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ASTM F2097-05

(Guide)

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

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

SCOPE
1.1 This guide provides directions for the design and evaluation of primary 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.

General Information

Status
Historical
Publication Date
31-Mar-2005
ICS
11.020 - Medical sciences and health care facilities in general
55.020 - Packaging and distribution of goods in general
Technical Committee
F02 - Primary Barrier Packaging
Drafting Committee
F02.50 - Package Design and Development
Current Stage
Ref Project

Relations

Replaces
ASTM F2097-01 - Standard Guide for Design and Evaluation of Primary Packaging for Medical Products
Effective Date
01-Apr-2005
Replaced By
ASTM F2097-07 - Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products
Effective Date
01-May-2007
Referred By
ASTM F99-21 - Standard Guide for Writing a Specification for Flexible Barrier Rollstock Materials
Effective Date
01-Apr-2005
Referred By
ASTM F3263-17 - Standard Guide for Packaging Test Method Validation
Effective Date
01-Apr-2005
Referred By
ASTM F2559/F2559M-21 - Standard Guide for Writing a Specification for Sterilizable Peel Pouches
Effective Date
01-Apr-2005
Referred By
ASTM F2902-16e1 - Standard Guide for Assessment of Absorbable Polymeric Implants
Effective Date
01-Apr-2005
Referred By
ASTM F392/F392M-21 - Standard Practice for Conditioning Flexible Barrier Materials for Flex Durability
Effective Date
01-Apr-2005
Referred By
ASTM F1980-21 - Standard Guide for Accelerated Aging of Sterile Barrier Systems and Medical Devices
Effective Date
01-Apr-2005
Referred By
ASTM D8233-19 - Standard Guide for Packaging and Labeling of Consumer Resin Cannabis Products for Sale to Adult Consumers, Legally Authorized Medical Users, and Caregivers in a Business-to-Consumer Retail Environment (Retailers)
Effective Date
01-Apr-2005

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ASTM F2097-05 - Standard Guide for Design and Evaluation of Primary Packaging for Medical Products
English language
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Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation:F2097–05
Standard Guide for
Design and Evaluation of Primary Packaging for Medical
1
Products
This standard is issued under the fixed designation F 2097; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (e) indicates an editorial change since the last revision or reapproval.
1. Scope D 1894 Test Method for Static and Kinetic Coefficients of
Friction of Plastic Film and Sheeting
1.1 This guide provides directions for the design and evalu-
D 1922 Test Method for Propagation Tear Resistance of
ation of primary packages for medical products. The package
Plastic Film and Thin Sheeting by Pendulum Method
materials must be selected appropriately for manufacturing
D 1938 Test Method for Tear-Propagation Resistance
process, end use, and the product being packaged.
(Trouser Tear) of Plastic Film and Thin Sheeting by a
1.2 This guide provides a compendium of test methods.
Single-Tear Method
Specific individual test methods must be selected based on the
D 2019 Test Method for Dirt in Paper and Paperboard
pertinent characteristics of the specific product to be packaged
D 2457 TestMethodforSpecularGlossofPlasticFilmsand
and the purpose for testing, research and development, or
Solid Plastics
compliance. Not all test methods will be applicable.
D 3078 Test Method for Determination of Leaks in Flexible
1.3 This guide does not address acceptability criteria, which
Packaging by Bubble Emission
need to be determined jointly by the package producer and the
D 3335 Test Method for Low Concentrations of Lead,
medical products manufacturer.
Cadmium, and Cobalt in Paint by Atomic Absorption Spec-
1.4 This guide does not assess the product to be packaged;
troscopy
the sterilization method to be used; or package performance
D 3420 Test Method for Pendulum Impact Resistance of
through sterilization, distribution, and handling.
Plastic Film
2. Referenced Documents D 3718 Test Method for Low Concentrations of Chromium
2
in Paint by Atomic Absorption Spectroscopy
2.1 ASTM Standards:
D 3776 Test Method for Mass Per Unit Area (Weight) of
D 374 Test Methods for Thickness of Solid Electrical Insu-
Fabric
lation
D 3985 Test Method for Oxygen Gas Transmission Rate
D 589 Test Method for Opacity of Paper (15° Diffuse
Through Plastic Film and Sheeting Using a Coulometric
IlluminantA,89 %ReflectanceBackingandPaperBacking)
Sensor
D 645/D 645M Test Method for Thickness of Paper and
D 4279 Test Methods for Water Vapor Transmission of
Paperboard
Shipping Containers—Constant and Cycle Methods
D 726 Test Method for Resistance of Nonporous Paper to
D 4321 Test Method for Package Yield of Plastic Film
Passage of Air
D 4754 Test Method for Two-Sided Liquid Extraction of
D 882 Test Method for Tensile Properties of Thin Plastic
Plastic Materials Using FDA Migration Cell
Sheeting
D 5264 Practice forAbrasion Resistance of Printed Materi-
D 1003 Test Method for Haze and Luminous Transmittance
als by the Sutherland Rub Tester
of Transparent Plastics
F88 Test Method for Seal Strength of Flexible Barrier
D 1709 Test Methods for Impact Resistance of Plastic Film
Materials
by the Free-Falling Dart Method
F 151 TestMethodforResidualSolventsinFlexibleBarrier
D 1777 Test Method for Thickness of Textile Materials
3
Materials
F 372 Test Method for Water Vapor Transmission Rate of
Flexible Barrier Materials Using an Infrared Detection
1
This guide is under the jurisdiction of ASTM Committee F02 on Flexible
Technique
Barrier Materials and is the direct responsibility of Subcommittee F02.50 on
Package Design and Development.
F 392 Test Method for Flex Durability of Flexible Barrier
Current edition approved April 1, 2005. Published June 2005. Originally
Materials
approved in 2001. Last previous edition approved in 2001 as F 2097 – 01.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Standards volume information, refer to the standard’s Document Summary page on
3
the ASTM website. Withdrawn.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
1

---------------------- Page: 1 ----------------------
F2097–05
4
F 748 Practice for Selecting Generic Biological Test Meth- 2.2 EN/ISO Standards:
ods for Materials and Devices EN 868/1 Annex C Gurley, Schopper, Dye Penetration
ISO 5636/5
F 813 PracticeforDirectContactCellCultureEvaluationof
Materials for Medical Devices ISO 11607 Annex A Gurley
5
2.3 Military Specification:
F 895 Test Method forAgar Diffusion Cell Culture Screen-
Mil Spec 36954C Bacterial Filtration Efficiency
ing for Cytotoxicity
6
2.4 TAPPI Standards:
F 904
...

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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.  
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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.  
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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.
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5.1 This test method can be used to determine whether the amount of draindown measured for a given asphalt mixture is within specified acceptable levels. The test provides an evaluation of the draindown potential of an asphalt mixture during mixture design and/or during field production. This test is primarily used for mixtures with high coarse aggregate content such as porous asphalt (open-graded friction course) and stone matrix asphalt (SMA).
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1.1 This test method covers the determination of the amount of draindown in an uncompacted asphalt mixture sample when the sample is held at elevated temperatures comparable to those encountered during the production, storage, transport, and placement of the mixture. The test is particularly applicable to mixtures such as porous asphalt (open-graded friction course) and stone matrix asphalt (SMA).  
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1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
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This specification covers UNS N06002, UNS N06030, UNS N06035, UNS N06022, UNS N06200, UNS N06230, UNS N06600, UNS N06617, UNS N06625, UNS N08020, UNS N08026, UNS N08024, UNS N08120, UNS N08926, UNS N08367, UNS N10242, UNS N10276, UNS N10665, UNS N10675, UNS N12160, UNS R20033, UNS N06059, UNS N06686, UNS N10629, UNS N08031, UNS N06045, UNS N06025, and UNS R30556 nickel alloy billets and bars for reforging. The products shall be hot worked from ingots by rolling, forging, extruding, hammering, or pressing. The material shall conform to the chemical composition requirements prescribed by the reference material. The chemical composition of the material shall be determined by chemical analysis in accordance with test method E1473.
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1.1 This specification covers UNS N06002, UNS N06030, UNS N06035, UNS N06022, UNS N06200, UNS N10362, UNS N06230, UNS N06600, UNS N06617, UNS N06625, UNS N08020, UNS N08026, UNS N08024, UNS N08120, UNS N08926, UNS N08367, UNS N10242, UNS N10276, UNS N10665, UNS N10675, UNS N12160, UNS R20033, UNS N06059, UNS N06686, UNS N10629, UNS N08031, UNS N06045, UNS N06025, UNS N06699, and UNS R305562 billets and bars for reforging.  
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