Standard Test Method for Determining Integrity of Seals for Medical Packaging by Visual Inspection
|Publication Date:||10 July 1998|
|ICS Code (Packaging materials and accessories):||55.040|
1.1 This test method covers the determination of channels in the package seal down to a width of 75 μm (0.003 in.) with a 60 - 100 % probability (see Section 8).
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.
1.2 This test method is applicable to flexible and rigid packages with at least one transparent side so that the seal area may be clearly viewed.
1.3 The values stated in SI units are to be regarded as the standard. The values given in parentheses are for information only.
1.4 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.