| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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060
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Date of Entry 05/29/2023
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FR Recognition Number
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9-143
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| Standard | |
ISO 20696 First edition 2018-06; Corrected 2019-12
Sterile urethral catheters for single use |
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Scope/Abstract| This document specifies requirements and test methods for sterile urethral catheters for single use, with or without a balloon. This document does not include drainage catheters covered by ISO 20697, e.g. ureteral catheters, nephrostomy catheters, and suprapubic catheters. This document also excludes ureteral stents. |
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Extent of Recognition
| Partial recognition. The following part(s) of the standard is (are) not recognized: |
Clause 6.3 and Annex C, Balloon Volume Maintenance
Clause 6.4 and Annex D and I, Deflation Reliability (Failure to Deflate)
Clause 6.5 and Annex E, Flow Rate
Clause 6.6 and Annex F, Balloon Integrity (Resistance to Rupture)
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Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
This standard is recognized in part because:
Clause 6.3 and Annex C are in conflict with the test method of an existing published final guidance. See Mechanical Testing, Balloon Volume Maintenance of the guidances (see Ref #1 & #2).
Clause 6.3 and Annex C are in conflict with the test method of an existing recognized standard. See Clause 4.4 and Annex A4, Balloon Volume Maintenance of ASTM F623-19 (Ref #3).
Clause 6.4 and Annex D and I are in conflict with the test method of an existing published final guidance. See Mechanical Testing, Deflation Reliability (Failure to Deflate) of the guidances (see Ref #1 & #2).
Clause 6.4 and Annex D and I are in conflict with the test method of an existing recognized standard. See Clause 4.6 and Annex A6, Deflation Reliability (Failure to Deflate) of ASTM F623-19 (Ref #3).
Clause 6.5 and Annex E are in conflict with the test method and acceptance criteria for French sizes of 12 and 14 in an existing published final guidance. See Mechanical Testing, flow rate through drainage lumen of the guidances(see Ref #1 & #2).
Clause 6.5 and Annex E are in conflict with the test method and acceptance criteria for French sizes of 12 and 14 in an existing recognized standard. See Clause 4.1 and Annex A1, Flow rate through drainage lumen of ASTM F623-19 (Ref #3).
Clause 6.6 and Annex F are in conflict with the test method of an existing published final guidance. See Mechanical Testing, Balloon Integrity (Resistance to Rupture) of the guidances (see Ref #1 & #2).
Clause 6.6 and Annex F are in conflict with the test method of an existing recognized standard. See Clause 4.2 and Annex A2, Balloon Integrity (Resistance to Rupture) of ASTM F623-19 (Ref #3). |
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Public Law, CFR Citation(s) and Procode(s)*
| Regulation Number |
Device Name |
Device Class |
Product Code |
| §876.5130 |
Catheter, Straight
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Class 2
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EZD
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| §876.5130 |
Catheter, Retention Type, Balloon
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Class 2
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EZL
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| §876.5130 |
Catheter, Urological
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Class 2
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KOD
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Relevant FDA Guidance and/or Supportive Publications*
1. Guidance for the Content of Premarket Notifications for Conventional and Antimicrobial Foley Catheters, issued September, 1994.
2. Conventional Foley Catheters - Performance Criteria for Safety and Performance Based Pathway, issued August, 2020.
3. ASTM F623-19, Standard Performance Specification for Foley Catheter.
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018. |
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| FDA Technical Contact
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| Standards Development Organization
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FDA Specialty Task Group (STG)
| ObGyn/Gastroenterology/Urology |
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| *These are provided as examples and others may be applicable. |
