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ASTM-F1886:2004 Edition

ASTM-F1886:2004 Edition

$35.75

F1886-98(2004) Standard Test Method for Determining Integrity of Seals for Medical Packaging by Visual Inspection

Published By Publication Date Number of Pages
ASTM 2004 4
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ASTM F1886-98-Reapproved2004

Historical Standard: Standard Test Method for Determining Integrity of Seals for Medical Packaging by Visual Inspection

ASTM F1886

Scope

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.

Keywords

channels; medical packaging; minimum seal width; spotty seals; sterile package integrity; visual seal inspection

ICS Code

ICS Number Code 55.040 (Packaging materials and accessories)

DOI: 10.1520/F1886-98R04

PDF Catalog

PDF Pages PDF Title
1 Scope
Referenced Documents
Terminology
Summary of Test Method
Significance and Use
Apparatus
Procedure
2 Precision and Bias
Keywords
TABLE 1
TABLE 2
TABLE 3
TABLE 4
3 X1. VISUAL SEAL APPEARANCE CHARACTERISTICS AND PROBABLE CAUSES
X1.1
X1.2 Unsealed Areas
X1.3 Nonhomogeneous or Undersealed Areas
X1.4 Oversealed Areas
X1.5 Narrow Seals
X1.6 Channels
X1.7 Wrinkles/Foldovers/Cracks
X1.8 Tears/Pinholes

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