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ISO 80369-3 TTest Equipment LIst

2020-09-23 21:21:35 admin

ISO 80369-6:2016 Reference Connectors and ISO 80369-20:2015 Test Equipment

ISO 80369-6:2016 Clause

Required Annex of ISO 80369-20:2015

Enersol equipment required

Requried Enersol reference connectors for testing

Neuraxial small-bore connectors

 

Clause 6 - all sub-clauses

Annex B through I requires the assembly of the appropriate reference connector (i.e. from ISO 80369- 6 Annex C) with the test sample, using a specified

force and torque to assemble them.

 

S15A - Connector assembly device

 

Any/all reference connectors

Clause 6.1.1 - Fluid leakage requirement

Evaluate using EITHER leakage by pressure decay, or positive pressure liquid leakage. It is inferred the same method is used after the stress cracking conditioning.

 

Clause 6.1.2 - Leakage by pressure decay

 

Annex B - Leakage by Pressure Decay

 

S77 - Automated pressure decay tester

 ISO80369-6 Fig. C.1 FC for testing MC S69  ISO80369-6 Fig. C.4 MC for testing FC

 ISO80369-6 Fig. C.2 MC for testing FC

 

Clause 6.1.3 - Positive pressure liquid leakage

 

Annex C - Positive Pressure Liquid Leakage

 

S16A - Positive pressure liquid leakage tester

ISO80369-6 Fig. C.1 FC for testing MC S69 - ISO80369-6 Fig. C.4 MC for testing FC S71 - ISO80369-6 Fig. C.2 MC for testing FC

 

Clause 6.2 - Subatmospheric pressure air leakage

 

Annex D - Subatmospheric pressure air leakage

S78 - Automated subatmospheric pressure air leakage tester

 ISO80369-6 Fig. C.1 FC for testing MC

 ISO80369-6 Fig. C.4 MC for testing FC S71 ISO80369-6 Fig. C.2 MC for testing FC

 

Clause 6.3 - Stress cracking*

 

Annex E - Stress cracking

 

Use S15A

ISO80369-6 Fig. C.1 FC for testing MC

ISO80369-6 Fig. C.4 MC for testing FC S71 - ISO80369-6 Fig. C.2 MC for testing FC

Clause 6.4 - Resistance to separation from axial load

Annex F - Resistance to separation from axial load

S18A - Separation force device

S68 - ISO80369-6 Fig. C.3 FC for testing MC

S70 - ISO80369-6 Fig. C.5 MC for testing FC

 

Clause 6.5 - Resistance to separation from unscrewing

 

Annex G - Resistance to separation from unscrewing

 

S19A - Unscrewing torque device

S67 - ISO80369-6 Fig. C.1 FC for testing MC S69 - ISO80369-6 Fig. C.4 MC for testing FC

S71 - ISO80369-6 Fig. C.2 MC for testing FC

Clause 6.6 - Resistance to overriding

Annex H - Resistance to overriding

Use S15A

S68 - ISO80369-6 Fig. C.3 FC for testing MC

S70 - ISO80369-6 Fig. C.5 MC for testing FC


KEY: FC = Female Connector MC = Male Connector

* = There is an error in ISO 80369-6:2016 Clause 6.3. This clause states that the connectors shall meet the requirements of Clause 6.1.2 after stress cracking. This reference to Clause 6.1.2 is a mistake that is intended to b

corrected. Clause 6.3 should state Clause 6.1.1 instead of Clause 6.1.2. Clause 6.1.1 requires either Clause 6.1.2 (Leakage by pressure decay) or 6.1.3 (Positive pressure liquid leakage) be used. There will be an update to correct the reference to Clause 6.1.1 in due course.