ASTM F2528-2006(2014) Standard Test Methods for Enteral Feeding Devices with a Retention Balloon《带压力气囊的肠给食装置的标准试验方法》.pdf

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1、Designation: F2528 06 (Reapproved 2014)Standard Test Methods forEnteral Feeding Devices with a Retention Balloon1This standard is issued under the fixed designation F2528; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of

2、 last revision. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon () indicates an editorial change since the last revision or reapproval.1. Scope1.1 These test methods cover the establishment of perfor-mance requirements for the utilization of a single-use, enteralf

3、eeding device with a retention balloon, used by medicalprofessionals for providing a means of nutrition and/or admin-istration of medication to patients by means of natural orifice(nasal, oral, transluminal) and or a surgically created stoma.The product is manufactured in various sizes and materials

4、such as silicone, urethane, and various polymers (as well ascombinations of these) and is provided nonsterile for steriliza-tion and sterile for single use only. Rationale for these testmethods can be found in Appendix X1.1.2 This standard does not purport to address all of thesafety concerns, if an

5、y, associated with its use. It is theresponsibility of the user of this standard to establish appro-priate safety and health practices and to determine theapplicability of regulatory limitations prior to use.2. Referenced Documents2.1 ASTM Standards:2F623 Performance Specification for Foley Catheter

6、2.2 Other Standard:Simulated Gastric Fluid, USP Official Compendia of Stan-dards33. Terminology3.1 Definitions:3.1.1 balloon integrity (resistance to rupture), nvolume ofliquid that corresponds with balloon failure, or bursting.3.1.2 distal, nrefers to the balloon end of the enteralfeeding device3.1

7、.3 enteral feeding device with retention balloon, natwo-way medical device intended to provide a means ofnutrition or administration of medication, or both, to patientsby means of natural orifice (nasal, oral, transluminal) or asurgically created stoma, or both, consisting of a drainagelumen and inf

8、lation lumen (see Fig. 1). Common ballooninflation sizes are 5 cm3,15cm3, and 20 cm3.3.1.4 French size (Fr), na scale used for denoting the sizeof catheters and other tubular instruments. The French sizevalue is three times the outer diameter of the tube as measuredin millimetres. For example, a dia

9、meter of 18 Fr indicates adiameter of 6 mm.3.1.5 inflation volume, nvolume of liquid used to inflatethe retention balloon of the enteral feeding device for proposedtesting in this standard.3.1.6 rated volume, nstated volume of inflation of theretention balloon of the enteral feeding device in the ma

10、nufac-turers labeling and instructions for use.3.1.7 simulated gastric fluid, na solution consisting ofhydrochloric acid, salt and pepsin with a pH of approximately1.2, per USP standard recipe.3.1.8 sterility, nthe state of being free from viable micro-organisms.4. Specimen Preparation4.1 All test s

11、pecimens for test methods listed below shallconsist of the manufacturers new, finished, untested, unsteril-ized product.At the minimum, statistically valid samples of thesmallest and the largest diameter of enteral feeding devicesshall be tested.5. Test MethodsPROCEDURE A: FLOW RATE THROUGH FEEDINGL

12、UMEN5.1 ScopeThis test method covers the determination offlow rates through the drainage lumen of the enteral feedingdevice with retention balloon.5.2 Summary of Test MethodThe apparatus is set up asshown in Fig. 2. The flow rate is adjusted through the waterinlet to a rate sufficient to maintain fl

13、ow through the overflowoutlet while each enteral feeding device is tested. A headpressure of 20 6 1.0 cm of water (196 6 10 kPa) above the1These test methods are under the jurisdiction of ASTM Committee F04 onMedical and Surgical Materials and Devices and are the direct responsibility ofSubcommittee

14、 F04.35 on GI Applications.Current edition approved June 1, 2014. Published June 2014. Originallyapproved in 2006. Last previous edition approved in 2006 as F2528 06. DOI:10.1520/F2528-06R14.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serv

15、iceastm.org. For Annual Book of ASTMStandards volume information, refer to the standards Document Summary page onthe ASTM website.3USP Official Compendia of Standards, available from U.S. Pharmacopeia(USP), 12601 Twinbrook Pkwy., Rockville, MD 20852.Copyright ASTM International, 100 Barr Harbor Driv

16、e, PO Box C700, West Conshohocken, PA 19428-2959. United States1tank bottom shall be maintained throughout the test to approxi-mate actual physiological conditions. The overflow outletshould not be covered by water.5.3 Significance and UseThe flow rate is measured inreverse flow for ease in testing,

17、 since differences in the flowrate as a result of flow direction are theoretically insignificant.5.4 Apparatus:5.4.1 Water Reservoir, capable of maintaining 20 6 1.0 cm(7.9 6 0.4 in.) of water (196 6 10 kPa) above the tip of theenteral feeding device connection throughout the test as shownin Fig. 2.

18、 (See Performance Specification F623.)5.4.2 Graduated Cylinder, calibrated for suitable measure-ment of the effluent.5.4.3 Syringe, with appropriate tip for inflation of enteralfeeding device balloon.5.5 Hazards:5.5.1 Overflow should not be covered. Head pressure mustbe kept constant; water should a

19、lways be exiting through theoverflow outlet.5.5.2 Establish equilibrium before testing.5.5.3 Flow rates through all fittings must exceed that of theenteral feeding device being tested.5.6 Procedure:5.6.1 Test at 23 6 4C (73.4 6 7F).5.6.2 Inflate the retention balloon of the test specimen withwater t

20、o labeled volume.5.6.3 Connect the enteral feeding device to enteral feedingdevice connector and open the stopcock. The tip of the enteralfeeding device connection at the junction of enteral feedingdevice on-off valve should be level with the bottom of the tank61 cm and it should deliver fluid at 20

21、 6 1 cm (196 6 10 kPa)head pressure at that junction.5.6.4 Establish flow equilibrium before taking test measure-ments.5.6.5 Record the amount of fluid through the device feedinglumen in 30 seconds.5.7 Interpretation of ResultsFlow rates for enteral feedingdevices tested must meet or exceed 9 cm3/mi

22、n.5.8 Precision and BiasTo be determined within five years.PROCEDURE B: BALLOON BURST VOLUME5.9 ScopeThis test method covers the determination ofballoon integrity of enteral feeding devices with retentionballoon.5.10 Summary of Test MethodThe enteral feeding devicewith retention balloon is submerged

23、 in a small container filledwith water. The balloon is then inflated with water untilrupture, which enables the volume at which the balloon burststo be observed.5.11 Significance and UseThe balloon burst volume ismeasured to quantify the resistance of rupture of the enteralfeeding device with retent

24、ion balloon member.5.12 ApparatusThe testing apparatus is set up as shown inFig. 3.5.12.1 System Reservoir.5.12.2 Syringe.5.12.3 Water.5.13 HazardsWater should be emptied from system res-ervoir through purge valve when fill marked is reached.5.14 Procedure:5.14.1 Test at 23 6 4C (73.4 6 7F).5.14.2 I

25、nsert uninflated enteral feeding device into testorifice in system reservoir per Fig. 3.5.14.3 Close orifice so that it is positioned proximal to theenteral feeding device with retention balloon member. Thedevice is not to be immersed in water within the reservoir perFig. 3.5.14.4 Fill syringe with

26、amount of water greater than thatlisted in Table 1 for the desired French size. Attach tip ofsyringe to enteral feeding device inflation valve.5.14.5 Inflate retention balloon at 1 cm3/sec with water untilballoon bursts. Record amount of water injected into balloon attime of burst.5.15 Interpretatio

27、n of ResultsBurst volumes for enteralfeeding devices tested must meet or exceed those listed inTable 1.5.16 Precision and BiasTo be determined within fiveyears.PROCEDURE C: BALLOON VOLUMEMAINTENANCE5.17 ScopeThis test method is applicable enteral feedingdevices with retention balloon to test the int

28、egrity of theinflation system to maintain balloon volume.5.18 Summary of Test MethodThe balloon retention de-vice of the enteral feeding device is inflated with a test liquid.This test liquid contains a colorant which enables a leak of thisfluid to be observed. If no leak is observed, the integrity

29、of theinflation system is upheld, therefore maintaining the balloonvolume.5.19 Significance and UseThis test method establishes astandard test method for determining the functional integrity ofthe inflation system of the enteral feeding device with retentionballoon enteral feeding device by observin

30、g the consistancy ofvolume of the balloon after it is filled with test liquid.Additionally, since it is the function of the inflated balloon toretain the feeding device in position, the ballon must inflate,retain inflation volume, and release that volume when required.5.20 Apparatus:5.20.1 Syringe.F

31、IG. 1 Enteral Feeding Device with Retention BalloonF2528 06 (2014)25.20.2 Methylene Blue Crystal Solution or EquivalentPrepare1gofmethylene crystals and dilute in 2000 cm3ofwater, to be detectable in the described retention test.5.20.3 Background Material, suitable for detection of anyleakage (for e

32、xample, paper towel).5.21 HazardsEnsure that the syringe is properly seated inthe valve.5.22 Procedure:5.22.1 Test at 23 6 4C (73.4 6 7F).5.22.2 Inflate the balloon with the methylene blue solutionto the labeled volume.5.22.3 Place on a surface suitable for detection of colorleakage for a 15 min per

33、iod. Cover or protect the enteralfeeding devices from light or ozone for the duration of the test.5.23 Interpretation Results:5.23.1 Failure to inflate is a failure of the liquid from thefilling device (syringe) to enter the retention balloon.5.23.2 Failure of retention is a discoloration of or leak

34、age onthe clean surface between the enteral feeding device.5.24 Precision and BiasTo be determined within fiveyears.PROCEDURE D: BALLOON CONCENTRICITY5.25 ScopeThis test method is applicable enteral feedingdevices with retention balloon to test the concentricy of theballoon.FIG. 2 Flow Rate Apparatu

35、sFIG. 3 Balloon Burst ApparatusTABLE 1 Minimum Burst VolumesRated Balloon Inflation Volumecm3Minimum Burst Volumecm351010 2015 3020 40All others 20 cm32 rated volumeF2528 06 (2014)35.26 Summary of Test MethodThe retention balloon of theenteral feeding device is inflated with water, and with the useo

36、f a gauge, evaluted for concentricty.5.27 Significance and UseThis test is designed to quantifyballoon concentricity and the overall shape geometry of theballoon. It is the purpose of the balloon to retain the feedingdevice in position during use, therefore, the balloon must be ofa functional unifor

37、mity that will not allow the enteral feedingdevice to move from its desired position.5.28 ApparatusThe testing apparatus is set up as shown inFig. 4.5.28.1 Syringes1cm3,5cm3, and 60 cm3.5.28.2 Water.5.29 HazardsNot applicable.5.30 Procedure:5.30.1 Test at 23 6 4C (73.4 6 7F).5.30.2 Fill syringe with

38、 volume of water equal to balloonrating.5.30.3 Attach syringe to enteral feeding device inflationvalve and inflate with water.5.30.4 Per Fig. 4, use snap gauge and measure the two sidesof the balloon that visually appear to have the least symmetry.Measurement should be taken 180 from each other.5.30

39、.5 Divide larger measurement by smaller measurementand quotient equals Concentricity Ratio. Tabulate all results.5.31 Interpretation of ResultsBalloon concentricity ratiomust not exceed those established in Table 2.5.32 Precision and BiasTo be determined within fiveyears.PROCEDURE E: BALLOON SIZE AN

40、D SHAFT SIZE5.33 ScopeThis test method is to evaluate the retentionballoon shaft size.5.34 Summary of Test MethodUsing a French size gauge,the distal balloon tip is measured to determine the size of theretention balloon over the shaft.5.35 Significance and UseThe overall outside diameter ofthe enter

41、al feeding device during passage should conform tothe required clinical orifice size.5.36 ApparatusThe testing apparatus is as shown in Fig.5.5.36.1 French Size Calibration Gauge, tolerance of 60.13mm (60.005 in.).5.36.2 Metric Scale Rule.5.37 Hazards:5.37.1 No lubrication or undue force shall be ap

42、plied to theenteral feeding device.5.37.2 The edges of each hole should be smooth to avoidinterference to the passage of the test enteral feeding device.5.38 Procedure:5.38.1 Test at 23 6 4C (73.4 6 7F).5.38.2 Per Fig. 5, without lubrication, push the proximal endof the uninflated enteral feeding de

43、vice through the variousholes of the French size gauge, advancing it to the uninflatedballoon.5.38.3 Uninflated balloon should fit in appropriate Frenchsize gauge hole snugly without undue insertion force. Labeleach test unit and the measured French size. Remove devicefrom gauge.5.39 Interpretation

44、of ResultsThe balloon section maywrinkle but shall not tear or distort, and the enteral feedingdevice shaft or tip may offer resistance but if distortion orstretching occurs it is considered a failure.5.40 Precision and BiasTo be determined within fiveyears.PROCEDURE F: BALLOON INTEGRITY5.41 ScopeTh

45、is test method is to evaluate the integrtity ofthe retention balloon of the enteral feeding device.5.42 Summary of Test MethodThe retention balloons areinflated with water and submerged in water at 37.8 6 3C (1006 5F) for seven days. The retention balloons are evaluated todetermine if they hold thei

46、r integrity and do not rupture.5.43 Significance and UseThis test method is designed tosubject the retention balloons to the inflation volume theywould be subjected to during use in the field, in order todetermine the integrity of the balloon. It is the purpose of theballoon to retain the feeding de

47、vice in position during use,therefore, the performance of the retention balloon must bemaintained and the balloon must not rupture.5.44 ApparatusThe testing apparatus is as shown in Fig.6.5.44.1 Corrosion Resistant TanksThe tanks should con-tain no exposed iron, copper, or brass elements and have ar

48、emovable mixing elements. The tanks should also havesufficient covers/lids in order to prevent evaporation of solu-tion.FIG. 4 Concentricity Test ApparatusTABLE 2 Concentricity RatiosRated Balloon Inflation Volumecm3Maximum ConcentricityRatio52:110 2:115 2:120 2:1All others 20 cm32:1F2528 06 (2014)4

49、5.44.2 Cover for Corrosion Resistant TankPermits enteralfeeding devices with retention balloon to be placed vertically inthe tank and inflated so that retention balloon is fully sub-merged in gastric fluid test solution. Cover should preventevaporation.5.44.3 Graduated Cylinder, calibrated for suitable measure-ment of the effluent.5.44.4 Water.5.44.5 Syringe, suitable for filling retention balloon torequired volume.5.45 HazardsNo materials/chemicals destructive to latexand/or silicone may contact balloons during