cocir
sustainable competence in advancing healthcare
European Coordination Committee of the Radiological, Electromedical and Healthcare IT Industry
cocir
sustainable competence in advancing healthcare
European Coordination Committee of the Radiological, Electromedical and Healthcare IT Industry
MENU

Standardisation

International Standard IEC 60601-1-9

“Medical electrical equipment, general requirements for basic safety and essential performance - Collateral Standard: requirements for environmentally conscious design”, published in July 2007, is a collateral standard to IEC 60601-1:2005 and has been developed by drawing on extensive practical experience.  IEC 60601-1-9:2007 requires manufacturers of medical electrical equipment to establish processes in order to consider, and where possible minimize, the environmental impact throughout a products entire lifecycle.

 
The standard also requires manufacturers to provide information to the user on how to use the product in the most environmentally sensitive way possible and how to proceed at the end of life of the product. This standard has been developed by working group WG 20 of Subcommittee SC 62A of Technical Committtee TC 62 of IEC.
 

At international level: IEC TC 62

COCIR was granted liaison of category A with the international Technical Committee 62 of IEC.  This technical committee is in charge of all international standards covering all electromedical equipment.  This category A liaison allows COCIR to submit new work item proposals (NWIP) at international level, to be considered as potential future international standards subject to approval by the National Committee Members of Technical Committee 62 of IEC.

 
All standards of IEC TC 62 issued at international level are adopted as European Standards through CEN/CENELEC and ratified at national level through the 27 Member States. Almost all of these standards are referenced under the Medical Device Directives.
 

At European level: CENELEC TC 62, CENELEC BT and Advisory Board for Health Sector (ABHS)

As part of COCIRs priority to be active on international standardisation, COCIR and CENELEC renewed in March 2009 their cooperation agreement in the standardisation of electromedical equipment.