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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 all manufactured lots 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 all manufactured lots, 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
From each of the mold's cavities; one part from beginning, middle, and end of a production run, could be validated by testing according to the Chapter 6 performance requirements of the operative ISO 80369 specification. In addition, conical gage tests of all cavities at scheduled intervals.
Optimum
One cavity of the mold's production could be validated by testing 3 pieces; one from beginning, middle, and end of a production run. The mold's cavity selected for the test could be cycled through all the mold's cavities over multiple production runs. In addition, during each production run, conical gage tests of all cavities at scheduled intervals.
Basic
Annually; from each of the mold's cavities; one part from beginning, middle, and end of a production run, could be validated by testing according to the Chapter 6 performance requirements of the operative ISO 80369 specification. Depending on the volume of production from the mold; this test may have to be more frequent. In addition, during each production run, conical gage tests of all cavities at scheduled intervals.
Compromise
Bi-annually; from each of the mold's cavities; one part from beginning, middle, and end of a production run, could be validated by testing according to the Chapter 6 performance requirements of the operative ISO 80369 specification. Depending on the volume of production from the mold; this test may have to be more frequent. In addition, during each production run, conical gage tests of all cavities at scheduled intervals.
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
For every lot during production and/or on receipt; spot test the tapered cone with a conical gage, and the screw thread with a fitment screw thread gage. These tests are not dictated by ISO 80369, but is a fast and simple way to identify out-of-tolerance connectors.
Resources:
Gages for testing: ISO-80369-3; ISO-80369-6; ISO-80369-7
Reference Connectors for testing: ISO-80369-3; ISO-80369-6; ISO-80369-7
Devices for conducting tests per: ISO-80369-20
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.
 

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: 3/24/2017
Error corrections in, or comments about, the above data can be sent to: gageguy@gagecrib.com

 

 

 

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