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ISO 80369-20 Common Test Methods for ISO 80369



 

ISO 80369-20 Common Test Methods for ISO 80369

ISO 80369 Foreword
The ISO 80369 consists of multiple parts. Here is a list of the parts.

ISO 80369-20 Introduction
Some of the attribute test methods in this standard are simlar to the ISO 594-1 and ISO 594-2 (the previous standards for Luer connectors). Modifications of the test methods were developed to permit testing using variable data.

ISO 80369-20 describes the common test methods for evaluating the performance requirements of the small-bore connectors specified in this series. During the development of the ISO 80369- series it became evident that many of the test methods were very similar for each of the applications. It was therefore decided to standardize all the test methods into a separate part of the series to prevent unnecessary duplication and minor differences. It is also recognized that not all connectors can be evaluated using each test method in this part. The test methods applicable to each connector are specified in the respective part of the ISO 80369- series.

ISO 80369-20 Scope
ISO 80369-20 specifies the common test methods to evaluate the performance requirements for small-bore connectors intended to be used for connections of medical devices and related accessories of the ISO 80369 series. ISO 80369-20 does not specify the functional requirements for the medical devices or accessories that use these connectors.

Below are the tests listed in ISO 80369-20:
Annex B Leakage by Pressure Decay Test Method
Annex C Falling Drop Positive-Pressure Liquid Leakage Test Method
Annex D Subatmospheric-Pressure Air Leakage Test Method
Annex E Stress Cracking Test Method
Annex F Resistance to Separation from Axial Load Test Method
Annex G Resistance to Separation from Unscrewing Test Method
Annex H Resistance to Overriding Test Method
Annex I Disconnection by Unscrewing Test Method

Annex B Leakage by Pressure Decay Test Method
Per ISO 80369-20; Annex A; Paragraph A.2; Page 4; Annex B: Leakage by pressure decay test method: This pressure decay test method is a new test method that was not part of the former ISO 594- series. However, it is based upon the informative liquid leakage test method of ISO 594-1:1986, Annex A.

Annex C Falling Drop Positive-Pressure Liquid Leakage Test Method (formerly: Liquid Leakage Test)
Per ISO 80369-20; Annex A; Paragraph A.2; Page 4; Annex C Falling drop positive-pressure liquid leakage test method: This liquid leakage test method is performed in the same manner as in the ISO 594- series.

Annex D Subatmospheric-Pressure Air Leakage Test Method (formerly: Air Leakage Test)
Per ISO 80369-20; Annex A; Paragraph A.2; Page 4; Annex D Subatmospheric-pressure air leakage test method: This subatmospheric-pressure air leakage test method is a new test method that was not part of the former ISO 594- series. The ISO 594- series test method for subatmospheric-pressure (ISO 594-1, 5.3 and ISO 594-2, 5.3) creates an unspecified subatmospheric test pressure and asks the observer to look for continued formation of bubbles of an unspecified size.

Annex E Stress Cracking Test Method
Per ISO 80369-20; Annex A; Paragraph A.2; Page 4; Annex E Stress cracking test method: This stress cracking test method is performed in the same manner as in the ISO 594- series. The acceptance criteria have been changed to require passing a functional leak test after the stress cracking test method has been performed.

Annex F Resistance to Separation from Axial Load Test Method (formerly: Separation Force Test)
Per ISO 80369-20; Annex A; Paragraph A.2; Page 5; Annex F Resistance to separation from axial load test method: This resistance to separation from axial load test method is performed in the same manner as in the ISO 594- series. The title and principle have been elaborated to describe the intent of the test.

Annex G Resistance to Separation from Unscrewing Test Method
Per ISO 80369-20; Annex A; Paragraph A.2; Page 5; Annex G Resistance to separation from unscrewing test method: This resistance to separation from unscrewing test method is performed in the same manner as the ISO 594- series. The title and principle have been elaborated to describe the intent of the test.

Annex H Resistance to Overriding Test Method
Per ISO 80369-20; Annex A; Paragraph A.2; Page 5; Annex H Resistance to overriding test method: This resistance to overriding test method is performed in the same manner as the ISO 594- series.

Annex I Disconnection by Unscrewing Test Method
Per ISO 80369-20; Annex A; Paragraph A.2; Page 5; Annex I Disconnection by unscrewing test method: This disconnection by unscrewing test method replaces the test method described in the ISO 594-x series to account for locking, non-locking (slip) and rotating-collar connectors. It is intended to ensure that connectors, which can be connected and disconnected multiple times per day, can be successfully disconnected by the user.

Discussion on change from ISO 594 to ISO 80369-20.
Discussion on the frequency of testing.

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 document: ISO80369-20:2015; which is a copyrighted document. To purchase a copy visit an Authorized Reseller.

Comments:
Original Posting: 9/1/2014
Last Revision: 2/13/2017
Error corrections in, or comments about, the above data can be sent to: gageguy@gagecrib.com

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