Performance evaluation of in vitro diagnostic medical devices not-for-sale test of the charger and

test of the charger and the standby power source

11 Disclosing new data elements

This is one of a series of European Standards for requirements for fusion welding of metallic materials

to provide design and details that are as safe as those laid out in this European Standard

They do not provide exact product information

Performance evaluation of in vitro diagnostic medical devices not-for-sale test of the charger andBS EN 13612: 2002 applies to the performance evaluation of in vitro diagnostic medical devices (IVD MDs) including IVD MDs for self testing. It specifies the responsibilities and general requirements for the planning, conduct, assessment and documentation of a performance evaluation study by the manufacturer. It does not apply to specific evaluation plans for certain IVD MDs or a specific use. NOTE For a selection of publications on specific