SBS - The best value in QMS software

Harmonization date of IEC 60601-1 , 3rd Edition

M

Marcelo

Inactive Registered Visitor
#21
#21
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)
 
Free Trial of DISCUS Desktop
Elsmar Forum Sponsor
A

Aviation2Healthcare

#22
#22
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?
 
W

Watchwait

#23
#23
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).
 
M

Marcelo

Inactive Registered Visitor
#24
#24
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.
 
A

Aviation2Healthcare

#25
#25
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)
 
W

Watchwait

#26
#26
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."
 

Attachments

M

Mike Schmidt

#27
#27
temujin said:
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
Click to expand...
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...
 
W

Watchwait

#28
#28
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:
 
S

SteveK

#30
#30
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
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
M Informational From Medtech Insight – QSR/ISO 13485 Harmonization Update: FDA Enforcement Discretion Likely When New Rule Stands Up; Draft Reg Coming By Year’s End; Medical Device and FDA Regulations and Standards News 0
N Harmonization dates of IEC 60601-1-2:2014 IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
shimonv Harmonization of ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 3
J GHTF (Global Harmonization Task Force) SG2 Guidance Documents EU Medical Device Regulations 3
M US FDA Harmonization of Label Symbol Rules 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
bio_subbu GHTF Proposes New Harmonization of Medical Device Audits Other Medical Device Regulations World-Wide 0
V Medical Device Definitions outside GHTF (Global Harmonization Task Force) Other Medical Device Regulations World-Wide 2
P GHTF's (Global Harmonization Task Force) Latest ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 5
M FDA Harmonization with Europe, Canada 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
M GHTF (Global Harmonization Task Force) "Archived" Document question EU Medical Device Regulations 3
Ajit Basrur GHTF (Global Harmonization Task Force) release 2 final documents Other Medical Device Regulations World-Wide 2
M Auditing and harmonization? Determining what is an "industry standard" ISO 13485:2016 - Medical Device Quality Management Systems 6
somashekar AHWP (Asian Harmonization Working Party) Other Medical Device and Orthopedic Related Topics 2
Ajit Basrur Proposed documents from GHTF (Global Harmonization Task Force) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
M The FDA says device regulation will move toward harmonization... 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
M Harmonization of ANSI/AAMI PB70:2003, EN 13795? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
Ajit Basrur Asian Harmonization Working Party to hold meeting on Nov 5, 6 in Delhi ISO 13485:2016 - Medical Device Quality Management Systems 0
M Harmonization of device classification with EU MDD? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
Ajit Basrur APEC Seminar on Harmonization of Medical Device Regulation (4-7, March) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
B ASEAN Harmonization Requirements - Particularly the Stability Calculation Food Safety - ISO 22000, HACCP (21 CFR 120) 0
A En 550/554 - The European Commission Standards Harmonization ISO 13485:2016 - Medical Device Quality Management Systems 2
A Should we assign the PRRC before the date of application of MDR (26 May 2021)? EU Medical Device Regulations 0
A Medical device labelling Date of manufacture US Food and Drug Administration (FDA) 2
M Why are EU harmonized particular standards so old & out-of-date? IEC 60601 - Medical Electrical Equipment Safety Standards Series 10
M EN 55032:2012/AC:2013 withdrawal date CE Marking (Conformité Européene) / CB Scheme 1
T EXCEL - How do I make the cell stay blank until a date is entered in N7? Excel .xls Spreadsheet Templates and Tools 6
P Do we need to retrospectively use the "MD" symbol (indicating device is a medical device) on labels, e.g. finished devices within expiration date? EU Medical Device Regulations 2
M Always Date format with letters After Work and Weekend Discussion Topics 17
T Sterilized components expiration date ISO 13485:2016 - Medical Device Quality Management Systems 1
B There is an estimated date of release of API Q1 10th edition? Oil and Gas Industry Standards and Regulations 8
W Next Calibration Due Date Calibration Frequency (Interval) 5
O Any info on release date of FDA “Computer Software Assurance for Manufacturing and Quality System Software” document? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
NDesouza FAI Due Date Calculator AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
B New Release of CQI-12 Coatings Process (Revision 3- Release date- 7/2020) Customer and Company Specific Requirements 2
T Commission proposal being drawn up for postponement for date of application of MDR (2017/745) EU Medical Device Regulations 7
H CQI-15 2nd Edition - Date of initial assessment? IATF 16949 - Automotive Quality Systems Standard 3
I Revision History Date - date of updates or date of release? ISO 13485:2016 - Medical Device Quality Management Systems 2
J Sterile medical device expiration date 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
T CE mark start date for a device EU Medical Device Regulations 7
Z Role of economic operators (EO) post the EU MDR Date of application in May 2020 EU Medical Device Regulations 1
I Date of Quality Management System - Training Records ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 19
CPhelan Nonconformance opened as incorrect expiration date placed on received product. Escalate to CAPA? Nonconformance and Corrective Action 4
K Labeling requirements - Date of manufacture for software devices EU Medical Device Regulations 5
S Is a specific day required in an expiration date? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
L Staying up to date on Regulations Other Medical Device Regulations World-Wide 8
M GSPR 23.3 (h) Manufacturing date on sterile barrier EU Medical Device Regulations 0
Q MDR Effectivity date for Legacy Class I Medical Devices EU Medical Device Regulations 5
S When is the last date for transition to ISO/IEC 80079-34:2018? Other ISO and International Standards and European Regulations 0
D FDA Date Format Requirement US Food and Drug Administration (FDA) 0
T No Defined Shelf Life/Expiration Date - Disposable single-use, non-invasive, non-sterile Other Medical Device Regulations World-Wide 2

Similar threads

Top Bottom