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ASTM F1980-21

(Guide)

Standard Guide for Accelerated Aging of Sterile Barrier Systems and Medical Devices

Standard Guide for Accelerated Aging of Sterile Barrier Systems and Medical Devices

SIGNIFICANCE AND USE
4.1 The loss of sterile barrier system integrity may occur as a result of physical properties of the materials and adhesive or cohesive bonds degrading over time or by subsequent dynamic events during shipping and handling, or both. Accelerated and real time aging verifies the time-related aspects of potential integrity loss only.  
4.2 ANSI/AAMI/ISO 11607–1: 2019, sub-clause 6.1.3, states that “the packaging system shall provide physical protection in order to maintain integrity of the sterile barrier system.” Sub-clause 6.1.6 states that, “A terminally sterilized sterile barrier system with its protective packaging, if included, shall be designed to, maintain sterility through exposure to expected conditions and hazards during the specified processing, storage, handling, and distribution until that SBS is opened at the point of use or until the expiry date.” Sub-clause 8.3.1 states, “Stability testing shall demonstrate that the sterile barrier system maintains integrity over time.” Sub-clause 8.3.3 states, “Stability testing, using accelerated aging protocols, shall be regarded as sufficient evidence for claimed expiry dates until data from real-time aging studies are available.”  
4.3 Real time aging programs provide the best data to ensure that sterile barrier system/medical device materials and sterile barrier system/medical device integrity do not degrade over time. However, due to market conditions in which products may become obsolete in a short time, and the desire to get new products to market in the shortest possible time, real time aging studies do not meet this objective. Accelerated aging studies can provide an alternative means of screening for possible aging-related failure mechanisms in the SBS or medical device. To ensure that accelerated aging studies represent real time effects, real time aging studies must be conducted in parallel to accelerated studies. Real time studies must be carried out to the claimed shelf life of the product and be perf...
SCOPE
1.1 This guide provides information for developing accelerated aging protocols to model the possible effects of the passage of time on the sterile integrity of the sterile barrier system (SBS), as defined in ANSI/AAMI/ISO 11607–1: 2019 and the physical properties of their component packaging materials. Guidance for developing accelerated aging protocols may also be used for medical devices and medical device materials.  
1.2 Information obtained using this guide may be regarded as sufficient evidence for expiration date claims for medical devices and sterile barrier systems until data from real-time aging studies are available.  
1.3 The accelerated aging guideline addresses sterile barrier systems as a whole with or without devices. The sterile barrier system material and device interaction compatibility that may be required for new product development or the resulting evaluation is not addressed in this guide.  
1.4 Real-time aging protocols are not addressed in this guide; however, it is essential that real-time aging studies be performed to confirm the accelerated aging test results using the same methods of evaluation. Real-time aging (stability) is the requirement of ANSI/AAMI/ISO 11607–1: 2019.  
1.5 Methods used for sterile barrier system performance validation, which include, environmental challenge, distribution, handling, and shipping events, are used for package performance (event-related loss of integrity) testing and are beyond the scope of this guide.  
1.6 This guide does not address environmental challenging that simulates extreme climactic conditions that may exist in the shipping and handling environment. Refer to Practice D4332 for standard conditions that may be used to challenge the sterile barrier system to realistic extremes in temperature and humidity conditions. See Terminology F17 for a definition of “environmental challenging.”  
1.7 The data obtained from accelerated aging studies is no...

General Information

Status
Published
Publication Date
14-Dec-2021
ICS
11.080.30 - Sterilized packaging
Technical Committee
F02 - Primary Barrier Packaging
Drafting Committee
F02.50 - Package Design and Development
Current Stage
Ref Project

Relations

Refers
ASTM F17-20 - Standard Terminology Relating to Primary Barrier Packaging
Effective Date
01-May-2020

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Standards Content (Sample)

This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the
Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
Designation: F1980 − 21
Standard Guide for
Accelerated Aging of Sterile Barrier Systems and Medical
1
Devices
This standard is issued under the fixed designation F1980; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope the shipping and handling environment. Refer to Practice
D4332 for standard conditions that may be used to challenge
1.1 This guide provides information for developing accel-
the sterile barrier system to realistic extremes in temperature
erated aging protocols to model the possible effects of the
and humidity conditions. SeeTerminology F17 for a definition
passage of time on the sterile integrity of the sterile barrier
of “environmental challenging.”
system (SBS), as defined in ANSI/AAMI/ISO 11607–1: 2019
and the physical properties of their component packaging 1.7 The data obtained from accelerated aging studies is not
materials.Guidancefordevelopingacceleratedagingprotocols to be used as a manner of establishing label storage conditions
may also be used for medical devices and medical device for sterile barrier systems.
materials.
1.8 The values stated in SI units are to be regarded as
1.2 Information obtained using this guide may be regarded standard. No other units of measurement are included in this
as sufficient evidence for expiration date claims for medical standard.
devices and sterile barrier systems until data from real-time
1.9 This standard does not purport to address all of the
aging studies are available.
safety concerns, if any, associated with its use. It is the
responsibility of the user of this standard to establish appro-
1.3 Theacceleratedagingguidelineaddressessterilebarrier
priate safety, health, and environmental practices and deter-
systems as a whole with or without devices.The sterile barrier
mine the applicability of regulatory limitations prior to use.
system material and device interaction compatibility that may
1.10 This international standard was developed in accor-
be required for new product development or the resulting
dance with internationally recognized principles on standard-
evaluation is not addressed in this guide.
ization established in the Decision on Principles for the
1.4 Real-time aging protocols are not addressed in this
Development of International Standards, Guides and Recom-
guide; however, it is essential that real-time aging studies be
mendations issued by the World Trade Organization Technical
performed to confirm the accelerated aging test results using
Barriers to Trade (TBT) Committee.
the same methods of evaluation. Real-time aging (stability) is
the requirement of ANSI/AAMI/ISO 11607–1: 2019.
2. Referenced Documents
1.5 Methods used for sterile barrier system performance
2
2.1 ASTM Standards:
validation, which include, environmental challenge,
D4332Practice for Conditioning Containers, Packages, or
distribution, handling, and shipping events, are used for pack-
Packaging Components for Testing
ageperformance(event-relatedlossofintegrity)testingandare
E337Test Method for Measuring Humidity with a Psy-
beyond the scope of this guide.
chrometer (the Measurement of Wet- and Dry-Bulb Tem-
1.6 This guide does not address environmental challenging
peratures)
that simulates extreme climactic conditions that may exist in
F17Terminology Relating to Primary Barrier Packaging
F2097Guide for Design and Evaluation of Primary Flexible
1
This guide is under the jurisdiction of ASTM Committee F02 on Primary
Barrier Packaging and is the direct responsibility of Subcommittee F02.50 on
2
Package Design and Development. For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Current edition approved Dec. 15, 2021. Published December 2021. Originally contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
approved in 1999. Last previous edition approved in 2016 as F1980–16. DOI: Standards volume information, refer to the standard’s Document Summary page on
10.1520/F1980-21. the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
F1980 − 21
Packaging for Medical Products
T = alpha temperature; heat distortion temperature.
α
2.2 Other Standards:
ANSI/AAMI/ISO 11607–1: 2019Packaging for Terminally
4. Significance and Use
3
Sterilized Medical Devices
4
4.1 The loss of sterile barrier system integrity may occur as
ASHRAE 170-20
...

This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation: F1980 − 16 F1980 − 21
Standard Guide for
Accelerated Aging of Sterile Barrier Systems forand Medical
1
Devices
This standard is issued under the fixed designation F1980; 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 (´) indicates an editorial change since the last revision or reapproval.
1. Scope
1.1 This guide provides information for developing accelerated aging protocols to rapidly determine the effects, if any, due to
model the possible effects of the passage of time on the sterile integrity of the sterile barrier system (SBS), as defined in
ANSI/AAMI/ISO 11607–1:2006 11607–1: 2019 and the physical properties of their component packaging materials. Guidance for
developing accelerated aging protocols may also be used for medical devices and medical device materials.
1.2 Information obtained using this guide may be used to support regarded as sufficient evidence for expiration date claims for
medical device sterile barrier systems.devices and sterile barrier systems until data from real-time aging studies are available.
1.3 The accelerated aging guideline addresses the sterile barrier systems in as a whole with or without devices. The sterile barrier
system material and device interaction compatibility that may be required for new product development or the resulting evaluation
is not addressed in this guide.
1.4 Real-time aging protocols are not addressed in this guide; however, it is essential that real-time aging studies be performed
to confirm the accelerated aging test results using the same methods of evaluation. Real-time aging (stability) is the requirement
of ANSI/AAMI/ISO 11607–1: 2019.
1.5 Methods used for sterile barrier system validation, which include the machine process, the effects of the sterilization process,
environmental challenge, distribution, handling, and shipping events, are performance validation, which include, environmental
challenge, distribution, handling, and shipping events, are used for package performance (event-related loss of integrity) testing
and are beyond the scope of this guide.
1.6 This guide does not address environmental challenging that stimulatessimulates extreme climactic conditions that may exist
in the shipping and handling environment. Refer to Practice D4332 for standard conditions that may be used to challenge the sterile
barrier system to realistic extremes in temperature and humidity conditions. See Terminology F1327F17 for a definition of
“environmental challenging.”
1.7 The data obtained from accelerated aging studies is not to be used as a manner of establishing label storage conditions for
sterile barrier systems.
1.8 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1
This guide is under the jurisdiction of ASTM Committee F02 on Primary Barrier Packaging and is the direct responsibility of Subcommittee F02.50 on Package Design
and Development.
Current edition approved Sept. 15, 2016Dec. 15, 2021. Published September 2016December 2021. Originally approved in 1999. Last previous edition approved in
20112016 as F1980 – 07F1980 – 16.(2011). DOI: 10.1520/F1980-16.10.1520/F1980-21.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
F1980 − 21
1.9 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 safety, health, and healthenvironmental practices and determine the
applicability of regulatory limitations prior to use.
1.10 This international standard was developed in accordance with internationally recognized principles on standardization
established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued
by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
2. Referenced Documents
2
2.1 ASTM Standards:
D4332 Practice for Conditioning Containers, Packages, or Packaging Components for Testing
E337 Test Method for Measuring Humidity with a Psychrometer (the Measurement of Wet- and Dry-Bulb Temperatures)
F17 Terminology Relating to Primary Barrier Packaging
3
F1327 Terminology Relating to Barrier Materials for Medical Packaging
...

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Annex A9  
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ASTM
ASTM E2552-23(Guide)
Standard Guide for Assessing the Environmental and Human Health Impacts of New Compounds for Military Use

SIGNIFICANCE AND USE
5.1 The purpose of this guide is to provide a logical, tiered approach in the development of environmental health criteria coincident with level and effort in the research, development, testing, and evaluation of new materials for military use. Various levels of uncertainty are associated with data collected from previous stages. Following the recommendation in the guide should reduce the relative uncertainty of the data collected at each developmental stage. At each stage, a general weight of evidence qualifier shall accompany each exposure/effect relationship. They may be simple (for example, low, medium, or high confidence) or sophisticated using a numerical value for each predictor as a multiplier to ascertain relative confidence in each step of risk characterization. The specific method used will depend on the stage of development, quantity and availability of data, variation in the measurement, and general knowledge of the dataset. Since specific formulations, conditions, and use scenarios may not be known until the later stages, exposure estimates can be determined when practical (for example, Engineering and Manufacturing Development; see 6.6). Exposure data can then be used with other toxicological data collected from previous stages in a quantitative risk assessment to determine the relative degree of hazard.  
5.2 Data developed from the use of this guide are designed to be consistent with criteria required in weapons and weapons system development (for example, programmatic environment, safety and occupational health evaluations, environmental assessments/environmental impact statements, toxicity clearances, and technical data sheets).  
5.3 Information shall be evaluated in a flexible manner consistent with the needs of the authorizing program. This requires proper characterization of the current problem. For example, compounds may be ranked relative to the environmental criteria of the prospective alternatives, the replacement compound, and within bo...
SCOPE
1.1 This guide is intended to determine the relative environmental influence of new substances, consistent with the research and development (R&D) level of effort and is intended to be applied in a logical, tiered manner that parallels both the available funding and the stage of research, development, testing, and evaluation. Specifically, conservative assumptions, relationships, and models are recommended early in the research stage, and as the technology is matured, empirical data will be developed and used. Munition constituents are included and may include propellants, oxidizers, explosives, binders, stabilizers, metals, dyes, and other compounds used in the formulation to produce a desired effect. Munition systems range from projectiles, grenades, rockets/missiles, training simulators, to smokes and obscurants. Given the complexity of issues involved in the assessment of environmental fate and effects and the diversity of the systems used, this guide is broad in scope and not intended to address every factor that may be important in an environmental context. Rather, it is intended to reduce uncertainty at minimal cost by considering the most important factors related to human health and environmental impacts of energetic materials. This guide provides an outline for collecting data useful in a relative ranking procedure to provide the systems scientist with a sound basis for prospectively determining a selection of candidates based on environmental and human health criteria. The general principles in this guide are applicable to substances other than energetics if intended to be used in a similar manner with similar exposure profiles.  
1.2 The scope of this guide includes:  
1.2.1 Energetic and other new/novel materials and compositions in all stages of research, development, test and evaluation.  
1.2.2 Environmental assessment, including:
1.2.2.1 Human and ecological effects of the unexploded energetics and ...

  • Guide
    9 pages
    English language
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  • Guide
    9 pages
    English language
    sale 15% off
ASTM
ASTM D8042-18(2023)(Test Method)
Test Method for Shrinkage Temperature of Wet Blue and Wet White

SIGNIFICANCE AND USE
5.1 This test method is designed to determine the temperature at which the Wet Blue or Wet White specimen experiences shrinkage. In this test method, shrinkage occurs as a result of hydrothermal denaturation of the collagen protein molecules which make up the fiber structure of the Wet Blue or Wet White. The shrinkage temperature of Wet Blue or Wet White is influenced by many different factors, most of which appear to affect the number and nature of crosslinking interactions between adjacent polypeptide chains of the collagen protein molecules. The value of the shrinkage temperature of Wet Blue or Wet White is commonly used as an indicator of the type of tannage or the degree of tannage, or both, of that particular Wet Blue or Wet White (especially for the more hydrothermally stable tannages such as chrome tannage).
SCOPE
1.1 This test method covers the determination of the shrinkage temperature of all types of Wet Blue and Wet White. The heating medium is water when the shrinkage temperature is at or below 98 °C. The heating medium is a glycerine-water solution when the shrinkage temperature is above 98 °C.  
1.2 The values stated in SI units are to be regarded as the standard. The values 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.  
1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

  • Standard
    3 pages
    English language
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