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FDA Consensus Standards

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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

 

 

 

 

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