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EU MDR Annex I section 11.3 - Medical Devices labelled as having a specific microbial state

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?
I "assume" it means the device is sterile, I suppose it could also include clean or another microbial state. I can only think of an Biological Indicator?.

11.4, 11.5 and 11.6 are all variations on different aspects of sterility. I am not sure why 11.3 is worded different.

Marcelo Antunes

Addicted to standards
Staff member
The most obvious is a sterile device, but even so, devices may have different sterility assurance level, so any level, would be a different state.

You may also have device which have other, different, specific defined microbial states.


Involved In Discussions
Reference the symbols in ISO 15223-1, which include the following:
Sterilized using aseptic processing techniques
Sterilized using ethylene oxide
Sterilized using irradiation
Sterilized using steam or dry heat
Sterile fluid path

To comply with the requirement that sterile medical devices..."remain so under the transport and storage conditions specified by the manufacturer," medical device manufacturers must include sterilization tests in their real-time aging studies to ensure a medical device remains sterile during the entire shelf life.
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