ASTM F 2097 : 2016 : REDLINE
Superseded
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products
Available format(s)
PDF
Superseded date
18-09-2020
Superseded by
Language(s)
English
Published date
01-04-2016
Important note : Users cannot be edited or removed once added to your Multi user PDF.CONTAINED IN VOL. 15.09, 2016 Gives directions for the design and evaluation of primary flexible packages for medical products.
| Committee |
F 02
|
| DocumentType |
Redline
|
| Pages |
19
|
| PublisherName |
American Society for Testing and Materials
|
| Status |
Superseded
|
| SupersededBy |
1.1This 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.
1.2This guide provides a compendium of test methods, practices, and procedures. 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.
1.3This guide does not address acceptability criteria, which need to be determined jointly by the package producer and the medical products manufacturer.
1.4This guide does not assess the product to be packaged or the sterilization method to be used.
1.5The units cited in the referenced standard should be used.
| ASTM F 3263 : 2017 | Standard Guide for Packaging Test Method Validation |
| CAN/CSA-ISO/TS 16775:17 | Packaging for terminally sterilized medical devices — Guidance on the application of ISO 11607-1 and ISO 11607-2 (Adopted ISO technical specification 16775:2014, first edition, 2014-05-15) |
| S.R. CEN ISO/TS 16775:2014 | PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - GUIDANCE ON THE APPLICATION OF ISO 11607-1 AND ISO 11607-2 (ISO/TS 16775:2014) |
| ASTM F 2559/F2559M : 2006 : R2010 : EDT 1 | Standard Guide for Writing a Specification for Sterilizable Peel Pouches |
| ASTM F 392/F392M : 2011 | Standard Practice for Conditioning Flexible Barrier Materials for Flex Durability |
| CEN ISO/TS 16775:2014 | Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2 (ISO/TS 16775:2014) |
| PD CEN ISO/TS 16775:2014 | Packaging for terminally sterilized medical devices. Guidance on the application of ISO 11607-1 and ISO 11607-2 |
| ASTM F 2559/F2559M : 2006 : R2015 | Standard Guide for Writing a Specification for Sterilizable Peel Pouches |
| ASTM F 99 : 2007 | Standard Guide for Writing a Specification for Flexible Barrier Rollstock Materials |
| ASTM F 99 : 2007 : R2011 | Standard Guide for Writing a Specification for Flexible Barrier Rollstock Materials |
| ASTM F 99 : 2007 : R2015 | Standard Guide for Writing a Specification for Flexible Barrier Rollstock Materials |
| ANSI/AAMI/ISO TIR16775:2014 | PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - GUIDANCE ON THE APPLICATION OF ISO 11607-1 AND ISO 11607-2 |
| ISO/TS 16775:2014 | Packaging for terminally sterilized medical devices Guidance on the application of ISO 11607-1 and ISO 11607-2 |
| UNI CEN ISO/TS 16775 : 2014 | PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - GUIDANCE ON THE APPLICATION OF ISO 11607-1 AND ISO 11607-2 |
| ASTM F 392/F392M : 2011 : R2015 | Standard Practice for Conditioning Flexible Barrier Materials for Flex Durability |
| ASTM F 1980 : 2016 : REDLINE | Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices |
| ASTM F 2559 : 2006 | Standard Guide for Writing a Specification for Sterilizable Peel Pouches |
| TAPPI T 547 : 2012 | AIR PERMEANCE OF PAPER AND PAPERBOARD (SHEFFIELD METHOD) |
| ASTM F 2228 : 2013 : REDLINE | Standard Test Method for Non-Destructive Detection of Leaks in Packaging Which Incorporates Porous Barrier Material by CO<sub>2</sub> Tracer Gas Method |
| ASTM F 1927 : 2014 : REDLINE | Standard Test Method for Determination of Oxygen Gas Transmission Rate, Permeability and Permeance at Controlled Relative Humidity Through Barrier Materials Using a Coulometric Detector |
| ASTM D 2019 : 1997 | Standard Test Method for Dirt in Paper and Paperboard |
| ASTM D 1894 : 2014 : REDLINE | Standard Test Method for Static and Kinetic Coefficients of Friction of Plastic Film and Sheeting |
| ISTA 3E : 2017 | SIMILAR PACKAGED-PRODUCTS IN UNITIZED LOADS FOR TRUCKLOAD SHIPMENT |
| ASTM D 4169 : 2016 : REDLINE | Standard Practice for Performance Testing of Shipping Containers and Systems |
| ASTM D 3420 : 2014 : REDLINE | Standard Test Method for Pendulum Impact Resistance of Plastic Film |
| ASTM F 2559 : 2006 | Standard Guide for Writing a Specification for Sterilizable Peel Pouches |
| TAPPI T 404 : 1992 | TENSILE BREAKING STRENGTH AND ELONGATION OF PAPER AND PAPERBOARD (USING PENDULUM-TYPE TESTER) |
| TAPPI T 460 : 2011 | AIR RESISTANCE OF PAPER (GURLEY METHOD) |
| ASTM F 3136 : 2015 | Standard Test Method for Oxygen Gas Transmission Rate through Plastic Film and Sheeting using a Dynamic Accumulation Method |
| ASTM F 2475 : 2011 : REDLINE | Standard Guide for Biocompatibility Evaluation of Medical Device Packaging Materials |
| ISO 2556:1974 | Plastics Determination of the gas transmission rate of films and thin sheets under atmospheric pressure Manometric method |
| ASTM F 1443 : 1993 | Standard Test Methods for Equipment and Procedures Used in Evaluating the Performance Characteristics of Protective Headgear |
| EN 868-1 : 1997 | PACKAGING MATERIALS AND SYSTEMS FOR MEDICAL DEVICES WHICH ARE TO BE STERILIZED - GENERAL REQUIREMENTS AND TEST METHODS |
| ASTM F 2227 : 2013 : REDLINE | Standard Test Method for Non-Destructive Detection of Leaks in Non-sealed and Empty Packaging Trays by CO<sub>2</sub> Tracer Gas Method |
| ASTM F 2029 : 2016 : REDLINE | Standard Practices for Making Laboratory Heat Seals for Determination of Heat Sealability of Flexible Barrier Materials as Measured by Seal Strength |
| ASTM D 4321 : 2015 : REDLINE | Standard Test Method for Package Yield of Plastic Film (Withdrawn 2024) |
| ASTM F 1307 : 2014 : REDLINE | Standard Test Method for Oxygen Transmission Rate Through Dry Packages Using a Coulometric Sensor |
| ASTM D 7386 : 2016 : REDLINE | Standard Practice for Performance Testing of Packages for Single Parcel Delivery Systems |
| ASTM D 4279 : 1995 | Standard Test Methods for Water Vapor Transmission of Shipping Containers-Constant and Cycle Methods |
| ASTM F 2981 : 2015 | Standard Test Method for Verifying Nonporous Flexible Barrier Material Resistance to the Passage of Air |
| ASTM F 2096 : 2011 | Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test) |
| MIL-M-36954 Revision C:1975 | MASK, SURGICAL, DISPOSABLE |
| ASTM D 2457 : 2013 : REDLINE | Standard Test Method for Specular Gloss of Plastic Films and Solid Plastics |
| ISO 15105-1:2007 | Plastics Film and sheeting Determination of gas-transmission rate Part 1: Differential-pressure methods |
| ASTM F 2476 : 2013 : REDLINE | Standard Test Method for the Determination of Carbon Dioxide Gas Transmission Rate (CO<sub>2</sub>TR) Through Barrier Materials Using An Infrared Detector |
| ASTM F 1929 : 2015 : REDLINE | Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration |
| TAPPI T 536 : 2012 | RESISTANCE OF PAPER TO PASSAGE OF AIR (HIGH-PRESSURE GURLEY METHOD) |
| ISO 5636-5:2013 | Paper and board — Determination of air permeance (medium range) — Part 5: Gurley method |
| ASTM F 1608 : 2016 : REDLINE | Standard Test Method for Microbial Ranking of Porous Packaging Materials (Exposure Chamber Method) |
| ISO 15105-2:2003 | Plastics — Film and sheeting — Determination of gas-transmission rate — Part 2: Equal-pressure method |
| ASTM D 1003 : 2013 : REDLINE | Standard Test Method for Haze and Luminous Transmittance of Transparent Plastics |
| ASTM F 748 : 2016 : REDLINE | Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices |
| ASTM F 1886 : 1998 | Standard Test Method for Determining Integrity of Seals for Medical Packaging by Visual Inspection |
| ASTM D 1922 : 2015 : REDLINE | Standard Test Method for Propagation Tear Resistance of Plastic Film and Thin Sheeting by Pendulum Method |
| ASTM F 1980 : 2016 : REDLINE | Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices |
| TAPPI T 494 : 2013 | TENSILE PROPERTIES OF PAPER AND PAPERBOARD (USING CONSTANT RATE OF ELONGATION APPARATUS) |
| ASTM E 398 : 2013 : REDLINE | Standard Test Method for Water Vapor Transmission Rate of Sheet Materials Using Dynamic Relative Humidity Measurement |
| ISO 11607-1:2006 | Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems |
| ASTM D 638 : 2014 : REDLINE | Standard Test Method for Tensile Properties of Plastics |
| ASTM F 1306 : 2016 : REDLINE | Standard Test Method for Slow Rate Penetration Resistance of Flexible Barrier Films and Laminates |
| ASTM F 904 : 2016 : REDLINE | Standard Test Method for Comparison of Bond Strength or Ply Adhesion of Similar Laminates Made from Flexible Materials |
| ASTM F 1249 : 2013 : REDLINE | Standard Test Method for Water Vapor Transmission Rate Through Plastic Film and Sheeting Using a Modulated Infrared Sensor |
| ASTM D 374 : 1999 | Standard Test Methods for Thickness of Solid Electrical Insulation |
| ASTM D 589 : 1997 | Standard Test Method for Opacity of Paper (15°Diffuse Illuminant A, 89% Reflectance Backing and Paper Backing) |
| ASTM F 3039 : 2015 : REDLINE | Standard Test Method for Detecting Leaks in Nonporous Packaging or Flexible Barrier Materials by Dye Penetration |
Access your standards online with a subscription
Features
-
Simple online access to standards, technical information and regulations.
-
Critical updates of standards and customisable alerts and notifications.
-
Multi-user online standards collection: secure, flexible and cost effective.