mikinnear
Starting to get Involved
Hi All,
I have been searching for a couple of days for the answers I seek with no avail. I thought the great minds here might be able to assist.
I am implementing ISO 13485:2016 for a client for a class IIb disinfectant preparation for "disinfecting intrusive medical devices".
It's my first time working with a disinfectant medical device, and I would like to know if there is a list of microbiological standards needed to prove efficacy and a list of pathogens that need to be tested against.
I have an idea from other products but any official literature would be ideal.
Does anyone have any information on this?
Many thanks,
Mike.
I have been searching for a couple of days for the answers I seek with no avail. I thought the great minds here might be able to assist.
I am implementing ISO 13485:2016 for a client for a class IIb disinfectant preparation for "disinfecting intrusive medical devices".
It's my first time working with a disinfectant medical device, and I would like to know if there is a list of microbiological standards needed to prove efficacy and a list of pathogens that need to be tested against.
I have an idea from other products but any official literature would be ideal.
Does anyone have any information on this?
Many thanks,
Mike.
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