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

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1、Designation: F 2528 06Standard Test Methods forEnteral Feeding Devices with a Retention Balloon1This standard is issued under the fixed designation F 2528; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of last revision.

2、A number in parentheses indicates the year of last reapproval. Asuperscript epsilon (e) 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, enteralfeeding device w

3、ith 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 materialssuch as silicon

4、e, 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 any, associated w

5、ith 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:2F 623 Performance Specification for Foley Catheter2.2 Other Stan

6、dard:Simulated Gastric Fluid, USP Official Compendia of Stan-dards33. Terminology3.1 Definitions:3.1.1 balloon integrity (resistance to rupture)volume ofliquid that corresponds with balloon failure, or bursting.3.1.2 distalrefers to the balloon end of the enteral feedingdevice3.1.3 enteral feeding d

7、evice with retention balloona two-way medical device intended to provide a means of nutrition oradministration of medication, or both, to patients by means ofnatural orifice (nasal, oral, transluminal) or a surgically createdstoma, or both, consisting of a drainage lumen and inflationlumen (see Fig.

8、 1). Common balloon inflation sizes are 5 cm3,15 cm3, and 20 cm3.3.1.4 French size (Fr)a scale used for denoting the size ofcatheters and other tubular instruments. The French size valueis three times the outer diameter of the tube as measured inmillimetres. For example, a diameter of 18 Fr indicate

9、s adiameter of 6 mm.3.1.5 inflation volumevolume of liquid used to inflate theretention balloon of the enteral feeding device for proposedtesting in this standard.3.1.6 rated volumestated volume of inflation of the reten-tion balloon of the enteral feeding device in the manufacturerslabeling and ins

10、tructions for use.3.1.7 simulated gastric fluida solution consisting of hy-drochloric acid, salt and pepsin with a pH of approximately1.2, per USP standard recipe.3.1.8 sterilitythe state of being free from viable micro-organisms.4. Specimen Preparation4.1 All test specimens for test methods listed

11、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 FEEDINGLUMEN5.1 ScopeThis test method cov

12、ers the determination offlow rates through the drainage lumen of the enteral feedingdevice with retention balloon.1These test methods are under the jurisdiction of ASTM Committee F04 onMedical and Surgical Materials and Devices and is the direct responsibility ofSubcommittee F04.35 on GI Appliations

13、.Current edition approved June 1, 2006. Published June 2006.2For 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.3

14、USP Official Compendia of Standards, available from U.S. Pharmacopeia(USP), 12601 Twinbrook Pkwy., Rockville, MD 20852.FIG. 1 Enteral Feeding Device with Retention Balloon1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.5.2 Summary of

15、 Test MethodThe apparatus is set up asshown in Fig. 2. The flow rate is adjusted through the waterinlet to a rate sufficient to maintain flow 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 thetank bottom shall be ma

16、intained 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, since differences in the flowrate as a result of flow direction are theoretically insi

17、gnificant.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. (See Performance Specification F 623.)5.4.2 Graduated Cylinder, calibrated for suitabl

18、e 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 always be exiting through theoverflow outlet.5.5.2 Establish equilibrium before testing

19、.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 to labeled volume.5.6.3 Connect the enteral feeding device to enteral feedingdevice con

20、nector 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 6 1 cm (196 6 10 kPa)head pressure at that junction.5.6.4 Establish flow equilibrium

21、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/min.5.8 Precision and BiasTo be determined within fiveyears.PROCEDURE B: BALLOON BURST V

22、OLUME5.9 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 in a small container filledwith water. The balloon is then inflated with water untilru

23、pture, which enables the volume at which the balloon burststo be observed.FIG. 2 Flow Rate ApparatusF25280625.11 Significance and UseThe balloon burst volume ismeasured to quantify the resistance of rupture of the enteralfeeding device with retention balloon member.5.12 ApparatusThe testing apparatu

24、s 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 Insert uninflated enteral feeding device into testorif

25、ice 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 amount of water greater than thatlisted in Table 1 fo

26、r 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 Interpretation of ResultsBurst volumes for enteralfeeding devices

27、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 integrity of theinflation system to maintain balloon vol

28、ume.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 of theinflation system is upheld, therefore maintaini

29、ng 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 observing the consistancy ofvolume of the balloon after it is

30、 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.5.20.2 Methylene Blue Crystal Solution or EquivalentPr

31、epare1gofmethylene 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 example, paper towel).5.21 HazardsEnsure that the syringe is properly seated inthe valve.5.22 Procedure:5.22.1 Test at 23

32、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 period. Cover or protect the enteralfeeding devices from light or ozone for the duration of the test.5.23 Interpretation Res

33、ults: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 leakage onthe clean surface between the enteral feeding device.5.24 Precision and BiasTo be determined within fiveyears.PROCE

34、DURE D: BALLOON CONCENTRICITY5.25 ScopeThis test method is applicable enteral feedingdevices with retention balloon to test the concentricy of theballoon.5.26 Summary of Test MethodThe retention balloon of theenteral feeding device is inflated with water, and with the useof a gauge, evaluted for con

35、centricty.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 uniformity that will not allow th

36、e enteral feedingdevice to move from its desired position.FIG. 3 Balloon Burst ApparatusTABLE 1 Minimum Burst VolumesRated Balloon Inflation Volumecm3Minimum Burst Volumecm351010 2015 3020 40All others 20 cm323 rated volumeF25280635.28 ApparatusThe testing apparatus is set up as shown inFig. 4.5.28.

37、1 Syringes1 cm3,5cm3, 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 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

38、 gauge and measure the two sidesof the balloon that visually appear to have the least symmetry.Measurement should be taken 180 from each other.5.30.5 Divide larger measurement by smaller measurementand quotient equals Concentricity Ratio. Tabulate all results.5.31 Interpretation of ResultsBalloon co

39、ncentricity ratiomust not exceed those established in Table 2.5.32 Precision and BiasTo be determined within fiveyears.PROCEDURE E: BALLOON SIZE AND 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 bal

40、loon tip is measured to determine the size of theretention balloon over the shaft.5.35 Significance and UseThe overall outside diameter ofthe enteral 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 Fren

41、ch 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 applied 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.

42、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 device through the variousholes of the French size gauge, advancing it to the uninflatedballoon.5.38.3 Uninflated balloon should fit in appropriate Frenchs

43、ize gauge hole snugly without undue insertion force. Labeleach test unit and the measured French size. Remove devicefrom gauge.5.39 Interpretation of ResultsThe balloon section maywrinkle but shall not tear or distort, and the enteral feedingdevice shaft or tip may offer resistance but if distortion

44、 orstretching occurs it is considered a failure.5.40 Precision and BiasTo be determined within fiveyears.PROCEDURE F: BALLOON INTEGRITY5.41 ScopeThis test method is to evaluate the integrtity ofthe retention balloon of the enteral feeding device.5.42 Summary of Test MethodThe retention balloons arei

45、nflated 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 their integrity and do not rupture.5.43 Significance and UseThis test method is designed tosubject the retention balloons to the inflation volume theywould b

46、e 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 device in position during use,therefore, the performance of the retention balloon must bemaintained and the balloon must not rupture.5.44 ApparatusThe test

47、ing 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 aremovable mixing elements. The tanks should also havesufficient covers/lids in order to prevent evaporation of solu-tion.5.44.2 Cover for Corrosion Resist

48、ant 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.

49、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 test.5.46 Procedure:5.46.1 Fill tank with water to level indicated in Fig. 6,sothat when hung all sample balloons are submerged under water.Maintain water temperature at 37.8 6 3C (100 6 5F).FIG. 4 Concentricity Test ApparatusTABLE 2 Concentricity RatiosRated Balloon Inflation Volumecm3Maximum ConcentricityRatio52:110 2:115 2:120 2:1All