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ISO 594/2; Conical Fittings with 6% (Luer) Taper



 

ISO 594/2; Conical Fittings with a 6% (Luer) Taper for Syringes, Needles and certain other Medical Equipment – Part 2: Lock Fittings

ISO 80369-7-2016 cancels and replaces the first edition ISO 594-1:1986 and the second edition of ISO 594-2:1998, clauses, subclauses, tables, figures, and annexes of which have been consolidated and technically revised. (read more...)

ISO 594/2 Scope
This part of ISO 594 specifies requirements for conical lock fittings with a 6% (Luer) taper for use with hypodermic syringes and needles and with certain other apparatus for medical use. The requirements apply to connectors/fittings made of rigid and of semi-rigid materials and include test methods using specified Gages and Reference Fittings, but exclude provision for more flexible or elastomeric materials.

List of the obsolete ISO 594/2 paragraph 4 Requirements:
ISO 594/2 paragraph 4.1 Gauging
ISO 594/2 paragraph 4.2.1 Liquid Leakage Test
ISO 594/2 paragraph 4.2.2 Air Leakage Test
ISO 594/2 paragraph 4.3 Separation Force Test
ISO 594/2 paragraph 4.4 Unscrewing Torque Test
ISO 594/2 paragraph 4.5 Ease of Assembly Test
ISO 594/2 paragraph 4.6 Resistance to Overriding
ISO 594/2 paragraph 4.7 Stress Cracking Test

Below is a list of the obsolete ISO 594/2 paragraph 4 Requirements with conversion to the new ISO 80369-20 Test Methods.

ISO 594/2 paragraph 4.1 Gauging
Gages are considered tools for in-process testing and incoming goods inspection, not connector validation; thus gauging is not discussed in ISO 80369-7 nor in ISO 80369-20.

ISO 594/2 paragraph 4.2.1 Liquid Leakage Test
The obsolete ISO 594/2 paragraph 4.2.1 Liquid Leakage Test is replaced by ISO 80369-20 Annex C: Falling Drop Positive-Pressure Liquid Leakage Test Method.
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.

ISO 594/2 paragraph 4.2.2 Air Leakage Test
The obsolete ISO 594/2 paragraph 4.2.2 Air Leakage Test is replaced by ISO 80369-20 Annex D: Subatmospheric-Pressure Air Leakage Test Method.
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.

ISO 594/2 paragraph 4.3 Separation Force Test
The obsolete ISO 594/2 paragraph 4.3 Separation Force Test is replaced by ISO 80369-20 Annex F: Resistance to Separation from Axial Load Test Method.
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.

ISO 594/2 paragraph 4.4 Unscrewing Torque Test
The obsolete ISO 594/2 paragraph 4.4 Unscrewing Torque Test has been replaced by ISO 80369-20 Annex E: 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.

ISO 594/2 paragraph 4.5 Ease of Assembly Test
The obsolete ISO 594/2 paragraph 4.5 Ease of Assembly Test has not been continued in any form in ISO 80369-20. The rationale given in Annex A; Paragraph A.2; Page 3; Clause 1 Scope:
The ease of assembly test method that was part of the ISO 594- series has been removed as a requirement from the application parts of ISO 80369 and is not present in this part of ISO 80369. The acceptance criterion of the ISO 594- series for ease of assembly was subjective. It was under defined for a standardized test method, i.e. “a satisfactory fit” is not repeatable. Furthermore, the intent of the ease of assembly test was to ensure that the user can complete the connection using the mating halves of the connector. This requirement is satisfied by the requirement for usability validation for all new connectors being added to ISO 80369. Therefore, the ease of assembly test method has been omitted from the ISO 80369- series of standards.

ISO 594/2 paragraph 4.6 Resistance to Overriding
The obsolete ISO 594/2 paragraph 4.6 Resistance to Overriding Test has been replaced by ISO 80369-20 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.

ISO 594/2 paragraph 4.7 Stress Cracking Test
The obsolete ISO 594/2 paragraph 4.7 Stress Cracking Test has been replaced by ISO 80369-20 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.

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: ISO594/1:1986; ISO 594/2:1998; ISO80369-7:2016; and ISO80369-20:2015 which are copyrighted documents. To purchase copies visit an Authorized Reseller.

Comments:
Original Posting: 10/29/2012
Last Revision: 7/5/2017
Error corrections in, or comments about, the above data can be sent to: office@gagecrib.com

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