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PARTNERS:
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Institute of Packaging Professionals
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Herndon, VA 20170
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FDA Consensus Standards
The table below lists the medical device packaging standards recognized by the FDA. For a complete list of all standards recognized by the FDA, visit their site at www.fda.gov . Enter "consensus standards" into their search engine and follow the links to their standards database.
FDA RECOGNIZED CONSENSUS STANDARDS
Title of Standard Standard Number Standards Organization
|
Standard Test Method for Determination of Leaks in Flexible Packaging by Bubble Emission |
D3078:1994 |
ASTM |
|
Standard Practice for Performance Testing of Shipping Containers and Systems |
D4169:1999 |
ASTM
|
|
Standard Test Method for Seal Strength of Flexible Barrier Materials |
F88:1999 |
ASTM |
|
Standard Terminology Relating to Barrier Materials for Medical Packaging |
F1327:1998 |
ASTM |
|
Standard Test Method for Determining Integrity of Seals for Medical Packaging by Dye Penetration |
F1929:1998 |
ASTM |
|
Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages for Medical Applications |
F1140:2000 |
ASTM |
|
Standard Guide for Integrity Testing of Porous Barrier Medical Packages |
F1585:2000 |
ASTM |
|
Standard Test Method for Microbial Ranking Porous Packaging Materials (Exposure Chamber Method) |
F1608:2000 |
ASTM |
|
Standard Guide for Accelerated Aging of Sterile Medical Device Packages |
F1980:2002 |
ASTM |
FDA RECOGNIZED CONSENSUS STANDARDS (CONTINUED)
Title of Standard Standard Number Standards Organization
|
Standard Test Method for Burst Testing of Flexible Package Seals Using Internal Air Pressurization Within Restraining Plates |
F2054-00 |
ASTM |
|
Standard Test Methods for Pressure Decay Leak Test for Nonporous Flexible Packages With and Without Restraining Plates |
F2095-01 |
ASTM |
|
Standard Test Method for Detecting Gross Leaks in Porous Medical Packaging by Internal Pressurization (Bubble Test) |
F2096-01 |
ASTM |
|
Standard Guide for Design and Evaluation of Primary Packaging for Medical Products |
F2097-01 |
ASTM |
|
Packaging for terminally sterilized medical devices |
ANSI/AAMI/ISO 11607-97 |
ANSI/AAMI/ISO |
