A presumption of conformity to the Medical Device Directive afforded by compliance with EN ISO 8359 will require evidence that amendment 1 is observed by the 31st January 2013 at the latest. See confirmation of the effective date here http://esearch.cen.eu/esearch/Details.aspx?id=7314685

 

 

Will you be ready? For assistance contact us at cs@bprmedical.com

 

 

A number of national standards bodies have already published the amendment, which can be obtained by visiting the below links:

 

AFNOR

http://www.boutique.afnor.org/norme/nf-en-iso-8359-a1/concentrateurs-d-oxygene-a-usage-medical-prescriptions-de-securite-amendement-1/article/804811/fa176600

 

DIN

http://www.nark.din.de/cmd?artid=157667806&bcrumblevel=1&contextid=nark&subcommitteeid=54754747&level=tpl-art-detailansicht&committeeid=54738959&languageid=de

 

UNI

http://store.uni.com/magento-1.4.0.1/index.php/uni-en-iso-8359-2012.html

 

NEN

http://www.nen.nl/web/Normshop/Norm/NENENISO-83592009A12012-en.htm

 

SIS

http://www.sis.se/hälso-och-sjukvård/medicinsk-utrustning/utrustning-för-anestesi-respiration-och-återupplivning/ss-en-iso-83592009-a12012