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ISO 10555 Catheter Testing

Intravascular catheters are designed for tasks such as supporting delivery of medicine and implantable devices into the human body. The best way to ensure that these devices are safe, retain their quality, and perform successfully is to subject them to a series of rigorous performance and durability tests. 

Our catheter testing services are performed according to pre-approved protocols and conform with required ISO and ASTM standards. We can assist you with your testing requirements and prepare your device for regulatory submission.

ISO 10555 Part 1, 3, 4, 5, Intravascular Catheters - Sterile and Single-Use

ISO 10555 defines tests for intravascular sterile use catheters. Catheter types that can be tested according to this standard include: general intravascular catheters, angiographic catheters, central venous catheters, balloon dilatation catheters and over-needle peripheral catheters.  

Catheter Testing Standards

ISO 10555  1, 3, 4, 5 test requirements include:

ISO 10555-1

Radio-detectability

 

Biocompatibility (Outsourced)

 

Surface

Corosion Resistance

 

Peak Tensile Force

 

Freedom from Leakage

 

Hubs

 

Flowrate

Power Injection

Side Holes

 

Distal Tip

 

Designation of Nominal Size

 

ISO 10555-3

Distance Markings

 

Lumen Markings

 

Peak Tensile Force

 

ISO 10555-4

Radio-detectability

 

Designation of  
Nominal Size

 

Balloon Rated  
Burst Pressure (RBP)

 

Balloon Fatigue 

Balloon Deflation Time

Balloon Diameter to 
Inflation Pressure

ISO 10555-5

Lumen Identification

 

Color Code 
 

Catheter Fit

Needle Material 

Needle Point 

Needle Hub 

Joint Strength



Vent Fitting


 

ISO 10555-1 – General Catheter Testing Requirements

ISO 10555-3 – Central Venous Catheter Testing Requirements

ISO 10555-4 – Balloon Dilatation Catheter Testing Requirements

ISO 10555-5 – Over-needle Peripheral Catheter Testing Requirements 

Please contact us today. Our experienced engineers look forward to working with you on your Catheter testing requirements. We can also develop and validate custom test protocols that conform with required ISO and FDA standards.

ISO 10555 Catheter Testing
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We’re ready for your next Catheter testing challenge!

We’re ready for your next Catheter testing challenge!

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Fax: 847.620.7995
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Ph: 847.620.7990
Fax: 847.620.7995
info@medicalmurray.com

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NORTH BARRINGTON, IL (HQ)
400 N. Rand Rd.
North Barrington, IL 60010
Ph: 847.620.7990
Fax: 847.620.7995
info@medicalmurray.com

CHARLOTTE, NC
4508 Westinghouse Blvd., Ste. B
Charlotte, NC 28273
Ph: 847.620.7990
Fax: 847.620.7995
info@medicalmurray.com

LAKE ZURICH, IL
540 Capital Drive, Ste. 150
Lake Zurich, IL 60047
Ph: 847.620.7990
Fax: 847.620.7995
info@medicalmurray.com

Contact Us

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