ASTM F2097-14
Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products

Standard No.
ASTM F2097-14
Release Date
2014
Published By
American Society for Testing and Materials (ASTM)
Status
Replace By
ASTM F2097-16
Latest
ASTM F2097-23
Scope

4.1 This design and evaluation guide describes multiple categories for evaluating flexible medical packages and packaging materials. These include safety, barrier properties, durability, package and seal integrity, visibility and appearance, processing, printing ink properties, and package performance.

4.2 The intent of this design and evaluation guide is to evaluate all cited categories and select those that are applicable. Once the product has been characterized and the sterilization methodology has been defined, there are numerous sets of requirements for any specific package. This design and evaluation guide provides an avenue for assessing these requirements and choosing test methods for both evaluating the package design and monitoring package compliance.

Note 1—Many of the standards included in this guide are consensus standards that are recognized by the United States Food and Drug Administration (FDA). Selection and use of a U.S. FDA recognized consensus standard is voluntary and the sole responsibility of the user in determining its applicability. For further information, consult the U.S. FDA Medical Device Standards Program at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/default.htm.

4.3 Product characterization shall include mass or weight, geometry (length and width, height, and shape) and product composition.

4.4  All categories must be considered for applicability.

4.5 The Summary of Test Methods for Medical Packaging Design and Evaluation (Fig. 1) provides a compact graphical presentation of the test methods referenced in this guide.

Summary of Test Methods for Medical Packaging DesignxA;and EvaluationSummary of Test Methods for Medical Packaging DesignxA;and Evaluation
FIG. 1 Summary of Test Methods for Medical Packaging Design and Evaluation
Summary of Test Methods for Medical Packaging DesignxA;and EvaluationSummary of Test Methods for Medical Packaging DesignxA;and Evaluation
FIG. 1 Summary of Test Methods for Medical Packaging Design and Evaluation (continued)

4.6 Test Description and Applicability (see Table 1):

4.6.1 Table 1 lists the test methods commonly used to evaluate flexible medical packaging. The test methods are used in two phases.

4.6.1.1 Package Design: Characterization of the Materials and Evaluation of the Resultant Package—This is referred to as “Ramp;D Evaluation” in Table 1. Testing during this phase is characterized by the generation of quantitative data on the performance of the component materials and the package assembly. These te......