Recognized Consensus Standards: Medical Devices

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FDA recognition of ISO 10555-1 Second edition 2013-06-15 [Rec# 6-408] will be superseded by recognition of ISO 10555-1 Third edition 2023-11 [Rec# 6-499].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

Keith Marin

FDA/OC/CDRH/OPEQ/OIDRH/

301-796-2462

keith.marin@fda.hhs.gov

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