ISO 10555-3 Second edition 2013-06-15

Standard Organization:

ISO 10555-3 Second edition 2013-06-15
Intravascular catheters -- Sterile and single-use catheters -- Part 3: Central venous catheters

• Recognition Date: 2014-01-30
• Recognition List: 034
• Recognition Number: 6-305
• Extent: Complete standard
• Standards Orgs: ISO International Organization for Standardization https://www.iso.org/
• STG: General Plastic Surgery/General Hospital
• FDA Tech: Keith Marin FDA/OMPT/CDRH/ODE/DAGID/GHDB/ 301-796-2462 keith.marin@fda.hhs.gov

Rationale:

This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.

Scope:

ISO 10555-3:2013 specifies requirements for central venous catheters supplied in the sterile condition, and intended for single use.

Code of Federal Regulations:

Regulation Number	Device Name	Device Class	Product Code
§880.5970	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	Class 2	LJS

FDA Guidance:

Guidance of Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters, Issued March 16, 1995