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ASTM F623-99e1

(Specification)

Standard Performance Specification for Foley Catheter

Standard Performance Specification for Foley Catheter

SCOPE
1.1 This 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.

General Information

Status
Historical
Publication Date
09-Oct-1999
ICS
11.040.20 - Transfusion, infusion and injection equipment
Technical Committee
F04 - Medical and Surgical Materials and Devices
Drafting Committee
F04.34 - Urological Materials and Devices
Current Stage
Ref Project

Relations

Replaces
ASTM F623-99 - Standard Performance Specification for Foley Catheter
Effective Date
10-Oct-1999
Replaced By
ASTM F623-99(2006) - Standard Performance Specification for Foley Catheter
Effective Date
01-Sep-2006
Referred By
ASTM F2528-06(2023) - Standard Test Methods for Enteral Feeding Devices with a Retention Balloon
Effective Date
10-Oct-1999

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ASTM F623-99e1 - Standard Performance Specification for Foley Catheter
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Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
e1
Designation: F 623 – 99
Standard Performance Specification for
1
Foley Catheter
This standard is issued under the fixed designation F623; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.A
superscript 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.
1
e NOTE—Section X2.1 was editorially corrected in February 2002.
INTRODUCTION
The objective of this specification is to describe those product requirements and associated test
3
methods that will assure 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.
3
1. Scope catheters,30-cm balloonandpediatriccatheters,andcatheters
whose surface has been chemically treated to enhance their
1.1 This specification establishes performance requirements
lubricityhavenotbeentestedtothisspecificationandexcluded
for the short-term utilization of a single-use, balloon-retention
from the scope of this specification and will require separate
catheter, French sizes 12 through 26 inclusive, used by the
standard development.
medical professions for providing a means of bladder drainage
1.3 This standard may involve hazardous materials, opera-
by means of the urethra. The product is manufactured in
tions, and equipment. This standard does not purport to
various sizes and materials such as latex, silicone, rubber, and
address all of the safety concerns associated with its use. It is
various polymers (as well as combinations of these) and is
the responsibility of the user of this standard to establish
provided nonsterile for sterilization and sterile for single use
appropriate safety and health practices and determine the
only. Catheters whose surface has been chemically treated to
applicability of regulatory limitations prior to use.
effectbiocompatibilityormicrobialpropertiesmaybetestedto
this specification.
2. Referenced Documents
1.2 Exclusions—Long-term indwelling usage (over 30
2.1 ASTM Standards:
days) is encountered with this product, but not commonly, and
F748 Practice for Selecting Generic Biological Test Meth-
is therefore considered an exception to this specification.
2
ods 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 10993–1 Biological 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
1
This performance specification is under the jurisdiction of ASTM Committee
F04 on Medical and Surgical Materials and Devices and is the direct responsibility
2
of Subcommittee F04.34 on Urological Materials and Devices. Annual Book of ASTM Standards, Vol 13.01.
3
Current edition approved October 10, 1999. Published December 1999. Origi- Available from American National Standards Institute, 25 W. 43rd St., 4th
nally published as F623–81. Last previous edition F623–89. Floor, New York, NY 10036.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
1

---------------------- Page: 1 ----------------------
e1
F623–99
FIG. 1 Balloon Retention (Foley) Type Catheter
4
U.S. Pharmacopeia 3.1.4 lumen—the channel within a tube.
3.1.5 proximal—refers to the balloon end of the catheter,
3. Terminology
since when in position for clinical use, the balloon end is
3.1 Definitions of Terms:
proximal or closest to the patient.
3.1.1 balloon (Foley) catheter—an indwelling catheter re- 3.1.6 referee test method—themethodcitedinthepublished
tained in the bladder by a ba
...

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4.3 Blood and blood components are usually irradiated using gamma radiation from 137Cs or 60Co sources, or X-radiation from X-ray units.  
4.4 Blood irradiation specifications include a lower limit of absorbed dose, and may include an upper limit or central target dose. For a given application, any of these values may be prescribed by regulations that have been established on the basis of available scientific data (see 2.6).  
4.5 For each blood irradiator, an absorbed-dose rate at a reference position within the canister is measured as part of irradiator acceptance testing using a reference-standard dosimetry system. That reference-standard measurement is used to establish operating parameters so as to deliver specified dose to blood and blood components.  
4.6 Absorbed-dose measurements are performed within the blood or blood-equivalent volume for determining the absorbed-dose distribution. Such measurements are often performed using simulated product (for example, polystyrene is considered blood equivalent for 137Cs photon energies).  
4.7 Dosimetry is part of a measurement management system that is applied to ensure that the radiation process meets predetermined specifications (see ISO/ASTM Practice 52628).  
4.8 Blood and blood components are usually irradiated in chilled or frozen condition. Care should be taken, therefore, to ensure that the dosimeters and radiation-sensitive indicators can be used under such temperature conditions.  
4.9 Proper ...
SCOPE
1.1 This practice outlines the irradiator installation qualification program and the dosimetric procedures to be followed during operational qualification and performance qualification of the irradiator. Procedures for the routine radiation processing of blood product (blood and blood components) are also given. If followed, these procedures will help ensure that blood product exposed to gamma radiation or X-radiation (bremsstrahlung) will receive absorbed doses with a specified range.  
1.2 This practice covers dosimetry for the irradiation of blood product for self-contained irradiators (free-standing irradiators) utilizing radionuclides such as 137Cs and  60Co, or X-radiation (bremsstrahlung). The absorbed dose range for blood irradiation is typically 15 Gy to 50 Gy.  
1.3 The photon energy range of X-radiation used for blood irradiation is typically from 40 keV to 300 keV.  
1.4 This practice also covers the use of radiation-sensitive indicators for the visual and qualitative indication that the product has been irradiated (see ISO/ASTM Guide 51539).  
1.5 This document is one of a set of standards that provides recommendations for properly implementing dosimetry in radiation processing and describes a means of achieving compliance with the requirements of ISO/ASTM Practice 52628 for dosimetry performed for blood irradiation. It is intended to be read in conjunction with ISO/ASTM Practice 52628.  
1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides ...

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ASTM
ASTM A908-03(2019)(Specification)
Standard Specification for Stainless Steel Needle Tubing

ABSTRACT
The specification covers austenitic, stainless steel, needle tubing in hard-drawn tempers for industrial application. An electric furnace or other similar primary melting process with or without degassing or refining may be used. Needle tubing shall be made by the seamless or welded and drawn process and shall be furnished in the hard-drawn temper condition. Tension tests shall be made to meet the required tensile requirements.
SCOPE
1.1 This specification covers austenitic, stainless steel, needle tubing in hard-drawn tempers for industrial applications.  
1.2 In general, needle tubing describes small-diameter tubing with outside diameters (ODs) in the range of 0.008 to 0.203 in. (0.2 to 5.2 mm) with nominal wall thicknesses in the range of 0.002 to 0.015 in. (0.05 to 0.4 mm). Needle tubing gages are normally 6 through 33.  
1.3 The values stated in inch-pound units are to be regarded as standard. The values given in parentheses are mathematical conversions to SI units that are provided for information only and are not considered standard.  
1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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