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Standard Test Method for Non-Destructive Detection of Leaks in Non-sealed and Empty Packaging Trays by CO2 Tracer Gas Method
NORMA vydaná dňa 15.1.2021
Označenie normy: ASTM F2227-13(2021)
Dátum vydania normy: 15.1.2021
Kód tovaru: NS-1018282
Počet strán: 4
Približná hmotnosť: 12 g (0.03 libier)
Krajina: Americká technická norma
Kategória: Technické normy ASTM
Lékařské vědy a ochrana zdraví všeobecně
Nedestruktivní zkoušení
Keywords:
carbon dioxide (CO2) leak testing, flexible packaging, infrared CO2 sensor, medical package integrity test, non-destructive testing, package integrity monitoring, pass/fail criteria, permeable packaging, pinhole leaks, porous packaging, sealing membrane performance, sterile integrity tests, trace gas leak testing, trays pass/fail levels,, ICS Number Code 11.020 (Medical sciences and health care facilities in general),19.100 (Non-destructive testing)
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. |
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1. Scope | ||||
1.1?This non-destructive test method detects pinhole leaks in trays, as small as 50 ?m (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. |
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2. Referenced Documents | ||||
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