Annex I section 11.3 states "Devices labelled as having a specific microbial state shall be designed, manufactured and packaged to ensure that they remain in that state when placed on the market and remain so under the transport and storage conditions specified by the manufacturer."
What is a medical device with 'specific microbial state'?
whether it is a sterilized device or not?
What is a medical device with 'specific microbial state'?
whether it is a sterilized device or not?