rob73
looking for answers
Hi Guys
What do we think about the requirement for device to have independent certification using an ISO 17025 laboratory. A friend has been asked for this in a new NHS contract, setting aside that if this is a new contractual agreement he may not have any choice, is this strictly necessary for CE marking a class 11a device? BTW he's being asked for certification to [FONT="]BS EN ISO 8836:2014 suction catheter by an ISO 17025 test house.
****edit*****
Since found out that BS EN ISO 8836:2014 does not appear in the official journal, so it is not harmonised, but could still be considered stat of the art??
[/FONT]
What do we think about the requirement for device to have independent certification using an ISO 17025 laboratory. A friend has been asked for this in a new NHS contract, setting aside that if this is a new contractual agreement he may not have any choice, is this strictly necessary for CE marking a class 11a device? BTW he's being asked for certification to [FONT="]BS EN ISO 8836:2014 suction catheter by an ISO 17025 test house.
****edit*****
Since found out that BS EN ISO 8836:2014 does not appear in the official journal, so it is not harmonised, but could still be considered stat of the art??
[/FONT]
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