Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Greetings everyone,

I am wondering how others compare old and new versions of digital standards, for example when doing a Gap Analysis. On the Techstreet subscription service, some standards come with redlines, which make the task much easier, others do not.

If you use Techstreet, some standards have very strict copyright protection via FileOpen software, which means you cannot copy text to compare to the old version of the standard.

It is a very time consuming task to look at the old and new versions of standards with the human eye. I am sure there are much more efficient ways of doing this. I would love to know how others undertake this task? There are programs that automatically highlight differences in text, but unfortunately with the copyright security on the Techstreet standards, this does not work.

My firm subscribes to Compliance Navigator (available from BSI) for most of the standards we use.  Sometimes this includes redlines to standards and sometimes expert commentary.   When those are not available, we do a search for any articles that may exist discussing the change.  We will also check both TechStreet and Document Center for any commentaries that may have been issued.  In absence of that we've also been left with manual comparison.   In the case of standards that support particular testing, sometimes it can be faster to review the applicable test protocols/reports to understand whether only certain clauses of the standard were followed (i.e. when the standard provides choices) and then to only assess those clauses for change.

------------------------------
Diane King RAC
San Jose CA
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Original Message:
Sent: 26-Aug-2020 10:08
From: Anonymous Member
Subject: Techstreet Standards- comparing old and new versions of standards

This message was posted by a user wishing to remain anonymous

Greetings everyone,

I am wondering how others compare old and new versions of digital standards, for example when doing a Gap Analysis. On the Techstreet subscription service, some standards come with redlines, which make the task much easier, others do not.

If you use Techstreet, some standards have very strict copyright protection via FileOpen software, which means you cannot copy text to compare to the old version of the standard.

It is a very time consuming task to look at the old and new versions of standards with the human eye. I am sure there are much more efficient ways of doing this. I would love to know how others undertake this task? There are programs that automatically highlight differences in text, but unfortunately with the copyright security on the Techstreet standards, this does not work.

Note, it is not up to TechStreet or other Standards distributors to issue the Redlines it is up to the Standards developers like IEC, ISO, CEN, CENELEC, ASTM, etc.  Not all versions of standards are issued as redlines.  I found out recently from the IEC Central office that Amendments are not always issued as redlines which was really disappointing to me as the Amendments that were just published for IEC 60601-1, 60601-1-6, 60601-1-8, -1-9, -1-10, -1-11, & -1-12 none of them have red lines available just consolidated (CSVs) editions or the separate Amendments.  For these standards that were just published, you can go to the following link to see the IEC publication information and check back to see when the IEC 60601-1-2 new amendment with be issued which should be almost any day now into Sept sometime. https://bit.ly/60601AmendsPublished

I have authored about ½ dozen of the compliance navigator reports for some of the 60601 standard updates and those are basically experts writing a focused article highlighting the key changes but not all the changes in the standard.  I haven't written one of those in a couple of years so they may have changed since I wrote those.  I assume I will be snagged to write a lengthy one on IEC 60601-1, amendment 2 which was just issued last Thursday 20 Aug.  Document Center writes very short commentaries and I find BSI material to be much more focused and much more detailed articles, white papers (which I was also involved in supporting as part of their reviewers for a couple years back several years ago), and online webinars that are really useful.

In terms of the Amended standards, I mentioned, I don't think you will find red lines out there.  I plan to put together gap assessment tools together and anyone can contact me offline from this forum to ask me about that.

------------------------------
Leonard (Leo) Eisner, P.E.
The "IEC 60601 Guy"
Principal Consultant, Eisner Safety Consultants
Phone: (503) 244-6151
Mobile: (503) 709-8328
Email: Leo@EisnerSafety.com
Website: www.EisnerSafety.com
------------------------------

Original Message:
Sent: 26-Aug-2020 10:08
From: Anonymous Member
Subject: Techstreet Standards- comparing old and new versions of standards

This message was posted by a user wishing to remain anonymous

Greetings everyone,

I am wondering how others compare old and new versions of digital standards, for example when doing a Gap Analysis. On the Techstreet subscription service, some standards come with redlines, which make the task much easier, others do not.

If you use Techstreet, some standards have very strict copyright protection via FileOpen software, which means you cannot copy text to compare to the old version of the standard.

It is a very time consuming task to look at the old and new versions of standards with the human eye. I am sure there are much more efficient ways of doing this. I would love to know how others undertake this task? There are programs that automatically highlight differences in text, but unfortunately with the copyright security on the Techstreet standards, this does not work.

Hello,

Just a comment, you should not purely go by just the redline either.  In some cases, the redline text may have more far reaching implications that need to be understood surrounding the context of the change.  Certainly there are redline which are just fixing spelling errors, grammatical, or reordering which does not have an impact on the regulatory aspects.  However, I would argue conducting a human eye read of the standard compared to the previous version is still a necessity in some cases.  In most cases as well, the standard when they get revised and published have gone through many years of not being updated - which typically is changing fundamental or core aspects of the standard.  When looking at Amendments or Corrigendums, those are usually updating the slight errors found or changing text for clarification.  But if you take the recent example of ISO 14971 going from 2007 to 2019, a "full" assessment should be performed though while the fundamentals have not changed, this does have impact on risk management files.  It is a lot of work and maybe burdensome to go through standards when changed, you can do a "quick" regulatory assessment from a risk based approach to determine if a more in depth review should be performed or if the standard is just say an amendment clarifying information, i.e. no new requirements.  As mentioned previously, usually you can find information where someone has already done a side by side comparison or an analysis of the new standard against the old.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs
------------------------------

Original Message:
Sent: 28-Aug-2020 02:37
From: Leonard Eisner
Subject: Techstreet Standards- comparing old and new versions of standards

Note, it is not up to TechStreet or other Standards distributors to issue the Redlines it is up to the Standards developers like IEC, ISO, CEN, CENELEC, ASTM, etc.  Not all versions of standards are issued as redlines.  I found out recently from the IEC Central office that Amendments are not always issued as redlines which was really disappointing to me as the Amendments that were just published for IEC 60601-1, 60601-1-6, 60601-1-8, -1-9, -1-10, -1-11, & -1-12 none of them have red lines available just consolidated (CSVs) editions or the separate Amendments.  For these standards that were just published, you can go to the following link to see the IEC publication information and check back to see when the IEC 60601-1-2 new amendment with be issued which should be almost any day now into Sept sometime. https://bit.ly/60601AmendsPublished

I have authored about ½ dozen of the compliance navigator reports for some of the 60601 standard updates and those are basically experts writing a focused article highlighting the key changes but not all the changes in the standard.  I haven't written one of those in a couple of years so they may have changed since I wrote those.  I assume I will be snagged to write a lengthy one on IEC 60601-1, amendment 2 which was just issued last Thursday 20 Aug.  Document Center writes very short commentaries and I find BSI material to be much more focused and much more detailed articles, white papers (which I was also involved in supporting as part of their reviewers for a couple years back several years ago), and online webinars that are really useful.

In terms of the Amended standards, I mentioned, I don't think you will find red lines out there.  I plan to put together gap assessment tools together and anyone can contact me offline from this forum to ask me about that.

------------------------------
Leonard (Leo) Eisner, P.E.
The "IEC 60601 Guy"
Principal Consultant, Eisner Safety Consultants
Phone: (503) 244-6151
Mobile: (503) 709-8328
Email: Leo@EisnerSafety.com
Website: www.EisnerSafety.com

Original Message:
Sent: 26-Aug-2020 10:08
From: Anonymous Member
Subject: Techstreet Standards- comparing old and new versions of standards

This message was posted by a user wishing to remain anonymous

Greetings everyone,

I am wondering how others compare old and new versions of digital standards, for example when doing a Gap Analysis. On the Techstreet subscription service, some standards come with redlines, which make the task much easier, others do not.

If you use Techstreet, some standards have very strict copyright protection via FileOpen software, which means you cannot copy text to compare to the old version of the standard.

It is a very time consuming task to look at the old and new versions of standards with the human eye. I am sure there are much more efficient ways of doing this. I would love to know how others undertake this task? There are programs that automatically highlight differences in text, but unfortunately with the copyright security on the Techstreet standards, this does not work.

This message was posted by a user wishing to remain anonymous

Depending on the issuing body , there will be an indication in the standard itself as to what has changed. For instance, for ISO standards, general information on the changes is listed in the foreword section of the standard.
Original Message:
Sent: 26-Aug-2020 10:08
From: Anonymous Member
Subject: Techstreet Standards- comparing old and new versions of standards

This message was posted by a user wishing to remain anonymous

Greetings everyone,

I am wondering how others compare old and new versions of digital standards, for example when doing a Gap Analysis. On the Techstreet subscription service, some standards come with redlines, which make the task much easier, others do not.

If you use Techstreet, some standards have very strict copyright protection via FileOpen software, which means you cannot copy text to compare to the old version of the standard.

It is a very time consuming task to look at the old and new versions of standards with the human eye. I am sure there are much more efficient ways of doing this. I would love to know how others undertake this task? There are programs that automatically highlight differences in text, but unfortunately with the copyright security on the Techstreet standards, this does not work.

Actually it is not up to the issuing body but the standards committee that is writing the standard to decide what they want to say about what is changing.  Every standards committee is very different in the detail that is stated and even within a committee, there are wide differences.  Sometimes even within teams within committees, you can have wide differences in the details you will find in the forwards about the details about what will show in the front of the standard about what is changing.  So, the moral of the story is to expect that there is a lot of inconsistency in what you will find.  Doesn't matter if it is IEC or ISO, CEN or CENELEC, etc.

------------------------------
Leonard (Leo) Eisner, P.E.
The "IEC 60601 Guy"
Principal Consultant, Eisner Safety Consultants
Phone: (503) 244-6151
Mobile: (503) 709-8328
Email: Leo@EisnerSafety.com
Website: www.EisnerSafety.com
------------------------------

Original Message:
Sent: 27-Aug-2020 18:15
From: Anonymous Member
Subject: Techstreet Standards- comparing old and new versions of standards

This message was posted by a user wishing to remain anonymous

Depending on the issuing body , there will be an indication in the standard itself as to what has changed. For instance, for ISO standards, general information on the changes is listed in the foreword section of the standard.
Original Message:
Sent: 26-Aug-2020 10:08
From: Anonymous Member
Subject: Techstreet Standards- comparing old and new versions of standards

This message was posted by a user wishing to remain anonymous

Greetings everyone,

I am wondering how others compare old and new versions of digital standards, for example when doing a Gap Analysis. On the Techstreet subscription service, some standards come with redlines, which make the task much easier, others do not.

If you use Techstreet, some standards have very strict copyright protection via FileOpen software, which means you cannot copy text to compare to the old version of the standard.

It is a very time consuming task to look at the old and new versions of standards with the human eye. I am sure there are much more efficient ways of doing this. I would love to know how others undertake this task? There are programs that automatically highlight differences in text, but unfortunately with the copyright security on the Techstreet standards, this does not work.