NSAI Workshop on the ISO 80369 Standards Series
Introduction
The revision of ISO 80369 in 2016 has introduced new requirements such as additional dimensions selected to represent the current design and dimensions of luer connectors in clinical use. The addition of the new requirements was made to further reduce the risk of misconnection with other small-bore connectors. These changes will impact the design, manufacture and testing of connectors and national manufacturers and suppliers need to develop a plan to move to these new requirements.
This event is for:
- Manufacturers and suppliers of connector products
- Quality engineers
- Test houses that carry out testing on behalf of manufacturers
This event will focus on:
- Standards development of ISO 80369
- Notified body perspective on biomechanical requirements
- Test house views on comparing the old and new Luer standard.
Workshop Details
- Date: March 26th, 2019
- Location: Clayton Hotel, Galway
- Time: 09:30am-1:00pm
Agenda
Standards development – Find out who is involved in the development of the ISO 80369 Series of standards and how national experts can contribute and get up to date information on revisions.
Speaker: L.Hendy – Standard Development
Find out about the Standards committee that is developing the ISO 80369 series of standards and get up to date information on the planned work programme for this group of standards. Hear how national experts can be kept up to date on standard developments.
Notified Body perspective on biomechanical requirements for technical testing required for CE Mark approvals.
Speaker: E.Hogan – NSAI Medical devices – Notified body - Technical file review
This presentation will provide an overview of the Notified Body review process regarding biomechanical testing and the way in which the technical review is carried out as part of CE mark approvals.
Test house perspective addressing comparisons between “old” and “new” Luer standards and how to achieve compliance to the new ISO 80369 Standards.
Speaker: Philip Roxby – Anecto – Designing Luer Connectors With Compliance in Mind
This presentation will provide an overview of Luer connectors with a focus on the basics of design and structure. Next it will introduce ISO 80369 and cover its family background. Differences between “old” Luer standards and “new” standards will also be discussed. Finally, the presentation will offer some practical suggestions on how to achieve compliance to ISO 80369
A networking lunch will take place after the presentations.
