Codeofchina.com is in charge of this English translation. In case of any doubt about the English translation, the Chinese original shall be considered authoritative.
This document is developed in accordance with the rules given in GB/T 1.1-2020 Directives for standardization — Part 1: Rules for the structure and drafting of standardizing documents.
This document is Part 12 of YY/T 0681 Test methods for sterile medical device package. The following parts of YY/T 0681 have been issued:
——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 within 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 materials;
——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 document replaces YY/T 0681.12-2014 Test methods for sterile medical device package — Part 12: Flex durability of flexible barrier films. In addition to structural adjustment and editorial changes, the following main technical changes have been made with respect to YY/T 0681.12-2014:
a) The standard scope has been modified (see Clause 1 herein; Clause 1 of Edition 2014);
b) The clause “Terms and definitions” has been added (see Clause 3 herein);
c) The expression of evaluation methods related to porous materials such as paper and polyolefin nonwovens has been added (see 4.2 herein, 3.2 of Edition 2014);
d) The 4.1 and 4.5 of "Meaning and application" have been deleted (see 4.1 and 4.5 of Edition 2014);
e) The dimensional accuracy of "Flex tester" has been added (see 6.1 herein, 5.1 of Edition 2014);
f) The subclause "Determination of the results of the flex test" has been added (see 9.3 herein);
g) The subclause "Pinhole count" has been deleted (see 8.3 of Edition 2014);
h) The contents of "report" have been modified (see Clause 10 herein; Clause 9 of Edition 2014).
i) The "Precision and bias" of Annex A has been deleted (Annex A of the Edition 2014);
j) The "Pinhole counting test" has been added (see Annex A herein);
k) The "Gas and/or water vapor transmission test" has been added (see Annex B herein).
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 document was proposed by the National Medical Products Administration of the People’s Republic of China.
This document is under the jurisdiction of National Technical Committee on Medical Syringes of Standardization Administration of China (SAC/TC 106).
The previous editions of this document are as follows:
——This standard was issued in 2014 as first edition (YY/T 0681.12-2014);
——This edition is the first revision.
Introduction
Sterile medical device package has the ability of sterile barrier to protect internal medical device products. Medical devices may be affected by external forces such as flex, twisting and bending during transportation, storage and use, and the package of sterile medical devices may keep them sterile continuously. This document shows the test conditions and evaluation methods of flex durability of sterile medical device package. YY/T 0681 temporarily consists of 18 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 within 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 materials;
——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.
Test methods for sterile medical device package — Part 12: Flex durability of flexible barrier materials
1 Scope
This document describes the test method for flex durability of flexible barrier materials.
This document is applicable to the test for flex durability of flexible barrier materials.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
GB/T 2918 Plastics — Standard atmospheres for conditioning and testing
3 Terms and definitions
For the purpose of this document, the following terms and definitions apply.
3.1
pinhole
small opening of non-specific shape or dimension that can completely penetrate all layers of flexible barrier materials
3.2
flexible
easily folded, bent, or twisted by hand
4 Summary of test methods
4.1 Unless otherwise specified, flex tests shall be conducted on flexible barrier material samples under standard atmospheric conditions. Flex conditions, times and degrees vary with different structural types of samples. Flex consists of a twisting movement and subsequent horizontal movement (in most cases). In this way, the sample is torsional and compressed repeatedly. The frequency shall be 45 times/min.
4.2 Determine the degree of damage to the structural and/or mechanical properties of the material by flex test. The performance to be evaluated in flex test determines the appropriate test condition level. Flexible barrier membrane materials may be subject to pinhole counting test, gas and/or water vapor transmission test methods, as shown in Annexes A and B. For the evaluation method of porous materials such as paper and polyolefin nonwovens, please refer to GB/T 19633.1 or YY/T 0698 and other standards1).
4.3 The various test conditions are summarized as follows:
a) Condition A: Flex completely for 1 h (i.e. 2,700 cycles);
b) Condition B: Flex completely for 20 min (i.e. 900 cycles);
c) Condition C: Flex completely for 6 min (i.e. 270 cycles);
d) Condition D: Flex completely for 20 cycles;
e) Condition E: Flex partially for 20 cycles.
5 Application
5.1 The various conditions described in this test are intended to prevent too many pinholes that are inconvenient to count and meaningless, and too few pinholes that are meaningless when testing a sample structure. Generally, the number of pinholes on each sample should be between 5 and 50. Material structure, test purpose and agreement between related parties are important factors to be considered when selecting test condition level.
5.2 This test method does not measure any worn parts related to flex to breakage.
5.3 Damage to the integrity of one or more layers in a composite layer structure requires different tests in addition to checking that it completely passes through pinholes in the structure. A gas transmission and/or water vapor transmission test may be combined with a flex test to measure whether the integrity of the layer is lost. However, in the case of pinholes, any transmission test requiring differential pressure cannot measure the penetration coefficient.
6 Test apparatus
6.1 The flex tester is designed to be set up according to the specifications listed in Clause 9. The apparatus shall mainly consist of a fixed shaft with a diameter of (90 ± 1) mm and a moving shaft with a diameter of (90 ± 1) mm. When the moving shaft is at the start position (i.e. the maximum distance), the distance between the two shafts is (180 ± 2) mm. The two shafts shall have vents to prevent the specimen from being subjected to pressure. The shoulder width of the two shafts for fixing the specimen shall be (13 ± 1) mm. The movement of the moving shaft is controlled by the groove shaft connected with it. For full-travel or maximum-travel, the groove shows a rotary motion of (440 ± 4)° in the first 90 mm of the travel of the moving shaft, followed by a horizontal linear motion of 65 mm. The nearest distance between the two axes is (25 ± 1) mm. The motion of a machine consists of a complete cycle of process and return. The machine runs at 45 times/min.
See Figure 1 for the unfolded plane view of the rotating spiral groove with the required 440° (37° helix angle) rotating motion and linear horizontal motion of the drive shaft.
For the partial flex used in Condition E, the moving shaft moves forward only 80 mm at a distance of 180 mm, so only about 90% of the rotational travel is used, and the rotational motion of 400° is given, and the horizontal travel is not used.
Foreword i
Introduction iv
1 Scope
2 Normative references
3 Terms and definitions
4 Summary of test methods
5 Application
6 Test apparatus
7 Test sample preparation
8 Conditioning
9 Procedure
10 Reporting
Annex A (Informative) Pinhole counting test
Annex B (Informative) Gas and/or water vapor transmission test
Bibliography
