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YY/T 0681 consists of the following parts under the general title Test methods for sterile medical device package:
——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;
——Part 14: Testing the microbial barrier for porous packaging materials under moist conditions and with passage of air;
——Part 15: Performance testing of shipping containers and systems;
——Part 16: Test for climatic stressing of packaging system.
——Part 17: Testing the microbial barrier performance of porous package materials using aerosol filtration method;
——Part 18: Nondestructive detection of leaks in packages by vacuum decay method.
This is Part 4 of YY/T 0681.
This part is developed in accordance with the rules given in GB/T 1.1-2009.
This part replaces YY/T 0681.4-2010 Test methods for sterile medical device package - Part 4: Detecting seal leaks in porous packages by dye penetration. The following main technical changes have been made with respect to YY/T 0681.4-2010:
——The content in the scope is modified (see clause 1; clause 1 in Edition 2010);
——The definition of “channel” is modified (see 2.3; 2.3 in Edition 2010);
——The contents of data comparability and puncture notes are deleted (see 3.4 and 3.6 in Edition 2010);
——The content of test apparatus is added (see 4.3, 4.4 and 4.5);
——The sampling is added (see clause 7);
——The edge immersion method and drip method are added (see 9.2 and 9.3);
——The precision and bias of Methods B and C are added (see Annex A);
——The false positive guide is added (see Annex B).
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. The issuing body of this document shall not be held responsible for identifying any or all such patent rights.
This part was proposed by the National Medical Products Administration of People’s Republic of China.
This part is under the jurisdiction of SAC/TC 106 National Technical Committee on Medical Syringes of Standardization Administration of China.
This part was firstly issued in December 2010, and firstly revised this time.
Introduction
Harmful organisms or particulate matters may enter the interior of the package through leaks. These leaks are generally found at seals of packages made of the same or dissimilar materials. In this method, the dye penetrant is used to detect the leaks at the sealing edge of the package. Visually inspect the penetration of the dye penetrant after this dye penetrant is in contact with the sealing position of the package for a period of time. This test method may be used to judge and locate the leak location, but it is not a quantitative method, and cannot measure the size of the aperture. Therefore, “Pass/Fail” is usually used in this method as the test result.
This method covers three testing methods: injection, edge immersion and drip. The drip method requires the package to have an unsealed area outside the sealing edge. Related information about the precision and bias of the three testing methods is given in Annex A.
Test methods for sterile medical device package - Part 4: Detecting seal leaks in porous packages by dye penetration
1 Scope
This part of YY/T 0681 specifies the test methods for detecting seal leaks in porous packages by dye penetration.
This part is applicable to the testing of channels larger than or equal to 50μm at the seal of packages made of transparent materials and porous materials.
This part is not applicable to porous materials which appear dyed within 5s due to wicking, and to situations where the contrast between dye penetrant and opaque materials is not large.
2 Terms and definitions
For the purposes of this standard, the following terms and definitions apply.
2.1
wicking
migration of a liquid into the body of a fibrous material
2.2
dye penetrant
mixed aqueous solution of a coloring agent and a surfactant designed to indicate a defect location in the time prior to the onset of wicking (which will mask the defect’s presence)
2.3
channel
any undamaged passage across the entire width of the intended sealing area
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3 Significance and use
3.1 Harmful microorganism or particulate contaminants may enter the apparatus through leaks. These leaks are frequently found at seals formed between same or dissimilar materials. and they may also be caused by the pores of the material itself.
3.2 The dye penetration is applicable only to detecting individual leaks at the seal of packages, not to a number of small leaks found in porous packaging material, which need to be detected by other techniques.
3.3 There is no general agreement concerning the level of leakage that is likely to be deleterious to a particular package. However, since this test is designed to detect leaks, components that exhibit any indication of leaks are normally rejected.
3.4 The dye penetrant will penetrate into the porous material over time under wicking, but this will not generally occur within the maximum time recommended (generally no more than 20s). The dye will not discolor the surface of the material until wicking occurs. Annex B introduces wicking and the guide for identifying false positive.
4 Apparatus
4.1 Tools for destroying packaging materials, such as scissors (Method A in 9.1).
4.2 Dye penetrant dispenser, such as straw or syringe which can be used to inject dye penetrant (Method A in 9.1).
4.3 Container for dye penetrant (Method B in 9.2).
4.4 Scissors or other cutting tools (Method B in 9.2).
4.5 Eye dropper or pipette (Method C in 9.3).
4.6 Microscope or optical magnifying glass with magnification of 5X to 20X.
4.7 The aqueous dye penetrant solution consisting of, by mass fraction:
Wicking agent: TRITON X-100 0.5%
Indicator: toluidine blue 0.05%
Carrier: water 99.45%
Note: The solution is homogeneous. It shall be substituted if precipitate is found.
Other coloring agents or fluorescent agents may be substituted for toluidine blue, but their precision and bias must be experimentally determined.
Because of the viscous nature of the wicking agent, the solution is preferably prepared by weighing a container containing about 10% of the desired amount of aqueous solution, adding the corresponding amount of wicking agent to the water, and stirring or vibrating to mix them. Once the wicking agent is dispersed, the remaining water can then be added, followed by the toluidine blue.
5 Safety measures
Injecting dye penetrant into a package with a hypodermic needle and syringe is a common method for performing this test. This practice may result in puncture of the skin with a contaminated needle and is therefore not recommended. Because of this hazard, it is recommended that the dye penetrant be dispensed using a flexible tube attached to a syringe through an opening cut with a cutting tool.
Foreword i
Introduction iii
1 Scope
2 Terms and definitions
3 Significance and use
4 Apparatus
5 Safety measures
6 Test samples
7 Sampling
8 Conditioning
9 Procedure
10 Report
Annex A (Informative) Precision and bias of test methods
Annex B (Informative) False positive guide
Bibliography
