60601-1-11 Changes

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
The most significant changes with respect to the previous edition include the following
modifications:
IEC 60601-1-11 ED. 1.0 B:2010 to IEC 60601-1-11 ED. 2.0 B:2015

1) correction of test method for relative humidity control at temperatures above 35 °C;
2) redrafting of subclauses that altered instead of adding to the general standard or other
collateral standards; and
3) harmonizing with the changes to the amendments to the general standard and other
collateral standards.

I am trying to digest the above changes and how it impacts our device. We have had our device tested to IEC 60601-1-11 Ed 1.0 and except for the above, we believe we are still compliant.

Can anyone help me understand these notes about the changes and how they could impact previous passed testing? The changes appear to be minor and language related without substance.
 
Rather than just using the notes, I suggest you perform a full gap analysis. Document the old and new wording. Determine if your existing test results meet the new requirements. If not, additional testing in that area will need to be performed. Hope that helps.
 

Peter Selvey

Leader
Super Moderator
A more slightly nuanced approach: if due to regulations or market you need to comply with a later edition of a standard, you should have a signed "report" showing compliance, regardless of the content of changes.

The person preparing and signing the report should be qualified and experienced with the standard.

One that person is designated, it is up to them to decide the format of the report. It could range from a simple one page statement "the changes have been reviewed and found to be not relevant to the device under test", or a gap analysis (few pages listing of the individual changes and a rational why they are not relevant, still comply, or need additional tests), or a full blown report for all clauses of the new standard and link or transfer the data from the old report where appropriate.

The point is it is up to the person writing the report to decide what they are comfortable signing, so it's best to identify that person and leave it up to them to decide. This is particularly important for updates to standards, as there may be grey zone stuff.

Having worked with both editions, if I were signing a report, I would go with a full blown listing and data link/transfer. There are too many changes between the editions in both wording and content. I would still expect that the additional testing is minimal, but I would not be comfortable signing without reviewing the new standard in full.
 

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
Rather than just using the notes, I suggest you perform a full gap analysis. Document the old and new wording. Determine if your existing test results meet the new requirements. If not, additional testing in that area will need to be performed. Hope that helps.

This is part of a complete 50 page gap analysis. We review the redline changes in total and determine applicability. This is the last section and we cant locate the red line changes for this comment.,
 
Last edited:

Peter Selvey

Leader
Super Moderator
On the 35°C test, the 2015 edition added the limit of 50 hPa (? or something?) on the water vapour pressure (??) which are units and terms we don't use normally, but in effect puts a limit on the humidity at higher temps, for example 40°C is around 60%RH and 70°C would be somewhere around 20-25%RH. Due to that limit, there would be no test at the 93% using the original methods. Therefore they added the 35°C/93% as well. Obviously if you passed the old standard at 70°C/93% then that should cover you for 35°C/93%.

For the other two items, I didn't really understand the issue. The redline version should have picked up all the changes. It looks like you are reading the introduction, but that's not official, it just gives an overview. As long you have all the redline changes in the normative part of the standard covered in your gap analysis, it should be fine.
 

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
On the 35°C test, the 2015 edition added the limit of 50 hPa (? or something?) on the water vapour pressure (??) which are units and terms we don't use normally, but in effect puts a limit on the humidity at higher temps, for example 40°C is around 60%RH and 70°C would be somewhere around 20-25%RH. Due to that limit, there would be no test at the 93% using the original methods. Therefore they added the 35°C/93% as well. Obviously if you passed the old standard at 70°C/93% then that should cover you for 35°C/93%.

For the other two items, I didn't really understand the issue. The redline version should have picked up all the changes. It looks like you are reading the introduction, but that's not official, it just gives an overview. As long you have all the redline changes in the normative part of the standard covered in your gap analysis, it should be fine.


I see our error. We reviewed the redlines then the summary and tried to match it up.
 
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