ISO 11070:2014/Amd 1:2018

Overview

ISO 11070:2014/Amd 1:2018 is the first amendment to the international standard ISO 11070:2014, which specifies requirements for sterile single-use intravascular introducers, dilators, and guidewires. These medical devices are critical for safe and effective vascular access and catheterization procedures. The amendment provides clarifications, adjustments, and additional testing requirements to enhance device safety, performance, and reliability.

Developed by ISO Technical Committee ISO/TC 84, which focuses on devices for the administration of medicinal products and catheters, this amendment reflects updated industry practices and advances in manufacturing controls. ISO standards like ISO 11070 facilitate global harmonization and ensure that single-use vascular access devices meet stringent quality and safety benchmarks.

Key Topics

• Scope of Amendment
  Updates focused on testing protocols, terminology, and device features, including guidewires with polymer jackets.

• Design and Testing Updates

  • Clarification of tensile force testing: "minimum force at break" updated to "peak tensile force" to better reflect real-world device stresses.
  • Modifications to coil testing in guidewires, emphasizing the correct direction of force application to simulate clinical use.
  • Revised clamp specifications for guidewire testing using a split tapered clamp with precise dimensional criteria.

• Risk-Based Testing Approaches
  Introduction of risk assessment considerations allowing manufacturers to adjust test speeds to ensure reliable force measurements without compromising safety.

• Documentation and User Notes
  Additional notes added to guidance sections to enhance manufacturer and user understanding of testing and design requirements, particularly for devices with polymer jacketed guidewires.

Applications

• Vascular Access Procedures
  ISO 11070:2014/Amd 1:2018 governs single-use devices intended for sterile and safe vascular access to facilitate catheter placement, blood sampling, and drug administration.

• Single-Use Device Manufacturing
  Manufacturers use this standard and amendment to align product development and quality control with internationally recognized practices, minimizing risks of contamination or mechanical failure.

• Clinical Safety Compliance
  Hospitals, clinics, and healthcare providers rely on adherence to ISO 11070 standards to select devices that meet critical sterility and mechanical performance criteria, improving patient outcomes.

• Regulatory Submissions
  Compliance with this ISO amendment supports medical device regulatory approvals worldwide by demonstrating the application of internationally accepted testing and design principles for intravascular components.

Related Standards

• ISO 13485 - Medical devices - Quality management systems - Requirements for regulatory purposes
  Supports quality management systems used by manufacturers of sterile medical devices like introducers and guidewires.

• ISO 14971 - Medical devices - Application of risk management to medical devices
  Provides a framework for risk assessment, which is incorporated in the testing adjustments within ISO 11070/Amd 1.

• ISO 10993 - Biological evaluation of medical devices
  Relevant for ensuring biocompatibility of materials used in single-use intravascular devices.

• ISO 10555 - Intravascular catheters
  Covers broader intravascular catheter standards related to uses similar to introducers and dilators referenced in ISO 11070.

ISO 11070:2014/Amd 1:2018 enhances the technical rigor and clinical safety requirements for sterile single-use intravascular introducers, dilators, and guidewires. By adhering to this updated standard, manufacturers and healthcare providers ensure consistent device quality, reliability, and patient safety during critical vascular access procedures. For more details, visit the ISO official website.