Test methods for sterile medical device package — Part 5: Detecting gross leaks in medical packaging by internal pressurization (bubble test)
1 Scope
This part of YY/T 0681 covers the detection of gross leakage in medical packaging. The detection probability of the sensitivity of the method for pore size above 250μm is 81% (see Annex B). This test method may be used for pallet and pouch packaging.
This test method only evaluates the sensitivity of spunbonded polyolefin or non-porous packaging, but does not evaluate the sensitivity of other packages with porous materials.
This method is a destructive test, in which air needs to be injected into the packaging to form internal pressure.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
GB/T 2918 Plastics — Standard atmospheres for conditioning and testing
3 Term and definition
For the purposes of this standard, the following term and definition apply.
3.1
breathing point pressure
pressure that causes the gas to start passing through the porous material
4 Test method abstract
4.1 Inflate the package to a predetermined pressure under water, and then observe the continuous bubble flow showing the package breakage.
Foreword i
1 Scope
2 Normative references
3 Term and definition
4 Test method abstract
5 Significance and use
6 Apparatus
7 Sampling
8 Conditioning
9 Procedure
10 Report
Annex A (Normative) Determination of test pressure
Annex B (Informative) Precision and bias
