Differences between BS EN IEC 60601-1:1990 and 2007 standards

U

uksmiler

#1
Hi,

I wonder if anyone can help me on this? Seems like the most appropriate place to ask....

Ok, so if a device has passed the BS EN 60601 - 1 : 1990 electrical safety test standard, is there any reason why this same device would not pass the BS EN 60601 -1 : 2007 standard? Were there any significant changes to the safety test requirements during these years? Or have I missed something more obvious?

Any detail of any changes would be greatly appreciated.

Thanks
 
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Stijloor

Staff member
Super Moderator
#2
Hi,

I wonder if anyone can help me on this? Seems like the most appropriate place to ask....

Ok, so if a device has passed the BS EN 60601 - 1 : 1990 electrical safety test standard, is there any reason why this same device would not pass the BS EN 60601 -1 : 2007 standard? Were there any significant changes to the safety test requirements during these years? Or have I missed something more obvious?

Any detail of any changes would be greatly appreciated.

Thanks


Welcome to The Cove Forums! :bigwave: :bigwave:

OK, I am NOT an electrical/medical devices guy....:nope:

But, could this be of help?

Stijloor.
 

Marcelo

Inactive Registered Visitor
#3
A device complying to the former edition of EN 60601-1 does not comply to the new edition.

There are two major new modifications in the third edition (IEC 60601-1:2005, the new EN standard is based on this edition). and some new requirements.

The first major modification is the requirement of a ISO 14971 compliant risk management system to claim compliance with IEC 60601-1. More that just a requirement to have a risk management system, there´s the need to have a risk management system integrated with the requirements of IEC 60601-1 and other safety standards (meaning that the requirements of IEC 60601-1 - and other safety standards - must be used as risk control measures in the risk management system). This alone would mean that a device complying with the former edition would not comply with the new.

The second major change is the introdution of essential perfornace. As essential performance is a new conept and determined thru risk management, this also means that devices compying with the second edition does not address this.

There´s also a LOT of new requirements (the standards almost doubled in size) such as vibration, noise, and new and modified mechanical requirements.

Finally, a lot of requirements now have to be determined thur risk management (for example, the test conditions or the test limists have to be determined thur risk management) meaning that you can´t even PRFORM the tests if your risk management does not address the test.
 
S

Scottep

#6
I would like to post a correction to the information provided on ISO 14971 being required. Conformance to ISO 14971 is not required by IEC 60601-1 3rd edition, it is one of two options to choose from regarding how you deal with risk management.

IEC 60601-1 3rd Edition does allow for a "question based approach" to risk assessment. In this case, you have the option of modifying your risk plan to meet the risk requirements set forth in the 3rd Edition. There are two sides to this decision.

One: Using the question based approach will save money up front. Allowing you to meet the risk requirements of the 3rd Edition without having to spend the money to get certified to ISO 14971

Two: If you do go ahead with certification to ISO 14971, you automatically meeting the risk assessment requirements of the 3rd edition. This would go for any product you develop under the 14971 system that you would have in place. Opposed to performing an evaluation of the risk assessment plan for each product.
 

Marcelo

Inactive Registered Visitor
#7
Hello Scottep, and welcome to the Cove!

I would like to post a correction to the information provided on ISO 14971 being required. Conformance to ISO 14971 is not required by IEC 60601-1 3rd edition, it is one of two options to choose from regarding how you deal with risk management.
I did not say that conformance with ISO 14971 is required (not implying that it needs a audit for exemple)... i just said that a "ISO 14971 compliant risk management system" is required, as is written in clause 4.1 of the third edition.....these are two different things :)

Anyway, the standard is being ammended to clarify what is really required (a risk management process complying with ISO 14971 but not the whole process, for example, it does not require production and post-production information).

"question based approach" to risk assessment. In this case, you have the option of modifying your risk plan to meet the risk requirements set forth in the 3rd Edition.
I´ve never heard about this, where does this come from?

If you do go ahead with certification to ISO 14971,
This is really not required by the third edition, and it´s one of the reasons that a clarification in the amendment is needed.

This would go for any product you develop under the 14971 system that you would have in place. Opposed to performing an evaluation of the risk assessment plan for each product.
Not really.

As IEC 60601 is for type testing, you need to evaluate it for each device. So you would need to evaluate the components of the ISO 14971 process required by the third edition for each device. For example, you need to evaluate if the risks presented by the product are acceptable. This acceptability is seen by comparing the results with the risk acdeptability criteria, which is device-specific, an not related to the system as a whole.
 
M

Martin IT

#8
Another difference between 2nd edition and 3rd edition is the introduction new paragraphs due to absorption by the 3rd edition of some side rules, including:

IEC 60601-1-4 standard on programmable devices (para. 14)
IEC 60601-1-1 standard on medical systems (para. 16)
Rule of usability IEC 60601-1-6 (para. 12)
IEC 60601-1-8 standard for alarms (para. 12)

This implies being aligned with a larger number of constraints and the need to
review the analysis of the electrical safety of the product.

In any case I would put emphasis on paragraph 4 and the need to perform a process of risk management according to ISO 14971. This is, in my opinion, the most delicate step of the 3rd edition.
 
S

Scottep

#9
Mmantunes, I misunderstood what you were saying about ISO 14971. I took what you said as saying that someone needs to be compliant with 14971, my apologies.

As far as the "question based approach" comment that I made. This is wording that I have heard from a number of different safety consultants (UL, Intertek, etc). Basically, you just meet the risk requirements in the 3rd Edition, opposed to having an all inclusive ISO 14971 certified risk management program, which would be the "audit based approach."

I didn't said that you had to be ISO 14971 certified. When you say:
This is really not required by the third edition
I 100% agree with you, it is not required.

Would you agree that being certified to ISO 14971 would ultimately make it easier for a company to consistently meet 3rd Edition risk management requirements for the products that they develop?
 
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