Luer Dimensional Testing - ISO 80369-7 Compliance Info

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

Purpose

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

Partnering to Meet ISO 80369-7 Compliance

Medical device manufacturers 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. This precision allows the detection of defects early, giving you confidence for swift corrective actions. Comprehensive deliverables include detailed reports on measurements and tolerance checks. With our accredited approach, you can adhere to the required specifications and uphold the highest standards of safety and performance.

Our Success lies in our people, process, and platform:

Our dedicated team of experts is unique in experience and talent.

We employ a robust process that captures micron-level details, ensuring thorough and precise inspections.

Our advanced platform leverages the latest 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

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 Meeting ISO Standards:

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.

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

Additional Benefits

Speed Up Product Development: Utilize our turnkey 3D scanning and engineering solutions.
Learn more with this case study
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.

Get More Out Of Your CT Scanning

Download the ultimate CT Scanning Buyer's Guide to improve understanding, time, and efficiency in your scanning needs. Over 50 Pages of useful data and case studies.

Download Now

Highly Accurate Luer Inspection: Meeting ISO 80369 Compliance for Top Medical Manufacturers

Ensuring Safety in Healthcare Delivery Systems Health care facilities rely on various devices to safely deliver medications and substances to patients. ISO 80369 standards aim to prevent dangerous misconnections between these devices.

Get Luers to Market Faster

Advanced Non-destructive Inspection

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

Common Medical Devices

Delivery Systems

ISO 80369 Standards

Challenges with Luer Connectors

Purpose

Get A No-Obligation Quote to fully SEE Any Product

Partnering to Meet ISO 80369-7 Compliance

Our Success lies in our people, process, and platform:

Our dedicated team of experts is unique in experience and talent.

We employ a robust process that captures micron-level details, ensuring thorough and precise inspections.

Our advanced platform leverages the latest 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

Material-Specific Requirements

Auxiliary Dimension for t Dimension

Modified N1 and N2 Dimensions

Common Medical Devices

Delivery Systems

Challenges with Luer Connectors

ISO 80369 Standards

Purpose

Case Studies

Challenge:

Solution:

Results:

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

Challenge:

Solution:

Results:

Grillers Rejoice: Pellet grills saved by industrial CT scanning.

Challenge:

Solution:

Results:

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

Need Luer Inspections?

Full Series of Standards for 80369:

How Does ISO 80369 Impact You?

Medical Device Manufacturers

Compliance: Adapting to ISO 80369 standards may require

Custom Fittings

Use of Luer Connectors

Dimensional Inspections on Specific ISO Standards

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

ISO 27186:

ISO 9626:

ISO 18250:

ISO 7864:

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

With our A2LA scope and certification, you can have confidence in our:

Additional Benefits

Get More Out Of Your CT Scanning

Nel PreTech Corporation is a 3D & CT scanning laboratory accredited to ISO 17025 by A2LA, providing value-add engineering & metrology services.

Seeing Is BetterThan Believing!

Seeing Is BetterThan Believing!

Ensuring Safety in Healthcare Delivery Systems

Health care facilities rely on various devices to safely deliver medications and substances to patients. ISO 80369 standards aim to prevent dangerous misconnections between these devices.

Seeing Is Better
Than Believing!

Seeing Is Better
Than Believing!