Testing Standard:
Standard Number
ASTM F1929
Standard Title
Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
Overview for ASTM F1929:
Rationale for ASTM F1929:
Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration. Its intended use is to observe the presence of channel defects that may allow harmful biological or particulate contaminants to enter. Leaks are frequently found at seals between package components of the same or dissimilar materials. ASTM F1929 is usually conducted during the manufacturing process and at various stages of the package’s life cycle.
Key Points:
- Comprised of three applications including injection, edge dip, and eyedropper
- Detects seal defects in medical packaging greater than or equal to 50 μm
- Use ISO 11607-1 with this test standard to set validation standards
Related Standards:
- ASTM D4332 – Practice for Conditioning Containers, Packages, or Packaging Components for Testing
- ASTM F2096 – Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test)
- ISO 11607-1 – Packaging for Terminally Sterilized Medical Devices – Part 1: Requirements for Materials, Sterile Barrier Systems and Packaging Systems
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Related Testing Standards
- ASTM D642
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- ASTM D880
- ASTM D951
- ASTM D999
- ASTM D3078
- ASTM D3103
- ASTM D3285
- ASTM D4169
- ASTM D4332
- ASTM D4728
- ASTM D5265
- ASTM D5276
- ASTM D5277
- ASTM D5487
- ASTM D6055
- ASTM D6179
- ASTM D6344
- ASTM D6653
- ASTM D7386
- ASTM F88
- ASTM F1140
- ASTM F1886
- ASTM F1929
- ASTM F1980
- ASTM F2096
- ASTM F2250
- ASTM F3039
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 The APASS program was designed by Amazon to help support vendors, sellers, and manufacturers in obtaining certification of their products as Frustration Free Packaging (FFP), Ships in Own Container (SIOC), or Prep-Free Packaging (PFP).
