IEC 60601-1-11 MEE used in Home Healthcare Environment Published

Marcelo

Inactive Registered Visitor
#1
IEC 60601-1-11 ed1.0

Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment

Has been published (and can be acquired in this link: http://webstore.iec.ch/Webstore/webstore.nsf/Artnum_PK/43967

From the IEC webstore:

IEC 60601-1-11:2010 applies to the basic safety and essential performance of medical electrical equipment and medical electrical systems which are intended by their manufacturer for use in the home healthcare environment, regardless of whether the medical electrical equipment or medical electrical system is intended for use by a lay operator or by trained healthcare personnel. The object of IEC 60601-1-11:2010 is to specify general requirements that are in addition to those of the general standard IEC 60601-1:2005 and to serve as the basis for particular standards. It is the recommendation of the committee that the content of this publication be adopted for implementation nationally not earlier than 3 years from the date of publication.


As home healthcare has been a growing trend in the medical device area, i´m pretty sure this standard will have a big impact on the future. Also, i´ve accpmpanied the development of the standard and it was quite discussed during the draft stage.

As can be seen in the contets (there´s a preview on the webstore) the standard focus on some aspects that are problematic for equipment which does not rely on a professional operator, such as usability of IFU and mechanical hazards.

Let´s see how it will affect members which have home healthcare products.
 
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A

andreiafilipaf

#2
Hello Marcelo
Thank you for th epost. I wanted to ak you to clarify the meaning of the phrase: "It is the recommendation of the committee that the content of this publication be adopted for implementation nationally not earlier than 3 years from the date of publication."
Is this the "translation" by each country´s responsible entity to national regulation?

Thank you
Andreia
 

Marcelo

Inactive Registered Visitor
#3
Hello Marcelo
Thank you for th epost. I wanted to ak you to clarify the meaning of the phrase: "It is the recommendation of the committee that the content of this publication be adopted for implementation nationally not earlier than 3 years from the date of publication."
Is this the "translation" by each country´s responsible entity to national regulation?

Thank you
Andreia
Hello Andreia

This phrase is a new addition to some IEC standards due to a requirement from some regulators. Basically, it suggests that standards need a transition period so that manufacturers, test houses, etc, can adapt to the new requirements.

Please take a look at the original statement, sort of: "“NOTE The attention of National Committees is drawn to the fact that
equipment manufacturers and testing organizations may need a
transitional period following publication of a new, amended or revised
IEC publication in which to make products in accordance with the new
requirements and to equip themselves for conducting new or revised
tests. It is the recommendation of the committee that the content of this
publication be adopted for implementation nationally not earlier than XXXXX
years from the date of publication".


Please note some things:

First, standards are voluntary and only mandatory after regulations "call" them. Second, this statement in particular is related to the IEC document, meaning, it suggests that the IEC document, if used by regulations, be giben a transition period. Third, generally regulation use their national or regionbal standard, not the IEC document.

So in practice this statement is a suggestion that, when IEC or derived standards are used in regulation, they be given some transition period.
 
V

vpjagadeesh

#4
Hello Marcelo

Whether 60601-1-11 is harmonized?? with US and Europe, Suppose , I am evaluating Home monitor for 3rd edition, is it really required to comply with -1-11 now??

Request you to clarify please!!
 
J

Joerg_R

#5
EN 60601-1-11:2010 is harmonised under the Europan MDD (93/42/EEC) as published in official journal (OJ) 2011/C 16/02 of 18.01.2011.

Best regards, Jörg
 
P

petruchio

#7
Hi

According to an article on the internet by SGS, IEC 60601-1-11:2010 is not mandatory in Europe until June 2013. Can anyone confirm this?

Also, if a company is still using the 2nd edition of 60601-1 (which makes no normative reference to 60601-1-11), is it necessary to invoke this standard? In other words, is 60601-1-11 only necessary in connection with the 3rd edition?

thanks,

petruchio
 

Marcelo

Inactive Registered Visitor
#8
According to an article on the internet by SGS, IEC 60601-1-11:2010 is not mandatory in Europe until June 2013. Can anyone confirm this?
It´s wrong. A standard is NEVER mandatory in Europe.

As with all 60601-1 third edition collaterals, if you use 60601 to give presumption of conformity and your device does not have an applicable particular standard, in June 2012 you cannot use the second edition series anymore, only the third edition (meaning, the general standard + all applicable collateral). If a particular standard on the 60601 series is applicable to your device, then you will have to verify the date of cessation of presumption of conformity.

Also, if a company is still using the 2nd edition of 60601-1 (which makes no normative reference to 60601-1-11), is it necessary to invoke this standard? In other words, is 60601-1-11 only necessary in connection with the 3rd edition?
Are you talking about the standards per se or the standards used to show presumption of conformity in the MDD?

In the 2nd edition series, the general standard makes no normative reference to any collateral - because the general standard was written before any collateral existed.

Anyway, for the regulatory use of standards in the MDD, it´s necessary to use all collateral harmonized applicable standards. This is true to the 2nd edition series.

However, IEC 60601-1-11 does not exist for the 2nd edition, only for the third edition. So you do not need to use with with the second edition (you "could", but there´s a philosophy in the use of 60601 in the MDD that expects that you do not mix different editions).
 
P

petruchio

#9
Thanks for the instant response.

By "mandatory" I meant that it must be used to establish MDD conformity after June 1, 2013 if one elets to use the standards route to establish MDD conformity.

My company is still using the 2nd edition and we've just submitted a technical file to our NB and the reviewer has insisted that we invoke 60601-1-11. I don't think it's applicable to our products (all non prescription, personal care products and available over the internet) but in any event I don't feel that the reviewer can force us to invoke it until 2013 (by which time we'll be using the 3rd edition).

petruchio
 

Marcelo

Inactive Registered Visitor
#10
If it's a medical electrical equipment and it's used in the home healthcare environment (as defined in 60601-1-1) then the standards is applicable (and the examples from the website of your company does look like they fit).

I'm not sure if 60601-2-57 is applicable to your equipment. I think it is, and if so you in principle do not fall under the June 2013 date.

But anyway, you are right, the reviewer should not "force you" (even if he could force you :)) to use a third edition standard before you use the whole third edition series.
 
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