Codeofchina.com is in charge of this English translation. In case of any doubt about the English translation, the Chinese original shall be considered authoritative.
YY/T 0681 comprises the following parts under the general title Test methods for sterile medical device package:
—— 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: Testing the microbial barrier for porous packaging materials under moist conditions and with passage of air;
—— Part 15: Performance testing of shipping containers and systems;
—— Part 16: Test for climatic stressing of packaging system.
This is part 1 of YY/T 0681.
This part is developed 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. In addition to editorial changes, the following main technical changes have been made with respect to YY/T 0681.1-2009:
——for sterile packaging, the term "packaging" is replaced with "sterile barrier system";
——"actual-time aging" is changed to "real-time aging" in a unified way;
——subclause 4.2 under "Significance and use" is modified to "the packaging system shall…";
——subclause 4.5 is added to "Significance and use";
——subclause 5.4 under “Apparatus” requires that the temperature-measuring device “can be properly recorded”;
——subclause 6.5 is added to the "Accelerated aging theory";
——"for example, the temperature selected should be at least 10℃ lower than the Tg of the material” is deleted from subclause 7.2.3 under "Accelerated aging plan";
——notes 3 and 4 are added to subclause 7.2.3 under "Accelerated aging plan";
——subclause 7.4.5 is added to the "Accelerated aging plan";
——subclause 7.5 is deleted from the "Accelerated aging plan";
——clause 8 "Post-aging testing guidance" is revised on the whole;
——Figure B.1 is deleted from Annex B;
——”where applicable, Practice ASTM D 4169 may be referred to for...” is deleted from B.5;
——the note to Annex B.6 is changed to “Humidity effects can be evaluated as part of the package system design performance qualification testing”;
——Annex C (Informative) “Using relative humidity in aging protocols” is added.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. The issuing body of this document shall not be held responsible for identifying any or all such patent rights.
This part was proposed by the National Medical Products Administration of People’s Republic of China.
This part is under the jurisdiction of the National Technical Committee 342 on Medical Syringes of Standardization Administration of China.
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 provides guidance for developing accelerated aging protocols.
This part is applicable to rapidly determine the effects, if any, due to the passage of time on the sterile integrity of the sterile barrier system (SBS), as defined in GB/T 19633.1-2015 and the physical properties of their component packaging materials.
Note 1: Information obtained using this part of YY/T 0681 may be used to support expiration date claims (i.e. shelf life) for medical device sterile barrier systems.
This part is not applicable to real-time aging protocols.
Note 2: The accelerated aging test addresses the sterile barrier systems in 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 part.
Note 3: It is essential that real-time aging test be performed to confirm the accelerated aging test results.
Note 4: Methods used for sterile barrier system validation, which include the machine process, the effects of the sterilization process, distribution, handling, and shipping events, are beyond the scope of this part. See YY/T 0681.15 for the resistance against shipping challenges of sterile barrier systems.
Note 5: This part does not address extreme climactic conditions that may exist in the shipping and handling environment. See YY/T 0681.16 for climatic adaptability test of sterile barrier systems.
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 - Basic tests for transport packages - Part 2: 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 given in GB/T 19633.1-2015 and the following apply.
3.1
accelerated aging
storage of samples at an elevated temperature in order to simulate real time aging in a reduced amount of time
3.2
accelerated aging factor
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 conditions
Note: The aging factor for a 10℃ increase or decrease in the temperature, Q10, is a conservative estimate of the accelerated aging factor.
3.3
accelerated aging temperature
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
3.4
accelerated aging time
the length of time the accelerated aging is conducted
3.5
ambient temperature
storage temperature for real-time aging samples that represents storage conditions
3.6
sterile barrier system shelf life
the amount of 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
Note: “Shelf life” is a term frequently used in the laws and regulations of China, referred to as “expiry date” in GB/T 19633.1-2015.
3.7
real-time aging
aging of samples under storage at ambient conditions
Note: The term “real-time aging” is referred to as "actual-time aging" in GB/T 19633.1-2015.
3.8
real-time equivalent
amount of real-time aging to which given accelerated aging conditions are estimated to be equivalent
3.9
zero time
the beginning of an aging study
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 and by subsequent dynamic events during shipping and handling.
4.2 The packaging system shall provide physical protection and maintain integrity of the sterile barrier system. The sterile barrier system shall maintain sterility to the point of use or until the expiry date. Stability testing shall demonstrate that the sterile barrier system maintains integrity over time. Stability testing using accelerated aging protocols shall be regarded as sufficient evidence for claimed expiry date 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 materials and sterile barrier system integrity do not degrade over time. However, due to market conditions in which products become obsolete in a short time, and the need 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. To ensure that accelerated aging studies do truly 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 shall be used if little is known about the sterile barrier system material being evaluated. More aggressive accelerated aging factors 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 claimed shelf life, it shall 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 expiry date or shelf life is based on the use of a conservative estimate of the aging factor (for example, Q10) and is tentative until the results of real time aging studies are completed on the sterile barrier system.
Note: Determining accelerated aging factor is beyond the scope of this part.
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.
5.2 Control apparatus, capable of maintaining the room (cabinet) at the required atmospheric conditions within the tolerance limits.
5.3 Hygrometer, the instrument used to indicate the relative humidity, which should be accurate to ±2 %.
Note: A psychrometer may be used either for direct measurement of relative humidity or for checking the hygrometer.
5.4 Thermometer, any temperature-measuring device which may be used provided it can accurately indicate the temperature to within 0.1℃ and be properly recorded.
Note: The dry-bulb thermometer of the psychrometer may be used either for direct measurement or for checking the temperature-indicating device.
Foreword i 1 Scope 2 Normative references 3 Terms and definitions 4 Significance and use 5 Apparatus 6 Accelerated aging theory 7 Accelerated aging plan 8 Post-aging testing guidance 9 Report Annex A (Normative) Accelerated aging of polymers Annex B (Informative) Examples for sterile barrier system shelf-life test plan Annex C (Informative) Using relative humidity in aging protocols Bibliography
Codeofchina.com is in charge of this English translation. In case of any doubt about the English translation, the Chinese original shall be considered authoritative.
YY/T 0681 comprises the following parts under the general title Test methods for sterile medical device package:
—— 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: Testing the microbial barrier for porous packaging materials under moist conditions and with passage of air;
—— Part 15: Performance testing of shipping containers and systems;
—— Part 16: Test for climatic stressing of packaging system.
This is part 1 of YY/T 0681.
This part is developed 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. In addition to editorial changes, the following main technical changes have been made with respect to YY/T 0681.1-2009:
——for sterile packaging, the term "packaging" is replaced with "sterile barrier system";
——"actual-time aging" is changed to "real-time aging" in a unified way;
——subclause 4.2 under "Significance and use" is modified to "the packaging system shall…";
——subclause 4.5 is added to "Significance and use";
——subclause 5.4 under “Apparatus” requires that the temperature-measuring device “can be properly recorded”;
——subclause 6.5 is added to the "Accelerated aging theory";
——"for example, the temperature selected should be at least 10℃ lower than the Tg of the material” is deleted from subclause 7.2.3 under "Accelerated aging plan";
——notes 3 and 4 are added to subclause 7.2.3 under "Accelerated aging plan";
——subclause 7.4.5 is added to the "Accelerated aging plan";
——subclause 7.5 is deleted from the "Accelerated aging plan";
——clause 8 "Post-aging testing guidance" is revised on the whole;
——Figure B.1 is deleted from Annex B;
——”where applicable, Practice ASTM D 4169 may be referred to for...” is deleted from B.5;
——the note to Annex B.6 is changed to “Humidity effects can be evaluated as part of the package system design performance qualification testing”;
——Annex C (Informative) “Using relative humidity in aging protocols” is added.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. The issuing body of this document shall not be held responsible for identifying any or all such patent rights.
This part was proposed by the National Medical Products Administration of People’s Republic of China.
This part is under the jurisdiction of the National Technical Committee 342 on Medical Syringes of Standardization Administration of China.
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 provides guidance for developing accelerated aging protocols.
This part is applicable to rapidly determine the effects, if any, due to the passage of time on the sterile integrity of the sterile barrier system (SBS), as defined in GB/T 19633.1-2015 and the physical properties of their component packaging materials.
Note 1: Information obtained using this part of YY/T 0681 may be used to support expiration date claims (i.e. shelf life) for medical device sterile barrier systems.
This part is not applicable to real-time aging protocols.
Note 2: The accelerated aging test addresses the sterile barrier systems in 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 part.
Note 3: It is essential that real-time aging test be performed to confirm the accelerated aging test results.
Note 4: Methods used for sterile barrier system validation, which include the machine process, the effects of the sterilization process, distribution, handling, and shipping events, are beyond the scope of this part. See YY/T 0681.15 for the resistance against shipping challenges of sterile barrier systems.
Note 5: This part does not address extreme climactic conditions that may exist in the shipping and handling environment. See YY/T 0681.16 for climatic adaptability test of sterile barrier systems.
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 - Basic tests for transport packages - Part 2: 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 given in GB/T 19633.1-2015 and the following apply.
3.1
accelerated aging
storage of samples at an elevated temperature in order to simulate real time aging in a reduced amount of time
3.2
accelerated aging factor
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 conditions
Note: The aging factor for a 10℃ increase or decrease in the temperature, Q10, is a conservative estimate of the accelerated aging factor.
3.3
accelerated aging temperature
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
3.4
accelerated aging time
the length of time the accelerated aging is conducted
3.5
ambient temperature
storage temperature for real-time aging samples that represents storage conditions
3.6
sterile barrier system shelf life
the amount of 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
Note: “Shelf life” is a term frequently used in the laws and regulations of China, referred to as “expiry date” in GB/T 19633.1-2015.
3.7
real-time aging
aging of samples under storage at ambient conditions
Note: The term “real-time aging” is referred to as "actual-time aging" in GB/T 19633.1-2015.
3.8
real-time equivalent
amount of real-time aging to which given accelerated aging conditions are estimated to be equivalent
3.9
zero time
the beginning of an aging study
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 and by subsequent dynamic events during shipping and handling.
4.2 The packaging system shall provide physical protection and maintain integrity of the sterile barrier system. The sterile barrier system shall maintain sterility to the point of use or until the expiry date. Stability testing shall demonstrate that the sterile barrier system maintains integrity over time. Stability testing using accelerated aging protocols shall be regarded as sufficient evidence for claimed expiry date 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 materials and sterile barrier system integrity do not degrade over time. However, due to market conditions in which products become obsolete in a short time, and the need 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. To ensure that accelerated aging studies do truly 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 shall be used if little is known about the sterile barrier system material being evaluated. More aggressive accelerated aging factors 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 claimed shelf life, it shall 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 expiry date or shelf life is based on the use of a conservative estimate of the aging factor (for example, Q10) and is tentative until the results of real time aging studies are completed on the sterile barrier system.
Note: Determining accelerated aging factor is beyond the scope of this part.
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.
5.2 Control apparatus, capable of maintaining the room (cabinet) at the required atmospheric conditions within the tolerance limits.
5.3 Hygrometer, the instrument used to indicate the relative humidity, which should be accurate to ±2 %.
Note: A psychrometer may be used either for direct measurement of relative humidity or for checking the hygrometer.
5.4 Thermometer, any temperature-measuring device which may be used provided it can accurately indicate the temperature to within 0.1℃ and be properly recorded.
Note: The dry-bulb thermometer of the psychrometer may be used either for direct measurement or for checking the temperature-indicating device.
Contents of YY/T 0681.1-2018
Foreword i
1 Scope
2 Normative references
3 Terms and definitions
4 Significance and use
5 Apparatus
6 Accelerated aging theory
7 Accelerated aging plan
8 Post-aging testing guidance
9 Report
Annex A (Normative) Accelerated aging of polymers
Annex B (Informative) Examples for sterile barrier system shelf-life test plan
Annex C (Informative) Using relative humidity in aging protocols
Bibliography
