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ASTM F2227-2002(2007)
Standard Test Method for Non-Destructive Detection of Leaks in Non-sealed and Empty Medical Packaging Trays by CO2 Tracer Gas Method
适用范围:<p id="s00014">Harmful biological or particulate contaminants may enter the package through imperfections such as pinholes or cracks in trays.</p> <p id="s00015">After initial instrument set-up and calibration, the operations of individual tests and test results do not need operator interpretation. </p> <p id="s00016">Leak test results that exceed the permissible threshold setting are indicated by audible or visual signal responses, or both, or by other means.</p> <p id="s00017">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.</p><p>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.</p><p>1.2 The values stated in SI units are to be regarded as standard units. Values in parentheses are for information only.</p><p>1.3 <i>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 and health practices and determine the applicability of regulatory limitations prior to use.</i></p>
实施日期: 2002-12-10
中标分类号: C08 - 医药、卫生、劳动保护 - 标志、包装、运输、贮存
ICS分类号: 11.020,19.100 - 医药卫生技术
标准组织: ASTM - 美国材料与试验协会标准
全文来源: WF
英文关键词: carbon dioxide (CO<sub>2</sub>) leak testing flexible packaging infrared CO<sub>2</sub> 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
语种: 汉语
页数: 4
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