YY/T 0681.11-2014 Test methods for sterile medical device package―Part 11:Determining integrity of seals for medical packaging by visual inspection (English Version)
1 Scope
This test method covers the determination of channels in the package seal down to a width of 75 µm with a 60 to 100 % probability (see Annex B).
This test method is applicable to flexible and rigid packages with at least one transparent side so that the seal area may be clearly viewed.
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.
ASTM F 17 Standard terminology relating to flexible barrier packaging
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
channel
any unimpaired pathway across the entire width of the intended seal
3.2
sterile package integrity
property of the package seal and material, which ensures that it presents a microbial barrier (see also ASTM F 17, Microbiological package integrity)
4 Summary of test method
This test method provides a qualitative visual inspection method to evaluate the appearance characteristics of unopened, intact seals in order to determine the presence of defects that may affect the integrity of the package.
Note: Annex A gives the appearance defects of the seal and their causes, and Annex B gives the precision and bias of the test methods specified in this standard.
Foreword i
Introduction iii
1 Scope
2 Normative references
3 Terms and definitions
4 Summary of test method
5 Significance and use
6 Apparatus
7 Procedure
Annex A (Informative) Seal appearance characteristics and probable causes
Annex B (Informative) Precision and bias
Bibliography
Standard
YY/T 0681.11-2014 Test methods for sterile medical device package―Part 11:Determining integrity of seals for medical packaging by visual inspection (English Version)
Standard No.
YY/T 0681.11-2014
Status
valid
Language
English
File Format
PDF
Word Count
5500 words
Price(USD)
150.0
Implemented on
2015-7-1
Delivery
via email in 1 business day
Detail of YY/T 0681.11-2014
Standard No.
YY/T 0681.11-2014
English Name
Test methods for sterile medical device package―Part 11:Determining integrity of seals for medical packaging by visual inspection
1 Scope
This test method covers the determination of channels in the package seal down to a width of 75 µm with a 60 to 100 % probability (see Annex B).
This test method is applicable to flexible and rigid packages with at least one transparent side so that the seal area may be clearly viewed.
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.
ASTM F 17 Standard terminology relating to flexible barrier packaging
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
channel
any unimpaired pathway across the entire width of the intended seal
3.2
sterile package integrity
property of the package seal and material, which ensures that it presents a microbial barrier (see also ASTM F 17, Microbiological package integrity)
4 Summary of test method
This test method provides a qualitative visual inspection method to evaluate the appearance characteristics of unopened, intact seals in order to determine the presence of defects that may affect the integrity of the package.
Note: Annex A gives the appearance defects of the seal and their causes, and Annex B gives the precision and bias of the test methods specified in this standard.
Contents of YY/T 0681.11-2014
Foreword i
Introduction iii
1 Scope
2 Normative references
3 Terms and definitions
4 Summary of test method
5 Significance and use
6 Apparatus
7 Procedure
Annex A (Informative) Seal appearance characteristics and probable causes
Annex B (Informative) Precision and bias
Bibliography
