1. Scope

1.1 This guide provides directions for the design and evaluation of primary flexible packages for medical products. The package materials must be selected appropriately for manufacturing process, end use, and the product being packaged.

1.2 This guide provides a compendium of test methods. Specific individual test methods must be selected based on the pertinent characteristics of the specific product to be packaged and the purpose for testing, research and development, or compliance. Not all test methods will be applicable.

1.3 This guide does not address acceptability criteria, which need to be determined jointly by the package producer and the medical products manufacturer.

1.4 This guide does not assess the product to be packaged; the sterilization method to be used; or package performance through sterilization, distribution, and handling.

1.5 The values stated in SI units are to be regarded as standard. The values given in parentheses are mathematical conversions to inch-pound units that are provided for information only and are not considered standard.

2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.

ASTM Standards

D374 Test Methods for Thickness of Solid Electrical Insulation

D589 Test Method for Opacity of Paper (15 Diffuse Illuminant A, 89 % Reflectance Backing and Paper Backing)

D638 Test Method for Tensile Properties of Plastics

D645/D645M Test Method for Thickness of Paper and Paperboard

D726 Test Method for Resistance of Nonporous Paper to Passage of Air

D882 Test Method for Tensile Properties of Thin Plastic Sheeting

D1003 Test Method for Haze and Luminous Transmittance of Transparent Plastics

D1434 Test Method for Determining Gas Permeability Characteristics of Plastic Film and Sheeting

D1709 Test Methods for Impact Resistance of Plastic Film by the Free-Falling Dart Method

D1777 Test Method for Thickness of Textile Materials

D1894 Test Method for Static and Kinetic Coefficients of Friction of Plastic Film and Sheeting

D1922 Test Method for Propagation Tear Resistance of Plastic Film and Thin Sheeting by Pendulum Method

D1938 Test Method for Tear-Propagation Resistance (Trouser Tear) of Plastic Film and Thin Sheeting by a Single-Tear Method

D2019 Test Method for Dirt in Paper and Paperboard

D2457 Test Method for Specular Gloss of Plastic Films and Solid Plastics

D3078 Test Method for Determination of Leaks in Flexible Packaging by Bubble Emission

D3079 Test Method for Water Vapor Transmission of Flexible Heat-Sealed Packages for Dry Products

D3335 Test Method for Low Concentrations of Lead, Cadmium, and Cobalt in Paint by Atomic Absorption Spectroscopy

D3420 Test Method for Pendulum Impact Resistance of Plastic Film

D3718 Test Method for Low Concentrations of Chromium in Paint by Atomic Absorption Spectroscopy

D3776 Test Methods for Mass Per Unit Area (Weight) of Fabric

D3985 Test Method for Oxygen Gas Transmission Rate Through Plastic Film and Sheeting Using a Coulometric Sensor

D4169 Practice for Performance Testing of Shipping Containers and Systems

D4279 Test Methods for Water Vapor Transmission of Shipping Containers--Constant and Cycle Methods

D4321 Test Method for Package Yield of Plastic Film

D4754 Test Method for Two-Sided Liquid Extraction of Plastic Materials Using FDA Migration Cell

D5264 Practice for Abrasion Resistance of Printed Materials by the Sutherland Rub Tester

D7386 Practice for Performance Testing of Packages for Single Parcel Delivery Systems

E398 Test Method for Water Vapor Transmission Rate of Sheet Materials Using Dynamic Relative Humidity Measurement

F17 Terminology Relating to Flexible Barrier Packaging

F88 Test Method for Seal Strength of Flexible Barrier Materials

F99 Guide for Writing a Specification for Flexible Barrier Rollstock Materials

F151 Test Method for Residual Solvents in Flexible Barrier Materials

F372 Test Method for Water Vapor Transmission Rate of Flexible Barrier Materials Using an Infrared Detection Technique

F392 Test Method for Flex Durability of Flexible Barrier Materials

F748 Practice for Selecting Generic Biological Test Methods for Materials and Devices

F813 Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices

F895 Test Method for Agar Diffusion Cell Culture Screening for Cytotoxicity

F904 Test Method for Comparison of Bond Strength or Ply Adhesion of Similar Laminates Made from Flexible Materials

F1140 Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages

F1249 Test Method for Water Vapor Transmission Rate Through Plastic Film and Sheeting Using a Modulated Infrared Sensor

F1306 Test Method for Slow Rate Penetration Resistance of Flexible Barrier Films and Laminates

F1307 Test Method for Oxygen Transmission Rate Through Dry Packages Using a Coulometric Sensor

F1443 Practice for Using 0.008-in. (0.203-mm) Aperture Reflectometers as Test Instruments for Measuring Visual Image Quality of Business Copy Images

F1608 Test Method for Microbial Ranking of Porous Packaging Materials (Exposure Chamber Method)

F1884 Test Methods for Determining Residual Solvents in Packaging Materials

F1886 Test Method for Determining Integrity of Seals for Medical Packaging by Visual Inspection

F1921 Test Methods for Hot Seal Strength (Hot Tack) of Thermoplastic Polymers and Blends Comprising the Sealing Surfaces of Flexible Webs

F1927 Test Method for Determination of Oxygen Gas Transmission Rate, Permeability and Permeance at Controlled Relative Humidity Through Barrier Materials Using a Coulometric Detector

F1929 Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration

F1980 Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices

F2029 Practices for Making Heatseals for Determination of Heatsealability of Flexible Webs as Measured by Seal Strength

F2054 Test Method for Burst Testing of Flexible Package Seals Using Internal Air Pressurization Within Restraining Plates

F2095 Test Methods for Pressure Decay Leak Test for Flexible Packages With and Without Restraining Plates

F2096 Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test)

F2203 Test Method for Linear Measurement Using Precision Steel Rule

F2217 Practice for Coating/Adhesive Weight Determination

F2227 Test Method for Non-Destructive Detection of Leaks in Non-sealed and Empty Medical Packaging Trays by CO2 Tracer Gas Method

F2228 Test Method for Non-Destructive Detection of Leaks in Medical Packaging Which Incorporates Porous Barrier Material by CO2 Tracer Gas Method

F2250 Practice for Evaluation of Chemical Resistance of Printed Inks and Coatings on Flexible Packaging Materials

F2251 Test Method for Thickness Measurement of Flexible Packaging Material

F2252 Practice for Evaluating Ink or Coating Adhesion to Flexible Packaging Materials Using Tape

F2338 Test Method for Nondestructive Detection of Leaks in Packages by Vacuum Decay Method

F2391 Test Method for Measuring Package and Seal Integrity Using Helium as the Tracer Gas

F2475 Guide for Biocompatibility Evaluation of Medical Device Packaging Materials

F2476 Test Method for the Determination of Carbon Dioxide Gas Transmission Rate (Co2TR) Through Barrier Materials Using An Infrared Detector

F2559 Guide for Writing a Specification for Sterilizable Peel Pouches

F2638 Test Method for Using Aerosol Filtration for Measuring the Performance of Porous Packaging Materials as a Surrogate Microbial Barrier

EN/ISO Standards

Military Specification

TAPPI Standards

Keywords

Design; Flexible packaging materials; Medical/surgical packaging materials ;

ICS Code

ICS Number Code 11.020 (Medical sciences and health care facilities in general); 55.020 (Packaging and distibution of goods in general)

DOI: 10.1520/F2097-08

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