YY/T 0681.11-2014Test methods for sterile medical device package - Part 11: Determining integrity of seals for medical packaging by visual inspection (English PDF)
无菌医疗器械包装试验方法 第11部分：目力检测医用包装密封完整性
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
June 17, 2014
Implementation date
July 1, 2015
Scope
YY/T 0681.11-2014 is the English-translated version of 无菌医疗器械包装试验方法 第11部分：目力检测医用包装密封完整性.
YY/T 0681.11-2014 is the Chinese pharmaceutical industry standard that gives the test method for judging the integrity of the seals of a medical package by visual inspection.
It is the eleventh part of the YY/T 0681 series and covers the detection of channels in a seal down to a width of 75 micrometres, with a probability of between 60 % and 100 %, setting out the lighting and the viewing conditions, the inspector and the procedure by which a package is examined and judged. Issued on 17 June 2014, it has applied since 1 July 2015.
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Document preview — YY/T 0681.11-2014
National Standard of the People's Republic of China
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword3
- Introduction5
- 1 Scope6
- 2 Normative references6
- 3 Terms and definitions6
- 4 Summary of test method7
- 5 Significance and use7
- 6 Apparatus7
- 7 Procedure7
- Appendix A9
- Appendix B11
- Bibliography13
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".
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 […]
11 Determining Integrity of Seals for Medical
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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.
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Related Standards
YY/T 0681.12-2022 — Test methods for sterile medical device package - Part 12: Flex durability of flexible barrier materials
YY/T 0681.10-2011 — Test methods for sterile medical device package - Part 10: Test for microbial barrier ranking of porous package material
YY/T 0681.12-2014 — Test methods for sterile medical device package - Part 12: Flex durability of flexible barrier films
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