Hi Anon
A good rouse where there is lack of clarity, is to search the document for uses of the same word. So in 2017/746 the following occur:
Annex VIII, 2,1, 3rd indent: 'determining the infectious load of a life-threatening disease where monitoring is critical in the process of patient management'.
Annex I, 17.2: Devices where the safety of the patient depends on an internal power supply shall be equipped with a means of determining the state of the power supply and an appropriate warning or indication for when the capacity of the power supply becomes critical. If necessary, such warning or indication shall be given prior to the power supply becoming critical.
In both these cases, the word 'critical' is DIRECTLY linked to patient safety. I would use that.
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Rod Ruston FRAPS, RAC
Director
Milton Keynes
United Kingdom
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Original Message:
Sent: 02-Oct-2020 17:11
From: Anonymous Member
Subject: EU Critical Characteristics Definition
This message was posted by a user wishing to remain anonymous
In EU 2017/746, Annex VIII section 2.5 states "The following devices are classified as class A: Products for general laboratory use, accessories which possess no critical characteristics,...., relating to a specific examination"
Can anyone expound on what is specifically meant by "critical characteristics" and/or what attribute and features are considered "critical" according to EU?
For example, would handling samples or sorting samples be considered as a critical characteristic?