ASTM F2227-02(2007)
Historical Standard: ASTM F2227-02(2007) Standard Test Method for Non-Destructive Detection of Leaks in Non-sealed and Empty Medical Packaging Trays by CO 2 Tracer Gas Method
SUPERSEDED (see Active link, below)
ASTM F2227
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 units. Values in parentheses are for information only.
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 and health practices and determine the applicability of regulatory limitations prior to use.
2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
ASTM Standards
D996 Terminology of Packaging and Distribution Environments
F1327 Terminology Relating to Barrier Materials for Medical Packaging
Keywords
carbon dioxide (CO 2 ) leak testing; flexible packaging; infrared CO 2 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 Code
ICS Number Code 11.020 (Medical sciences and health care facilities in general); 19.100 (Non-destructive testing)
DOI: 10.1520/F2227-02R07
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