How get prepared for IEC 60601 series testing

T

tallu

#1
Hello Folks,

Preparing device (Class II) for 60601 series tests is new to me.

We asked quote from testing facility for tests listed below.
EN 60601-1 (3rd ed)
EN 60601-1-2

Is there anything what we can do while waiting testlab answering our quote?

Should we start to preparate some documentation?

Tips and Hints are welcome!!
 
Elsmar Forum Sponsor
#2
Re: How get prepared for 60601 series testing

You could try here:

http://www.mecassociates.us/download.html

On that page you will find a 60601-1 guide, another for 14971 and further guidance on labelling and critical components.

There is much useful information on that site.

Disclosure:
No connections

For 60601-1-2 I would suggest considering 2 key things. Firstly, Essential Performance. This is what your device MUST keep doing whilst the various immunity tests take place and is the responsibility of the manufacturer to define (and justify). If there is an applicable "Part 2" for your device look in there for guidance.

Secondly, how are you going to monitor correct functioning of your device during these tests, bearing in mind that they go on for hours and for some the device is remote from you.
 

yodon

Staff member
Super Moderator
#3
Re: How get prepared for 60601 series testing

Pads nailed it but maybe under-emphasized 14971. Part of 3rd edition testing is a very thorough review of your risk file. Having one compliant with 14971 (hazard analysis, risk analysis, risk report, etc.) will certainly help facilitate the process. And, of course, that brings in the ever-fun issues with the harmonized version of 14971 (plenty of discussion here in the Cove over that one!)
 
#4
The first form from that linked site (Meca Associates) is their pre-test submission form where, for each clause of 60601-1 that mentions 'Risk' or 'Risk Management File' you are asked to detail how you have dealt with each part of the 14971 process.

So - Clause 4.6 on parts that contact the patient you have to fill in (or provide a pointer) for (14971) 4.2 Intended purpose, 4.3 Hazard identification, 4.4 Risk estimation, 5 Risk Evaluation, 5.2 Option analysis.

This may seem onerous (the blank form is 76 pages long!) but a test house cannot make assumptions - you have to provide them with every last detail.
 
T

tallu

#5
We have pre-EMC tested our device without any critical issues and our risk management is clearly described on our QMS.

Design phase risk analysis is performed and documented.

Anything else?
 
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