YY/T 0681.3-2010 (YY/T0681.3-2010, YYT 0681.3-2010, YYT0681.3-2010)
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 0681.3-2010 | English | 175 |
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Test methods for sterile medical device package. Part 3: Internal pressurization failure resistance of unrestrained packages
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YY/T 0681.3-2010
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| Standard ID | YY/T 0681.3-2010 (YY/T0681.3-2010) | | Description (Translated English) | Test methods for sterile medical device package. Part 3: Internal pressurization failure resistance of unrestrained packages | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C31 | | Classification of International Standard | 11.080.40 | | Word Count Estimation | 10,147 | | Date of Issue | 2010-12-27 | | Date of Implementation | 2012-06-01 | | Quoted Standard | GB/T 2918; YY/T 0681.2 | | Adopted Standard | ASTM F1140-2007, MOD | | Drafting Organization | Shandong Province Quality Inspection Center of Medical Devices | | Administrative Organization | National Technical Committee of Standardization for medical infusion | | Regulation (derived from) | State Food and Drug Administration Notice 2010 No. 97 | | Issuing agency(ies) | China Food and Drug Administration | | Summary | This standard specifies the ability to withstand the internal pressure was measured packing procedures. Bursting test was gradually pressurized inside the packaging until the package damage. Creep test was applied to a predetermined pressure and maintaining a predetermined time or until the package damage. |
YY/T 0681.3-2010
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 3. Internal Pressurization Failure
Resistance of Unrestrained Packages
ISSUED ON. DECEMBER 27, 2010
IMPLEMENTED ON. JUNE 01, 2012
Issued by. China Food and Drug Administration
Table of Contents
Foreword ... 3
1 Scope ... 5
2 Normative references ... 5
3 Terms and definitions ... 5
4 Summary of test method ... 6
5 Significance and use ... 6
6 Apparatus ... 8
7 Sampling ... 8
8 Conditioning ... 9
9 Procedure ... 9
10 Report ... 12
Appendix A ... 13
Appendix B ... 14
Foreword
The general title of YY/T 0681 is “Test methods for sterile medical device package”,
which 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.
Other parts will be formulated continuously1.
This Part is Part 3 of YY/T 0681.
This Part was drafted according to the rules given in GB/T 1.1-2009.
This Part of YY/T 0681 revises and adopts ASTM F 1140-07 “Internal Pressurization
Failure Resistance of Unrestrained Packages”.
This Part shall be under jurisdiction of the National Standardization Technical
Committee on Infusion Equipment for Medical Use.
Drafting organization of this Part. Shandong Quality Inspection Center for Medical
Devices.
1 Other parts will convert the relevant test method standards about packages for medical use
in ASTM F.
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 packages
to withstand internal pressurization.
The burst test is to gradually pressurize the package until the package fails.
The creep test maintains a specified pressure for a specified time or until the package
fails.
Note. Appendix A gives the relevant information of the precision and bias of the test methods
specified in this Standard.
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.
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 battier materials
3 Terms and definitions
The following terms and definitions apply to this document.
3.1 Flexible
A material of the proper flexural strength and thickness to permit a turn back at an
appropriate 180° angle. In order to fulfill all terms of the definition, at least one of the
sealed materials must be flexible.
Appendix B
(Informative)
Testing packages with a large porous area
B.1 The testing of the seals of packages with porous barrier materials may be limited
due to the inability to provide sufficient air volume. An example of this inability to
provide sufficient air volume may be encountered when the package is so large that
air leaks through the porous barrier faster than it can be applied. Because of this air
leakage, inadequate force due to lower pressure will not allow either the bursting of
the seals or reaching the desired holding pressure level.
B.2 Industry has typically responded to this effect by limiting the porous barrier area.
There are two major classifications of barrier blocking agents, the first being labels or
tape, and the second being non-solid agents that are spread across the porous barrier
material. Caution must be used with any method of blocking to ensure that the porous
barrier area is consistently and uniformly covered or coated. When using labels or tape
as blocking agents, it is important that the blocking material does not reinforce the seal
area being tested on the package. When using non-solid blocking agents that require
spreading over the porous barrier material, caution must be used to ensure that the
blocking agent does not affect the seal bonding area by penetrating the porous barrier
material.
B.3 Regardless of the method used, consistency of the area blocked is necessary to
provide minimum variability in the method. Validation of this method is necessary when
used for regulated products.
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