YY/T 0681.11-2014 English PDF (YYT0681.11-2014)

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YY/T 0681.11-2014: Test methods for sterile medical device package. Part 11: Determining integrity of seals for medical packaging by visual inspection
YY/T 0681.11-2014
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.080.40
C 31
Test Methods for Sterile Medical Device
Package - Part 11. Determining Integrity of Seals
for Medical Packaging by Visual Inspection
ISSUED ON. JUNE 17, 2014
IMPLEMENTED ON. JULY 01, 2015
Issued by. China Food and Drug Administration
Table of Contents
Foreword ... 3 
Introduction ... 5 
1 Scope ... 6 
2 Normative references ... 6 
3 Terms and definitions ... 6 
4 Summary of test method ... 7 
5 Significance and use ... 7 
6 Apparatus ... 7 
7 Procedure ... 7 
Appendix A ... 9 
Appendix B ... 11 
Bibliography ... 13 
Foreword
YY/T 0681 is “Test methods for sterile medical device package” consists of the
following 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.
This Part is Part 11 of YY/T 0681.
This Part was drafted according to the rules given in GB/T 1.1-2009.
This Part was formulated by referencing ASTM F 1886-1998 “Determining Integrity of
Seals for Medical Packaging by Visual Inspection”.
Please note that some of the content of this document may involve patents. The issuing
agency of this document does not undertake the responsibility of identifying these
patents.
This Part shall be under the jurisdiction of the National Standardization Technical
Test Methods for Sterile Medical Device Package - Part
11. Determining Integrity of Seals for Medical
Packaging by Visual Inspection
1 Scope
The test method specified in this Part of YY/T 0681 covers the determination of
channels in the package seal down to a width of 75 μm with a 60 % ~ 100 % probability
(see Appendix 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 documents are essential to the application of this document. For the
dated documents, only the versions with the dates indicated are applicable to this
document; for the undated documents, only the latest version (including all the
amendments) are applicable to this document.
ASTM F 17 Standard terminology relating to flexible barrier packaging
3 Terms and definitions
The following terms and definitions apply to this document.
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
Bibliography
[1] ASTM E 691 Practical for Conducting an Interlaboratory Study to Determine the
Precision of a Test Method