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Position: Chinese Standard in English/YY/T 0681.2-2010
YY/T 0681.2-2010   Test methods for sterile medical device package—Part 2:Seal strength of flexible battier materials (English Version)
Standard No.: YY/T 0681.2-2010 Status:valid remind me the status change

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Implemented on:2012-6-1 Delivery: via email in 1 business day

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Standard No.: YY/T 0681.2-2010
English Name: Test methods for sterile medical device package—Part 2:Seal strength of flexible battier materials
Chinese Name: 无菌医疗器械包装试验方法 第2部分:软性屏障材料的密封强度
Chinese Classification: C31    General and microsurgical devices
Professional Classification: YY    Professional Standard - Pharmaceutics
Issued on: 2010-12-27
Implemented on: 2012-6-1
Status: valid
Target Language: English
File Format: PDF
Word Count: 9000 words
Translation Price(USD): 270.0
Delivery: via email in 1 business day
1 Scope This part of YY/T 0681 covers the measurement of the strength of seals in flexible barrier materials. The test may be conducted on seals between a flexible material and rigid material. Seals tested in accordance with this test method may be from any source, laboratory or commercial. This test method may measure the force required to separate the tested seal. It can also identify the mode of specimen failure. Note: Annexes C and D respectively show the precision and bias of the test method specified in this standard, and relevant information determined. 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 3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO 11607-12) and the following apply. 3.1 average seal strength average force per unit width of seal required to separate progressively a flexible material from a rigid material or another flexible material, under the conditions of the test Note: The average force normally is calculated by the testing machine from the digitized plot of force versus grip travel. The plot starts from zero force after clack has been removed from the test strip. The initial ramp-up from zero to the force level required to peel the seal is not indicative of seal strength, and data from that part of the curve should not be included in the calculation of average strength, nor should the return to zero following complete failure of the specimen. The amount of data actually discarded on each end of the measured seal-profile curve must be the same for all tests within any set of comparisons of average seal strength (see 6.1 and 9.8.1). 3.2 flexible indicates a material with flexural strength and thickness permitting a turn back at an approximate 180 degree angle 3.3 maximum seal strength maximum force per unit width of seal required to separate progressively a flexible material from a rigid material or another flexible material, under the conditions of the test 4 Significance and use 4.1 Seal strength is a quantitative measure for use in process validation, process control, and capability. Seal strength is not only relevant to opening force and package integrity, but to measuring the packaging processes’ ability to produce consistent seals. Seal strength at some minimum level is a necessary package requirement, and at times it is desirable to limit the strength of the seal to facilitate opening. The maximum seal force is important information, but for some applications, average force to open the seal may be useful, and in those cases also should be reported. 4.2 When a seal fails adhesively (peel seal) the value of the bond strength measured is reported. A cohesive failure of the bond, delamination, or failure elsewhere in the test strip indicates that the substrate, not the seal interface, would be the limiting factor in the strength of a package. In those cases seal strength may be reported as “no less than” the strength measured. 4.3 A portion of the force measured when testing materials may be a bending component and not seal strength alone. A number of fixtures and schemes have been devised to hold samples at various angles to the pull direction to control this bending force. Because the effect of each of these on test results is varied, consistent use of one technique throughout a test series is recommended. Examples of fixtures and schemes are illustrated in Figure 1.
Foreword i 1 Scope 2 Normative references 3 Terms and definitions 4 Significance and use 5 Interferences 6 Apparatus 7 Sampling 8 Aging and conditioning 9 Procedure 10 Report Annex A (Normative) Interferences Annex B (Normative) Modes of seal failure Annex C (Informative) Precision and bias of the test method Annex D (Informative) ILS Background, Rationale and Analysis Bibliography
YY/T 0681.2-2010 is referred in:
*YY/T 0681.9-2011 Test methods for sterile medical device package—Part 9:Burst testing of flexible package seals using internal air pressurization weight restraining plates
Code of China
Standard
YY/T 0681.2-2010  Test methods for sterile medical device package—Part 2:Seal strength of flexible battier materials (English Version)
Standard No.YY/T 0681.2-2010
Statusvalid
LanguageEnglish
File FormatPDF
Word Count9000 words
Price(USD)270.0
Implemented on2012-6-1
Deliveryvia email in 1 business day
Detail of YY/T 0681.2-2010
Standard No.
YY/T 0681.2-2010
English Name
Test methods for sterile medical device package—Part 2:Seal strength of flexible battier materials
Chinese Name
无菌医疗器械包装试验方法 第2部分:软性屏障材料的密封强度
Chinese Classification
C31
Professional Classification
YY
ICS Classification
Issued by
Issued on
2010-12-27
Implemented on
2012-6-1
Status
valid
Superseded by
Superseded on
Abolished on
Superseding
Language
English
File Format
PDF
Word Count
9000 words
Price(USD)
270.0
Keywords
YY/T 0681.2-2010, YY 0681.2-2010, YYT 0681.2-2010, YY/T0681.2-2010, YY/T 0681.2, YY/T0681.2, YY0681.2-2010, YY 0681.2, YY0681.2, YYT0681.2-2010, YYT 0681.2, YYT0681.2
Introduction of YY/T 0681.2-2010
1 Scope This part of YY/T 0681 covers the measurement of the strength of seals in flexible barrier materials. The test may be conducted on seals between a flexible material and rigid material. Seals tested in accordance with this test method may be from any source, laboratory or commercial. This test method may measure the force required to separate the tested seal. It can also identify the mode of specimen failure. Note: Annexes C and D respectively show the precision and bias of the test method specified in this standard, and relevant information determined. 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 3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO 11607-12) and the following apply. 3.1 average seal strength average force per unit width of seal required to separate progressively a flexible material from a rigid material or another flexible material, under the conditions of the test Note: The average force normally is calculated by the testing machine from the digitized plot of force versus grip travel. The plot starts from zero force after clack has been removed from the test strip. The initial ramp-up from zero to the force level required to peel the seal is not indicative of seal strength, and data from that part of the curve should not be included in the calculation of average strength, nor should the return to zero following complete failure of the specimen. The amount of data actually discarded on each end of the measured seal-profile curve must be the same for all tests within any set of comparisons of average seal strength (see 6.1 and 9.8.1). 3.2 flexible indicates a material with flexural strength and thickness permitting a turn back at an approximate 180 degree angle 3.3 maximum seal strength maximum force per unit width of seal required to separate progressively a flexible material from a rigid material or another flexible material, under the conditions of the test 4 Significance and use 4.1 Seal strength is a quantitative measure for use in process validation, process control, and capability. Seal strength is not only relevant to opening force and package integrity, but to measuring the packaging processes’ ability to produce consistent seals. Seal strength at some minimum level is a necessary package requirement, and at times it is desirable to limit the strength of the seal to facilitate opening. The maximum seal force is important information, but for some applications, average force to open the seal may be useful, and in those cases also should be reported. 4.2 When a seal fails adhesively (peel seal) the value of the bond strength measured is reported. A cohesive failure of the bond, delamination, or failure elsewhere in the test strip indicates that the substrate, not the seal interface, would be the limiting factor in the strength of a package. In those cases seal strength may be reported as “no less than” the strength measured. 4.3 A portion of the force measured when testing materials may be a bending component and not seal strength alone. A number of fixtures and schemes have been devised to hold samples at various angles to the pull direction to control this bending force. Because the effect of each of these on test results is varied, consistent use of one technique throughout a test series is recommended. Examples of fixtures and schemes are illustrated in Figure 1.
Contents of YY/T 0681.2-2010
Foreword i 1 Scope 2 Normative references 3 Terms and definitions 4 Significance and use 5 Interferences 6 Apparatus 7 Sampling 8 Aging and conditioning 9 Procedure 10 Report Annex A (Normative) Interferences Annex B (Normative) Modes of seal failure Annex C (Informative) Precision and bias of the test method Annex D (Informative) ILS Background, Rationale and Analysis Bibliography
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