ASTM F1980-21 无菌屏障系统和医疗器械的加速老化(EN)

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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 F 1 9 8 0 ; t h e 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(8) indicates an editorial change since the last revision or reapproval.

1.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 ofANSI/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 challenges

that simulate extreme climatic conditions that may exist in

¹This 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 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 means 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

a pp r o p r i a t e safety, health, and environmental practices

and determine the applicability of regulatory limitations

prior to use.

1.10 This international standard was developed in

a c c o r d a n c e

with internationally recognized principles

on standardization established in the Decision on

Principles for the Development of International Standards,

Guides, and

R e c o m m e n d a t i o n s

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

Psychrometer (the Measurement of Wet-and Dry-Bulb

T e m p e r a t u r e s )

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.

States 1

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

A c c e le r a t e d a g i n g ( A A ) , 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 agingfactor (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

A c c e le r a t e d

aging temperature (TAA)

—

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 temperature

for real-time

a g i n g ( R T ) s a m p l e s

that is typical for

storage

c o n d i t i o n s .

Also, the temperature used to

calculate the accelerated aging duration.

3.2.6 sterile barrier system shelf life—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 R eal -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

estimated to be equivalent.

3.2.9 zero time (t

₀

), n—the beginning of an aging study.

3.3 Symbols:

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

in temperature.

Tm =temperature at which a material melts.

T₈ =glass transition temperature.

³Available from the American National Standards Institute (ANSI), 25 W.

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 t h e I n t e r n a t i o n a l Organization for

S t a n d a r d i z a t i o n ( I S O ) , I S O Central Secretariat, Chemin de

Blandonnet 8, CP 401, 1214 Vernier, Geneva,

Switzerlandhttps://www.iso.org.

Ta =alpha temperat ure; 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.

4.5 When conducting accelerated aging programs for

es ta b li sh i ng ex p i ra ti o n

dating claims, it must be

recognized that the data obtained from the study are 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 co n s e rv a t i v e 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 is beyond the scope ofthis guide.6

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

MDDI Online, 2021.

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标签： #医疗器械 #ASTM #无菌

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ThisinternationalstandardwasdevelopedinaccordancewithinternationallyrecognizedprinciplesonstandardizationestablishedintheDecisiononPrinciplesfortheDevelopmentofInternationalStandards,Guides,andRecommendationsissuedbytheWorldTradeOrganizationTechnicalBarrierstoTrade(TBT)Committee.Designation:F1980-21...

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ASTM F1980-21 无菌屏障系统和医疗器械的加速老化(EN)

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