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ASTM F1886/F1886M-2009

用目测法测定医用包装密封完整性的试验方法

Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection

适用范围:<p>Seal attributes can be linked directly to a number of variables in process parameters, equipment, or material, as well as environmental (room temperature and relative humidity). Visual seal characteristics and defects can provide evidence of package integrity and production sealing problems.</p> <p>Visual seal defects often will be the first indication of heat sealing process variation. They also will indicate a lack of, or potential compromise to, package integrity after physical package performance testing. </p><p id="s00002">1.1 This test method covers the determination of channels in the package seal down to a width of 75 <span class=''unicode''>x03BC;</span>m [0.003 in.] with a 60<span class=''unicode''>x2013;</span>100 % probability (see Section 8).</p> <p id="s00003">1.1.1 The ability to visually detect channel defects in package seals is highly dependent on the size of channel, the degree of contrast from sealed and unsealed areas, the amount and type of adhesive between the two package layers, reflecting light angle, types of material used, the use of magnification, and the inspector''s level of training and experience. </p> <p id="s00004">1.2 This test method is applicable to packages with at least one transparent side so that the seal area may be clearly viewed.</p> <p id="s00005">1.3 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in non-conformance with the standard.</p> <p id="s00006">1.4 <span class="italic">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.</span>

实施日期: 2009-10-01

中标分类号: A82 - 综合 - 包装材料与容器

ICS分类号: 55.040 - 货物的包装和调运 - 包装材料和辅助物

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: channels minimum seal width spotty seals sterile package integrity visual seal inspection Integrity testing Medical/surgical packaging materials Sealing/securing packages/containers Seal integrity Sterile medical device packages

语种: 汉语

页数: 4

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