M
Hi Everyone,
Planning a draft of the instructions for use for a ME equipment used in the home.
As such, we'd like to comply with the home healthcare standard IEC 60601-1-11.
Having some difficulty. In particular, with the following requirement:
"...usability of identification, marking and accompanying documents...shall be evaluated based on an operator profile that includes a maximum of eight years education." (underline added)
Anyone have any experience as to how this is evaluated in practice?
Presumably there are exceptions, namely with regards to technical specifications and contraindications?
The contraindications, in particular, list a bunch of conditions that most people, let alone with a "maximum of eight years education" would recognize.
...but the contraindications must be stated. No way around that....
Any input?
Thanks,
MM.
Planning a draft of the instructions for use for a ME equipment used in the home.
As such, we'd like to comply with the home healthcare standard IEC 60601-1-11.
Having some difficulty. In particular, with the following requirement:
"...usability of identification, marking and accompanying documents...shall be evaluated based on an operator profile that includes a maximum of eight years education." (underline added)
Anyone have any experience as to how this is evaluated in practice?
Presumably there are exceptions, namely with regards to technical specifications and contraindications?
The contraindications, in particular, list a bunch of conditions that most people, let alone with a "maximum of eight years education" would recognize.
...but the contraindications must be stated. No way around that....
Any input?
Thanks,
MM.