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U.S. Department of Health and Human Services

Recognized Consensus Standards

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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
Standard
ISO 10555-1 Second edition 2013-06-15 Intravascular catheters - Sterile and single-use intravascular catheters - Part 1: General requirements [Including AMENDMENT 1 (2017)]
Scope/Abstract
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.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§880.5200 Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days Class 2 FOZ
§880.5200 Catheter, Umbilical Artery Class 2 FOS
§880.5200 Central Venous Catheter Dressing Change Kit Class 2 PEZ
§880.5200 Heparin Flush In 0.45% Sodium Chloride Class 2 PEF
§880.5200 Heparin, Vascular Access Flush Class 2 NZW
§880.5200 Peripheral Catheter Insertion Kit Class 2 OWL
§880.5200 Saline, Vascular Access Flush Class 2 NGT
§880.5200 Water, Vascular Access Flush Class 2 NZX
§880.5970 Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days Class 2 LJS
§870.1250 Catheter, Angioplasty, Peripheral, Transluminal Class 2 LIT
§870.1250 Catheter, Percutaneous Class 2 DQY
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.
FDA Technical Contact
 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 Group (STG)
General Plastic Surgery/General Hospital
*These are provided as examples and others may be applicable.
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