Is BS EN ISO 15223-1 a harmonised standard?

rangani_rj

Involved In Discussions
#1
Hello Friends,

Hope you all are doing well.

I came to know that ISO 15223-1 is not listed in list of harmonised standards published on 16/05/2014 still it is shown as BS EN ISO 15223-1:2012 (see links below).

http://ec.europa.eu/enterprise/poli...onised-standards/medical-devices/index_en.htm

http://shop.bsigroup.com/ProductDetail/?pid=000000000030268772

Any idea whether it is harmonized (or harmonized and waiting for publication). Do we need to comply to show conformity?

Great thanks in advance.
 
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bio_subbu

Super Moderator
#2
Re: BS EN ISO 15223-1, is this harmonised standard?

The standard EN ISO 15223-1 has not yet been recognized by the European Commission as a Harmonized Standard though it was published by CEN as a European Standard. I understand that CEN is currently modifying its Annexes, so as to make it fully acceptable to the EC. Once re-published, the EN ISO 15223-1 will be considered/proposed again to the EC for OJEU citation as a Harmonized Standard. To obtaining the presumption of conformity, only the references officially published in the OJEU are valid.
 
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