EN ISO 13485:2016 or just ISO 13485:2016 without the "EN" as a prefix?

[SGquality]

Hello,

We have EN ISO 13485:2012 certification and migrating to ISO 13485:2016 standard.

When I see references else where, I just see "ISO 13485:2016" without the "EN" as a prefix. So would the standard be referred as :

EN ISO 13485:2016 or just ISO 13485:2016 ?

Thanks

 

[somashekar]

ISO 13485: 2016 is an ISO standard
EN ISO 13485: 2016 is an European standard (see CENELEC)
This is published and date of publication is 2016-09-30
See THIS

 

[Ronen E]

Normative contents are identical.
You still need the 2012 EN version, though, for presumption of conformity with the MDD.

 

[somashekar]

One has to know their requirements well and work with reputed CB to know what thay are going to get post a successful audit. There are many european NB who offer the 13485, and if you, as a customer do not know, you will end up with an EN ISO certification and not an ISO. Same is the case with the 9001, 14001, where you can get an EN ISO 9001 or an EN ISO 14001

 

[Randy]

Hello,

We have EN ISO 13485:2012 certification and migrating to ISO 13485:2016 standard.

When I see references else where, I just see "ISO 13485:2016" without the "EN" as a prefix. So would the standard be referred as :

EN ISO 13485:2016 or just ISO 13485:2016 ?

Thanks

Just use the plain ISO standard, the "EN" is probably one of the reasons many of our ancestors came over here on leaky boats

 

[paulag]

Please consider that there might have been a reason for getting certified acc. EN ISO... If you are the legal manufacturer of a CE-marked medical device for the EU market, plain ISO is not enough