Applicability of the standard IEC 60601-2-18 to an arthroscopy pump

[Souheil]

I have a question regarding the applicability of the standard 60601-2-18 to an arthroscopy pump.

The pump is intended to be used with endoscopes of different brands. It has no viewing means. It is intended to inject a liquid under a given pressure to the body cavity (knee or shoulder) and to maintain the pressure at a given value. It also helps evacuating the debries produced by the shaver.
In the scope of this standard, it is stated:

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ENDOSCOPIC EQUIPMENT together with its INTERCONNECTION CONDITIONS and INTERFACE CONDITIONS.

How do you interpret “together with” ? Does it mean that the standard applies to every equipment connected to an endoscope ?
If we consider the pump as an ENDOTHERAPY DEVICE rather than an ENDOSCOPE, does the standard applies ?

Thank you in advance for your help.

 

[Pads38]

I am not familiar with that particular standard but -

you show the scope of the standard. In that certain terms are capitalised; this indicates that they are "defined terms". That means that later in the standard (section 3) they will each have a formal definition that should allow a better understanding of exactly what-is-what.

 

[Souheil]

Thank you Pads38 for your answer.

After going through the Annex AA of the standard, I'm now convinced that this standard is applicable.

Thank you for the hint regarding the definitions

 

[Pads38]

You may find that you can use applicable parts of the standard. But where I have used that approach in the past and stated, in my list of 'Applicable Standards', that the standard 'Applies in part' that has tended to cause confusion with reviewers/auditors.

Instead, I would suggest that you mark it simply as 'Applicable' and then use your Test Report Form to indicate which parts are applicable and which are N/A (with rationale for the Not part).