Is BS EN ISO 15223-1 a harmonised standard?

[rangani_rj]

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.

 

[bio_subbu]

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.

 

[Ronen E]

Do we need to comply to show conformity?

Even if it was harmonized, you wouldn't have to comply to show conformity. Harmonized standards application is voluntary. If you choose an alternative route, you need to justify how the relevant ERs are satisfied.