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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 060 Date of Entry 05/29/2023 
FR Recognition Number 6-490
Standard
ISO  10555-6 First edition 2015-04-15 [Including AMD1:2019]
Intravascular catheters - Sterile and single-use catheters - Part 6: Subcutaneous implanted ports [Including AMENDMENT 1 (2019)]
Scope/Abstract
ISO 10555-6:2015 specifies requirements, performance, and user safety issues related to subcutaneous implanted ports and catheters for intravascular long-term use supplied in sterile condition and intended for single use.
ISO 10555-6:2015 does not specify requirements, performance, and user safety issues related to non-coring needles.
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Extent of Recognition
Complete standard
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.
Transition Period
FDA recognition of ISO 10555-6 First edition 2015-04-15 [Rec# 6-357] will be superseded by recognition of ISO 10555-6 First edition 2015-04-15 [Including AMD1:2019] [Rec# 6-490]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 6-357] until July 6, 2025. After this transition period, declarations of conformity to [Rec# 6-357] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§880.5965 Port & Catheter, Implanted, Subcutaneous, Intravascular Class 2 LJT
Relevant FDA Guidance and/or Supportive Publications*
510(k) Submissions for Implanted Infusion Ports - Guidance, issued October 1990.

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contacts
 Keith Marin
  FDA/OC/CDRH/OPEQ/OIDRH/
  301-796-2462
  keith.marin@fda.hhs.gov
 Kyran Gibson
  FDA/OC/CDRH/OPEQ/OHTIII/DHTIIIC/
  --
  Kyran.Gibson@fda.hhs.gov
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
General Plastic Surgery/General Hospital
*These are provided as examples and others may be applicable.
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