YY/T 0681.12-2014 Translated English of Chinese Standard. (YYT 0681.12-2014, YY/T0681.12-2014, YYT0681.12-2014): Test methods for sterile medical device package - Part 12: Flex durability of flexible barrier filmshttps://www.chinesestandard.net, 2020 M02 22 - 12 pages This part of YY/T 0681 includes the determination of the flex durability of flexible barrier films. In this test method, the formation of pinhole is used as the criterion for determining the damage. Other tests such as gas transmission may also be used instead of pinhole tests. |
Contents
| 3 | |
Scope | 5 |
Significance and application | 6 |
Preparation of specimen | 8 |
Report | 10 |
Appendix A Informative Precision and bias | 11 |
References | 12 |
Common terms and phrases
15 cm spiral 20 cycles 45 cycles/min 45 times/min action of complete adhesive tape anhydrous ASTM Completely rubbed cycles/min for 20 determine diameter of 90 document double-sided pressure-sensitive tape drafting organization durability of flexible dyed turpentine film specimen fix the samples fixed shaft Flex durability flexible barrier films flexible barrier sample flexible packaging materials frequency of 45 GB/T gives a rotation giving a 400 horizontal linear movement laboratory medical device package methods for sterile minutes i.e. movement of 65 moving shaft moves Number of pinholes partial rubbing penetration test Pinhole count pinhole test porous package Precision and bias relative humidity rotation of 440 rotational motion rubbed at 45 rubbed for 20 rubbing and rotation Rubbing conditions rubbing test rubbing tester samples are rubbed Set the rubbing specimen structure Standard atmospheres standard deviation sterile medical device stretch polyester test conditions test method Toilet paper Unless otherwise specified unrubbed control water vapor penetration YY/T