Intravascular catheters are used to support tasks such as the delivery of medicine and implantable devices into the human body. There are a number of tests that can be used to ensure that these devices are safe, retain their quality, and perform successfully.
ISO 10555 is a series of standards that provide guidelines for testing and evaluating various aspects of intravascular catheters to ensure their safety and efficacy throughout their shelf life. ISO 10555 testing encompasses a range of evaluations, including physical, mechanical, and biological tests, which are conducted to assess the characteristics and performance of catheters.
ISO 10555 Test Standards
- ISO 10555-1 Intravascular Catheters – Sterile and Single-use Catheters – Part 1: General Requirements
- ISO 10555-3 Intravascular Catheters – Sterile and Single-use Catheters – Part 3: Central Venous Catheters
- ISO 10555-4 Intravascular Catheters – Sterile and Single-use Catheters – Part 4: Balloon Dilation Catheters
- ISO 10555-5 Intravascular Catheters – Sterile and Single-use Catheters – Part 5: Over-needle Peripheral Catheters
- ISO 10555-6 Intravascular Catheters – Sterile and Single-use Catheters – Part 6: Subcutaneous implanted ports
Watch DDL’s Tech Talk on ISO 10555 Catheter Testing
Power injection capabilities per the ISO 10555 standard
ISO 10555 Tensile Testing on Catheters
Following are some of the other common catheter test standards that DDL can help you perform.
- ASTM F623 Standard Performance Specification for Foley Catheter
- BS EN 1618 Catheters other than intravascular catheters – Test methods for common properties
- BS EN 13868 Catheters – Test methods for kinking of single lumen catheters and medical tubing
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