ISO 11070 and FDA Guidance on Guidewire Testing

ISO 11070 is a standard that ensures proper development of a safe and easy to use guidewire. Since the advent of the ISO 11070 standard, there have been various technological advancements that require additional information and clarity for new/modified guidewires, which are called out in a recent FDA Guidance document.


This DDL white paper highlights and compares some of the common test requirements called out in both documents.

Fill out the form below to download the white paper.

ISO 11070 Whitepaper Download