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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 062 Date of Entry 05/29/2024 
FR Recognition Number 6-499
Standard
ISO  10555-1 Third edition 2023-11
Intravascular catheters - Sterile and single-use intravascular catheters - Part 1: General requirements
Scope/Abstract
This document specifies general requirements for intravascular catheters, supplied sterile and intended for single use, for any application.

This document does not apply to intravascular catheter accessories.
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FDA recognition of ISO 10555-1 Second edition 2013-06-15 [Rec# 6-408] will be superseded by recognition of ISO 10555-1 Third edition 2023-11 [Rec# 6-499]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 6-408] until July 05, 2026. After this transition period, declarations of conformity to [Rec# 6-408] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§870.1250 Catheter, Percutaneous Class 2 DQY
§870.1250 Catheter, Angioplasty, Peripheral, Transluminal Class 2 LIT
§880.5200 Catheter, Umbilical Artery Class 2 FOS
§880.5200 Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days Class 2 FOZ
§880.5200 Saline, Vascular Access Flush Class 2 NGT
§880.5200 Heparin, Vascular Access Flush Class 2 NZW
§880.5200 Water, Vascular Access Flush Class 2 NZX
§880.5200 Peripheral Catheter Insertion Kit Class 2 OWL
§880.5200 Heparin Flush In 0.45% Sodium Chloride Class 2 PEF
§880.5200 Central Venous Catheter Dressing Change Kit Class 2 PEZ
§880.5970 Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days Class 2 LJS
Relevant FDA Guidance and/or Supportive Publications*
Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters, issued March 1995.

Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters - Class II Special Controls Guidance for Industry and FDA, issued September 2010.

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
 Angel Soler-Garcia
  FDA/OC/CDRH/OPEQ/OHTIII/DHTIIIB/
  301-796-6535
  Angel.Soler-Garcia@fda.hhs.gov
 Sevan Oungoulian
  CDRH/OPEQ/OHTII/DHTIIC
  301-796-9631
  Sevan.Oungoulian@fda.hhs.gov
 Keith Marin
  FDA/OC/CDRH/OPEQ/OIDRH/
  301-796-2462
  keith.marin@fda.hhs.gov
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Groups (STG)
General Plastic Surgery/General Hospital (primary)
Cardiovascular
*These are provided as examples and others may be applicable.
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