Guidewires are utilized to gain access to a vessel or vessels within the vascular system through the hollow introducer needle. Various length, thickness, and stiffness are used for pertinent applications. The key characteristics being responsiveness/steerability, gliding, strength, and most importantly safety. Once inserted, the vessels or regions of interest will require dilation for the various tools for the operation. This can be accomplished by the use of dilators or introducers.
ISO 11070 is the main test standard used to help medical device manufacturers to ensure that products such as introducers and guidewires are safe for use. For guidewires in development, ISO 11070 provides a set of relatively quick and uncomplicated methods with which to evaluate different materials, manufacturing means, and engineering configurations in order to optimize the final product. Our engineers will work one on one with you to provide the testing necessary to ensure your product is ready for submission to the appropriate regulatory agency.
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