ISO 80369-20:2015 pdf free

ISO 80369-20:2015 pdf free.Small-bore connectors for liquids and gases in healthcare applications
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.
Formula B.1 utilized in this TEST METHOD is derived from ISO 594-1:1986, Annex A. The following paragraphs are a discussion of the derivation of Formula B.1 and practicalities of the usage of this formula.
Formula B.1 yields a leakage index as opposed to a more traditional leak rate (mass or volume over time). In a common leak test, the leak rate is proportional to the applied pressure, requiring the initial applied pressure to be tightly specified in order to compare results from one test to another. To eliminate this discrepancy, Formula B.1 includes a term (1/tp) which normalizes the results, making all results comparable to the requirement regardless of different initial applied pressures.
The results from Formula B.1 are approximated from a linear pressure versus time law instead of the exact exponential relationship that occurs for a compressible fluid and rigid container. Because of this derivation, the error between the exact and approximated pressure versus time equations is less than 4 % when the recorded pressure decay does not exceed 22 % of the starting pressure.
Formula B.1 neglects a temperature correction. Within the specified range of test condition temperatures,15°C to 25°C, the error is less than±1 %, which is noticeably less than the expected variability range for a common product, as well as the effects of the linear approximation for pressure decay.
In this TEST METHOD the use of a compressible fluid, usually air or other gases, is preferable to liquids because the test, when performed with fluids that are considered incompressible, is strongly biased by the artifact of the elastic compliance of the components of the connection under test. In this case, the true effect of the leaking orifice cannot be detected.ISO 80369-20 pdf download.