Overview
ISO 11070:2014 - Sterile single-use intravascular introducers, dilators and guidewires is an international standard that specifies safety, performance and test requirements for devices supplied sterile and intended for single use with intravascular catheters. It covers introducer needles, introducer catheters, sheath introducers, guidewires and dilators used to gain and maintain vascular access. The second edition (2014) updates functional requirements and size designation and replaces the 1998 edition.
Key Topics and Technical Requirements
ISO 11070:2014 defines general and device-specific requirements, and includes normative test methods in annexes. Major topics include:
- Sterilization and sterility: devices must be supplied sterile and sterilized by a validated method (see referenced sterilization standards).
- Biocompatibility: materials and biological evaluation requirements reference ISO 10993‑1.
- Surface and corrosion resistance: guidance on material selection and a normative corrosion resistance test (Annex B).
- Size designation: standardized size labelling for introducer needles, catheters, sheath introducers, guidewires and dilators.
- Mechanical tests:
- Peak tensile force tests for catheters, sheaths and dilators (Annex C).
- Leakage tests for sheath introducers and haemostasis valves (Annex D, E).
- Guidewire fracture and flexing tests and tensile testing (Annex F, G, H).
- Strength of union test for needle hub and needle (Annex I).
- Information to be supplied by the manufacturer: labeling, intended use, effective length, tips, hubs and instructions for single use and sterile condition.
- Kits: additional requirements when devices are supplied as combinations in kits.
Practical Applications - Who Uses ISO 11070:2014
This standard is practical for:
- Medical device manufacturers designing and producing single‑use intravascular introducers, guidewires and dilators - to guide design, testing and labeling.
- Quality & regulatory teams preparing technical files and conformity evidence for regulatory submissions.
- Test laboratories performing mechanical, leakage, fracture and corrosion tests specified in the annexes.
- Procurement and clinical engineering evaluating supplier compliance and device compatibility with intravascular catheters.
- Clinicians and hospital device committees assessing device specification, safety and intended use.
Adoption of ISO 11070:2014 helps ensure device safety, consistent size designation and reliable performance during catheterization procedures.
Related Standards
Keywords: ISO 11070:2014, sterile single-use intravascular introducers, guidewires, dilators, introducer needles, sheath introducers, medical device standards, sterilization, biocompatibility, test methods.
