ISO 80369-7 Compliance: Your Top FAQs Answered

The Luer is a standardized connection type based on a conical taper design. Luer lock fittings have threads added to the Luer taper for a more fitted connection. Initially, the FDA stated it would no longer accept submissions showing conformance of Luers to ISO 594 after December 31, 2019. That deadline has now been extended to December 17, 2023. The ISO's function is to make sure that the connectors it covers are unable to connect to other products NOT covered by the ISO and this is why the ISO 80369-7 standard is being implemented.

Whether you are a medical device original equipment manufacturer (OEM) or you're a company that uses their products, compliance to the new ISO 80369-7 is approaching and you should consider how it will affect your product and reputation. Dimensional and functional requirements must be met to be ISO 80369-7 compliant and modern measurement tools and techniques prove to be a viable solution. Here are the answers to your most frequently asked questions about ISO 80369-7 compliance:

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1.    What is ISO 80369-7 functional and dimensional compliance?

ISO 80369-7 functional and dimensional compliance refers to the adherence of medical device OEMs to the functional and dimensional requirements set forth in the ISO 80369-7 standard for small-bore connectors or Luers.

2.    What are the key functional requirements for ISO 80369-7 compliance?

The key functional requirements for ISO 80369-7 compliance include proper flow rates, resistance to occlusion and disconnection, and compatibility with other devices and accessories. Semi-rigid and rigid material definitions have been included as well as a separation of requirements for these materials.

3.    What are the key dimensional requirements for ISO 80369-7 compliance?

The key dimensional requirements for ISO 80369-7 compliance include the size and shape of the connector, as well as the location and orientation of the key features. Some exceptions may be made if devices pass functional testing.

4.    How can medical device OEMs ensure ISO 80369-7 functional and dimensional compliance?

Medical device OEMs can ensure ISO 80369-7 functional and dimensional compliance by conducting testing and validation to ensure their products meet the standard's specifications. Some inspection labs, including Nel PreTech Corporation, are a one-stop-shop for your functional and dimensional Luer testing needs.

5.    What happens if a medical device OEM is not ISO 80369-7 compliant?

If a medical device OEM is not ISO 80369-7 compliant, their products may not be compatible with other devices and accessories within ISO standards, which can limit their usefulness and marketability.

6.    Does ISO 80369-7 compliance apply to all medical devices?

ISO80369-7 compliance applies to medical devices that incorporate small-bore connectors used in intravenous or hypodermic capacities.

7.    How can medical device OEMs ensure compatibility with ISO 80369-7?

Medical device OEMs can ensure compatibility with ISO 80369-7 by designing, testing, and validating their small-bore connectors to meet the ISO 80369-7 standard's requirements. It may require new designs, new parts, new moldings, or updating/replacing components. Get started by teaming up with an accredited dimensional inspection lab that knows the requirements and delivers the reports you need.

8.    What are the benefits of ISO 80369-7 compliance for medical device OEMs?

The benefits of ISO 80369-7 compliance for medical device OEMs include improved product safety, reduced risk of regulatory action, lowered liability, and enhanced reputation and marketability.

9.    Is ISO 80369-7 compliance mandatory for medical device OEMs?

ISO 80369-7 compliance is not mandatory for medical device OEMs, but many countries, healthcare organizations, and medical regulatory agencies across the world have already begun adopting the standard and addressing medical misconnections to improve patient safety. The ISO standard is the medical device OEM's best guide for decision making on their small-bore connectors.

10. Are there penalties for non-compliance with ISO 80369-7?

There are no specific penalties for non-compliance with ISO 80369-7, but medical device OEMs may face regulatory action, legal action, or damage to their reputation if their products are deemed unsafe or incompatible with other devices and accessories.

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This is how the standard is commonly referenced: ISO 80369-7, but here are some other commonly used terms:

80369

80369-7:2021

80369 7

luer 80369-7

iso 80369

iso 80369-7:2021

iso 80369 7

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Now that your ISO 80369-7 questions have been answered, contact Nel PreTech for your dimensional and functional testing needs!

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