Hi Gary,
David Schaefer said on June 1, 2016, in this chain, the DOW (date of
withdrawal) for the 3rd ed. of IEC 60601-1-2 is December 31st, 2018. I am
pretty sure that is the correct info.
The knee is almost totally healed so working pretty normal hours now. Thx for
your note back in Mid June.
All the best,
Leonard (Leo) Eisner, P.E.
Principal Consultant, Eisner Safety Consultants
Phone: (503) 244-6151
Mobile: (503) 709-8328
Email: [email protected]
Website: www.EisnerSafety.com
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> On Jun 17, 2016, at 1:33 PM, Leo Eisner <[email protected]> wrote:
>
> Hi Gary,
> For the US I believe from memory it is April 1, 2017 so pretty soon.
> I have the EU info buried somewhere so when I get a chance (may be awhile as
> I am only working couple hours per day max with being post knee surgery 1
> week).
> Thx,
>
> Leonard (Leo) Eisner, P.E.
> Principal Consultant, Eisner Safety Consultants
> Phone: (503) 244-6151
> Mobile: (503) 709-8328
> Email: [email protected] <mailto:[email protected]>
> Website: www.EisnerSafety.com <http://www.eisnersafety.com/>
>
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>
> On Jun 1, 2016, at 9:23 AM, Gary McInturff <[email protected]
> <mailto:[email protected]>> wrote:
>
>> Are these dates still valid?
>> US and Canada requiring 4th edition in 2017?
>> EU accepting 4th edition but 3rd edition still acceptable for new products.
>> What is the EU DOW. I tried hunting through the EU journal but could never
>> find the standards dates. A link please?
>>
>>
>> In February 2014, the IEC published IEC 60601-1-2:2014, ed 4.0 for Medical
>> EMC. There are a number of changes in the 4th edition, including new
>> immunity and risk analysis requirements.
>> Dates
>> For new products in the U.S., the FDA will make a decision on the 4th
>> edition this July, with a likely 3-year transition period (2017
>> recognition). The FDA does not currently require retesting of legacy
>> products unless changes are made to the product that may affect its
>> compliance.
>> Canada is planning to review the 4th Edition sometime in 2015 so it will not
>> be accepted before 2015/2016. It’s typically 3 years before accepted
>> standards are required for new submittals.
>> In Europe, CENELEC has voted affirmatively to accept the 4th edition but has
>> not set a date to withdrawal (DOW) the 3rd edition. The DOW of the current
>> 3rd Edition is expected in the 2017-2018 timeframe. There is no
>> grandfathering in Europe.
>>
>>
>> Gary McInturff
>> Reliability/Compliance Engineer
>>
>> Esterline Interface Technologies Featuring
>> ADVANCED INPUT, GAMESMAN, LRE MEDICAL, and MEMTRON products
>>
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