ASTM F1980-21 Standard Guide for Accelerated Aging of Sterile Barrier Systems and Medical Devices

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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

Devices¹

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(e)indicates an editorial change since the last revision or reapproval.

1.Scope

1.1 This guide provides information for developing accel-

erated 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 pack-

age 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

!This guide is under the jurisdiction of ASTM Committee F02 on Primary

Barrier Packaging and is the direct responsibility of Subcommitte F02.50 on

Package Design and Development.

Current edition approved Dec.15,2021.Published December 2021.Originally

approved in 1999.Last previous edition approved in 2016 as F1980-16.DOI:

10.1520/F1980-21.

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 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.

1.9 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 appro-

priate safety,health,and environmental practices and deter-

mine the applicability of regulatory limitations prior to use.

1.10 This international standard was developed in accor-

dance with internationally recognized principles on standard-

ization established in the Decision on Principles for the

Development of International Standards,Guides and Recom-

mendations issued by the World Trade Organization Technical

Barriers to Trade(TBT)Committee.

2.Referenced Documents

2.1 ASTM Standards:²

D4332 Practice for Conditioning Containers,Packages,or

Packaging Components for Testing

E337 Test Method for Measuring Humidity with a Psy-

chrometer(the Measurement of Wet-and Dry-Bulb Tem-

peratures)

F17 Terminology Relating to Primary Barrier Packaging

F2097 Guide for Design and Evaluation of Primary Flexible

2For 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

the ASTM website.

F1980-21

Packaging for Medical Products

2.2 Other Standards:

ANSI/AAMI/ISO 11607-1:2019 Packaging for Terminally

Sterilized Medical Devices³

ASHRAE 170-2017 Ventilation of Health Care Facilities⁴

ISO TS 16775:2014 Packaging for terminally sterilized

medical devices —Guidance on the application of ISO

11607-1 and ISO 11607-2⁵

3.Terminology

3.1 Definitions—For general definitions of packaging for

medical devices,see ANSI/AAMI/ISO 11607-1:2019.For

terminology related to barrier materials for medical packaging

see Terminology F17 .

3.2 Definitions of Terms Specific to This Standard:

3.2.1 accelerated aging(AA),n—storage of samples at an

elevated temperature(TAA)in order to simulate real time aging

in a reduced amount of time.

3.2.2 accelerated aging factor (AAF),n—an estimated or

calculated ratio of the time to achieve the same level of

physical property change as a sterile barrier system stored at

real time(RT)conditions.

3.2.3 accelerated aging temperature (TAA),n—the elevated

temperature at which the aging study is conducted,and it may

be based on the estimated storage temperature,estimated usage

temperature,or both.

3.2.4 accelerated aging time(AAT),n—the length of time

the accelerated aging is conducted.

3.2.5 ambient temperature(TRT),n—storage temperaturefor

real-time aging(RT)samples that is typical for storage condi-

tions.Also,the temperature used to calculate the accelerated

aging duration.

3.2.6 sterile barrier system shelf life,n—the amount of real

time that a sterile barrier system can be expected to remain in

storage at ambient conditions,or under specified conditions of

storage,and maintain its critical performance properties.

3.2.7 real-time aging(RT),n—storage time of samples at

ambient conditions.

3.2.8 real-time equivalent(RTE),n—amount of real-time

aging to which given accelerated aging conditions are esti-

mated to be equivalent.

3.2.9 zero time (t₀),n—the beginning of an aging study.

Ta =alpha temperature;heat distortion temperature.

4.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 performed to their completion.

4.4 Conservative accelerated aging factors(AAFs)must be

used if little is known about the sterile barrier system material

being evaluated.More aggressive AAFs may be used with

documented evidence to show a correlation between real time

and accelerated aging.

3.3 Symbols:

Q10 =an aging factor for 10℃ increase or decrease in

temperature.

Tm =temperature at which a material melts.

T₈ =glass transition temperature.

³Available from American National Standards Insitute(ANSD),25W.43rd St.,

4th Floor,New York,NY 10036,http://www.ansi.org.

⁴Available from American Society of Heating,Refrigerating,and Air-

Conditioning Engineers,Inc.(ASHRAE),1791 Tullie Circle,NE,Atlanta,GA

30329,http://www.ashrae.org.

5Available from International Organization for Standardization ISO),ISO

Central Secretariat,Chemin de Blandonnet 8,CP 401,1214 Vernier,Geneva,

Switzerlandhttps://www.iso.org.

4.5 When conducting accelerated aging programs for estab-

lishing expiry dating claims,it must be recognized that the data

obtained from the study is based on conditions that simulate the

effects of aging on the materials.The resulting creation of an

expiration date or shelf life is based on the use of a conserva-

tive estimate of the aging factor (that is,Q10)and is tentative

until the results of real time aging studies are completed on the

sterile barrier system.

NoTE 1—Determining AAFs are beyond the scope of this guide.⁶

⁶Thor,P.,“Humidity as Use Condition for Accelerated Aging of Polymers”

MDDI Online,2021.

F1980-21

5.Apparatus

5.1 Room(or Cabinet)of such size that samples may be

individually exposed to circulating air at the temperature and

relative humidity chosen.See 7.4.1 for sample configuration

guidance.

5.1.1 Control Apparatus,capable ofmaintaining the room at

the required atmospheric conditions within the tolerance limits.

5.2 Hygrometer—The instrument used to indicate the rela-

tive humidity should be accurate to±2%relative humidity.A

psychrometer may be used either for direct measurement of

relative humidity or for checking the hygrometer(see Test

Method E337).

5.3 Thermometer—Any temperature-measuring device may

be used provided it can accurately indicate the temperature to

within 0.1℃ or 0.2°F and be properly recorded.The dry-bulb

thermometer of the psychrometer may be used either for direct

measurement or for checking the temperature-indicating de-

vice.

6.Accelerated Aging Theory

6.1 Aging of materials refers to the study of variation of

their properties over time,generally due to various degradation

mechanisms(for example,thermo-oxidative or hydrolytic)

inherent in the materials.For the purposes of this guide,the

properties of interest are those related to the safety and function

of the material or sterile barrier system.

6.2 In an accelerated aging study,the material or sterile

barrier system is subjected to conditions which accelerate the

reaction kinetics of possible degradation pathways.

6.3 Accelerated aging techniques are based on the empirical

guidance that chemical reactions (including those involved in

the deterioration of materials)follow the Arrhenius reaction

rate function,and assume little or no change in reactant

concentration(s).This function states that,in general,a 10℃

increase in temperature of a homogeneous process results in a

two-fold increase in the rate of a chemical reaction(Q10).7

6.4 Determining the Q10 involves testing materials at vari-

ous temperatures and defining the differences in reaction rate

for a 10℃ change in temperature.Modeling the kinetics of

material deterioration is complex and difficult and is beyond

the scope of this guide.8

6.5 Since sterile barrier systems and medical device are

stored in environments that comprise varying levels of ambient

humidity,and since the properties of some materials may

depend on the level of absorbed moisture(for example,

polyamides absorb moisture from the environment and may

have degradation pathways involving moisture,while polyole-

fins do not),it is important to consider not only the accelerated

aging temperature conditions but also the ambient relative

7Hemmerich,K.J.,“General Aging Theory and Simplified Protocol for

Accelerated Aging of Medical Devices,"Medical Plastics and Biomaterials,

July/August 1998,pp.16-23

8Nelson,W.,Accelerated Testing Statistical Models,Test Plans,and Data

Analyses,John Wiley and Sons,New York,1999.

humidly during that accelerated aging.See Appendix X3 for

more details on the use of humidity in accelerated aging

protocols.

NoTE 2—Degradation mechanisms for most flexible packaging mate-

rials used as sterile barrier systems do not involve moisture.However,

materials used in medical devices are far more varied,and hydrolytic

degradation may be a factor in some of those materials.Knowledge of the

materials used in either the SBS or the device,and their relevant

degradation mechanisms,is important in the proper design of an acceler-

ated aging protocol.

6.6 It is important to consider that humidity will be part of

the long-term storage use condition.Controlling humidity

during accelerated aging is intended to compensate for low

relative humidity at intentionally elevated temperatures,nec-

essary to accelerate the effect of time.The goal of controlling

humidity during accelerated aging is to avoid drying out

materials (primarily polymers)to moisture levels lower than

typical in the long-term storage use condition.Dry accelerated

aging conditions may cause the user of this practice to miss

moisture driven degradation that can occur on the shelf in

long-term storage.Appropriate control of relative humidity

during accelerated aging ensures that potential moisture driven

degradation mechanisms will be caught during accelerated

aging for moisture sensitive materials.The same relative

humidity considerations are not necessary when the tempera-

ture is not artificially elevated (for example,real-time aging).

Control of relative humidity outside the scope of this standard

is left to the discretion of the user.

7.Accelerated Aging Plan

7.1 Characterization of Materials—AA theory and its ap-

plication are directly related to packaging material composi-

tion.Examples of material properties that may affect the results

of accelerated aging studies may include:

7.1.1 Composition(including laminating adhesives,

primers,and coatings),

7.1.2 Morphology(glassy,amorphous,semi-crystalline,

highly crystalline,%crystallinity,and so forth),

7.1.3 Thermal transitions(TmTg,Ta),as defined in 3.3,

7.1.4 Additives,processing agents,catalysts,lubricants,

residual solvents,corrosive gases,and fillers,

7.1.5 Moisture absorption characteristics,and

7.1.6 Known degradation mechanisms (for example,

hydrolysis,metal ion oxidation(MIO),photo-degradation,

environmental stress cracking(ESC),corrosion,oxidation).

This can be accomplished by reviewing published literature/

research.

7.2 Accelerated Aging Plan-Design Guidelines:

7.2.1 Temperature boundaries,based on the characterization

of the device and sterile barrier system materials,must be

considered in order to ensure that initial,conservative aging

factors are applied appropriately.The temperatures used should

be based on the characterization of the packaging materials and

the intended storage conditions.Material characterization and

composition are factors in establishing the accelerated aging

temperature boundaries.Temperature selection should be lim-

ited to prevent any physical transition of material.

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1ThisinternationalstandardwasdevelopedinaccordancewithinternationallyrecognizedprinciplesonstandardizationestablishedintheDecisiononPrinciplesfortheDevelopmentofInternationalStandards,GuidesandRecommendationsissuedbytheWorldTradeOrganizationTechnicalBarrierstoTrade(TBT)Committee.Designation:F1980-21...

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