Overview
EN ISO 11070:2014/A1:2018 (ISO 11070:2014/Amd 1:2018) is a CEN-endorsed amendment to the international standard for sterile single-use intravascular introducers, dilators and guidewires. Approved July 2018, this amendment clarifies test methods, updates terminology and adds specific test guidance for modern guidewire constructions (including polymer-jacketed wires). The amended standard forms part of the regulatory and quality framework for non‑active vascular access devices and was to be adopted as a national standard across CEN members by January 2019.
Key Topics and Requirements
- Scope and status: Amendment A1 modifies EN ISO 11070:2014 without technical changes to the original text but adds procedural and test clarifications.
- Material-specific guidance: A new note explicitly states that certain requirements apply to guidewires with polymer jackets (NOTE 2).
- Tensile testing terminology: Replaces the term “minimum force at break” with “peak tensile force”, aligning wording with contemporary test practice.
- Test method clarifications:
- Corrects internal references (e.g., changes to "(see 8.4)" and "(see 8.5)").
- Adds handling instructions during coil testing: push coils toward the distal end and avoid non‑clinically relevant pull forces.
- Specifies a split tapered clamp for certain clamp tests, with a closed diameter 0.02 mm less than the minimum guidewire diameter, and removes Figure H.1.
- Permits manufacturers, based on risk assessment, to apply a slower test speed in I.3.2 to reach the target force.
- Practical test cautions: Emphasizes test setup to avoid artifacts (e.g., improper coil direction, unrealistic pull force) that could invalidate results.
Applications
- Ensures safe performance and consistent testing for single‑use intravascular introducers, dilators and guidewires used in vascular access procedures.
- Supports device design verification, manufacturing quality control, and pre-market technical documentation.
- Useful in establishing clinically relevant test conditions and limits for tensile strength, coil integrity and clamp interactions.
Who should use this standard
- Medical device manufacturers (R&D, QA/RA)
- Test laboratories and conformity assessment bodies
- Hospital procurement and clinical engineering teams evaluating device safety
- Regulatory affairs specialists preparing CE marking/technical files for vascular access devices
Related standards
- ISO 11070 main edition (2014) - base standard for intravascular introducers, dilators and guidewires
- EN 1617:1997 - previously superseded by ISO 11070 (refer to the standard foreword for historical context)
Keywords: EN ISO 11070:2014/A1:2018, ISO 11070, sterile single-use intravascular introducers, dilators, guidewires, medical device standard, tensile testing, polymer-jacketed guidewires, CEN amendment.