ASTM F623-99(2013)
(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 Exclusions—Long-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.
1.3 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 2013)
Standard Performance Specification for
Foley Catheter
ThisstandardisissuedunderthefixeddesignationF623;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginal
adoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscript
epsilon (´) indicates an editorial change since the last revision or reapproval.
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 whose surface has been chemically treated to enhance their
lubricityhavenotbeentestedtothisspecificationandexcluded
1.1 This performance specification establishes performance
from the scope of this specification and will require separate
requirements for the short-term utilization of a single-use,
standard development.
balloon-retention catheter, French sizes 12 through 26
inclusive, used by the medical professions for providing a 1.3 This standard may involve hazardous materials,
operations, and equipment. This standard does not purport to
means of bladder drainage by means of the urethra. The
product is manufactured in various sizes and materials such as address all of the safety concerns associated with its use. It is
the responsibility of the user of this standard to establish
latex, silicone, rubber, and various polymers (as well as
combinations of these) and is provided nonsterile for steriliza- appropriate safety and health practices and determine the
applicability of regulatory limitations prior to use.
tionandsterileforsingleuseonly.Catheterswhosesurfacehas
been chemically treated to effect biocompatibility or microbial
properties may be tested to this specification. 2. Referenced Documents
1.2 Exclusions—Long-termindwellingusage(over30days)
2.1 ASTM Standards:
is encountered with this product, but not commonly, and is F748PracticeforSelectingGenericBiologicalTestMethods
therefore considered an exception to this specification.
for Materials and Devices
Similarly, the use of such catheters for nonurethral catheter-
2.2 Other Documents:
ization (such as for nephrostomy, suprapubic cystostomy,
ISO/AAMI/ANSI 10993–1Biological Testing of Medical
ureterostomy, gastrostomy, enemas, and so forth) is excluded
and Dental Material and Devices — Part 1: Guidance on
from the scope of this specification. Likewise, three lumen 3
Selection of Tests
catheters,30-cm balloonandpediatriccatheters,andcatheters
1 2
This performance specification is under the jurisdiction of ASTM Committee For referenced ASTM standards, visit the ASTM website, www.astm.org, or
F04 on Medical and Surgical Materials and Devices and is the direct responsibility contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
of Subcommittee F04.34 on Urological Materials and Devices. Standards volume information, refer to the standard’s Document Summary page on
Current edition approved Oct. 1, 2013. Published October 2013. Originally the ASTM website.
approved in 1981. Last previous edition approved in 2006 as F623–99 (2006). Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
DOI: 10.1520/F0623-99R13. 4th Floor, New York, NY 10036, http://www.ansi.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
F623−99 (2013)
FIG. 1 Balloon Retention (Foley) Type Catheter
U.S. Pharmacopeia
26 0.341 (8.7)
3.1.4 lumen—the channel within a tube.
3. Terminology
3.1.5 proximal—refers to the balloon end of the catheter,
3.1 Definitions:
since when in position for clinical use, the balloon end is
3.1.1 balloon (Foley) catheter—an indwelling catheter re-
proximal or closest to the patient.
tained in the bladder by a balloon that is inflated with liquid.
3.1.6 referee test method—themethodcitedinthepublished
3.1.1.1 Discussion—A two-way balloon catheter has a
specification for the device. This method and the correspond-
drainage lumen and inflation lumen (see Fig. 1). Common
3 3 ing requirements will be invoked when the performance of the
balloon inflation sizes are 5 cm with the 5-cm balloon being
3 medical device will be questioned. The manufacturer need not
usedtoholdthecatheterinplacefornormalusage,and30cm
use this referee test method in his usual inspection and quality
wheresodesignatedwhenalargerballoonisused.Athree-way
control.
balloon catheter is used for continuous bladder irrigation and
3.1.7 sterility—generally, the state of being free of micro-
features both a drainage lumen and an irrigation lumen (but as
organisms. For purposes of this specification, sterility is
noted above is excluded from consideration in this specifica-
defined as freedom from microorganisms when tested accord-
tion).
ing to the methodology defined by the USP for nonparenteral
3.1.2 FDA—the abbreviation for the Food and Drug
devices.
Administration, the Federal agency under Health, Education,
3.1.8 tolerances—the allowable deviation from a standard
and Welfare responsible for the regulation of medical device
size. In usual engineering practice, the maximum permitted
products.
sizeisdenotedbyaplussignfollowedbythetoleranceandthe
3.1.3 French size—a scale used for denoting the size of
minimum permitted size denoted by a minus sign followed by
other tubular instruments and devices, each unit being roughly
the tolerance. In this standard, the label French size has
equivalent to 0.33 mm in diameter. Label French sizes are as
tolerances given for several dimensions. For example,+3,−1
follows:
means that a nominal 14 label French size can be permitted to
French Size Outside Diameter, in. (mm)
go as high as 17, but not below 13. Another way of writing
tolerance, when both tolerances are equal, is: 62, meaning the
12 0.157 (4.0)
13 0.171 (4.3)
14labelFrenchsizemustbebetween12Frenchand16French.
14 0.184 (4.7)
15 0.197 (5.0) 3.1.9 USP—U.S. Pharmacopeia.
16 0.210 (5.3)
17 0.223 (5.7)
4. Requirements
18 0.236 (6.0)
19 0.249 (6.3)
4.1 Flow Rate through Drainage Lumen—LabelFrenchsize
20 0.262 (6.7)
catheters 14 through 24 inclusive shall have a minimum
21 0.276 (7.0)
average flow rate of 100 cm /min, and a label French size 12
22 0.289 (7.3)
23 0.302 (7.7) catheter shall have a flow rate of 70 cm /min. Tests shall be
24 0.315 (8.0)
conducted in accordance with 6.1.
25 0.328 (8.3)
Supporting data for this specification, which provides a rationale of the
AvailablefromU.S.Pharmacopeia(USP),12601TwinbrookPkwy.,Rockville, performance requirements and test methods, have been filed atASTM International
MD 20852-1790, http://www.usp.org. Headquarters and may be obtained by requesting Research Report RR:F04-1003.
F623−99 (2013)
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.
or similar guidance established by the U.S. Food and Drug
Administration ortheInternationalOrganizationforStandard-
ization (ISO).
4.7.1 The grading of any positive reaction that might be
observed should reflect the degree of erythema or edema, or
both, on the test sites. The pass or fail conclusion is based on
the mild or severe nature of the reactions, respectively.
4.7.2 Criteria as to the microscopical evaluation of tissue
reaction to the methods are included in this document. The
FIG. 2 Test Funnel
question of pass or fail should be dealt with by reliable,
competentscientistsorpathologistsandshouldbebasedonthe
degree of histological findings as compared with the response
4.2 Balloon Integrity (Resistance to Rupture)—Theinflation to the recommended USPpolyethylene as “negative controls.”
balloonmustbeinflatedeasilywithdistilledordeionizedwater
4.7.3 Packaging and Labeling—Packaged and individual
to labeled volume without showing any evidence of breakage items shall be properly labeled and conform to (1) legal
throughout the test period. Leakage and failure to deflate are
requirements, (2) the needs of medical usage (such as size
dealt with in 4.4 and 4.6. Tests shall be conducted in accor- identification), (3) requirements for traceability and identifica-
dance with 6.2.
tion in event of failure, and (4) requirements for precautions in
usage. In the majority of situations, current GMP (good
4.3 Inflated Balloon Response to Traction—The entire bal-
manufacturing practice) will provide guidelines for proper
loonofcatheterslabelFrenchsize14through26shallnotpass
labeling.
into or through the funnel barrel (Fig. 2). Tests shall be
conducted in accordance with 6.3.
5. Special Precautions
4.4 Balloon Volume Maintenance—The catheter shall main-
5.1 The following cautionary comments recognize the sen-
tain its volume throughout the test.Tests shall be conducted in
sitivity of the materials of construction to potential environ-
accordance with 6.4.
mental conditions. These are outlined here to point out poten-
4.5 Balloon Size and Shaft Size—Thebasedimensionforthe
tialsituationsthatcouldadverselyaffecttheperformanceofthe
requirement on sizes and tolerances on the diameter of the
catheter during referee testing.
catheter tip, the size of the balloon, and the diameter of the
5.1.1 Care shall be taken during testing and use to prevent
shaft is the “label French size.” The proximal catheter tip, the
damage to the catheters. Such damage can be caused by
balloon,andtheshaft,for10in.distaltotheballoon,shallmeet
abrasion and contact with sharp objects or chemical products.
the requirements on size and tolerances on diameter shown in
Contact shall be avoided with any of the following substances:
Table 1. Tests shall be conducted in accordance with 6.5.
vegetable oils, mineral oils or petrolatum, cleaning solvents,
phenol, ether, cresols, oxidizing agents, copper, and manga-
4.6 Deflation Reliability (Failure to Deflate)—The balloon
nese.
shalldeflatetowithinfourFrenchsizesofthelabelFrenchsize
5.1.2 In addition, catheters should be kept away from the
within 15 min or be otherwise manipulated to effect drainage
vicinity of generators, electric motors, diathermy machines,
within this time period.Tests shall be conducted in accordance
fluorescent lights, and so forth, because the ozone produced
with 6.6.
attacks rubber. This applies to both storage and handling.
4.7 Biocompatibility—Foley catheters are considered to be
prolonged term (24 h to 30 days) surface devices contacting
mucosal membranes and shall pass the appropriate biological
Available from Food and DrugAdministration (FDA), 10903 New Hampshire
tests conducted using the specification inASTM Practice F748 Ave., Silver Spring, MD 20993-0002, http://www.fda.gov.
F623−99 (2013)
FIG. 3 Flow Rate Apparatus for Reverse Flow Technique
5.1.3 To help avoid contamination of the catheters, proper 6.1.4.2 Graduated Cylinder,calibratedforsuitablemeasure-
handling precautions shall be observed. ment of the effluent.
6.1.4.3 Syringe,withappropriatetipforinflationofcatheter
6. Test Methods
balloon.
6.1 Flow Rate Through Drainage Lumen:
6.1.5 Warnings:
6.1.1 Scope—This method covers the determination of flow
6.1.5.1 Overflow should not be covered. Head pressure
rates through the drainage lumen of the balloon retention
must be kept constant; water should always be exiting through
catheters.
the overflow outlet.
6.1.2 Significance and Use—The flow rate is measured in
6.1.5.2 Establish equilibrium before testing.
reverse flow for ease in testing, since differences in the flow
6.1.5.3 Flow rates through all fittings must exceed that of
rate as a result of flow direction are theoretically insignificant.
the catheter being tested.
6.1.3 Summary of Test Method—The apparatus is set up as
6.1.6 Test Specimen—The test specimen shall consist of the
shown in Fig. 3. The flow rate is adjusted through the water
manufacturer’s new, finished, untested product; at least statis-
inlet to a rate sufficient to maintain flow through the overflow
tically valid samples of the smallest and the largest diameter
outletwhileeachcatheteristested.Aheadpressureof20 61.0
catheters shall be tested.
cm of water (196 6 10 kPa) above the tank bottom shall be
6.1.7 Procedure:
maintained throughout the test to approximate actual physi-
6.1.7.1 Test at 23 6 4°C (73.4 6 7°F).
ologic conditions. The overflow outlet should not be covered
by water. 6.1.7.2 Inflate the retention balloon of the test specimen
6.1.4 Apparatus: with distilled or deionized water to labeled volume. For
6.1.4.1 Water Reservoir, capable of maintaining 20 6 1.0 example, a 5-cm balloon should be inflated with 5+2,−0
cm(7.9 60.4in.)ofwater(196 610kPa)abovethetipofthe cm of distilled or deionized water (or as recommended by the
catheter connection throughout the test as shown in Fig. 3. individual manufacturer on the label).
F623−99 (2013)
6.1.7.3 Connect the catheter to catheter connector and open 6.2.7.4 After seven days, inspect the catheters for ruptured
the stopcock.The tip of the catheter connection at the junction balloons.
of catheter on-off valve should be level with the
...
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