What kind of materials should I prepare for passing ISO IEC 60601-1-4

W

wangyang

#1
Hi all:
I am preparing materials for passing 60601-1-4, and this is the first time that i contact such test--i mean, i have to prepare a lot of materials, and i don't know where to start?

Anyone who have experiances?

Thanks a lot.
 
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Marcelo

Inactive Registered Visitor
#2
Re: What kind of materials should i prepare for passing 60601-1-4

Basically, you have to define and use a development life-cycle for your software, and also apply risk managemt to the software during development, because this is the only approach to verify the safety of the software. What the standard asks if for the definition and implementation of the processes so the deliverables are the documentation of the processes.

For the development life-cycle, it would be interesting to use EC 62304:2006: Medical device software -- Software life cycle processes.

In the case of risk management, although IEC 60601-1-4 has a risk management framework, it´s an old one, and you should use ISO 14971 instead.
 
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C

celia4237

#3
Thank you for your response!

What i am worrying about is the documentation and the file that created from the software life cycle.

I don't know what exactly are the documents that is needed by 60601-1-4.

Can you give me more detail? Such as a checklist as well as the main content of every document.

Thanks a lot.
 
W

Watchwait

#4
Marcelo,

Just about the time I think I have the relationship between EN 62304 & IEC 60601-1-4 figured out, I lose it again...so once again:

IEC 60601-1-4 is a collateral standard to the base standard 60601. As a collateral standard, presumption with it is "presumed" if you are claiming compliance with the base standard. This much I think I finally get.

Insofar as EN 62304 goes, are you saying that this standard provides a framework for meeting the life-cycle development requirements of IEC 62304-1-4? Is that the nature of the relationship between these two standards? If so, I find it interesting that EN 62304 is not even mentioned anywhere in the text of IEC 60601-1-4 (I just did a complete document search for the text). Is this typical?
 

Marcelo

Inactive Registered Visitor
#5
Hello Watchwait

Your using your search on the wrong document :).

You really need to look at the third edition of IEC 60601-1 (which incorporates 60601-1-4) to find the answer you want.

From IEC 60601-1:2005

H.3 Software PROCESSES
H.3.1 PEMS DEVELOPMENT LIFE-CYCLE
A PEMS DEVELOPMENT LIFE-CYCLE, such as the one illustrated in Figure H.2, consists of a
number of PROCESSES that are composed of activities. Each activity is performed to
accomplish specific goals. To apply RISK MANAGEMENT, confidence in the engineering activities
on which the RISK MANAGEMENT is based is needed. In particular, this is a requirement for the
software life-cycle.
IEC 62304 [26] (under development) describes the processes to be included in the software
development life-cycle for the development of safe medical device software.

IEC 60601-1-4 does not mention IEC 62304 for one simply reason - IEC 60601-1-4 is from 2000 (last version) and IEC 62304 is from 2006.

Cheers!
 
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Marcelo

Inactive Registered Visitor
#6
What i am worrying about is the documentation and the file that created from the software life cycle.

I don't know what exactly are the documents that is needed by 60601-1-4.
For the documentation of the software lifecycle, again i suggest your read IEC 62304 ...... or a software engineering book, for example.

The documentation requirements of IEC 60601-1-4 can be found in Annex DDD, there is a table with a "Suggested correlation of the documentation requirement (from IEC 60601-1-4) to the DEVELOPMENT LIFE-CYCLE phases.

Keep in mind that the later are not the only documents from the development lifecycle, they´re are only the documents required by IEC 60601-14. Also keep in mind that these requirements, as i said before, are out of date (some documents in this table will better be included in the genereal device risk management of ISO 14971, for example).

If i may, maybe you should contact a software engineer. The point with IEC 60601-1-4, IEC 62304 and IEC/TR 80002-1 - Medical device software – Guidance on the application of ISO 14971 to medical device software (this is a technical report in the last phase of development at IEC) and the like is that they expect that they´re are implemented by a software engineer, as they borrow heavily from the software engineering field.
 
W

Watchwait

#7
Thanks Marcelo! I may not have mentioned that we are not yet claiming compliance with 60601-1 3rd Edition as it is not yet definitively required. We have some time yet.

More importantly (to me) is that I now understand I can (and probably should) use 14971 for the risk management issues in software development instead of 60601-1-4. And that 62304 is the current standard for software life-cycle development.
 
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