ASTM F623-2019 pdf free download

ASTM F623-2019 pdf free download.Standard Performance Specification for Foley Catheter
1. 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 non-sterile for steril- ization 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 specifica- tion. 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 catheter- ization (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-cm 3 balloon and pediatric catheters, and catheters whose surface has been enhanced for lubricity using liquids or gels.
3. Terminology
3.1 Definitions: 3.1.1 Balloon (Foley) catheter—an indwelling catheter re- tained in the bladder by a balloon that is inflated with liquid. 3.1.1.1 Discussion—A two-way balloon catheter has a drainage lumen and inflation lumen (see Fig. 1). Common balloon inflation sizes are 5 cm 3 with the 5-cm 3 balloon being used to hold the catheter in place for normal usage, and 30 cm 3 where so designated when a larger balloon is used. Athree-way balloon catheter is used for continuous bladder irrigation and features both a drainage lumen and an irrigation lumen (but as noted above is excluded from consideration in this specifica- tion). 3.1.2 French size—a scale used for denoting the size of other tubular instruments and devices, each unit being roughly equivalent to 0.33 mm in diameter. Label French sizes are as follows:3.1.4 proximal—refers to the balloon end of the catheter, since when in position for clinical use, the balloon end is proximal or closest to the patient. 3.1.5 referee test method—the method cited in the published specification for the device. This method and the correspond- ing requirements will be invoked when the performance of the medical device will be questioned. The manufacturer need not use this referee test method in his usual inspection and quality control. 3.1.6 sterility—generally, the state of being free of micro- organisms. For purposes of this specification, sterility is defined as freedom from microorganisms when tested accord- ing to the methodology defined by the USP for non-parenteral devices. 3.1.7 tolerances—the allowable deviation from a standard size. In usual engineering practice, the maximum permitted size is denoted by a plus sign followed by the tolerance and the minimum permitted size denoted by a minus sign followed by the tolerance. In this standard, the label French size has tolerances given for several dimensions. For example, +3, −1 means that a nominal 14 label French size can be permitted to go as high as 17, but not below 13. Another way of writing tolerance, when both tolerances are equal, is: 62, meaning the 14 label French size must be between 12 French and 16 French. 3.1.8 USP—U.S. Pharmacopeia.