ASTM F1980-21-无菌屏障系统和医疗器械加速老化的标准指南--中英对照
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wTEMA70M
Designation:F1980-21
Standard Guide for
Accelerated Aging of Sterile Barrier Systems and Medical
Devices¹
无菌屏障系统和医疗器械加速老化的标准指南
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 ofrevision,the year of last revision.A number in parentheses indicates thee
year of last reapproval.A superscript epsilon(e)indicates an editorial change since the last revision or reapproval.
本标准以固定名称F1980 发布；紧跟在指定后面的数字表示最初采用的年份，如果是修订，则表示最后修订
的年份。括号中的数字表示最后一次重新批准的年份。上标 e表示自上次修订或重新批准以来的编辑更改。
1. Scope
1.1 This guide provides information for developing
accelerated aging protocols to model the possible effects of
the passage oftime 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 packing
materials.Guidance for developing accelerated aging
protocols may also be used for medical device and medical
device materials.
1.2 Information obtained using this guide may be
regarded as sufficient evidence for expiration date claims for
medical device and sterile barrier systems until data from real-
time aging studies are available.
1.3 The accelerated aging guideline addresses 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,handing,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
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
appropriate safety,health,and environmental practices and
determine the applicability of regulatory limitations prior to
use.
1.10 This international standard was developed in
accordance with internationally recognized principled on
standardization established in the Decision on Principlesforr
the Development of International Standards,Guides and
Recommendations ssued by the Word Trade Organization
Technical Barriers to Trade (TBT)Committee.
1. 范围
1.1 本指南为制定加速老化方案提供了信息，以模拟
时间流逝对 ANSI/AAMI/ISO 11607-1:2019中定义的无菌
屏障系统 ( SBS) 的无菌完整性及其组件包装材料的物理
特性的可能影响。开发加速老化协议的指南也可用于医疗
器械和医疗器械材料。
1.2在实时老化研究的数据可用之前，使用本指南获
得的信息可被视为医疗器械和无菌屏障系统有效期声明
的充分证据。
1.3加速老化指南涉及新产品开发可能需要的无菌
屏障系统材料和设备相互作用兼容性，或者本指南未涉及
由此产生的评估。
1.4本指南未涉及实时老化协议；然而，使用相同的
评估方法进行实时老化研究以确认加速老化试验结果是
至关重要的。实时老化(稳定性)是ANSI/AAMI/ISO 11607-
1:2019的要求。
1.5用于无菌屏障系统性能验证的方法，包括环境挑
战、分配、搬运和运输事件，用于包装性能(与事件相关
的完整性损失)测试，超出了本指南的范围。
1.6本指南不涉及模拟运输和装卸环境中可能存在
的极端气候条件的环境挑战。参考规程D4332,了解可用
于挑战无菌屏障系统在温度和湿度条件下达到实际极端
的标准条件。有关“环境挑战性”的定义，请参见术语F17
1.7从加速老化研究中获得的数据不得用于建立无
菌屏障系统的标签储存条件。
1.8以国际单位制表示的数值应视为标准。本标准不
包括其他计量单位。
1. 9本标准并不旨在解决与其使用相关的所有安全
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问题(如有)。本标准的使用者有责任在使用前制定适当
的安全、健康和环境实践，并确定监管限制的适用性。
1.10
本国际标准是根据世界贸易组织技术性贸
易壁垒委员会发布的《关于制定国际标准、指南和建议的
原则的决定》中确立的国际公认的标准化原则制定的。
2. Referenced Documents/参考文件
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
Temperatures)
F17 Terminology Relating to Primary Barrier Packaging
F2097 Guide for Design and Evaluation of Primary
Flexible 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 11607-2⁵
3.Terminology
3.1 Definitions-For general definitions ofpackaging for
medical device,see ANSI/AAMI/ISO 11607-1:2019.For
terminology related to barrier materials for medical packaging
see Terminology F17.
3.2 Definitions ofTerms 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
temperature for real-time aging(RT)samples that is typical for
storage conditions.Also,the temperature used to calculate the
accelerated aging duration.
3.2.6 Sterile barrier system shelflife, n-the amount
of real time that a sterile barrier system can be expected to
remain in storage at ambient condition,or under specified
conditions of storage,and maintain its critical performance
properties.
3.2.7 real-time aging(RT),n-storage time of sample
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(To),n-the beginning of an aging
study.
3.3 Symbols:
Q10=an aging factor for 10℃ increase or decrease in
temperature.
Tm=temperature at which a material melts.
Tg=glass transition temperature.
Ta=alpha temperature;heat distortion temperature.
2. 参考文件
2.1 ASTM标准：²
D4332 试验用容器、包装或包装部件的调节实施规程
E337 用湿度计测量湿度的试验方法(湿球和干球温
度的测量)
F17 与初级屏障包装相关的术语
F2097 医疗产品初级柔性包装的设计和评估指南
2.2其他标准：
ANSI/AAMI/ISO 11607-1:2019 最终灭菌医疗器械的
包 装
ASHRAE 170-2017 卫生保健设施通风⁴
ISO TS 16775:2014 最终灭菌医疗器械的包装——
ISO 11607-1和11607-2的应用指南⁵
3. 术语
3.1定义--有关医疗器械包装的一般定义，请参见
ANSI/AAMI/ISO 11607-1:2019。有关医疗包装用阻隔材料
的术语，请参阅术语F17。
3. 2本标准专用术语的定义：
3.2. 1加速老化 (
AA),n- 在升高的温度下储存样品
(TAA), 以模拟在减少的时间内的实时老化。
3.2. 2加速老化因子 (
AAF),n——实现与实时(RT)
条件下储存的无菌屏障系统相同水平的物理性能变化的
估计或计算时间比率。
3.2. 3加速老化温度 (
TaA),n——进行老化研究的升
高温度，它可能基于估计的储存温度、估计的使用温度，
或两者兼而有之。
3.2. 4加速老化时间(
AAT), n——进行加速老化的时
间长度。
3.2.5环境温度 (
TRT),n-
实时老化 (
RT)
样品的储
存温度，这是储存条件下的典型温度。此外，用于计算加
速老化持续时间的温度。
3.2. 6无菌屏障系统的保质期，
n——无菌屏障系统
在环境条件下或规定的储存条件下可预期保持储存状态
并保持其关键性能的实时量。
3.2.7实时老化(RT),n- 样品在环境条件下的储存时
间。
3.2.8实时当量(
RTE), n——给定加速老化条件下估
计等效的实时老化量。
3.2.9零时间 (
To), n——老化研究的开始。
3.3符号：
Q10= 温度升高或降低10℃时的老化系数。
Tm= 材料熔化的温度。
Tg= 玻璃化转变温度。
Ta=α 温度；热变形温度。
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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 state 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 shelflife 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
establishing 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 conservative 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
4.意义和用途
4.1无菌屏障系统完整性的丧失可能是由于材料的物
理性能和粘合剂或内聚键随时间退化，或运输和搬运过程
中的后续动态事件，或两者兼而有之。加速和实时老化仅
验证潜在完整性损失的时间相关方面。
4.2 ANSI/AAMI/ISO 11607-1:2019,第6 . 1 . 3条规
定，“包装系统应提供物理保护，以保持无菌屏障系统的
完整性。”第6.1.6条规定：“带保护性包装的最终灭菌
无菌屏障系统(如有)应设计为，在规定的加工、储存、
搬运和分发过程中，通过暴露于预期条件和危险来保持无
菌，直到SBS在使用点打开或直到有效期。”第8.3.1条
规定：”稳定性测试应证明无菌屏障系统随时间保持完整
性。“第8.3.3条规定，”使用加速老化协议进行的稳定
性测试应视为声称有效期的充分证据。实时老化研究数据
可用之前的日期。
4.3实时老化程序提供了最佳数据，以确保无菌屏障
系统/医疗器械材料和无菌屏障系统-医疗器械的完整性
不会随着时间的推移而退化。然而，由于产品可能在短时
间内过时的市场条件，以及在尽可能短的时间内将新产品
推向市场的愿望，实时老化研究无法达到这一目标。加速
老化研究可以为 SBS 或医疗器械中可能的老化相关故障
机制的筛查提供一种替代方法。为了确保加速老化研究代
表实时效应，实时老化研究必须与加速研究并行进行。必
须对产品声称的保质期进行实时研究，并完成研究。
4.4如果对所评估的无菌屏障系统材料知之甚少，则
必须使用保守的加速老化因子(AAF)。更具攻击性的AAF
可以与记录在案的证据一起使用，以显示实时性和加速老
化之间的相关性。
4.5在为建立有效期索赔进行加速老化计划时，必须
认识到从研究中获得的数据是基于模拟老化对材料影响
的条件。由此产生的有效期或保质期是基于对老化因子
(即Q10)的保守估计，并且在无菌屏障系统的实时老化研
究结果完成之前是暂定的。
注 1 - 确 定 AAF超出了本指南的范围。
摘要：
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1/12wTEMA70MDesignation:F1980-21StandardGuideforAcceleratedAgingofSterileBarrierSystemsandMedicalDevices¹无菌屏障系统和医疗器械加速老化的标准指南ThisstandardisissuedunderthefixeddesignationF1980;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginaladoptionor,inthecaseofrevision,theyearoflastrevision.Anu...
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作者：大傻蛋
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时间：2026-06-26
