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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 050 Date of Entry 09/17/2018 
FR Recognition Number 6-408
ISO  10555-1 Second edition 2013-06-15
Intravascular catheters - Sterile and single-use intravascular catheters - Part 1: General requirements [Including AMENDMENT 1 (2017)]
ISO 10555-1:2013 specifies general requirements for intravascular catheters, supplied in the sterile condition and intended for single use, for any application.
Extent of Recognition
Partial recognition. The following part(s) of the standard is (are) not recognized:
When this standard is used to support a regulatory submission for an interventional or diagnostic cardiovascular catheter (e.g. balloon angioplasty catheter or stent delivery system), Section 4.6 (Peak Tensile Force) is not recognized.

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 "Section 4.6 (Peak Tensile Force)" is in conflict with an existing published final guidance, see Section VII.B. of the FDA Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters, issued September 8, 2010.
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FDA recognition of ISO 10555-1 Second edition 2013-06-15 [Rec# 6-408] will be superseded by recognition of ISO 10555-1 Third edition 2023-11 [Rec# 6-499].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.

Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters, 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 Contact
 Keith Marin
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.