Tiêu chuẩn quốc tế
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Số hiệu
Standard Number
ASTM F2096-04
Năm ban hành 2004
Publication date
Tình trạng
W - Hết hiệu lực
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Tên tiếng Anh
Title in English Standard Test Method for Detecting Gross Leaks in Medical Packaging by Internal Pressurization (Bubble Test)
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Chỉ số phân loại Quốc tế (ICS)
By field |
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Số trang
Page 5
Giá:
Price Liên hệ / Contact us
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Phạm vi áp dụng
Scope of standard 1.1 This test method covers the detection of gross leaks in medical packaging. Method sensitivity is down to 250 µm with an 81 % probability (see Section 11). This test method may be used for tray and pouch packages.1.2 The sensitivity of this test method has not been evaluated for use with porous materials other than spunbonded polyolefin or with nonporous packaging.1.3 This test method is destructive in that it requires entry into the package to supply an internal air pressure1.4 The values stated in SI units are to be regarded as the standard. The values given in parentheses are for information only.1.5 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.
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