YY/T 0681.3-2010 Test methods for sterile medical device package—Part 3:Internal pressurization failure resistance of unrestrained packages (English Version)
1 Scope
This part of YY/T 0681 specifies the procedure for determining the ability of packaging to withstand internal pressure.
The burst test increasingly pressurizes the package until the package fails.
The creep test maintains a specified pressure for a specified time or until the package fails.
Note: Annex A gives information of the precision and bias of the test method specified in this standard.
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 2918 Plastics — Standard atmospheres for conditioning and testing
YY/T 0681.2 Test methods for sterile medical device package — Part 2: Seal strength of flexible barrier materials
3 Terms and definitions
For the purposes of this standard, the following terms and definitions apply.
3.1
flexible
characteristic of a material, i.e., the proper flexural strength and thickness to permit a turn back at an appropriate 180° angle; in order to fulfill all terms of the definitions, at least one of the sealed materials must be flexible
3.2
package failure
rupture of seal or material
3.3
restraint
mechanism that prevents package movement during inflation
4 Summary of test method
4.1 Test method A (burst test)
Packages are tested in an apparatus that internally pressurizes the package until the package fails. The pneumatic supply and pressurization equipment need the capability to maintain an increasing pressure until the package bursts. This test measures the maximum pressure detected before the package fails.
4.2 Test method B1 (creep test)
Packages are tested in apparatus that internally pressurizes the package to a specified pressure and maintains that internal package pressure for a specific time. This apparatus requires the ability to maintain the internal package pressure. The measurement result of this test is acceptable/rejectable.
4.3 Test method B2 (creep to failure)
Packages are subjected to creep test until the package fails. Test setup is similar to that of the creep test except the pressure setting will need to be higher to ensure the package fails in a reasonable amount of time (that is, about 15 s). The measurement result of this test is the time until failure.
5 Significance and use
5.1 These test methods provide a rapid means of evaluating tendencies for package failure when the package is exposed to a pressure differential. Pressure differentials may occur during processes such as sterilization and transportation.
5.2 These test methods are frequently used to quickly evaluate packages during the manufacturing process and at various stages of the package’s life cycle.
5.3 If the test results are to be repeatable, it is important that all parameters of the test method be exactly the same. Typical parameters may include, but are not limited to, package size, material, seal configuration, test equipment, rate of air flow into the package, sensitivity (machine response to pressure drop), and position of test article (see Figure 1).
5.4 These test methods do not necessarily provide correlation with actual package seal strength as typically measured using test method (or equivalent) specified in YY/T 0681.2.
Foreword i
1 Scope
2 Normative references
3 Terms and definitions
4 Summary of test method
5 Significance and use
6 Apparatus
7 Sampling
8 Conditioning
9 Procedure
10 Report
Annex A (Informative) Precision and bias of test methods
Annex B (Informative) Testing packages with a large porous area
YY/T 0681.3-2010 Test methods for sterile medical device package—Part 3:Internal pressurization failure resistance of unrestrained packages (English Version)
Standard No.
YY/T 0681.3-2010
Status
valid
Language
English
File Format
PDF
Word Count
6000 words
Price(USD)
170.0
Implemented on
2012-6-1
Delivery
via email in 1 business day
Detail of YY/T 0681.3-2010
Standard No.
YY/T 0681.3-2010
English Name
Test methods for sterile medical device package—Part 3:Internal pressurization failure resistance of unrestrained packages
1 Scope
This part of YY/T 0681 specifies the procedure for determining the ability of packaging to withstand internal pressure.
The burst test increasingly pressurizes the package until the package fails.
The creep test maintains a specified pressure for a specified time or until the package fails.
Note: Annex A gives information of the precision and bias of the test method specified in this standard.
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 2918 Plastics — Standard atmospheres for conditioning and testing
YY/T 0681.2 Test methods for sterile medical device package — Part 2: Seal strength of flexible barrier materials
3 Terms and definitions
For the purposes of this standard, the following terms and definitions apply.
3.1
flexible
characteristic of a material, i.e., the proper flexural strength and thickness to permit a turn back at an appropriate 180° angle; in order to fulfill all terms of the definitions, at least one of the sealed materials must be flexible
3.2
package failure
rupture of seal or material
3.3
restraint
mechanism that prevents package movement during inflation
4 Summary of test method
4.1 Test method A (burst test)
Packages are tested in an apparatus that internally pressurizes the package until the package fails. The pneumatic supply and pressurization equipment need the capability to maintain an increasing pressure until the package bursts. This test measures the maximum pressure detected before the package fails.
4.2 Test method B1 (creep test)
Packages are tested in apparatus that internally pressurizes the package to a specified pressure and maintains that internal package pressure for a specific time. This apparatus requires the ability to maintain the internal package pressure. The measurement result of this test is acceptable/rejectable.
4.3 Test method B2 (creep to failure)
Packages are subjected to creep test until the package fails. Test setup is similar to that of the creep test except the pressure setting will need to be higher to ensure the package fails in a reasonable amount of time (that is, about 15 s). The measurement result of this test is the time until failure.
5 Significance and use
5.1 These test methods provide a rapid means of evaluating tendencies for package failure when the package is exposed to a pressure differential. Pressure differentials may occur during processes such as sterilization and transportation.
5.2 These test methods are frequently used to quickly evaluate packages during the manufacturing process and at various stages of the package’s life cycle.
5.3 If the test results are to be repeatable, it is important that all parameters of the test method be exactly the same. Typical parameters may include, but are not limited to, package size, material, seal configuration, test equipment, rate of air flow into the package, sensitivity (machine response to pressure drop), and position of test article (see Figure 1).
5.4 These test methods do not necessarily provide correlation with actual package seal strength as typically measured using test method (or equivalent) specified in YY/T 0681.2.
Contents of YY/T 0681.3-2010
Foreword i
1 Scope
2 Normative references
3 Terms and definitions
4 Summary of test method
5 Significance and use
6 Apparatus
7 Sampling
8 Conditioning
9 Procedure
10 Report
Annex A (Informative) Precision and bias of test methods
Annex B (Informative) Testing packages with a large porous area
