Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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059
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Date of Entry 12/19/2022
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FR Recognition Number
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9-144
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Standard | |
ISO 20697 First edition 2018-06; Corrected 2018-09 Sterile drainage catheters and accessory devices for single use |
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Scope/AbstractThis document specifies requirements for sterile, single use drainage catheters, wound and fluid accumulation drainage systems, surgical drainage catheters and their components, where the catheter is placed in a body cavity or wound, surgically or percutaneously, for drainage of fluid or air to the exterior.
The drainage catheter is left to drain naturally or connected to a suction source for faster tissue granulation.
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Extent of Recognition
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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. |
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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. |