1、Designation: F623 99 (Reapproved 2013)Standard Performance Specification forFoley Catheter1This standard is issued under the fixed designation F623; the number immediately following the designation indicates the year of originaladoption or, in the case of revision, the year of last revision.Anumber
2、in parentheses indicates the year of last reapproval.Asuperscriptepsilon () indicates an editorial change since the last revision or reapproval.This standard has been approved for use by agencies of the Department of Defense.INTRODUCTIONThe objective of this specification is to describe those produc
3、t requirements and associated testmethods that will ensure the safety and effectiveness of a disposable, 5-cm3(mL) balloon,retention-type catheter used in urinary bladder drainage.This specification includes referee test methods that can be used to determine compliance with thestated performance req
4、uirements. Note that the test methods are not to be construed as productionmethods, quality control techniques, or manufacturers lot release criteria. The product parametersaddressed by the standard include those determined by the FDA Panel on Review ofGastroenterological-Urological Devices to be pe
5、rtinent to the proposed classification of the Foleycatheter to FDA Class II standards, plus other parameters determined by the ASTM task force to bepertinent to the product.This specification represents the state of the art at this time and is a minimum performancespecification. It is recognized tha
6、t the document must remain dynamic; suggestions for revision areencouraged, and should be directed to Committee F04 Staff Manager,ASTM, 100 Barr Harbor Dr., POBox C700, West Conshohocken, PA 194282959.1. Scope1.1 This performance specification establishes performancerequirements for the short-term u
7、tilization of a single-use,balloon-retention catheter, French sizes 12 through 26inclusive, used by the medical professions for providing ameans of bladder drainage by means of the urethra. Theproduct is manufactured in various sizes and materials such aslatex, silicone, rubber, and various polymers
8、 (as well ascombinations of these) and is provided nonsterile for steriliza-tion and sterile for single use only. Catheters whose surface hasbeen chemically treated to effect biocompatibility or microbialproperties may be tested to this specification.1.2 ExclusionsLong-term indwelling usage (over 30
9、 days)is encountered with this product, but not commonly, and istherefore considered an exception to this specification.Similarly, the use of such catheters for nonurethral catheter-ization (such as for nephrostomy, suprapubic cystostomy,ureterostomy, gastrostomy, enemas, and so forth) is excludedfr
10、om the scope of this specification. Likewise, three lumencatheters, 30-cm3balloon and pediatric catheters, and catheterswhose surface has been chemically treated to enhance theirlubricity have not been tested to this specification and excludedfrom the scope of this specification and will require sep
11、aratestandard development.1.3 This standard may involve hazardous materials,operations, and equipment. This standard does not purport toaddress all of the safety concerns associated with its use. It isthe responsibility of the user of this standard to establishappropriate safety and health practices
12、 and determine theapplicability of regulatory limitations prior to use.2. Referenced Documents2.1 ASTM Standards:2F748 Practice for Selecting Generic Biological Test Methods1This performance specification is under the jurisdiction of ASTM CommitteeF04 on Medical and Surgical Materials and Devices an
13、d is the direct responsibilityof Subcommittee F04.34 on Urological Materials and Devices.Current edition approved Oct. 1, 2013. Published October 2013. Originallyapproved in 1981. Last previous edition approved in 2006 as F623 99 (2006).DOI: 10.1520/F0623-99R13.2For referenced ASTM standards, visit
14、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, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959.
15、 United States1for Materials and Devices2.2 Other Documents:ISO/AAMI/ANSI 109931 Biological Testing of Medicaland Dental Material and Devices Part 1: Guidance onSelection of Tests3U.S. Pharmacopeia43. Terminology3.1 Definitions:3.1.1 balloon (Foley) catheteran indwelling catheter re-tained in the bl
16、adder by a balloon that is inflated with liquid.3.1.1.1 DiscussionA two-way balloon catheter has adrainage lumen and inflation lumen (see Fig. 1). Commonballoon inflation sizes are 5 cm3with the 5-cm3balloon beingused to hold the catheter in place for normal usage, and 30 cm3where so designated when
17、 a larger balloon is used.Athree-wayballoon catheter is used for continuous bladder irrigation andfeatures both a drainage lumen and an irrigation lumen (but asnoted above is excluded from consideration in this specifica-tion).3.1.2 FDAthe abbreviation for the Food and DrugAdministration, the Federa
18、l agency under Health, Education,and Welfare responsible for the regulation of medical deviceproducts.3.1.3 French sizea scale used for denoting the size ofother tubular instruments and devices, each unit being roughlyequivalent to 0.33 mm in diameter. Label French sizes are asfollows:French Size Ou
19、tside Diameter, in. (mm)12 0.157 (4.0)13 0.171 (4.3)14 0.184 (4.7)15 0.197 (5.0)16 0.210 (5.3)17 0.223 (5.7)18 0.236 (6.0)19 0.249 (6.3)20 0.262 (6.7)21 0.276 (7.0)22 0.289 (7.3)23 0.302 (7.7)24 0.315 (8.0)25 0.328 (8.3)26 0.341 (8.7)3.1.4 lumenthe channel within a tube.3.1.5 proximalrefers to the b
20、alloon end of the catheter,since when in position for clinical use, the balloon end isproximal or closest to the patient.3.1.6 referee test methodthe method cited in the publishedspecification for the device. This method and the correspond-ing requirements will be invoked when the performance of the
21、medical device will be questioned. The manufacturer need notuse this referee test method in his usual inspection and qualitycontrol.3.1.7 sterilitygenerally, the state of being free of micro-organisms. For purposes of this specification, sterility isdefined as freedom from microorganisms when tested
22、 accord-ing to the methodology defined by the USP for nonparenteraldevices.3.1.8 tolerancesthe allowable deviation from a standardsize. In usual engineering practice, the maximum permittedsize is denoted by a plus sign followed by the tolerance and theminimum permitted size denoted by a minus sign f
23、ollowed bythe tolerance. In this standard, the label French size hastolerances given for several dimensions. For example, +3, 1means that a nominal 14 label French size can be permitted togo as high as 17, but not below 13. Another way of writingtolerance, when both tolerances are equal, is: 62, mea
24、ning the14 label French size must be between 12 French and 16 French.3.1.9 USPU.S. Pharmacopeia.3Available from American National Standards Institute (ANSI), 25 W. 43rd St.,4th Floor, New York, NY 10036, http:/www.ansi.org.4Available from U.S. Pharmacopeia (USP), 12601 Twinbrook Pkwy., Rockville,MD
25、20852-1790, http:/www.usp.org.FIG. 1 Balloon Retention (Foley) Type CatheterF623 99 (2013)24. Requirements54.1 Flow Rate through Drainage LumenLabel French sizecatheters 14 through 24 inclusive shall have a minimumaverage flow rate of 100 cm3/min, and a label French size 12catheter shall have a flow
26、 rate of 70 cm3/min. Tests shall beconducted in accordance with 6.1.4.2 Balloon Integrity (Resistance to Rupture)The inflationballoon must be inflated easily with distilled or deionized waterto labeled volume without showing any evidence of breakagethroughout the test period. Leakage and failure to
27、deflate aredealt with in 4.4 and 4.6. Tests shall be conducted in accor-dance with 6.2.4.3 Inflated Balloon Response to TractionThe entire bal-loon of catheters label French size 14 through 26 shall not passinto or through the funnel barrel (Fig. 2). Tests shall beconducted in accordance with 6.3.4.
28、4 Balloon Volume MaintenanceThe catheter shall main-tain its volume throughout the test. Tests shall be conducted inaccordance with 6.4.4.5 Balloon Size and Shaft SizeThe base dimension for therequirement on sizes and tolerances on the diameter of thecatheter tip, the size of the balloon, and the di
29、ameter of theshaft is the “label French size.” The proximal catheter tip, theballoon, and the shaft, for 10 in. distal to the balloon, shall meetthe requirements on size and tolerances on diameter shown inTable 1. Tests shall be conducted in accordance with 6.5.4.6 Deflation Reliability (Failure to
30、Deflate)The balloonshall deflate to within four French sizes of the label French sizewithin 15 min or be otherwise manipulated to effect drainagewithin this time period. Tests shall be conducted in accordancewith 6.6.4.7 BiocompatibilityFoley catheters are considered to beprolonged term (24 h to 30
31、days) surface devices contactingmucosal membranes and shall pass the appropriate biologicaltests conducted using the specification inASTM Practice F748or similar guidance established by the U.S. Food and DrugAdministration6or the International Organization for Standard-ization (ISO).34.7.1 The gradi
32、ng of any positive reaction that might beobserved should reflect the degree of erythema or edema, orboth, on the test sites. The pass or fail conclusion is based onthe mild or severe nature of the reactions, respectively.4.7.2 Criteria as to the microscopical evaluation of tissuereaction to the meth
33、ods are included in this document. Thequestion of pass or fail should be dealt with by reliable,competent scientists or pathologists and should be based on thedegree of histological findings as compared with the responseto the recommended USP polyethylene as “negative controls.”4.7.3 Packaging and L
34、abelingPackaged and individualitems shall be properly labeled and conform to (1) legalrequirements, (2) the needs of medical usage (such as sizeidentification), (3) requirements for traceability and identifica-tion in event of failure, and (4) requirements for precautions inusage. In the majority of
35、 situations, current GMP (goodmanufacturing practice) will provide guidelines for properlabeling.5. Special Precautions5.1 The following cautionary comments recognize the sen-sitivity of the materials of construction to potential environ-mental conditions. These are outlined here to point out poten-
36、tial situations that could adversely affect the performance of thecatheter during referee testing.5Supporting data for this specification, which provides a rationale of theperformance requirements and test methods, have been filed at ASTM InternationalHeadquarters and may be obtained by requesting R
37、esearch Report RR:F04-1003.6Available from Food and Drug Administration (FDA), 10903 New HampshireAve., Silver Spring, MD 20993-0002, http:/www.fda.gov.FIG. 2 Test FunnelTABLE 1 Requirements for Dimensions, Label French SizeMaterial TypeTip,Tolerance(3.5 and5.5)Shaft,Tolerance(3.5 and 5.5)Balloon Si
38、ze, MaximumAsReceived,Uninflated(3.5 and5.5)Deflated,AfterImmersion(3.6 and5.6)Latex and coatedlatex1 + 2, 1A+3 +4All-silicone 1 1 + 4 + 4Others 1 1 + 3 + 4ADuring the development of this standard, there was much discussion of thetolerance on the dimension of the shaft of the “latex and coated latex
39、” typecatheter. The industry recognizes that 1 label French size is the desired value.The tolerance in this table is representative of the present state of the art inmanufacturing Foley catheters, however, it is argued that this value can beimproved.F623 99 (2013)35.1.1 Care shall be taken during te
40、sting and use to preventdamage to the catheters. Such damage can be caused byabrasion and contact with sharp objects or chemical products.Contact shall be avoided with any of the following substances:vegetable oils, mineral oils or petrolatum, cleaning solvents,phenol, ether, cresols, oxidizing agen
41、ts, copper, and manga-nese.5.1.2 In addition, catheters should be kept away from thevicinity of generators, electric motors, diathermy machines,fluorescent lights, and so forth, because the ozone producedattacks rubber. This applies to both storage and handling.5.1.3 To help avoid contamination of t
42、he catheters, properhandling precautions shall be observed.6. Test Methods56.1 Flow Rate Through Drainage Lumen:6.1.1 ScopeThis method covers the determination of flowrates through the drainage lumen of the balloon retentioncatheters.6.1.2 Significance and UseThe flow rate is measured inreverse flow
43、 for ease in testing, since differences in the flowrate as a result of flow direction are theoretically insignificant.6.1.3 Summary of Test MethodThe apparatus is set up asshown in Fig. 3. The flow rate is adjusted through the waterinlet to a rate sufficient to maintain flow through the overflowoutl
44、et while each catheter is tested.Ahead pressure of 20 6 1.0cm of water (196 6 10 kPa) above the tank bottom shall bemaintained throughout the test to approximate actual physi-ologic conditions. The overflow outlet should not be coveredby water.6.1.4 Apparatus:6.1.4.1 Water Reservoir, capable of main
45、taining 20 6 1.0cm (7.9 6 0.4 in.) of water (196 6 10 kPa) above the tip of thecatheter connection throughout the test as shown in Fig. 3.6.1.4.2 Graduated Cylinder, calibrated for suitable measure-ment of the effluent.6.1.4.3 Syringe, with appropriate tip for inflation of catheterballoon.6.1.5 Warn
46、ings:6.1.5.1 Overflow should not be covered. Head pressuremust be kept constant; water should always be exiting throughthe overflow outlet.6.1.5.2 Establish equilibrium before testing.FIG. 3 Flow Rate Apparatus for Reverse Flow TechniqueF623 99 (2013)46.1.5.3 Flow rates through all fittings must exc
47、eed that ofthe catheter being tested.6.1.6 Test SpecimenThe test specimen shall consist of themanufacturers new, finished, untested product; at least statis-tically valid samples of the smallest and the largest diametercatheters shall be tested.6.1.7 Procedure:6.1.7.1 Test at 23 6 4C (73.4 6 7F).6.1
48、.7.2 Inflate the retention balloon of the test specimenwith distilled or deionized water to labeled volume. Forexample, a 5-cm3balloon should be inflated with 5 + 2, 0cm3of distilled or deionized water (or as recommended by theindividual manufacturer on the label).6.1.7.3 Connect the catheter to cat
49、heter connector and openthe stopcock. The tip of the catheter connection at the junctionof catheter on-off valve should be level with the bottom of thetank 61 cm and it should deliver fluid at 20 6 1 cm (196 6 10kPa) head pressure at that junction.6.1.7.4 Establish the inflow and outflow equilibrium beforetest measurements.6.1.7.5 Record the amount of water flowing through thecatheter drainage lumen in 1 min. Express results in cubiccentimetres per minute as flow rate. Test each catheter threetimes and calculate the average flow rate
