ASTM F623-1999(2006) Standard Performance Specification for Foley Catheter《弗利医用导管的性能规范》.pdf

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1、Designation: F 623 99 (Reapproved 2006)Standard Performance Specification forFoley Catheter1This standard is issued under the fixed designation F 623; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of last revision. A num

2、ber in parentheses indicates the year of last reapproval. Asuperscript epsilon (e) 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

3、 product 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 performa

4、nce requirements. 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 t

5、o be pertinent 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 recogni

6、zed that 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

7、-term utilization of a single-use,balloon-retention catheter, French sizes 12 through 26 inclu-sive, used by the medical professions for providing a means ofbladder drainage by means of the urethra. The product ismanufactured in various sizes and materials such as latex,silicone, rubber, and various

8、 polymers (as well as combinationsof these) and is provided nonsterile for sterilization and sterilefor single use only. Catheters whose surface has been chemi-cally treated to effect biocompatibility or microbial propertiesmay be tested to this specification.1.2 ExclusionsLong-term indwelling usage

9、 (over 30days) is encountered with this product, but not commonly, andis therefore 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 e

10、xcludedfrom 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 re

11、quire separatestandard development.1.3 This standard may involve hazardous materials, opera-tions, 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 healt

12、h practices and determine theapplicability of regulatory limitations prior to use.2. Referenced Documents2.1 ASTM Standards:2F 748 Practice for Selecting Generic Biological Test Meth-ods for Materials and Devices2.2 Other Documents:ISO/AAMI/ANSI 109931 Biological Testing of Medical1This performance

13、specification is under the jurisdiction of ASTM CommitteeF04 on Medical and Surgical Materials and Devices and is the direct responsibilityof Subcommittee F04.34 on Urological Materials and Devices.Current edition approved Sept. 1, 2006. Published September 2006. Originallyapproved in 1981. Last pre

14、vious edition approved in 1999 as F 623 99e1.2For 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.1Copyright ASTM

15、International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.and Dental Material and Devices Part 1: Guidance onSelection of Tests3U.S. Pharmacopeia43. Terminology3.1 Definitions of Terms:3.1.1 balloon (Foley) catheteran indwelling catheter re-tained in the blad

16、der 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 a

17、 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 DrugAdmin-istration, the Federal

18、 agency under Health, Education, andWelfare 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 Out

19、side 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 ba

20、lloon 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 them

21、edical 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 fo

23、llowed 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, mean

24、ing the14 label French size must be between 12 French and 16 French.3.1.9 USPU.S. Pharmacopeia.4. 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 123Available from Americ

25、an 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 20852-1790, http:/www.usp.org.5Supporting data for this specification, which provides a rationale of theperformance re

26、quirements and test methods, have been filed at ASTM InternationalHeadquarters and may be obtained by requesting Research Report RR: F041003FIG. 1 Balloon Retention (Foley) Type CatheterF 623 99 (2006)2catheter shall have a flow rate of 70 cm3/min. Tests shall beconducted in accordance with 6.1.4.2

27、Balloon Integrity (Resistance to Rupture)The infla-tion balloon must be inflated easily with distilled or deionizedwater to labeled volume without showing any evidence ofbreakage throughout the test period. Leakage and failure todeflate are dealt with in 4.4 and 4.6. Tests shall be conductedin accor

28、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 6.3.4.4 Balloon Volume MaintenanceThe catheter shall main-tain its volume thro

29、ughout the test. Tests shall be conducted inaccordance with 6.4.4.5 Balloon Size and Shaft SizeThe base dimension forthe requirement on sizes and tolerances on the diameter of thecatheter tip, the size of the balloon, and the diameter of theshaft is the “label French size.” The proximal catheter tip

30、, 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 Deflate)The balloonshall deflate to within four French sizes of the labe

31、l 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 days) surface devices contactingmucosal membranes and shall pass the app

32、ropriate biologicaltests conducted using the specification inASTM Practice F 748or similar guidance established by the U.S. Food and DrugAdministration6or the International Organization for Standard-ization (ISO).34.7.1 The grading of any positive reaction that might beobserved should reflect the de

33、gree 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 methods are included in this document. Thequestion of pass or fail should b

34、e 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 LabelingPackaged and individualitems shall be properly labeled and confo

35、rm 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 situations, current GMP (goodmanufacturing practice) will provide guid

36、elines 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-tial situations that could adversely affect the performance of thecathe

37、ter during referee testing.5.1.1 Care shall be taken during testing 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 petrol

38、atum, cleaning solvents,phenol, ether, cresols, oxidizing agents, 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 bo

39、th storage and handling.6Available from Food and Drug Administration (FDA), 5600 Fishers Ln.,Rockville, MD 20857, 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 Size, MaximumAsReceive

40、d,Uninflated(3.5 and5.5)Deflated,AfterImmersion(3.6 and5.6)Latex and coatedlatex61+2,1A+3 +4All-silicone 61 61+4+4Others 61 6 3ADuring the development of this standard, there was much discussion of thetolerance on the dimension of the shaft of the “latex and coated latex” typecatheter. The industry

41、recognizes that 61 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.F 623 99 (2006)35.1.3 To help avoid contamination of the catheters, properhand

42、ling 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 for ease in testing, si

43、nce 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 overflowoutlet while each catheter i

44、s 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 maintaining 20 6 1.0cm (7.9

45、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 mea-surement of the effluent.6.1.4.3 Syringe, with appropriate tip for inflation of catheterballoon.6.1.5 Warnings:6.1.5.1 Overflow sh

46、ould not be covered. Head pressuremust be kept constant; water should always be exiting throughthe overflow outlet.6.1.5.2 Establish equilibrium before testing.6.1.5.3 Flow rates through all fittings must exceed that ofthe catheter being tested.6.1.6 Test SpecimenThe test specimen shall consist of t

47、hemanufacturers 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).6.1.7.2 Inflate the retention balloon of the test specimenwith distilled or deionized water to

48、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).FIG. 3 Flow Rate Apparatus for Reverse Flow TechniqueF 623 99 (2006)46.1.7.3 Connect the catheter to catheter connector and ope

49、nthe 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 for each catheter.6.1.8 Interp