IEC 60601-2-18 (IEC 601-2-18) Particular Requirements for Endoscopic Equipment

[DaGusta]

Hello @ all,

is there anybody out there who work with the IEC601-2-18?

I have a question regarding 20.2 B-d ( and the annex 20.2). What is the reason why we have to test the dielectric strength test only on the endoscop. The standard says in the annex 20.2 "without connection to their supply units". That make for me no sense, because if the endoscope is inside the human body, the connector of the endoscope is not connected to the supply unit and lay on the floor. What should happen? The connector is made of a kind of medical plastic and if there is a hazardous voltage on the applied part... there is no closed electrical circuit.

For a response many thanks in advance and best regards

 

[harry]

Re: Iec 601-2-18

Hello @ all,

is there anybody out there who work with the IEC601-2-18? ..........

Is that IEC 60601-2-18?

 

[DaGusta]

Re: Iec 601-2-18

Hello Harry,

yes thats right, that is the IEC 60601-2-18. There is an older version from 1996 .. on the standard is written: 601-2-18 IEC:1996. But i think that means the same.

Best regards
DG

 

[Peter Selvey]

The comment in the Annex is informative only, and seems to indicate that the endoscope "can" be tested by itself, but this does not mean it "must".

In my experience I have seen both cases: Type BF insulation is in the endoscope, and Type BF insulation is in the equipment. Both have been OK in testing and accepted with CB scheme test reports and also for NRTL marking.

The Annex remark may have been historical basis on the assumption that endoscope might be interchangeable, but these days most endoscopes with internal circuits (CCD cameras or ultrasound etc) are custom designed for specific equipment.

Also, this comment seems to have been removed in the 2009 edition (3rd edition).

 

[DaGusta]

Hi Peter,

for your statement. This helps me a lot! I thought this Annex is a "must" but if that is a "can" is everything ok. Because we have the insulation in the supply unit.

Yes you are right. In the third edition of the -2-18 this comment does not exist any more.

Best regards
DG

 

[DaGusta]

Does someone know when the DIN EN 60601-2-18 will be harmonized? The IEC 60601-2-18 is available since 2009 and since 2008 there is a draft. But i miss a date for the 3rd version.

For a short info many thanks in advance
Dagusta

 

[KevinSun]

Hi DaGusta,
I am glad can have a chance know you. I am kevin come from China one endoscopy accessories manufacturer. We have polypectomy snare Chinese report and need to translate into English. Now i have IEC 60601-1 and IEC 60601-2-2, i also need IEC 60601-2-18, can you send me English version of this full documents to my mail (old version is also ok), i appreciate you in advance. My mail is .

Thanks you, my friend!

kevin

 

[Pads38]

Hi Kevin,

60601-2-18, like all standards, is copyright material so cannot be shared.

The English version may be downloaded from here:

https://webstore.iec.ch/webstore/webstore.nsf/Artnum_PK/43263

Welcome to the forums.

 

[KevinSun]

Hi Marc Smith,
Thanks for your reply. I know that link but it is too expensive for me to download that documents. I am not expert, just need some lines which can corresponding our Chinese version, such as Clause 6, 6.1, 6.8.2 etc... help me translate our Chinese report into English report.
If you can help me will be appreciated!

Thanks you again.

Kevin Sun

 

[rezayatmand]

Hi
Hi please share IECEE TRF 60601-2-18E:2010
Thanks