Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products

Importancia y uso:

4.1 This design and evaluation guide describes multiple categories for evaluating flexible medical packages and packaging materials. These include safety, barrier, material and package performance attributes and characteristics, package integrity, visibility and appearance, processing, printed ink, distribution simulation, and conditioning.

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 (see Note 2) 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 Standards and Conformity Assessment Program at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatoryassistance/standards-and-conformity-assessment-program

Note 2: Requirements and acceptance criteria are not defined in this guide. Requirements may be derived from applicable standards and regulations, the product contained in the package or applied to the packaging design by the user of this guide.

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.

ASTM F1980

R&D Evaluation

This is a guide to the selection of time and temperature conditions for accelerated aging of medical packaging.

Accelerated aging is frequently used in the early development of medical packaging. Failures often occur due to the selection of aging conditions outside of the material's operational capability. This guide is an aid in selecting appropriate test conditions.

Subcomité:

F02.50

Referida por:

F0392_F0392M-23, F1980-21, F0099-21, F2559_F2559M-21, D8233-19, F1980-21, F1980-21, F2902-24, F3263-17R25

Volúmen:

15.10

Número ICS:

11.020 (Medical sciences and health care facilities in general), 55.020 (Packaging and distibution of goods in general)

Palabras clave:

compliance testing; R&D evaluation; test method selection;