YY/T 0698.5-2009: Translated English of Chinese Standard. (YYT 0698.5-2009, YY/T0698.5-2009, YYT0698.5-2009): Packaging materials for terminal sterilized medical devices - Part 5: Heat and self-sealable and reels of paper and plastic film construction - Requirements and test methods24 jul 2016 - 17 pagina's This Part of YY/T 0698 provides requirements and test methods for sealable pouches complying with the Part 3, Part 6, Part 7, Part 9 and Part 10 in YY/T 0698 and reels manufactured from porous materials specified in 4.2.2 of this Part. This Part adds no additional requirements to the general requirements specified in ISO 11608-1. As such, the particular requirements in 4.2~4.5 can be used to verify compliance with one or more but not all of the requirements specified in ISO 11607-1. Sealable pouches and reels specified in this Part apply to the packaging of medical devices which are to be terminally sterilized. The use of sealable pouches and reels as preformed sterile barrier systems enables ease of presentation; most importantly, the users are able to see the contents of the pack before it is opened. |
