Luer CT scan data colormap

Luer Inspection: 
Meeting ISO 80369 Compliance for Top Medical Manufacturers

Non-destructive Testing for Medical Device Delivery Systems

Luer dimensional testing to ISO 80369-7 provides trustworthy compliance data. CT Scanning services are used to reduce risk of dangerous misconnections and support patient safety in medical device applications.

Why Dimensional Testing Matters for Luers

Diameter measurement of Luer connector.
  • Accurate and repeatable data reported per Luer standard specification
  • Make quick and confident decisions on designs or deviations
  • Questions answered in minutes/hours
  • Option to expedite results for your convenience
  • Reduce manufacturing delays, and ensure safety & compatibility across the industry
ISO 80369 FAQs blog

Advanced Approach to Non-destructive Luer Inspection

Point to point distance measurement on CT scan data
  • Cross-sectional analysis without potting, disassembly, or damage
  • Expedite design and development process with rapid inspection reports
  • Inspect internal and external geometry with micrometer-level accuracy
  • Full part comparison against CAD models or ISO reference standards
See how industrial CT scanning enhances precision inspection.

Your End-to-End Partner for ISO-80369 Compliance

Common Medical Devices

  • Catheters
  • Tubing
  • Syringes

Delivery Systems

  • Vascular
  • Enteral
  • Respiratory
  • Epidural
  • Intrathecal

ISO 80369 Standards

  • Developed by ISO and IEC
  • Focus on non interchangeable, small-bore connectors
  • Aim to prevent wrong route delivery errors

Challenges with Luer Connectors

  • Ubiquitous and easy-to-use
  • Compatible across different systems
  • Risk of inadvertent misconnections
  • Potential for serious patient injuries and deaths

3D Scanning Technology

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Partnering to Meet ISO 80369-7 Compliance

Medical device OEMs and suppliers who need to meet rigorous industry standards for Luer connectors rely on Nel PreTech Corporation for accurate dimensional inspections. Leverage our advanced dimensional inspection services and seamlessly integrate them into your manufacturing process, ensuring consistent quality and reliability. Utilizing state-of-the-art 3D scanning technology, we measure the physical dimensions of Luers with accuracy you can trust. Detect defects early, acquire critical dimensions, and gain confidence for swift corrective actions. Comprehensive deliverables include detailed reports on measurements and tolerance checks. With our ISO/IEC 17025-accredited approach, you can adhere to the required specifications and sustain the highest standards of safety and performance.

Our Success lies in our people, process, and platform:
Our team of experts is unique in experience and talent. They are long-term, dedicated designers, engineers, and physicists. Read more about Nel PreTech.
    We employ a robust process that captures micron-level details.
    Nel PreTech’s ISO/IEC 17025 accreditation through A2LA demonstrates proven reliability and adherence to international testing standards. This ensures data traceability and confidence in every dimensional report we deliver.
    Our advanced platform leverages the latest 3D scanning technology to provide reliable and accurate results, making Nel PreTech your trusted partner for Luer dimensional inspections.

    Key Updates on ISO 80369-7

    Increased Tolerances
    • Tolerances for several reference connector dimensions have been increased to simplify manufacturing and certification.
    • Most affected tolerances do not contact the test connector, hence not impacting test results.
    • The angle tolerance for the bearing side of the threads, which does contact the test connector, is expected to have minimal to no effect on outcomes.
    Material-Specific Requirements
    • Requirements for Luer connectors are now differentiated between semi-rigid and rigid materials to ensure compatibility across the design spectrum.
    • Definitions for semi-rigid and rigid materials have been added.
    Auxiliary Dimension for t Dimension
    • The distance from the connector tip to the bottom of the first complete thread profile (t dimension) is now an auxiliary dimension due to measurement difficulties.
    • Its functional impact is assessed with the resistance to separation (axial load) test.
    Modified N1 and N2 Dimensions
    • For female Luer lock connector variant A (lugs at right angle to axis), N1 and N2 dimensions are now measured from the open end of the connector to ensure compatibility across the design spectrum.

    Common Medical Devices

    • Catheters
    • Tubing
    • Syringes

    Delivery Systems

    • Vascular
    • Enteral
    • Respiratory
    • Epidural
    • Intrathecal

    Challenges with Luer Connectors

    • Ubiquitous and easy-to-use
    • Compatible across different systems
    • Risk of inadvertent misconnections
    • Potential for serious patient injuries and deaths

    ISO 80369 Standards

    • Developed by ISO and IEC
    • Focus on noninterchangeable, small-bore connectors
    • Aim to prevent wrong route delivery errors

    Purpose

    • Enhance patient safety by ensuring connectors are incompatible with incorrect delivery systems
    • Minimize risk of delivery errors in healthcare settings

    Case Studies

    Colormap of CT scan data within VG software
    Challenge:

    A major consumer product company struggles to develop, approve, and launch multiple high-level cavitation molds for high-volume production & global distribution.

    Solution:

    Computed tomography and value-add services from Nel PreTech.

    Results:

    Client saves $1 million in direct cost and gains $60 million in cash flow four months sooner.

    The Scoop: Product development & launch expedited with industrial CT scanning of new tooling.

    View Full Case Study
    Industrial CT scanning services allows analysis of hidden elements
    Challenge:

    Major grill manufacturer reaches out with malfunctioning glow plugs.

    Solution:

    Industrial CT scanning (x-ray material testing) provides digital 3D x-ray images of internal components of the glow plug & finds a wire break inside the heating device.

    Results:

    Client is able to investigate the root cause of the glow plug failure and fix the problem.

    Grillers Rejoice: Pellet grills saved by industrial CT scanning.

    Read Full Case Study
    Blue light scan of an automotive door handle
    Challenge:

    Global OEM medical device company needs help developing and launching drug delivery pumps.

    Solution:

    CT scanning and value-add services create a turnkey solution to give the client a competitive advantage.

    Results:

    20 new tools in 20 weeks.

    A Medical Miracle: Drug delivery pumps developed and launched in record time with 3D scanning services.

    Read the full Case Study
    CT scan of Luer showing porosity

    Need Luer Inspections?

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    Full Series of Standards for 80369:

    • ISO 80369-1: First in the series of standards. Specifies applications with unique connector geometries.
    • ISO 80369-2: Breathing Systems and Driving Gases
    • ISO 80369-3: Enteral and Gastric
    • ISO 80369-4: Urethral and Urinary
    • ISO 80369-5: Limb Cuff Inflation
    • ISO 80369-6: Neuraxial
    • ISO80369-7: Intravascular (IV)

    Visit our FAQ page for answers to your top questions about ISO 80369-7.

    How Does ISO 80369 Impact You?

    Medical Device Manufacturers

    Compliance: Adapting to ISO 80369 standards may require
    • New designs
    • New parts
    • New moldings
    • Updating or replacing millions of components

    Custom Fittings

    • Significant costs involved in manufacturing custom fittings
    • Risk of unintended compatibility with undefined applications

    Use of Luer Connectors

    • Luer connectors can still be used in referenced markets until new connectors are defined and approved
    • No immediate action required until specific market connectors are established

    Dimensional Inspections on Specific ISO Standards

    Medical device manufacturers in the United States must obtain specific ISO certifications before marketing their products globally. These standards are essential for establishing credibility and ensuring that devices meet international quality, risk management, and safety requirements.

    Benefits of Achieving ISO Compliance:

    • Credibility: Gain trust from customers by demonstrating adherence to international standards.
    • Quality Assurance: Ensure products meet rigorous quality and safety benchmarks.
    • Market Access: Facilitate entry into global markets with recognized certifications.

    Let us help you save time, money, and effort with our comprehensive medical device dimensional inspection services. When testing is complete, deliverables can include:

    -Raw dimensional data
    -Pass/fail compliance results against ISO 80369-7
    -Annotated 2D and 3D visuals for quick interpretation
    -Optional CAD-to-scan overlay analysis

    Additional Relevant ISO Standards Covered by Our 3D & CT Scanning Services:

    ISO 27186:

    Four-poleconnector system for active implantable medical devices

    ISO 9626:

    Rigid stainless-steel tubing

    ISO 18250:

    Reservoir delivery systems in enteral applications

    ISO 7864:

    Single-use hypodermic needles

    Keep Up with Regulatory Requirements and Changes with Our Accredited Quality Management System

    Point to point distance measurement on CT scan data
    With our A2LA scope and certification, you can have confidence in our:
    • Procedures and Policies
    • Quality of Environment
    • Measurement Uncertainty Analysis
    • Calibration Standards
    • Data Traceability

    Additional Benefits

    • Speed Up Product Development: Utilize our turnkey 3D scanning and engineering solutions. We helped a major OEM medical device manufacturer launch 20 tools in 20 weeks!
      READ THE FULL CASE STUDY HERE.
    • Integrate New Technology: Seamlessly incorporate new scanning services into your existing workflows for faster decision-making.
    • Team Accessibility: Provide your entire team with simultaneous access to inspection reports and datasets at their fingertips.
    • Problem Mitigation: Effectively address issues that could lead to recalls.
    Diameter measurement of Luer connector.

    Get More Out Of Your CT Scanning

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