What is ISO 11070 - Sterile single-use intravascular introducers, dilators, and guidewires about?
ISO 11070 is an international standard that discusses sterile single-use intravascular introducers, dilators, and guidewires. It provides the best industry guidance on sterile single-use intravascular introducers, dilators, and guidewires to ensure the prevention of hazards to patients and operators.
ISO 11070 layouts requirements for introducer needles, introducer catheters, sheath introducers, guidewires, and dilators supplied in the sterile condition.
Sterile single-use intravascular introducers, dilators, and guidewires are intended for single use in conjunction with intravascular catheters specified in ISO 105551.
ISO 11070 assists in meeting the updated requirements, test methods to support the guidewire, and provides updated size designs for sterile single-use intravascular introducers, dilators, and guidewires.
Who is ISO 11070 - Sterile single-use intravascular introducers, dilators, and guidewires for?
ISO 11070 on sterile single-use intravascular introducers, dilators, and guidewires is useful for:
- Sterile single-use intravascular devices manufacturers
- Test centres for intravascular devices
- Regulatory authorities
Why should you use ISO 11070?
An Intravascular catheter introducer is designed to be used in conjunction with an intravascular catheter to facilitate introduction into the vascular system. A guidewire is a flexible device over which a catheter or dilator is passed to assist in the insertion and location of the catheter or dilator into a blood vessel. A dilator is a flexible, tubular device used for dilating the percutaneous opening into a blood vessel.
ISO 11070 guideline assists you with general requirements and additional requirements for introducer needles, for introducer catheters, for sheath introducers, for guidewires, for dilators, and kits containing combinations of devices specified in ISO 11070 for sterile single-use intravascular instruments.
With compliance and obedience to ISO 11070, you can assess and achieve the acceptable quality and performance for sterile single-use intravascular instruments. In addition, assists in minimizing the hazards to patients as well as to operators.
