YY/T 0681.1-2018 PDF English
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YY/T 0681.1-2018: Test methods for sterile medical device package - Part 1: Test guide for accelerated aging
---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/YYT0681.1-2018
MEDICAL INDUSTRY STANDARD OF
THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.080.040
C 31
Replacing YY/T 0681.1-2009
Test methods for sterile medical device package -
Part 1.Test guide for accelerated aging
Issued on. DECEMBER 20, 2018
Implemented on. JANUARY 01, 2020
Issued by. National Medical Products Administration
Table of Contents
Foreword... 3
1 Scope... 6
2 Normative references... 6
3 Terms and definitions... 7
4 Meaning and application... 8
5 Instruments... 9
6 Accelerated aging theory... 9
7 Accelerated aging plan... 10
8 Post-aging test guide... 13
9 Report... 14
Annex A (normative) Accelerated aging of polymers... 15
Annex B (informative) Example of shelf life test plan for sterile barrier system
... 16
Annex C (informative) Relative humidity used in aging solution... 18
Bibliography... 20
Foreword
YY/T 0681 “Test methods for sterile medical device package” consists of the
following 16 parts.
- Part 1.Test guide for accelerated aging;
- Part 2.Seal strength of flexible battier materials;
- Part 3.Internal pressurization failure resistance of unrestrained packages;
- Part 4.Detecting seal leaks in porous packages by dye penetration;
- Part 5.Detecting gross leaks in medical packaging by internal
pressurization (bubble test);
- Part 6.Evaluation of chemical resistance of printed inks and coatings on
flexible packaging materials;
- Part 7.Evaluating inks or coating adhesion to flexible packaging materials
using tape;
- Part 8.Coating/adhesive weight determination;
- Part 9.Burst testing of flexible package seals using internal air
pressurization weight restraining plates;
- Part 10.Test for microbial barrier ranking of porous package material;
- Part 11.Determining integrity of seals for medical packaging by visual
inspection;
- Part 12.Flex durability of flexible barrier films;
- Part 13.Slow rate penetration resistance of flexible barrier films and
laminates;
- Part 14.Breathable packaging materials for wet and dry microbial barrier
tests;
- Part 15.Performance test of transport containers and systems;
- Part 16.Packaging system climate strain capability test.
This is Part 1 of YY/T 0681.
This Part was drafted in accordance with the rules given in GB/T 1.1-2009.
This Part replaces YY/T 0681.1-2009 “Test methods for sterile medical device
package - Part 1.Test guide for accelerated aging”. Compared with YY/T
0681.1-2009, in addition to editorial modifications, the main technical changes
are as follows.
- for sterile package, used the term “sterile barrier system” to replace the
term “package”;
- uniformly modified “actual-time aging” as “real-time aging”;
- in “Meaning and application”, modified sub-clause 4.2 as “the packaging
system shall...”;
- in “Meaning and application”, added sub-clause 4.5;
- required the thermometer “be able to record” in 5.4 of “Instruments”;
- added sub-clause 6.5 in “accelerated aging theory”;
- in sub-clause 7.2.3 of “Accelerated aging plan”, deleted “for example, the
temperature chosen shall be at least 10°C lower than the Tg of the
material”;
- in sub-clause 7.2.3 of “Accelerated aging plan”, added NOTE 3, NOTE 4;
- in “Accelerated aging plan”, added sub-clause 7.4.5;
- in “Accelerated aging plan”, added sub-clause 7.5;
- revised “8 Post-aging test guide”;
- deleted Figure B.1 from Annex B;
- deleted “Where appropriate, in accordance with ASTM D 4169...” from
Annex B.5;
- modified the note in Annex B.6 as “the effect of humidity can be used as a
packaging system design...”
- added Annex C (informative) “Relative humidity used in aging solutions”.
Attention is drawn to the possibility that some of the elements of this Standard
may be the subject of patent rights. The issuing authority shall not be held
responsible for identifying any or all such patent rights.
This Part was proposed by National Medical Products Administration.
This Part shall be under the jurisdiction of National Technical Committee on
Medical Infusion Device of Standardization Administration of China (SAC/TC
116).
The drafting organizations of this Part. Shandong Medical Device Product
Quality Inspection Center, DuPont (China) R&D Management Co., Ltd.,
Shandong Weigao Group Medical Polymer Products Co., Ltd., Medico
(Shanghai) Packaging Materials Co., Ltd.
Main drafters of this Part. Zhang Jing, Qian Jun, Yu Haichao, Gong Yaoren.
This Part replaces YY/T 0681.1-2009.
Test methods for sterile medical device package -
Part 1.Test guide for accelerated aging
1 Scope
This Part of YY/T 0681 specifies the guide for designed accelerated aging
solutions.
This Part applies to the rapid determination of the sterile integrity of the sterile
barrier system specified in GB/T 19633.1-2015 and the effects that physical
properties of its packaging material components are affected by the elapsed
time.
NOTE 1.Use the information in this Part of YY/T 0681 to support the expiration date of the medical device
sterile barrier system (i.e. shelf life).
This Part is not applicable to real-time aging solution.
NOTE 2.Accelerated aging test involves sterile barrier system with or without instruments. This Part does
not address the compatibility of sterile barrier system materials with instrument interactions required during
new product development or evaluation.
NOTE 3.Real-time aging test is a basic aging study used to determine the results of accelerated aging
tests.
NOTE 4.This Part does not address methods for confirmation of sterile barrier system, including effects
on mechanical processing, sterilization processes, circulation, handling and transport. The ability of the
sterile barrier system to resist transport challenges is given in YY/T 0681.15.
NOTE 5.This Part does not address the effects of extreme weather conditions that may be experienced
in a simulated transport environment. For the climatic strain capacity test of the sterile barrier system, see
YY/T 0681.16.
2 Normative references
The following referenced documents are indispensable for the application of
this document. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any
amendments) applies.
GB/T 4857.2, Packaging - Transport packages - Temperature and humidity
conditioning
GB/T 19633.1-2015, Packaging for terminally sterilized medical devices -
Part 1.Requirements for materials, sterile barrier systems and packaging
systems
3 Terms and definitions
For the purposes of this document, the terms and definitions defined in GB/t
19633.1-2015 as well as the followings apply.
3.1 accelerated aging
store samples at a higher temperature to reduce time to simulate real-time
aging
3.2 accelerated aging factor
an estimated or calculated time ratio of physical performance changes to the
same level as the package stored in real-time conditions
NOTE. The aging factor (Q10) at which the temperature increases or decreases by 10°C is a conservatively
estimated accelerated aging factor.
3.3 accelerated aging temperature
a higher temperature that enters aging study; it is calculated based on the
estimated storage temperature, the estimated operating temperature, or both
3.4 accelerated aging time
duration of accelerated aging test
3.5 ambient temperature
storage temperature of the sample representing the actual aging time of the
storage conditions
3.6 sterile barrier system shelf life
the expected storage time of the sterile barrier system to maintain its key
performance parameters under ambient conditions or under specified storage
conditions
4 Meaning and application
4.1 Degradation of physical properties of materials over time and degradation
of materials at bonding or heat sealing over time and dynamic events during
subsequent transport and handling, may lead to loss of integrity of the sterile
barrier system.
4.2 The packaging system shall provide protection and maintain the integrity of
the sterile barrier system.
4.3 Real-time aging procedures provide the best data to ensure that sterile
barrier system materials and sterile barrier system integrity do not degrade over
time.
4.4 If there is a lack of understanding of the material of the sterile barrier system
being evaluated, a conservative accelerated aging factor shall be used. More
realistic accelerated aging factors can be used.
4.5 When accelerating the aging process to establish a nominal shelf life, it shall
be recognized that the data obtained from the study is based on a simulation of
the aging effect of the material.
5 Instruments
5.1 A room (or box). its size may allow the sample to be independently exposed
to the selected temperature and relative humidity of the circulating air.
5.2 Control instrument. keep the room (box) within the limits of the required
atmospheric conditions.
5.4 Thermometer. a measuring device capable of recording and displaying
temperature with an accuracy of 0.1°C can be used.
6 Accelerated aging theory
6.1 Accelerated aging of materials refers to accelerated changes in material
properties associated with the safety and functionality of materials or sterile
barrier system over time.
6.2 In aging study, material or sterile barrier system are subjected to harsher or
more frequent external strains than usual in a relatively short period of time.
6.3 Accelerated aging technology is based on this assumption.
6.4 The determination method for Q10 is to test each material at various
temperatures and define the difference in reaction rate between materials for
every 10°C change in temperature.
6.5 The accelerated aging time in the accelerated aging scheme does not use
the humidity factor. However, extreme temperature and humidity conditions that
are inconsistent with actual conditions may affect the performance of the entire
sterile barrier system.
7 Accelerated aging plan
7.1 Material characterization
Accelerated aging theory and its application are directly related to the
composition of packaging materials. Material properties that may affect the
results of accelerated aging study include.
7.2 Design guide for accelerated aging plan
7.2.3 Select accelerated aging temperature based on material characterization.
The higher the accelerated aging temperature, the greater the accelerated
aging factor, and the shorter the time to accelerate aging. It shall be noted that
the accelerated aging temperature cannot be reduced in an uncontrolled
manner to shorten the time for accelerated aging.
7.3 Determination of accelerated aging factor
7.4 Accelerated aging plan steps
7.4.1 Select Q10 value.
7.4.2 Determine the shelf life of the desired sterile barrier system based on
market demand, product demand, etc.
7.4.3 Determine the time interval for the aging test, including zero time.
7.4.4 Determine test conditions, ambient temperature and accelerated aging
temperature.
7.4.5 Determine whether humidity conditions are used in aging studies. If used,
determine the relative humidity (RH) target value and allowable deviation.
7.4.6 Use Q10, TRT, and TAA to calculate test duration time.
7.4.10 Evaluate whether the sterile barrier system meets its original design
requirements after real-time aging.
8 Post-aging test guide
8.1 Evaluate physical properties and integrity of sterile barrier systems after
aging (e.g., accelerated aging and real-time aging).
8.2 The test selected for evaluation shall be able to challenge the most critical
function of the material or package or the function that is most likely to fail due
to aging.
8.5 If the packaging system has documented acceptable limits for performance
such as seal strength, puncture or impact resistance that meet the requirements
of the intended packaging system, then the specified physical test data shall be
complete.
8.6 Sometimes, packaging performance test can be performed on an aged
packaging system so as to evaluate the performance of the packaging system
during simulated flow, handling, and storage.
8.7 Establish acceptance criteria before all aging tests.
9 Report
The accelerated aging test report shall have the following information.
......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
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