CEN is producing European Standards to meet the requirements of the European Union directives for medical devices (93/42/EEC), active implantable medical devices (90/385/EEC) and in vitro diagnostic devices (98/79/EC) that are acceptable to manufacturers, regulators and other interested parties.
References to the 'harmonized' European Standards cited in the Official Journal:
The monthly 
snapshot identifies work items for which (i) drafts have been received in CMC for formal vote or UAP, (ii) the formal vote or UAP has been launched, (iii) the formal vote or UAP is closed, (iv) standards which have become available within the last six months.
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prEN 15986
'Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates'
Phthalates have been extensively used as plasticizers due to the increased flexibility they impart to polyvinyl chloride (PVC), a plastic polymer used in a wide array of products including medical devices.
In December 2008, CEN received a mandate from the European Commission to develop a European Standard for a label to be used to indicate the presence of phthalates in medical devices.
In accordance with this mandate, a European Standard is currently being prepared regarding the use of symbols to provide information for the safe use of medical devices, and to the legislative requirement for labelling to show the presence of certain phthalates in medical devices.
Due to the high levels of interest, this section will provide regularly updated information on the progress of the development of this important document.
Note: Due to the need for timely availability of this standard, CEN and its members are trying to speed up internal procedures as much as possible.
Current status:
The draft standard is being prepared for launching the Formal Vote. |
The CEN Advisory Board for Health Standards (ABHS) is the sector forum for the healthcare sector.
SPIDIA
'Standardization and Improvement of generic pre-analytical tools and procedures for in vitro diagnostics'
CEN is a full partner in this project under the EU's Seventh Framework Programme for Research and Development (FP7).
More information about SPIDIA.