Compliance Date of EN 60601-2-10:2015 & related 60601-1-XX

[bennylee]

Dear All,

I just found that EN version of 60601-2-10:2015 will be issued soon, the related web site (CENELEC):
http://www.cenelec.eu/dyn/www/f?p=1...G_ID,FSP_PROJECT,FSP_LANG_ID:1257161,55955,25

that's mean all related 60601-1-XX (linked to 3rd ver.) MUST comply soon.

Hence, for CE products, may I know the deadline to comply all related 60601-1-XX (linked to 3rd ver.) is
a) 3 year after EN 60601-2-10:2015 officially issued
b) Immediate after EN 60601-2-10:2015 listed in EU OJ
c) Immediate after EN 60601-2-10:2015 officially issued

 

[Marcelo]

that's mean all related 60601-1-XX (linked to 3rd ver.) MUST comply soon.

Nope. First, standards are voluntary in the EU, so there?s no "MUST" comply. Second, even if you use the standards to gain presumption of conformity, it only gives presumption of conformity after being harmonized to the directives, not published. The timeframe from publication to harmonization varies (for example, the old edition of EN 60601-2-10 took years to harmonize).

Hence, for CE products, may I know the deadline to comply all related 60601-1-XX (linked to 3rd ver.) is
a) 3 year after EN 60601-2-10:2015 officially issued
b) Immediate after EN 60601-2-10:2015 listed in EU OJ
c) Immediate after EN 60601-2-10:2015 officially issued

The same idea as I mentioned above. The dates (IF you want to apply harmonized standards to gain presumption of conformity) is the date give in the Official Journal after the specific standard is harmonized.

 

[bennylee]

Thanks for your reply !

As from harmonized standards, old edition of EN60601-2-10 is still listed, for this kind of device, I supposed that old edition of EN60601-1 series still accepted right now.

As I know from customer, it seems that auditor may request gap analysis (to prove no unacceptable risk if some already-listed harmonized standards for 3rd edition 60601-1-XX not apply right now).

If I prepare
gap analysis for EN60601-1-XX (3rd edition)
+ EN60601-1:2005 & EN60601-1-2:2007 (3rd edition) test report
+ EN60601-2-10:2000 (2nd edition) self-declaration with own test
, my approach is acceptable right now?

 

[Marcelo]

As from harmonized standards, old edition of EN60601-2-10 is still listed, for this kind of device, I supposed that old edition of EN60601-1 series still accepted right now.

As I know from customer, it seems that auditor may request gap analysis (to prove no unacceptable risk if some already-listed harmonized standards for 3rd edition 60601-1-XX not apply right now).

If I prepare
gap analysis for EN60601-1-XX (3rd edition)
+ EN60601-1:2005 & EN60601-1-2:2007 (3rd edition) test report
+ EN60601-2-10:2000 (2nd edition) self-declaration with own test
, my approach is acceptable right now?

First, there are some details that need to be clear here.

You need to define which harmonized standard in the list is applicable to your medical electrical equipment.

If it?s a particular standard such as EN 60601-2-10, the harmonized standard is the the particular standard listed, not the general standard (the general standard is only on the list to be applicable to medical electrical equipment with no particulars).

If the harmonized standard is EN60601-2-10:2000, you need to use the second edition general and collateral standards. You can?t mix editions.

The gap analysis you mentioned should only be requested (and this is already an stretch in the regulations ) if the applicable harmonized standard is, in this case, a particular in the new edition EN60601-2-10:2015 for example. If there?s no particular in the new edition listed as an harmonized standard (not simply published), only the old edition one, there?s no reason to to request a gap analysis.

So, if the harmonized standard is EN60601-2-10:2000 (which means you need to apply EN 60601-1:1990, EN 60601-1-1:2001, EN 60601-1-4:1996, EN 60601-1-2:2001, etc.) and you comply with them, it?s ok by now.

 

[Bill Evans]

Marc


Can you assist with a question regarding 60601-1 3rd ED and FDA recognition. Our company manufactures Class II "510k Exempt" products. The FDA has identified that August 2016 the old standard will not be recognized. I am not certain but I believe this is for premarket NOT existing listings.

My question is two parts.

1. Our Class II product is exempt from premarket notification; will the current device listings be recognized with declarations of conformity to the previous standard?
2. If no, do we need to have all current product re-tested to 60601-1 3rd edition?


Recognition List Number: 036 FR Publication Date: 07/09/2014 Part B: Supplementary Information.

http://www.accessdata.fda.gov/scrip.../detail.cfm?standard__identification_no=32317

 

[Marcelo]

Can you assist with a question regarding 60601-1 3rd ED and FDA recognition. Our company manufactures Class II "510k Exempt" products. The FDA has identified that August 2016 the old standard will not be recognized. I am not certain but I believe this is for premarket NOT existing listings.

My question is two parts.

1. Our Class II product is exempt from premarket notification; will the current device listings be recognized with declarations of conformity to the previous standard?
2. If no, do we need to have all current product re-tested to 60601-1 3rd edition?

This is for new registrations only.

 

[Eurodep]

Hi BCSNave and Marcelo, I read with interest regarding the 3rd edition and FDA recognition for a Class II 510k.

Do you, or does anyone, have any link or information from FDA regarding the recognition of 60601 3rd edition? I cannot find definitive answers on FDA on when they will end recognition of 2nd edition and only recognize 3rd edition. Non-FDA links are contradictory, some say 2013, others Aug 1 2016.