ASTM_F_2528_-_06_2014.pdf

Designation:F252806(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 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,enteralfeeding 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 materialssuch 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 any,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 Catheter2.2 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 device3.1.3 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 inflation lumen(see Fig.1).Common ballooninflation sizes are 5 cm3,15 cm3,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 diameter 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 manufac-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 specimens 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 FEEDINGLUMEN5.1 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 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 the1These test methods are under the jurisdiction of ASTM Committee F04 onMedical and Surgical Materials and Devices and are the direct responsibility ofSubcommittee 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 serviceastm.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 Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 tank 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,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 showni