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Significance and Use
5.1 Harmful biological or particulate contaminants may enter the package through imperfections such as pinholes or cracks in trays.
5.2 After initial instrument set-up and calibration, the operations of individual tests and test results do not need operator interpretation.
5.3 Leak test results that exceed the permissible threshold setting are indicated by audible or visual signal responses, or both, or by other means.
5.4 This non-destructive test method may be performed in either laboratory or production environments and may be undertaken on either a 100 % or a statistical sampling basis. This test method, in single instrument use and current implementation, may not be fast enough to work on a production packaging line, but is well suited for statistical testing as well as package developmental design work.
1.1 This non-destructive test method detects pinhole leaks in trays, as small as 50 μm (0.002 in.) in diameter, or equivalently sized cracks, subject to trace gas concentration in the tray, tray design and manufacturing tolerances.
1.2 The values stated in SI units are to be regarded as standard. The values given in parentheses after SI units are provided for information only and are not considered standard.
1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
D996 Terminology of Packaging and Distribution Environments
F1327 Terminology Relating to Barrier Materials for Medical Packaging
ICS Number Code 11.020 (Medical sciences and health care facilities in general); 19.100 (Non-destructive testing)
|Link to Active (This link will always route to the current Active version of the standard.)|
ASTM F2227-13(2021), Standard Test Method for Non-Destructive Detection of Leaks in Non-sealed and Empty Packaging Trays by CO