Performance evaluation of in vitro diagnostic medical devices Ingestion-build-46800 are therefore requested to refer

are therefore requested to refer to ISO 6360 in their catalogues

BS EN 10277-5 is superseded by BS EN 10277:2018 which you can buy here

Understanding the terminology is a tangible and significant benefit from BS ISO/IEC 20000

Annex A (informative) - Statute and policy underpinning forward planning in the UK

The charts have been based on the assumptions laid down in BS 8110-1

Performance evaluation of in vitro diagnostic medical devices Ingestion-build-46800 are therefore requested to referBS 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