Dear Forum,

Does anyone know when the 3rd edition of 60601-1 will be harmonized?
(I mean are we talking years here...)?

Will all the collateral and particular standards have to be updated before the 3rd edition can be harmonized?

regards
temu

Dear Forum,

Does anyone know when the 3rd edition of 60601-1 will be harmonized?
(I mean are we talking years here...)?

Will all the collateral and particular standards have to be updated before the 3rd edition can be harmonized?

regards
temu

Hi Temujin:

I just sat in on a Webinar sponsored by Intertek a couple weeks ago. The speaker from the Webinar indicated that the DOP (Date of Publication) of Ed. 3 was 12-Sep-2006 and the DOW (Date of Withdrawl) of Ed. 2 will be 3 years hence, on 12-Sep-2009. He also indicated that a lot of the colateral standards (Part 1 & 2 standards) will be getting released in 2008.

I hope this helps. Keep your eyes open for the particular colateral standards that apply directly to your type of equipment.

-Steve

Just some clarificatios...although the standard was published in the date mentioned by Steve and the DOW of the standard itself is correct, it still isn´t published as an harmonized standar and therefore there´s no DOW for the standard used as a regulatory compliance mechanism (if you want to understand the differences between a standard being published and a standard being used in regulatory schemes, take a look at this thread: When should the medical device industry show compliance to EN ISO 14971(2007) (http://elsmar.com/Forums/showthread.php?t=21493)).

Regarding particular standards, IEC (NOT CENELEC - remember, harmonizaed standard have to be EN) has a target date of publishing new versions of particular standard aligned to IEC 6060101:2005 until the end of 2008.

Colaterall standards are already harmonized (IEC 60601-1-2, IEC 60601-1-6 and IEC 60601-1-8)

Theoretically you do not need to wait for the particular be published to use the new edition (the risk management loop guarantees that the hazards adressed by particular have to be taken into accout), but legally speaking i think it´ll be sometime, at least when the EN collaterals and some particulars be published before the standards are harmonized.

mmantunes:

Thanks for the additional clarification to my original post. After you mentioned the "harmonized standard" reference, I seem to recall that discussion in the Webinar as well. There was some discussion about the EU typically being way ahead of the US and Canada, but I had forgotten the particulars.

:topic: This is why I like this forum so much. Some one like me as "part of the story" and there seems generally to be someone who always has the additional details for the "better answer" to the question posed! :agree1:

-Steve

Hello Steve, i totally agree with you on the the off-topic..this is, in my opinion, one of the strenghts of the knowledge building in this community...

Anyway, you´re right when you say that the EU are almost always ahead on regulatory requirements... actually, the regulatory requirements of medical devices in the worls are gearing towards the EU model, as can be seen by the work of the Global Harmonization Task Force... even the EUA, which has a fundamental difference in approach, are slowly turning to the EU model (but it might time some time).

One interesting point regarding particulars is that not all of them will be aligned with the third edition..because some might be cancelled! IEC posted a internal rule on the development of particulars that says taht if a particular doesn´t reach CDV (comittee draft fot vote) stage at the beginning of 2008, then the standard will be revoked. This is because some particulars standard writing groups weren´t active in developing the new edition and IEC felt this was because of lack of interest.

So, complementing my complementation to the question from Temu, i don´t think they´ll wait for every particular to be published, because they don´t even know how many particulars will remain.

Cheers.

EN 60601-1 has been published by 2006-10-00 (and the 1990 version of the standard has been withdrawn by this date)

The DOW of the old 60601-1:1990 is defined as 2009-09-12.

The last update of the "higher" (EN 50000 and above) list of harmonized standards was published almost one year ago (2006-07-26).

As I already mentioned in an other posting, I am expecting a new list of harmonized standards soon, so lets just sit and wait... (and there is plenty enough time to put the 3rd edition on the list of harmonized standards until 2009-09-12)

~ghw

Publication/withdrawal/harmonization dates aside...I believe I saw a summary of the key differences in the 3rd edition standard. Anyone recall seeing this info?

Great timing on the question....Intertek just published some days ago a white paper (based on a webinar they did last year) about the changes..you can download it here: **DEAD LINK REMOVED***

Also (i´m not sure if i can do this because it may seem as self-marketing, if so please someone remove the post) i made a old list of papers on the new edition some time ago on my blog: http://www.electromedicalinfo.com/papers-about-the-new-edition-of-the-medical-electrical-equipment-general-standard-iec-60601-12005/

Keep in mind that the list is more than a year old and some new papers have come. One that is particular interesting, written by the secretary of 62A, can be found on the IEEE PSES Newsletter on this link: http://www.ewh.ieee.org/soc/pses/Downloads/newsletters/06V2N3.pdf

Publication/withdrawal/harmonization dates aside...I believe I saw a summary of the key differences in the 3rd edition standard. Anyone recall seeing this info?

There's a publication put out by the IEC that is a Free Download from their web site. I've included the Link here;
http://webstore.iec.ch/webstore/webstore.nsf/artnum/036126

This is for TR 62348 and shows a direct mapping of Ed.2 to Ed.3. This should help.

-Steve

Perfect! EXACTLY what we needed!! I wish this type of overview were available more often. As standards are revised it's always nice to know whether the revision is applicable to you or not.

BTW, our NB indicated that typically, conformance to the most current revision of any given standard is encouraged, e.g. 14971:2007, 60601 3rd Ed., etc. However...I would like to posit that if the content of the latest revision of any given standard is NOT applicable to ones product/business, it is perfectly acceptable to remain in conformance with that revision of the standard that better reflects your needs.

Has anyone ever gone down that dialog path with their NB?

Well, that´s some discussion, and the problem i see is "thinking in standard´s terms".

If you think using a risk management perspective, standards are just collections of information about risk controls. As you need to control risks to be in conformance with regulations, there´s no need to stick to any version of any standard.

You just have to make sure that all the risks related to the device have been identified and controled. You can use half of the content of a standard, for example, but not use the other because their risk controls options are not the best for you, and you have found another document or managed to find a particular solution that fits better your device.

In this way, it´s the RISK INFORMATION and the options for risk control they give the manufacturer that are essential, not the standard per se, or the version, or the year.

But surely few people have this kind of perception (and mine has just developed after many years working with tests and producing standards).

Right on. The practical aspect here is whether or not you want to "engage" your NB in this type of dialog (for the reasons your clearly cited), or just agree with the notion of compliance to the most current revision of a standard.....and then go do what makes the most sense! ; ^ )

I read in a 2004 publication that IEC 62366 was slated to replace IEC 60601-1-6. Does anyone know if this has actually happened? I have the current version of IEC 62366 published in 2007 so I'm assuming this still to be current. This version also makes NO reference to IEC 60601-1 or IEC 60601-1-6. However, this leaves the 60601-1-6 question hanging! An Intertek publication from July 2008 lists 60601-1-6:2007 as an independent collateral standard to 60601-1 3rd Ed.

So has 62366 replaced 60601-1-6 and if so why is Intertek still referencing 60601-1-6 as a current collateral std. to IEC 60601-1 3rd Ed.?

The second edition of IEC 60601-1-6 still is a collateral standard to the third edition of IEC 60601-1.

There will still be a third edition of IEC 60601-1-6 with links to IEC 62366, but IEC 60601-1-6 will be withdrawn after the release of Amendment 1 to the third edition of IEC 60601. When this happens (at least 3 or 4 years yet), only IEC 62366 will be used as the usability standard for medical devices (medical electrical equipment included).

[QUOTE=mmantunes;262999]The second edition of IEC 60601-1-6 still is a collateral standard to the third edition of IEC 60601-1.QUOTE]

Got it! But is 60601-1-6 1st Ed. a collateral standard to 60601-1 2nd Ed.? Since we plan to remain in compliance with 60601-1 2nd Ed. as long as possible this is a valid question for us.

Also, could I possibly be confusing the terms "collateral standard" and "normative reference"?

From the point of view pofstandards production and the IEC, the only IEC 60601-1 in existance is the third edition (there can be only one edition/version of any standard available at any time).

You´re question is related to the regulatory application of standards, not the standard as normative documents produced by a normative international body. I think this distinction is important right now when regulatory requirements use the second edition but we have the third edition published (please take a look at this thread for further explanation : http://elsmar.com/Forums/showthread.php?t=21493)

Anyway, the first edition of IEC 60601-1-6 was a collateral standard to IEC 60601-1, and still is in the way you´re asking.

Collateral standards are, from the IEC point of view (and not necessarily regulatory) part of the general standard (meaning, for example, that the general standard IEC 60601-1 second edition was in fact comprised of documents IEC 60601-1, Am 1, Am2, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-1-3, IEC 50501-1-4, IEC 60601-1-6, and IEC 60601-1-8). The rationale is that collateral standards deals with general aspects of medical devices which were not treated when the IEC 60601-1 document was produced. A lot of people were not aware of this fact so the third edition fix this by requiring that all collateral standard are required to claim compliance with IEC 60601-1 3 ed.

Normative references are references to other standards in some tests, the rationale being that you do not need to write the whole test again because other standard already has it, so you just call it in the standard body.

You are, in fact, the most knowledgeable person on standards I have ever had the privilege of communicating with! How lucky the Cove is to have someone with your addict, er, knowledge of standards ;^)

Once again, the explanation you provided are very helpful as many of these distinctions in the standards world are indeed subtle.

So to further belabor the point, I am still not completely clear on when a standard becomes "mandatory", e.g. required "by law". And as importantly, where can one go to simply and reliably obtain this information? Am I being naive in hoping to locate "one, definitive source" for such (critical) information? I HAVE read most of the prior postings on this subject but the "clear and definitive" answer still eludes me - and it probably is just me...

Thanks for the compliment Watchwait, i´m glad to be of help.

Well, keeping things only on the EUA and Europe side, there´s lists of recognized consensus standards (in fact a search engine) in the FDA website at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm, n the case of the MDD there´s a list of harmonized standards at http://ec.europa.eu/enterprise/newapproach/standardization/harmstds/reflist/meddevic.html.

Always keep in mind that "recognized" and "harmonized" means that the standards are not mandatory, but are only one option of risk control for the hazardous situations related to the devices, and in this way provide "presumption of conformity" with some related requirements for the devices.

Great sites - both of them Thanks again.

But, if I may, back to my question. "Recognition" of a standard sounds far from "mandatory", e.g. required by some (any!) law. In this regard, are *any* standards ever "mandatory", e.g. required by law? Or is it just "directives" that are legal obligations with standards providing "presumption of conformity"? If the answer to this is a simple "yes", I feel my day will have been worthwhile...:)

In the majority of countries that i know standards are voluntary (only in Brazil where i live standards are mandatory, at least as far as i know).

The directives, essential principles and the like are the legal requirements. Standards are one mean to fulfill them. This is because the requirements are ris management-based, so their fulfillment needs a risk management process, not any standard (a further explanation on this thread: http://elsmar.com/Forums/showthread.php?p=237965#post237965)

OK...First post after reading a ton of threads on this forum.

Now that we're approaching the DoW (Sept '09) for IEC 60601-1 Ed2 and while I understand that until Ed3 is harmonized as an EN document, CE compliance is still granted if a product meets IEC 60601-1 Ed2, does anyone have an update on the harmonization of Ed3 into EN 60601-1? I'm figuring we're still years away, right?

I'm sure there will be voluminous redsponses to this question but, IMHO, the short answer is: Yes, years (meaning more than two) from any mandatory compliance to 60601-1 3rd Ed. (fully realizing that standards compliance is always voluntary).

EN 60601-1 3 ed has already been harmonized - and all collaterals to the third edition are also harmonized (since the last update on the list of harmonized standards, last year). But there´s no "date of cessation of presumption of conformity" yet. People are expecting to use the date on the standard (the september 2009 you cited) but this applies only to equipment which does not use particulars (60601-2-x) standards; they will have to wait till the particulars are harmonized.

If your equipment uses only the general and collaterals, it´s reasonably to expected that it might be asked after september 2009.

Thanks for the replies....

So, as I understand it now, the Ed3 of IEC 60601-1 is now harmonized and released as EN60601-1:2006, but, because Particular standards (eg 60601-2-xx) may not be harmonized, the removal of the "date of presumption of conformity" has not been set and a medical device that uses Particulars as well as the General and Collaterals will continue to receive CE certification by notified bodies if compliance with IEC60601-1 Ed2 is shown. (understood that compliance to standards is voluntary and is only one avenue to show compliance to the MDD)

We received a very helpful publication (attached) from our testing company, Intertek entitled "IEC 60601-1: Changes from 2nd to 3rd Edition". Like many other manufacturers, we are in no hurry to claim conformance with the 3rd Edition of the standard. Rather than "when can we start using the 3rd Ed.?", our question is "how long can we continue to use the 2nd Ed?".

I have a feeling we are not alone in this regard as a quote a comment from the Intertek publication: "Since both the FDA and Health Canada now recognize the 3rd Edition, Intertek can follow the 3rd Edition when testing for the ETL C/US Mark. However, most of our clients continue to use the 2nd Edition."

Dear Forum,

Does anyone know when the 3rd edition of 60601-1 will be harmonized?
(I mean are we talking years here...)?

Will all the collateral and particular standards have to be updated before the 3rd edition can be harmonized?

regards
temu

There is significant discussion in the EU right now. The sensible people involved are pressing to make the end of transition June of 2012 (all devices must be updated by that date). However, the current foreward of EN 60601-1: 2006 says that for devices with no particular standard (part 2) the 1990 (2nd edition) version will be withdrawn as of October 2009 (for devices with particulars, 2 years after the 3rd edition versions are published)! Worse yet, the responsible Technical Board has just circulated a proposal that this schedule (Oct 2009) be upheld! The situation is definitely a mess and my best recomendation is to apply the new 60601-1 to new designs (in process) NOW and to start evaluating what will be required to update your existing catalogue of products.

Regarding particular standards, several have been or are being publsihed and roughly 80% will be done by the end of this year (I am Secretary of the SC responsible for many of them). There is a gap analysis matrix available (commercially) and a free sample (partial) can be downloaded at the web site for strategic device compliance services Devicecompliance dot com. Click on the "Download a free sample" text at the top of the home page. The document not only compares the 2nd and 3rd edition but includes notes on specifics of compliance and identifies requirements requiring documentation in the risk management file. Also, other compliance support docments are available on the downloads page of the site.

BTW: FDA HAS NOT YET recognized the 3rd Edition but plans to later this year. I am also involved in the writing of NFPA 99 and the NEC to align them with ANSI/AAMI ES 60601-1: 2005 and this will be finished soon. Things are falling into place quickly and most importantly, don't forget that to claim compliance with the general standard ALL applicable collateral standards must be applied (usability, alarms, environmental and other new ones).

EN 60601-1: 2006 was harmonized just a few months ago, but as I said its possible (if no particular) transition could end in October!:mg:

WHile FDA recognition does indicate optional, some reviewers will make you do so much to not apply a recognized standard its easier to just go ahead and apply it. In the EU, the "optional" is a joke. Few Notified Bodies will allow a risk based aproach only and again the effort is significant. What's worse is that they require existing certifications to be updated (which virtually no one else does). We've been trying to bring some sanity to this and we've got Germany on board but don't hold your breath. There's a lot of financial interests involved in keeping the existing system.

Good luck, it will be a bit confusing for a while...

Mike - GREAT feedback. Those of us bound to the 60601 series are watching these developments very closely as you might imagine. Your feedback was the best/most current to date! Thanks again!:thanx:

Hey Mike

Welcome to the cove!

Great update on the subject.

DEal all,

I feel a little like Winnie the Pooh with this thread - “I am a Bear of Very Little Brain”!
Bottom line – we have a portable and a mobile device that were tested to the 2nd addition of 60601-1 (with all the amendments). Do I have to have them retested to this third version after October 2009 to retain the CE mark? They both also comply to (have been tested to) ISO 10079-1 (medical suction – also to previous version of 2009 edition, but no change to original requirements/text). Both have a formal risk management process in place (3rd edition clause 4.2 requirement) which complies with ISO 14971:2007 and information retained in Technical Files. By the way, what further makes my brain sore is that this ISO 10079-1 standard is based on and references IEC 60601-1:1988!

Help!

Steve

Steve,
I'm sure Marcelo will weigh in here with some sage advise. From our standpoint, I posed this exact question to our German NB yesterday, who replied "we'll discuss this in June during the surveillance audit". So we'll know their take next month. Based on what I'm seeing/reading, I think the smart money will have any NEW products complying with 3rd Ed beginning Oct 2009. Existing products already compliant w/2nd Ed? We're betting that they will NOT need to be compliant w/3rd Ed. Could be wrong, but think about it: zillions of products needing to be "retrofitted" to 3rd Ed requirements? Just doesn't seem reasonable. As we say...just doesn't pass the sanity check.

BTW, and I could be way off base here...our Electrical Engineers have made a "1st pass" through the 3rd Ed requirements and their comments were that it looked like some of the electrical requirements had been relaxed! Then, our Mechanical Engineers looked at 3rd Ed and remarked that all the mechanical requirements were already in the 2nd Ed! Gadzooks! If this is true then is it possible that the only really NEW requirements are those that relate to Risk Management? Inquiring minds want to know...

Watchwait,

Thanks for the sanity check. My reading of the 3rd edition (and transition guidance documents e.g. from Intertel-Etlsemko) also seems to agree with your engineers - a relaxation in some requirements. My next audit is likely to be in August, so your feedback on this matter after your audit would be great.

:thanx:

Steve

Hi - I work for UL and I just hooked into this thread. In mid-July, I sent this email out to our subscribers. I just double checked with our PDE on whether or not the dates had been officially revised and he wrote:

"There is supposed to be a ratification as a result of an EU committee meeting this August." - so we should know more soon.

Here is the content of the information we provided in July.

During the recent CENELEC TC 62 meeting June 19, 2009 in Brussels, Technical Committee members agreed with the proposal outlined in document 1008/INF and accepted June 1, 2012 as the recommended date of presumption of conformity for third edition of IEC/EN 60601. This 2012 date would extend the date by which manufacturers of electromedical equipment would need to show conformity to EN 60601-1:2005. Based on the original date of publication, industry has assumed a September 2009 date of presumption of conformity.


In order to become official, the final decision needs to be rendered by the CENELEC BT (Technical Board).

Please note the changes referenced in document 1008/INF will probably be issued as a Corrigendum to the EN Standards and several EN Standards will be affected by the Proposal.



If I hear additional news, I will post it.

This information is correct. I was at the CLC meeting in Brussels and the description of the reolution is correct. Only addition worth noting is that the BT has never refused to accept a positively voted CLC/TC 62 resolution so the June 2012 date is virtually a done deal.

Also, due to objections completely unrelated to AAMI ES60601-1: 2005 (US National Version), publication of NFPA 99 updated for the new 60601-1 has been delayed until 2011.

While OSHA has AAMI ES60601-1 for review and several NRTL's have requested their scope be expanded to include the standard, heavy work load at OSHA is delaying the process and they will not comit to a date certain for inclusion in the NRTL program in the US. The CSA version is now available for NRTL certification.

Thanks Mike.

It's always good to hear from someone who was actually at the meetings.

I was a little confused by your comment about using the CSA version of IEC 60601 to satisfy the U.S. NRTL requirements. Just to be sure, I confirmed the following with UL's Accreditations Services manager.

Although CSA, like UL, is a NRTL under the U.S. OSHA program, the NRTL is still required to use standards that are recognized under the OSHA NRTL program. At this time, UL 60601 (IEC 60601-1 2nd edition, with U.S. National deviations) is the only version of the IEC 60601 standard for electromedical safety listed on the OSHA NRTL website.


A list of recognized standards is on the NRTL site. I have the link if anyone wants it.



I know we are offering a concurrent certification/assessment to both 2nd and 3rd editions, so that companies can meet requirements in the U.S., and EU + Canada. The other NRTLs may have similar programs.


-Tara

Tara,

Didn't mean to indicate that the CSA standard was acceptable in the US. First of all, we'd never put that many deviations in the US document (I'm Co-Chair of the AAMI ES Committee)! The reference to the CSA version of the 3rd Ed was for Canada only. I was alluding to the fact that the NRTL program is reciprocal and that NRTL test houses who can certify to the US standard can also certify to the Canadian version (such as the ULc mark).

Mike

Dear All,

I believe that Cenelec were going to make a anouncement about the 3rd edition 60601-1 implementation date! For devices that dont require a part2 standard is still the date of cessation for Europestill 12 september 09?


I know for companys that have a part 2 its the 1st june 2012 or when part 2 is published!


Regards,
Mark

No. The earliest anyone will need to comply is June 2012. There may be a few particulars (primarily anaesthesia and similar documents where ISO TC 121 has the lead) may actually get published after June 2012. In such cases it will be up to Notified Bodies on how to handle. For the most part, its really not that difficult to use an old particular with the 3rd edition. Not rocket science...

Mike

For the most part, its really not that difficult to use an old particular with the 3rd edition.

Heh. Well, perhaps most of the time. A rational reconciliation of EN 60601-2-46:1998 (Surgical Tables) with EN 60601-1 3rd Edition does not seem possible in regard to structural load capacity and related load carrying calculations/requirements, if the device in question is to have a rated load capacity other than 135 kg.

Actually this problem existed with 2nd Edition as well. IEC 60601-2-46 was not well thought out, and not well written.

3rd Edition was a big improvement over 2nd Edition in regard to patient-load structural issues, but only if -2-46 isn't brought into the picture.

This of course is Off Topic from the core thrust of this thread...sorry.

Keep in mind that particular standards rule (yes must admit bias since I'm Secretary of the SC that produces most of them). Particular standards are created to "modify" horizontal standards including the General & Collaterals. This means (in the case you cite for OR Tables) that where there is a conflict, the requirements of the particular standard apply.

Another option would be to continue using the 2nd edition of 60601-1 with the old particular. Technically, since the 2nd edition of the General standard is normatively referenced in the old particular standard it retains the presumption of compliance as long as the particular stays on the harmonized list. The problem now is that even if the CLC/TC 62 resolution is accepted by BT, this issue does not get locked down.

I did double check with the CLC TC62 Chair and the CLC Resolution from Brussels removing the text with the 2009 date will go to the Technical Board this month (hopefully- they haven't acknowledged its on their docket officially) so we should have the final decision by end of the month. I "suggested" that he consider producing an official opinion on the situation with "late" particuars. This would give manufacturer's a defined process with enough authority that any reasonable notified body would accept following it.

Mike Schmidt

Particular standards are created to "modify" horizontal standards including the General & Collaterals. This means (in the case you cite for OR Tables) that where there is a conflict, the requirements of the particular standard apply.

Yes, that's a given. The problem with -2-46 all along has been that it was drafted around core assumptions as to the product's load rating and load distribution, but (1) those assumptions were not clearly stated, therefore the exact meaning of their superposition over the -1 standard was a matter of interpretation and/or not universally recognized, and (2) no interpretation within the bounds of the stated wording allowed for products with significantly greater load ratings than what -2-46's drafters apparently thought were the norm, thus application of the standard to real marketable products required a stated deviation from the standard's requirements.

Another option would be to continue using the 2nd edition of 60601-1 with the old particular.

Actually the problem was worse with 2nd Edition. As I noted before, 3rd Edition was a big improvement over 2nd Edition in regard to patient-load structural issues.

Hi Mike,

Thanks for that!

Do you have any spreadsheets that you could advise we use for considering risk management requirements in relation to the third edition?

Mark

The recent decision (October 2009) of the CENELEC/BT regarding the date of withdrawal associated with EN 60601-1:2006

BT agreed to associate a date of withdrawal (2012-06-01) with EN 60601-1:2006 and its collaterals and invites CS to issue the relevant corrigenda.
As a consequence,
- BT agreed to the deletion of the following wording in the present forewords of EN 60601-1:2006 and its collaterals:
“However, EN 60601-1:1990 remains valid until all parts 2 that are used in conjunction with it have been withdrawn. No date of withdrawal of conflicting national standards (dow) has therefore been fixed. However, when Part 1 is used for appliances not covered by a part 2, EN 60601-1:1990 is not to be used after 2009-09-12.” and asked CS to issue the relevant corrigenda.

New post on the Cenelec website about the third edition series and the EU medical devices directives:

QUESTIONS AND ANSWERS ON THE EN 60601-SERIES OF STANDARDS IN RELATION TO THE MDD AND AIMD (http://www.cenelec.eu/Cenelec/CENELEC+in+action/Horizontal+areas/ICT/Collateral_standards_under_MDD_AIMD.htm)

Is there a published projected timetable for revisions to -2 parts...and perhaps a listing of those -2 parts that will be discontinued rather than revised, and/or info on changes to titles and scope definitions?

My particular focus is -2-46 "Operating Tables". I need to determine our structural-engineering compliance approach for radiographic tables that might or might not be interpretable as meeting an "operating" definition. This problem exists in the context that the existing -2-46 is in some ways inexpert regarding its subject matter, and mostly describes radiographic tables, not operating tables, notwithstanding its title.

-1 Third Edition by itself is greatly superior to the combination of -1 Second Edition plus the existing -2-46, from the perspective of consistency with sensible engineering decisions to create a marketable, technical-state-of-the-art product...but the possibility that a new -2-46 could incorporate scope changes or new definitions or rules is a black hole from a regulatory planning perspective.

The original projected timetable was that at the end of 2009 all particulars were aligned with third edition. Obviously, this could not be accomplished. There´s a new expectancy that the majority of standards will be aligned at the end of 2010, but this will also not be possible (some particulars have just had their CD circulated...for the ones from IEC 62D, please see http://www.iec.ch/cgi-bin/procgi.pl/www/iecwww.p?wwwlang=e&wwwprog=sea1122.p&progdb=db1&css_color=purple&class=&refno=&committee=&pubno=&header=*+(all)&search=program&pcomm=62D)

From this page, you can see that in general at the end of 2010 or beginning 2011 almost all old particulars should be harmonized.

I haven´t updated my data, but as far as i remember, no particular will be discontinued.

Finally, regarding 2-49, it will have some technical changes, mainly to align the new mechanical requirements of the third edition. But the scope and definitions remais the same, at least at the present circulated CDV (the definition of operating table changed, but essentially it´s the same).