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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 non-sterile 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 Catheters whose surface has been chemically treated to enhance their lubricity with a coating may be tested to this specification.
1.3 The annexes in this specification include detailed information, such as apparatus or materials for this specification.
1.4 The appendixes in this specification contain information intended to provide guidance only and are not a mandatory part of the specification.
1.5 Regulatory bodies may require additional information, such as clinical data, to support different design features.
1.6 The values stated in SI units are to be regarded as the standard. The values given in parentheses are for information only.
1.7 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 enhanced for lubricity using liquids or gels.
1.8 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.
1.9 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.
2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
D412 Test Methods for Vulcanized Rubber and Thermoplastic ElastomersTension
D573 Test Method for RubberDeterioration in an Air Oven
D1076 Specification for RubberConcentrated, Ammonia Preserved, Creamed, and Centrifuged Natural Latex
D3078 Test Method for Determination of Leaks in Flexible Packaging by Bubble Emission
D3767 Practice for Rubber--Measurement of Dimensions
D4483 Practice for Evaluating Precision for Test Method Standards in the Rubber and Carbon Black Manufacturing Industries
E691 Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method
F748 Practice for Selecting Generic Biological Test Methods for Materials and Devices
Other DocumentsISO/AAMI/ANSI 10993–1 Biological Testing of Medical and Dental Material and Devices Part 1: Guidance on Selection of Tests
ISO StandardISO 10993 Biological Evaluations of Medical Devices
ICS Number Code 11.040.20 (Transfusion, Infusion)
UNSPSC Code 42142702(Urethral urinary catheters)
|Link to Active (This link will always route to the current Active version of the standard.)|
ASTM F623-19, Standard Performance Specification for Foley Catheter, ASTM International, West Conshohocken, PA, 2019, www.astm.orgBack to Top