ASTM F623-99(2006)
(Specification)Standard Performance Specification for Foley Catheter
Standard Performance Specification for Foley Catheter
SCOPE
1.1 This performance specification establishes performance requirements for the short-term utilization of a single-use, balloon-retention catheter, French sizes 12 through 26 inclusive, used by the medical professions for providing a means of bladder drainage by means of the urethra. The product is manufactured in various sizes and materials such as latex, silicone, rubber, and various polymers (as well as combinations of these) and is provided nonsterile for sterilization and sterile for single use only. Catheters whose surface has been chemically treated to effect biocompatibility or microbial properties may be tested to this specification.
1.2 ExclusionsLong-term indwelling usage (over 30 days) is encountered with this product, but not commonly, and is therefore considered an exception to this specification. Similarly, the use of such catheters for nonurethral catheterization (such as for nephrostomy, suprapubic cystostomy, ureterostomy, gastrostomy, enemas, and so forth) is excluded from the scope of this specification. Likewise, three lumen catheters, 30-cm3 balloon and pediatric catheters, and catheters whose surface has been chemically treated to enhance their lubricity have not been tested to this specification and excluded from the scope of this specification and will require separate standard development.
This standard may involve hazardous materials, operations, and equipment. This standard does not purport to address all of the safety concerns associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
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Designation:F623 −99(Reapproved 2006)
Standard Performance Specification for
Foley Catheter
ThisstandardisissuedunderthefixeddesignationF623;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginal
adoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscript
epsilon (´) indicates an editorial change since the last revision or reapproval.
This standard has been approved for use by agencies of the Department of Defense.
INTRODUCTION
The objective of this specification is to describe those product requirements and associated test
methods that will ensure the safety and effectiveness of a disposable, 5-cm (mL) balloon,
retention-type catheter used in urinary bladder drainage.
This specification includes referee test methods that can be used to determine compliance with the
stated performance requirements. Note that the test methods are not to be construed as production
methods, quality control techniques, or manufacturer’s lot release criteria. The product parameters
addressed by the standard include those determined by the FDA Panel on Review of
Gastroenterological-Urological Devices to be pertinent to the proposed classification of the Foley
catheter to FDA Class II standards, plus other parameters determined by the ASTM task force to be
pertinent to the product.
This specification represents the state of the art at this time and is a minimum performance
specification. It is recognized that the document must remain dynamic; suggestions for revision are
encouraged,andshouldbedirectedtoCommitteeF04StaffManager,ASTM,100BarrHarborDr.,PO
Box C700, West Conshohocken, PA 19428–2959.
1. Scope ization (such as for nephrostomy, suprapubic cystostomy,
ureterostomy, gastrostomy, enemas, and so forth) is excluded
1.1 This performance specification establishes performance
from the scope of this specification. Likewise, three lumen
requirements for the short-term utilization of a single-use,
catheters,30-cm balloonandpediatriccatheters,andcatheters
balloon-retention catheter, French sizes 12 through 26
whose surface has been chemically treated to enhance their
inclusive, used by the medical professions for providing a
lubricityhavenotbeentestedtothisspecificationandexcluded
means of bladder drainage by means of the urethra. The
from the scope of this specification and will require separate
product is manufactured in various sizes and materials such as
standard development.
latex, silicone, rubber, and various polymers (as well as
1.3 This standard may involve hazardous materials,
combinations of these) and is provided nonsterile for steriliza-
operations, and equipment. This standard does not purport to
tionandsterileforsingleuseonly.Catheterswhosesurfacehas
address all of the safety concerns associated with its use. It is
been chemically treated to effect biocompatibility or microbial
the responsibility of the user of this standard to establish
properties may be tested to this specification.
appropriate safety and health practices and determine the
1.2 Exclusions—Long-termindwellingusage(over30days)
applicability of regulatory limitations prior to use.
is encountered with this product, but not commonly, and is
therefore considered an exception to this specification.
2. Referenced Documents
Similarly, the use of such catheters for nonurethral catheter-
2.1 ASTM Standards:
F748PracticeforSelectingGenericBiologicalTestMethods
This performance specification is under the jurisdiction of ASTM Committee
F04 on Medical and Surgical Materials and Devices and is the direct responsibility
of Subcommittee F04.34 on Urological Materials and Devices. For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Current edition approved Sept. 1, 2006. Published September 2006. Originally contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
´1
approved in 1981. Last previous edition approved in 1999 as F623–99 . DOI: Standards volume information, refer to the standard’s Document Summary page on
10.1520/F0623-99R06.
the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
F623−99 (2006)
FIG. 1 Balloon Retention (Foley) Type Catheter
for Materials and Devices
18 0.236 (6.0)
19 0.249 (6.3)
2.2 Other Documents:
20 0.262 (6.7)
ISO/AAMI/ANSI 10993–1Biological Testing of Medical
21 0.276 (7.0)
and Dental Material and Devices — Part 1: Guidance on
22 0.289 (7.3)
23 0.302 (7.7)
Selection of Tests
4 24 0.315 (8.0)
U.S. Pharmacopeia
25 0.328 (8.3)
26 0.341 (8.7)
3. Terminology
3.1.4 lumen—the channel within a tube.
3.1 Definitions:
3.1.5 proximal—refers to the balloon end of the catheter,
3.1.1 balloon (Foley) catheter—an indwelling catheter re-
since when in position for clinical use, the balloon end is
tained in the bladder by a balloon that is inflated with liquid.
proximal or closest to the patient.
3.1.1.1 Discussion—A two-way balloon catheter has a
3.1.6 referee test method—themethodcitedinthepublished
drainage lumen and inflation lumen (see Fig. 1). Common
3 3
specification for the device. This method and the correspond-
balloon inflation sizes are 5 cm with the 5-cm balloon being
usedtoholdthecatheterinplacefornormalusage,and30cm ing requirements will be invoked when the performance of the
medical device will be questioned. The manufacturer need not
wheresodesignatedwhenalargerballoonisused.Athree-way
balloon catheter is used for continuous bladder irrigation and use this referee test method in his usual inspection and quality
control.
features both a drainage lumen and an irrigation lumen (but as
noted above is excluded from consideration in this specifica-
3.1.7 sterility—generally, the state of being free of micro-
tion).
organisms. For purposes of this specification, sterility is
3.1.2 FDA—the abbreviation for the Food and Drug
defined as freedom from microorganisms when tested accord-
Administration, the Federal agency under Health, Education, ing to the methodology defined by the USP for nonparenteral
and Welfare responsible for the regulation of medical device
devices.
products.
3.1.8 tolerances—the allowable deviation from a standard
3.1.3 French size—a scale used for denoting the size of
size. In usual engineering practice, the maximum permitted
other tubular instruments and devices, each unit being roughly
sizeisdenotedbyaplussignfollowedbythetoleranceandthe
equivalent to 0.33 mm in diameter. Label French sizes are as
minimum permitted size denoted by a minus sign followed by
follows:
the tolerance. In this standard, the label French size has
French Size Outside Diameter, in. (mm) tolerances given for several dimensions. For example,+3,−1
means that a nominal 14 label French size can be permitted to
12 0.157 (4.0)
go as high as 17, but not below 13. Another way of writing
13 0.171 (4.3)
14 0.184 (4.7) tolerance, when both tolerances are equal, is: 62, meaning the
15 0.197 (5.0)
14labelFrenchsizemustbebetween12Frenchand16French.
16 0.210 (5.3)
17 0.223 (5.7) 3.1.9 USP—U.S. Pharmacopeia.
Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
4th Floor, New York, NY 10036, http://www.ansi.org.
AvailablefromU.S.Pharmacopeia(USP),12601TwinbrookPkwy.,Rockville,
MD 20852-1790, http://www.usp.org.
F623−99 (2006)
TABLE 1 Requirements for Dimensions, Label French Size
Balloon Size, Maximum
Tip, As Deflated,
Shaft,
Tolerance Received, After
Material Type Tolerance
(3.5 and Uninflated Immersion
(3.5 and 5.5)
5.5) (3.5 and (3.6 and
5.5) 5.6)
A
Latex and coated ±1 + 2, − 1 +3 +4
latex
All-silicone ±1 ±1 + 4 + 4
Others ±1 ±1 + 3 + 4
A
During the development of this standard, there was much discussion of the
tolerance on the dimension of the shaft of the “latex and coated latex” type
catheter. 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 in
manufacturing Foley catheters, however, it is argued that this value can be
improved.
4.6 Deflation Reliability (Failure to Deflate)—The balloon
shalldeflatetowithinfourFrenchsizesofthelabelFrenchsize
within 15 min or be otherwise manipulated to effect drainage
within this time period.Tests shall be conducted in accordance
with 6.6.
4.7 Biocompatibility—Foley catheters are considered to be
prolonged term (24 h to 30 days) surface devices contacting
FIG. 2 Test Funnel
mucosal membranes and shall pass the appropriate biological
tests conducted using the specification inASTM Practice F748
5 or similar guidance established by the U.S. Food and Drug
4. Requirements
Administration ortheInternationalOrganizationforStandard-
4.1 Flow Rate through Drainage Lumen—LabelFrenchsize 3
ization (ISO).
catheters 14 through 24 inclusive shall have a minimum
4.7.1 The grading of any positive reaction that might be
average flow rate of 100 cm /min, and a label French size 12
observed should reflect the degree of erythema or edema, or
catheter shall have a flow rate of 70 cm /min. Tests shall be
both, on the test sites. The pass or fail conclusion is based on
conducted in accordance with 6.1.
the mild or severe nature of the reactions, respectively.
4.2 Balloon Integrity (Resistance to Rupture)—Theinflation 4.7.2 Criteria as to the microscopical evaluation of tissue
balloonmustbeinflatedeasilywithdistilledordeionizedwater reaction to the methods are included in this document. The
to labeled volume without showing any evidence of breakage question of pass or fail should be dealt with by reliable,
throughout the test period. Leakage and failure to deflate are competentscientistsorpathologistsandshouldbebasedonthe
dealt with in 4.4 and 4.6. Tests shall be conducted in accor- degree of histological findings as compared with the response
dance with 6.2. to the recommended USPpolyethylene as “negative controls.”
4.7.3 Packaging and Labeling—Packaged and individual
4.3 Inflated Balloon Response to Traction—The entire bal-
items shall be properly labeled and conform to (1) legal
loonofcatheterslabelFrenchsize14through26shallnotpass
requirements, (2) the needs of medical usage (such as size
into or through the funnel barrel (Fig. 2). Tests shall be
identification), (3) requirements for traceability and identifica-
conducted in accordance with 6.3.
tion in event of failure, and (4) requirements for precautions in
4.4 Balloon Volume Maintenance—The catheter shall main-
usage. In the majority of situations, current GMP (good
tain its volume throughout the test.Tests shall be conducted in
manufacturing practice) will provide guidelines for proper
accordance with 6.4.
labeling.
4.5 Balloon Size and Shaft Size—Thebasedimensionforthe
requirement on sizes and tolerances on the diameter of the 5. Special Precautions
catheter tip, the size of the balloon, and the diameter of the
5.1 The following cautionary comments recognize the sen-
shaft is the “label French size.” The proximal catheter tip, the
sitivity of the materials of construction to potential environ-
balloon,andtheshaft,for10in.distaltotheballoon,shallmeet
mental conditions. These are outlined here to point out poten-
the requirements on size and tolerances on diameter shown in
tialsituationsthatcouldadverselyaffecttheperformanceofthe
Table 1. Tests shall be conducted in accordance with 6.5.
catheter during referee testing.
Supporting data for this specification, which provides a rationale of the
performance requirements and test methods, have been filed atASTM International Available from Food and Drug Administration (FDA), 5600 Fishers Ln.,
Headquarters and may be obtained by requesting Research Report RR:F04-1003. Rockville, MD 20857, http://www.fda.gov.
F623−99 (2006)
FIG. 3 Flow Rate Apparatus for Reverse Flow Technique
5.1.1 Care shall be taken during testing and use to prevent 6.1.3 Summary of Test Method—The apparatus is set up as
damage to the catheters. Such damage can be caused by
shown in Fig. 3. The flow rate is adjusted through the water
abrasion and contact with sharp objects or chemical products. inlet to a rate sufficient to maintain flow through the overflow
Contact shall be avoided with any of the following substances:
outletwhileeachcatheteristested.Aheadpressureof20 61.0
vegetable oils, mineral oils or petrolatum, cleaning solvents, cm of water (196 6 10 kPa) above the tank bottom shall be
phenol, ether, cresols, oxidizing agents, copper, and manga-
maintained throughout the test to approximate actual physi-
nese. ologic conditions. The overflow outlet should not be covered
5.1.2 In addition, catheters should be kept away from the
by water.
vicinity of generators, electric motors, diathermy machines,
6.1.4 Apparatus:
fluorescent lights, and so forth, because the ozone produced
6.1.4.1 Water Reservoir, capable of maintaining 20 6 1.0
attacks rubber. This applies to both storage and handling.
cm(7.9 60.4in.)ofwater(196 610kPa)abovethetipofthe
5.1.3 To help avoid contamination of the catheters, proper
catheter connection throughout the test as shown in Fig. 3.
handling precautions shall be observed.
6.1.4.2 Graduated Cylinder,calibratedforsuitablemeasure-
ment of the effluent.
6. Test Methods
6.1.4.3 Syringe,withappropriatetipforinflationofcatheter
6.1 Flow Rate Through Drainage Lumen:
balloon.
6.1.1 Scope—This method covers the determination of flow
6.1.5 Warnings:
rates through the drainage lumen of the balloon retention
6.1.5.1 Overflow should not be covered. Head pressure
catheters.
must be kept constant; water should always be exiting through
6.1.2 Significance and Use—The flow rate is measured in
the overflow outlet.
reverse flow for ease in testing, since differences in the flow
rate as a result of flow direction are theoretically insignificant. 6.1.5.2 Establish equilibrium before testing.
F623−99 (2006)
6.1.5.3 Flow rates through all fittings must exceed that of bacteria or bacteriological inhibitors could also damage the
the catheter being tested. balloons and should not be used in test baths.
6.1.6 Test Specimen—The test specimen shall consist of the 6.2.6 Test Specimens—Thetestspecimenshallconsistofthe
manufacturer’s new, finished, untested product; at least statis- manufacturer’s new, finished, untested product; at least statis-
tically valid samples of the smallest and the largest diameter tically valid samples of the smallest and the largest diameter
catheters shall be tested. catheters shall be tested.
6.1.7 Procedure: 6.2.7 Procedure:
6.1.7.1 Test at 23 6 4°C (73.4 6 7°F). 6.2.7.1 Fill the tanks with artificial urine and raise the
6.1.7.2 Inflate the retention balloon of the test specimen te
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