SIST EN ISO 11070:2015 PDF

Overview

EN ISO 11070:2014 - Sterile single-use intravascular introducers, dilators and guidewires is the European adoption of ISO 11070:2014. It specifies safety and performance requirements, test methods and manufacturer information for devices supplied sterile and intended for single use with intravascular catheters. Covered devices include introducer needles, introducer catheters, sheath introducers, guidewires and dilators. The standard replaces earlier editions and is maintained by ISO/TC 84 and CEN/TC 205.

Key topics and technical requirements

EN ISO 11070:2014 addresses both general and device-specific requirements:

• General requirements: sterilization, biocompatibility, surface condition, corrosion resistance, radio‑detectability and mandated information to be supplied by the manufacturer (labeling and instructions).
• Introducer needles & catheters: size designation, needle point and tip design, hub integrity and tests for peak tensile force where applicable.
• Sheath introducers: dimensional and size designation requirements, leakage resistance of the sheath and haemostasis valve, hub strength and peak tensile force tests.
• Guidewires: size designation, presence and testing of safety wires, fracture and flexing tests, and peak tensile force requirements to ensure mechanical integrity during intravascular use.
• Dilators: size designation, hub design and manufacturer information.
• Kits: additional requirements for kits that combine components covered by the standard.
• Test methods and annexes: normative annexes define methods for corrosion testing, tensile testing, leakage tests, fracture/flexing of guidewires and other performance verifications.

Keywords: EN ISO 11070:2014, sterile single-use intravascular introducers, guidewires, dilators, introducer catheters, medical device test methods.

Applications and who uses this standard

EN ISO 11070:2014 is used by:

• Medical device manufacturers - to design, test and declare compliance for introducers, guidewires, dilators and related kits.
• Quality and regulatory teams - to support CE marking, technical files and conformity assessment for single‑use intravascular devices.
• Test laboratories - to perform standardized tensile, leakage, corrosion, fracture and flexing tests described in the normative annexes.
• Procurement, clinical engineering and healthcare providers - to specify safe, compatible sterile single‑use components for catheterization and vascular access procedures. The standard helps reduce patient risk (device failure, contamination, embolism) by defining consistent safety, performance and labeling expectations.

Related standards

EN ISO 11070:2014 complements other medical device requirements such as standards on biocompatibility and sterile packaging/sterilization (e.g., ISO 10993 series, ISO 11607) and should be used alongside applicable regulatory guidance when preparing technical documentation and risk assessments.

For full requirements and test protocols, obtain the official standard from ISO or your national standards body.