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ASTM F2097-01

(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
09-Oct-2001
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
Current Stage
Ref Project

Relations

Replaced By
ASTM F2097-05 - Standard Guide for Design and Evaluation of Primary Packaging for Medical Products
Effective Date
01-Apr-2005
Referred By
ASTM F392/F392M-21 - Standard Practice for Conditioning Flexible Barrier Materials for Flex Durability
Effective Date
10-Oct-2001
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
10-Oct-2001
Referred By
ASTM F99-21 - Standard Guide for Writing a Specification for Flexible Barrier Rollstock Materials
Effective Date
10-Oct-2001
Referred By
ASTM F3263-17 - Standard Guide for Packaging Test Method Validation
Effective Date
10-Oct-2001
Referred By
ASTM F2559/F2559M-21 - Standard Guide for Writing a Specification for Sterilizable Peel Pouches
Effective Date
10-Oct-2001
Referred By
ASTM F2902-16e1 - Standard Guide for Assessment of Absorbable Polymeric Implants
Effective Date
10-Oct-2001
Referred By
ASTM F1980-21 - Standard Guide for Accelerated Aging of Sterile Barrier Systems and Medical Devices
Effective Date
10-Oct-2001

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ASTM F2097-01 - 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:F2097–01
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.
5
1. Scope D 1777 Test Method for Thickness of Textile Materials
D 1894 Test Method for Static and Kinetic Coefficients of
1.1 This guide provides directions for the design and evalu-
4
Friction of Plastic Film and Sheeting
ation of primary packages for medical products. The package
D 1922 Test Method for Propagation Tear Resistance of
materials must be selected appropriately for manufacturing
4
Plastic Film and Thin Sheeting by Pendulum Method
process, end use, and the product being packaged.
D 1938 Test Method for Tear Propagation Resistance of
1.2 This guide provides a compendium of test methods.
4
Plastic Film and Thin Sheeting by a Single Tear Method
Specific individual test methods must be selected based on the
3
D 2019 Test Method for Dirt in Paper and Paperboard
pertinent characteristics of the specific product to be packaged
D 2457 Test Method for Specular Gloss of Plastic Film and
and the purpose for testing, research and development, or
6
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
3
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
1.4 This guide does not assess the product to be packaged;
7
Spectroscopy
the sterilization method to be used; or package performance
D 3420 Test Method for Dynamic Ball Burst Pendulum
through sterilization, distribution, and handling.
6
Impact Resistance of Plastic Film
2. Referenced Documents D 3718 Test Method for Low Concentrations of Chromium
7
in Paint by Atomic Absorption Spectroscopy
2.1 ASTM Standards:
D 3776 Test Methods for Mass per Unit Area (Weight) of
D 374 Test Methods for Thickness of Solid Electrical Insu-
8
2
Woven 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 Columetric
Illuminant A, 89 % Reflectance Backing and Paper Back-
3
3
Sensor
ing)
D 4279 Test Methods for Water Vapor Transmission of
D 645/D 645M Test Method for Thickness of Paper and
3
3
Shipping Containers—Constant and Cycle Methods
Paperboard
6
D 4321 Test Method for Package Yield of Plastic Film
D 726 Test Methods for Resistance of Nonporous Paper to
3
D 4754 Test Method for Two-Sided Liquid Extraction of
Passage of Air
9
Plastic Materials Using FDA Migration Cell
D 882 Test Methods for Tensile Properties of Thin Plastic
4
D 5264 Practice forAbrasion Resistance of Printed Materi-
Sheeting
3
als by the Sutherland Rub Tester
D 1003 Test Method for Haze and Luminous Transmittance
4
F 88 Test Method for Seal Strength of Flexible Barrier
of Transparent Plastics (Gardner)
3
Materials
D 1709 Test Methods for Impact Resistance of Plastic Film
4
F 151 TestMethodforResidualSolventsinFlexibleBarrier
by Free-Falling Dart Method
3
Materials
1
This guide is under the jurisdiction of ASTM Committee F02 on Flexible
Barrier Materials and is the direct responsibility of Subcommittee F02.60 on
5
Medical Packaging. Annual Book of ASTM Standards, Vol 07.01.
6
Current edition approved Oct. 10, 2001. Published December 2001. Annual Book of ASTM Standards, Vol 08.02.
2 7
Annual Book of ASTM Standards, Vol 10.01. Annual Book of ASTM Standards, Vol 06.01.
3 8
Annual Book of ASTM Standards, Vol 15.09. Annual Book of ASTM Standards, Vol 07.02.
4 9
Annual Book of ASTM Standards, Vol 08.01. Annual Book of ASTM Standards, Vol 08.03.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
1

---------------------- Page: 1 ----------------------
F2097–01
14
F 372 Test Method for Water Vapor Transmission Rate of 2.5 TAPPI Standards:
Flexible Barrier Materials Using an Infrared Detection TAPPI T 404 Tensile Breaking Strength and Elongation of
3
Technique Paper and Paperboard
F 392 Test Method for Flex Durability of Flexible Barrier TAPPI T 437 Dirt in Paper and Paperboard
3
Materials TAPPI T 460 Air Resistance of Paper (Gurley Method)
F 748 Practice for Selecting Generic Biological Test Meth- TAPPI T 494 Tensile Breaking Properties of Paper and
10
ods for Materials and Devices Paperboard (Using Constant Rate of Elongatio
...

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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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4.1 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 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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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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This specification covers hot- and cold-worked precipitation-hardenable nickel alloy rod, bar, forgings, and forging stock for high-temperature service. Chemical analysis shall be performed on the alloy and shall conform to the chemical composition requirement in carbon, manganese, silicon, phosphorus, sulfur, chromium, cobalt, molybdenum, columbium, tantalum, titanium, aluminum, zirconium, boron, iron, copper, and nickel. The material shall follow recommended annealing treatment, solution treatment, stabilizing treatment, and precipitation hardening treatment. Tension testing, hardness testing and stress-rupture testing shall be performed on the material and shall comply to the required tensile strength, yield strength, elongation, reduction in area, and Brinell hardness.
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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).
Note 1: The quality of the results produced by this standard are dependent on the competence of the personnel performing the procedure and the capability, calibration, and maintenance of the equipment used. Agencies that meet the criteria of Specification D3666 are generally considered capable of competent and objective testing, sampling, inspection, etc. Users of this standard are cautioned that compliance with Specification D3666 alone does not completely ensure reliable results. Reliable results depend on many factors; following the suggestions of Specification D3666 or some similar acceptable guideline provides a means of evaluating and controlling some of those factors.
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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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1.3 The text of this standard references notes and footnotes which provide explanatory material. These notes and footnotes (excluding those in tables and figures) shall not be considered as requirements of the standard.  
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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Standard Test Methods for Preformed Expansion Joint Fillers for Concrete Construction (Nonextruding and Resilient Types)

SIGNIFICANCE AND USE
3.1 The compression resistance perpendicular to the faces, the resistance to the extrusion during compression, and the ability to recover after release of the load are indicative of a joint filler's ability to continuously fill a concrete expansion joint and thereby prevent damage that might otherwise occur during thermal expansion. The asphalt content is a measure of the fiber-type joint filler's durability and life expectancy. In the case of cork-type fillers, the resistance to water absorption and resistance to boiling hydrochloric acid are relative measures of durability and life expectancy.
Note 2: The quality of the results produced by this standard are dependent on the competence of the personnel performing the procedure and the capability, calibration, and maintenance of the equipment used. Agencies that meet the criteria of Specification D3666 are generally considered capable of competent and objective testing, sampling, inspection, etc. Users of this standard are cautioned that compliance with Specification D3666 alone does not completely ensure reliable results. Reliable results depend on many factors; following the suggestions of Specification D3666 or some similar acceptable guideline provides a means of evaluating and controlling some of those factors.
SCOPE
1.1 These test methods cover the physical properties associated with preformed expansion joint fillers. The test methods include:    
Property  
Section  
Expansion in Boiling Water  
7.1  
Recovery and Compression  
7.2  
Extrusion  
7.3  
Boiling in Hydrochloric Acid  
7.4  
Asphalt Content  
7.5  
Water Absorption  
7.6  
Density  
7.7
Note 1: Specific test methods are applicable only to certain types of joint fillers, as stated herein.  
1.2 The values stated in inch-pound units are to be regarded as standard. The values given in parentheses are mathematical conversions to SI units that are provided for information only and are not considered standard.  
1.3 The text of this standard references notes and footnotes which provide explanatory material. These notes and footnotes (excluding those in tables and figures) shall not be considered as requirements of the standard.  
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ASTM D517-23(Specification)
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ABSTRACT
This specification covers asphalt plank used for bridge decks as well as for industrial floors. Asphalt planks shall be classified according to usage: Type Ia; Type Ib; and Type II. Asphalt plank shall be formed from a mixture of asphalt, fibers, modifiers, or a combination thereof, and mineral filler in such a manner as to produce a uniformly dense mass. The following test methods shall be intended to measure those attributes necessary to measure the ability of asphalt plank to provide a reasonably long and satisfactory service: absorption; brittleness; dimensions; and hardness.
SCOPE
1.1 This specification covers asphalt plank used for bridge decks as well as for industrial floors.  
1.2 The values stated in SI units are to be regarded as the standard. The values given in parentheses are for information only.  
1.3 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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