Medical Luer Small Bore Connector OEM Testing to ISO 80369
Medical Luer Small Bore Connector OEM Testing ISO 80369
Reasons To Assure Quality Of Your OEM Products
From Perspective Of OEM Manufacturer
-- To protect your brand. It is well known that one demerit on your reputation quickly overshadows ten positive reviews. It is best to avoid demerits completely by assuring the on-going quality of your product.
-- To reduce the cost. Scrap, with its associated results: Product recall; Discarded production pieces; Reproducing that which was scrapped, carries a much higher cost than appropriate quality assurance measures.
-- To provide a value-added service. The value-added service of product testing is a nice marketing benefit of what should be a standard quality assurance program/process; especially if your competition provides none.
-- To protect against litigation.
Nothing can save you from litigation, but assuring that you have up-to-date copies of all applicable specifications related to your products, and have conducted basic testing of each manufactured lot will go a long way in limiting your exposure when the inevitable occurs.
From the Perspective of OEM User
-- To protect your brand.
It is well known that one demerit on your reputation quickly overshadows ten positive reviews. It is then best to avoid demerits completely by insisting on documented on-going testing of your OEM product.
-- To reduce the cost. Scrap, with its associated results: Product recall; Discarded production pieces; Reproducing that which was scrapped, carries a much higher cost than appropriate quality assurance measures. The cost to you, the OEM purchaser, considering the assembled components and processes, may be greater than that of the manufacturer of the failed piece.
-- To protect against litigation.
Nothing can save you from litigation, but assuring that you have up-to-date copies of all applicable specifications related to your products, and have documented basic testing results of each manufactured lot, will go a long way in limiting your exposure when the inevitable occurs.
Suggested Testing Frequency For Plastic Molded ISO 80369 Parts.
Unrealistic
All pieces from each of the mold's cavities could be validated by testing according to the Chapter 6 performance requirements of the operative ISO 80369 specification.
Idealistic
Product from each cavity:
o 3-pieces, 1-part from beginning, 1-part from middle, and 1-part from end of the production run, could be validated by testing according to the Chapter 6 performance requirements of the ISO 80369-n specification.
o 1-part tested with a conical gage to validate the cone.
o 1-part tested with Reference Connector to validate the thread.
Optimum
Product from each cavity of the mold tested sequentially one-cavity-at-a-time over multiple production lots.
From each production lot select one cavity of the mold for testing. Select 3-pieces, 1-part from beginning, 1-part from middle, and 1-part from end of the production lot, to be validated by testing according to the Chapter 6 performance requirements of the ISO 80369-n specification.
Also, product from each cavity:
o 1-part tested with a conical gage to validate the cone.
o 1-part tested with Reference Connector to validate the thread.
Basic
Annually, product from each cavity:
o 3-pieces, 1-part from beginning, 1-part from middle, and 1-part from end of the production run, could be validated by testing according to the Chapter 6 performance requirements of the ISO 80369-n specification.
o 1-part tested with a conical gage to validate the cone.
o 1-part tested with Reference Connector to validate the thread.
Compromise
Bi-annually, product from each cavity:
o 3-pieces, 1-part from beginning, 1-part from middle, and 1-part from end of the production run, could be validated by testing according to the Chapter 6 performance requirements of the ISO 80369-n specification.
o 1-part tested with a conical gage to validate the cone.
o 1-part tested with Reference Connector to validate the thread.
Unacceptable
Test results over two years old.
Test results from the initial mold production run.
Test results from the FDA submission.
Only conical gage tests.
Gage Testing Suggestions For ISO 80369 Connectors
Gages are not appropriate for first piece product validation. Gages are best suited for in-process testing and for incoming parts testing. Here are links to deeper discussion of the available gages: Conical Ring Gages Conical Plug Gages Screw Thread Gages
NOTE:
As of 15 October 2016; ISO 594 was replaced by ISO 80369-7 (more... ISO 594/1; or ISO 594/2). This change is mostly a clerical change (more...). Existing ISO 594/2 Reference Fittings/Connectors can be DUO-marked and DUO-certified to both ISO 594 and ISO 80369-7 (more...). All reference to ISO 594 in any document or drawing should be understood as
ISO 80369-7 (more...). Parts designed/molded to ISO 594 should easily pass ISO 80369-7 tests. Insist that all tests for
grandfathered ISO 594 connectors be validated according to the listed performance requirements listed in Chapter 6 of
ISO 80369-7.
Notice:
This website is funded by the sale of medical small bore connector and screw thread measurement tools. It will help us continue to offer this data if you allow us to have the opportunity to sell our tools to your company. If you find this information useful, please work to get Gage Crib Worldwide Inc. on the bid list for future purchases of medical small bore connector measurement tools.
Disclaimer:
This data is provided for general information only. The intention
is to provide accurate information; regardless; errors may exist
in the supplied information. If accuracy is critical, base your
final decisions on the data provided in the root documents: ISO594/1; ISO 594/2; ISO80369-1; ISO80369-2; ISO80369-3; ISO80369-6; ISO80369-7; and ISO80369-20 which are copyrighted documents. To purchase copies, visit
an Authorized Reseller.
Comments:
Original Posting: 2/13/2017
Last Revision: 9/28/2021
Error corrections in, or comments about, the above data can be sent to: office@gagecrib.com
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