Luer Dimensional Testing - ISO 80369-7 Compliance Info

Compliance — Everything You Need Know to Understand ISO Requirements

ISO 80369-7, the new standard for Luer connectors, has replaced the ISO 594 standard. The FDA no longer accepts devices using ISO 594 for new submissions.

Compliance transition timeline:

ISO 594 was replaced by ISO 80369-7.
FDA began rejecting ISO 594-based submissions starting December 31, 2019.
Devices already cleared under ISO 594 are not required to be resubmitted but new submissions must meet ISO 80369-7.

Why the change matters:

ISO 80369-7 aims to reduce the risk of misconnections in medical applications.

It provides standardized dimensions and performance testing for small-bore connectors.

As a result, testing and compliance with ISO 80369-7 is now a critical path requirement for medical device manufacturers submitting new devices that incorporate Luer connectors.

Nel PreTech can guide you through the ISO 80369-7 transition and ensure your products are compliant before you submit.

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Technical Info — Required Dimensions & Technical Specs to Ensure Your Product is ISO Compliant

Overview of technical challenge:

Luer connectors, while small and simple in appearance, must meet strict dimensional requirements to be ISO 80369-7 compliant.

What’s measured:

Outside diameter of male Luer taper
Inside diameter of female Luer taper
Length, thread engagement, and concentricity
Minimum wall thickness
Axial misalignment
Surface finish and angularity

Metrology method:

Nel PreTech provides non-contact, non-destructive inspection of Luer connectors using CT (Computed Tomography) scanning

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Point to point distance measurement on CT scan data

Benefits of CT scanning

3D visualization of all internal and external geometry
High accuracy measurements, no need to cut or section parts
Consistent results even on fragile or complex geometries

Precision + Repeatability:

Our scanning technology allows for measurement of all relevant Luer dimensions within microns, verified in our ISO/IEC 17025 accredited lab.

Luer dimensional testing brochure

Guide to dimensional testing of Luers for ISO 80369-7

Luer Dimensional Testing Brochure

Latest News

ISO 80369-7 Compliance: Your Top FAQs Answered

Learn about ISO 80369-7 dimensional and functional requirements and more!

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Luer ISO 80369-7 Compliance: Preventing Catastrophe

CT scanning luer dimensions for IV & hypodermic applications.

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ISO 80369: Standardizing Medical Connectors for Safety

Learn how ISO 80369 standards improve patient safety by preventing small-bore connection errors in medical devices.

View Full Article

Services — Looking For An End-to-End ISO Compliance Partner? The services and know-how all in one place.

Get precise, reliable Luer inspection for ISO 80369-7 compliance.

Service Description:

Nel PreTech offers Luer connector dimensional testing to meet ISO 80369-7 requirements.
CT-based inspection delivers a complete dimensional report including pass/fail results, 3D visualization, and STL exports.
Fast turnaround options available

Why manufacturers choose NPC

Eliminate the need for multiple suppliers by working with one experienced partner
Get to market faster with verified compliance data
Reduce inspection variability and rework
Access engineering support for interpretation and validation

Core benefits

Accurate and repeatable data
Fast turnaround
Expedited options available
Avoid costly manufacturing delays

Accreditation + Trust:

NPC is ISO/IEC 17025 accredited
Industry-trusted across the medical device sector

What Our Customers Are Saying

"Tried Nel PreTech services for the first time. Very professional and timely with the completion of the project we had to have done. The cost of services was within our budget. Dave was very accommodating to our inspection requirements."

- Quality Manager (Precision Manufacturing Company)

"Nel PreTech did a great job of reverse engineering some part drawings for us. They provided both 3D and 2D drawings in a timely manner. The drawings were thorough and complete. I look forward to working with Nel PreTech again in the future."

- Engineer (Medical Equipment Manufacturing)

Nel PreTech provides excellent metrology services! I've worked with Mike and Greg for a few months now. Nel CT scanned parts for First Article Inspections -their scans are great quality, within budget, and always delivered in a timely manner. Nel's team does a fantastic job providing quality services. Looking forward to working with Nel on more jobs in the future!"

- Advanced Quality Engineer (Plastics Industry)

"I couldn't be more pleased with the services Nel PreTech has been providing to me. Their data is well organized and accurate. I highly recommend them."

- Sr. Manufacturing Engineer (Medical Device Industry)

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.

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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

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.

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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.

Compliance

Technical Info

Testing Services

Compliance — Everything You Need Know to Understand ISO Requirements

Compliance transition timeline:

ISO 594 was replaced by ISO 80369-7.

FDA began rejecting ISO 594-based submissions starting December 31, 2019.

Devices already cleared under ISO 594 are not required to be resubmitted but new submissions must meet ISO 80369-7.

Why the change matters:

Technical Info — Required Dimensions & Technical Specs to Ensure Your Product is ISO Compliant

Overview of technical challenge:

What’s measured:

Metrology method:

Benefits of CT scanning

Precision + Repeatability:

Luer dimensional testing brochure

Luer Dimensional Testing Brochure

Latest News

ISO 80369-7 Compliance: Your Top FAQs Answered

Luer ISO 80369-7 Compliance: Preventing Catastrophe

ISO 80369: Standardizing Medical Connectors for Safety

Services — Looking For An End-to-End ISO Compliance Partner? The services and know-how all in one place.

Service Description:

Why manufacturers choose NPC

Core benefits

Accreditation + Trust:

Get A No-Obligation Quote to fully SEE Any Product

What Our Customers Are Saying

- Quality Manager (Precision Manufacturing Company)

- Engineer (Medical Equipment Manufacturing)

- Advanced Quality Engineer (Plastics Industry)

- Sr. Manufacturing Engineer (Medical Device Industry)

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.

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!

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.

Seeing Is Better
Than Believing!

Seeing Is Better
Than Believing!