IEC 61010 3rd Edition - When devices are listed to the 2nd edition

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Guest
#1
My company produces several kinds of borderline medical devices, most of which are listed to 61010-1 2nd edition. When the 3rd edition becomes mandatory for assumption of compliance to the Low Voltage Directive (Oct 2013), how do I show compliance when most of my models are listed to particulars which have not been uplifted to 2nd edition?

If a product is listed to a particular (i.e. 61010-2-010 or 61010-2-051) can I update to 61010-1 3rd edition?
 

CharlieUK

Quite Involved in Discussions
#3
You seem to be mixing some requirements/directives.

Equipment is either covered by Medical Device Directive, or it isn't - even if it's "borderline", it doesn't "sit on the fence", it falls under one or the other.

Fully Applying Harmonised Standards gives a Presumption of Conformity. When your existing Harmonised Standard is superceded, you are not actually required to do anything under LVD or EMC Directives (but might be under other directives) - you can choose to still declare to previous standard.
Should you wish to update to latest standard (and this would be the "recommended" approach) then check what has changed that applies to your product, perform any required tests, update Technical File and issue new DoC.

Since you're following CB scheme, also talk to you're test lab about when they will be able to assess to 3rd edition and give CB cert.
 
P

Pick 5

Guest
#4
Thanks for the reply. Let me clarify.

To meet he LVD, the 2nd edition of 61010-1 can no longer be used to assume conformity after Oct 2013. Is this correct?

If it is correct, what must we do with products which are listed to 61010-1 2nd edition, but can not be uplifted to 3rd edition because the coresponding particular is not available in 3rd edition?

Can I have a device listed to a base standard and the particulars listed to the preceeding edition of the base standard?

THanks in advance
 

CharlieUK

Quite Involved in Discussions
#5
>To meet he LVD, the 2nd edition of 61010-1 can no longer be used to assume conformity after Oct 2013. Is this correct?

It won't give you a Presumption of Conformity - correct.

There are a number of changes between 2nd and 3rd editions, including:
  • Test and measurement circuit requirements moved to a separate part 2 standard IEC 61010-2-30
  • The scope now covers both professional and non-professional products
  • Rewritten clause regarding solid and thin film insulation
  • More detailed mechanical requirements
  • Temperature requirements modified due to EN563
  • X-ray requirements modified to include intended and non-intended emissions
  • Added requirements for foreseeable misuse and ergonomics
  • New requirements for risk assessment
  • New informative section on pollution degree and micro-environments
  • New requirements for conformal coatings
I don't know enough about your product to comment as to how these might affect you.
Did you do the initial safety assessment or did a 3rd party lab do it?
If lab - suggest you talk to them as they will have experience of you product.
 

Sarah Stec

Quite Involved in Discussions
#6
I agree with CharlieUK to talk to your 3rd party lab (or a 3rd party lab) with whom you can share more information about your device. Generally, our stance is that if a standard that exists in the 2nd edition has not yet been translated into the 3rd edition format, the manufacturer should wait for the standard to be translated to see when is the date of cessation of presumption of conformity. Obviously, this has different implications that depend on the device and the standards you use. Your lab could also have information about when updated standards and how to handle them.
 
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