IEC 60601-1:2005 - Medical device standardization - Seeking information

[mmantunes]

Right now there´s a lot of papers on the new IEC 60601. Some links can be found on my website at www.electromedicalinfo.com. The standard isn´t valid in certifications schemes yet, so there´s no need to a new certification right now. For example, in the EU, a standard has to be published in the journal of the EC to be used as a harmonized standard, and even then , there´s the transition period (which is being discussed right now and will be between three and five years, in this period both standards will be valid as means to have a presumption of conformity with the essential requirements.

[amjadrana]

The following link can be used to register for free webinars for various medical device regulations including IEC 60601-1 transition and risk based processes. It requires registration.

http://www.intertek-etlsemko.com/por...ma=CUST_PORTAL

If there is any problem, this link can be copied and added in the browser.

Amjad Rana

[RLewing]

Originally Posted by amjadrana

Would anybody direct me to an official site that tells me when second edition of IEC 60601-1 is going to be obsolete/expire. Our product has been certified to IEC 60601-1 second edition. Do we need to recertify? When should we start to recertify at the latest?

Thanks

Hi,

regarding the question of when being obsolete:
In the EU, the "harmonized standards" list gives the dates. It is is available at the EU website: ec.europa.eu enterprise newapproach standardization harmstds reflist meddevic.html

(I'm sorry for being so new at the site that I am not yet allowed to post working links. Workaround: Put slashes instead of spaces there, and replace the -dot- with dot ;-)

It still states IEC 60601-1:1988 (with amendments) to be applicable. And after they change it in the list, you'll still have ample time to adjust.

For FDA, you can make a search in the "Recognized Consensus Standards" list
www-dot-accessdata-dot-fda-dot-gov scripts cdrh cfdocs cfStandards search.cfm
Also giving the old version there.

But we all know that a product change (especially one which is not considered important by marketing) may take a looong time, so why not start as soon as your engineering people have some time to look into this?

Regards
Raimo

[Dmitry]

From 15’th of December 2008 second edition of IEC60601-1 will be removed from the list of recognized standards in Canada.
Does anyone know the following statement ?
hc-sc.gc.ca/dhp-mps/md-im/standards-normes/md_rec_stand_im_norm_lst_2_e.html

specially pointed out:
“On December 15, 2008, IEC 60601-1 Ed. 2.0 and IEC 60601-2 Ed. 2.0 will be removed from the List of Recognized Standards. This establishes a transition period for these standards that will be adequate to allow manufacturers to comply in an appropriate manner.”