The organization shall maintain records of the process parameters for the sterilization process which was used for each sterilization batch (see 4.2.4). Sterilization records shall be traceable to each production batch of medical devices (see 7.5.1.1).
bag
quality_public
created
Thu, 16 Apr 2015 15:00:32 GMT
creator
dirkjan
modified
Thu, 16 Apr 2015 15:00:32 GMT
modifier
dirkjan
tags
ISO13485