.10.1.2 Non-defective Huber needles were identified 99.8 %of the time when the test method was performed as written.10.2 BiasAt the time of the study, there was no acceptedreference material suitable for determ

34、ining the bias for this testmethod, therefore no statement of bias is being made.10.3 The precision statement was determined through sta-tistical examination of 725 test results, from seven laboratories,on both intentionally defective and standard Huber needles.11. Keywords11.1 core; Huber needle; m

35、edical device; non-coring needle4Supporting data have been filed at ASTM International Headquarters and maybe obtained by requesting Research Report RR:F04-1015. ContactASTM CustomerService at serviceastm.org.FIG. 6 Septum RestrictorNote: Brake sharp edges, not to exceed 0.02 in. by 45FIG. 7 Top Cla

36、mpF3212 165FIG. 8 SeptumFIG. 9 CylinderF3212 166FIG. 10 Guide Template (three possible designs)FIG. 11 Stainless Steel Clamping Top and Bottom along withSeptum and Septum RestrictorFIG. 12 Clamped Septum with Guide Template and CylinderF3212 167FIG. 13 Clamping Test FixtureFIG. 14 Needle InsertionF3

37、212 168FIG. 15 Examples of Visible CoresFIG. 16 Examples of Visible Cores Observed while Deflected Needles Tip is almost Aligned with the Microscopes Line-of-SightF3212 169REFERENCES(1) Vesnovsky, O., Casamento, J. P., Brooks, M. E., Schwerin, M. R.,Herman, W., A., Pollack, S. K., Flack, M. N., Coll

38、ins, B. W., andGrossman, L. W., “Performance Testing of Huber Needles for Coringof Port Septa,” Journal of Medical Devices, 4, 2010, 031008-1031008-7.(2) Vesnovsky, O. and Casamento, J. P., “Development of a Coring Testfor Non-Coring Huber Needles,” Journal of Medical Devices, 7, 2013,020930-1020930

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