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ASTM F1980 procedure for accelerated aging is comprised of the following: Select the Q10 value Define the desired shelf life of the package (marketing and product needs, etc.). Define package material properties, seal strength and integrity tests, sample sizes, and acceptance criteria. The ASTM F1980 guide provides documentation for developing accelerated aging protocols to promptly determine the effects, if any at all, due to the passage of time on the sterile integrity of the sterile barrier system (SBS), as defined in ANSI/AAMI/ISO 11607-1:2006, and the physical properties of their component packaging materials. Scope 1.1This guide provides directions for the design and evaluation of primary flexible packages for medical products. 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 D4332 Practice for Conditioning Containers, Packages, or Packaging Components for Testing D4754 Test Method for Two-Sided Liquid Extraction of Plastic Materials Using FDA Migration Cell 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 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.

Reprints and Permissions Permissions to reprint documents can be acquired throughCopyright Clearance Center Visit Copyright Clearance Center . (714) 672-1090 . Not all test methods will be applicable. FDA Medical Device Standards Program at 4.3Product characterization shall include mass or weight, geometry (length and width, height, and shape) and product composition. 1.2This guide provides a compendium of test methods, practices, and procedures. ..

Evaluate package, or package performance, or both, after real time aging relative to the initial package requirements. Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products. ASTM-F1980 MPT About Us FAQ Standards ISO ISO-11607 ASTM-D ASTM-D3078 ASTM-D4169 ASTM-D4728 ASTM-D5276 ASTM-D642 ASTM-D999 ASTM-D6653 ASTM-D6344 ASTM-F ASTM-F1140 ASTM-F1929 ASTM-F1980 ASTM-F1866 ASTM-F88 ASTM-F2096 ISTA ISTA 1A ISTA 2A ISTA 3A ISTA 1G Services Accelerated Aging Package Testing Real Time Aging Distribution Simulation Package Design Primary Packaging Secondary Packaging Price Guarantee Request for Quote Contact Us ASTM-F1980Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices The introduction of new or modified products to the marketplace requires the assurance that they can be stored for an extended period (one year, two years, etc.) without any decrease in performance that may affect safety and efficacy when the products are used. Define aging test time intervals (including time zero). All rights reserved. 1. (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 Packaging Trays by CO2 Tracer Gas Method F2228 Test Method for Non-Destructive Detection of Leaks in 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 F2622 Test Method for Oxygen Gas Transmission Rate Through Plastic Film and Sheeting Using Various Sensors F2638 Test Method for Using Aerosol Filtration for Measuring the Performance of Porous Packaging Materials as a Surrogate Microbial Barrier F2714 Test Method for Oxygen Headspace Analysis of Packages Using Fluorescent Decay F2824 Test Method for Mechanical Seal Strength Testing for Round Cups and Bowl Containers with Flexible Peelable Lids F2825 Practice for Climatic Stressing of Packaging Systems for Single Parcel Delivery F3004 Test Method for Evaluation of Seal Quality and Integrity Using Airborne Ultrasound F3039 Test Method for Detecting Leaks in Nonporous Packaging or Flexible Barrier Materials by Dye Penetration EN/ISO Standards EN 868/1 Annex C Gurley, Schopper, Dye Penetration ISO 10993 Biological Evaluation of Medical Devices ISO11607–1 Packaging for Terminally Sterilized Medical Devices, Annex C ISO15105–1 Plastics--Film and Sheeting--Determination of Gas Transmission Rate--Part 1: Differential-Pressure Method ISO15105–2 Plastics--Film and Sheeting--Determination of Gas Transmission Rate--Part 2: Equal-Pressure Method ISO2556 Plastics--Determination of Gas Transmission Rate of Films and Thin Sheets Under Atmospheric Pressure--Manometric Method ISO 5636–5 Paper and Board--Determination of Air Permeance (Medium Range)--Part 5: Gurley Method Military Specification Mil Spec 36954C Bacterial Filtration Efficiency TAPPI Standards TAPPI T 404 Tensile Breaking Strength and Elongation of Paper and Paperboard TAPPI T 460 Air Resistance of Paper (Gurley Method) TAPPI T 494 Tensile Breaking Properties of Paper and Paperboard (Using Constant Rate of Elongation Apparatus) TAPPI T 536 Resistance of Paper to Passage of Air (High Pressure Gurley Method) TAPPI T 547 Air Permeance of Paper and Paperboard (Sheffield Method) ICS Code ICS Number Code 11.020 (Medical sciences and health care facilities in general); 55.020 (Packaging and distibution of goods in general) UNSPSC Code UNSPSC Code 24120000(Packaging materials) Referencing This Standard Link Here Link to Active (This link will always route to the current Active version of the standard.) DOI: 10.1520/F2097-16 ASTM International is a member of CrossRef. 6c2930289c

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