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General requirements for in vitro diagnostic medical devices for self-testing
Description
General requirements for in vitro diagnostic medical devices for self-testingWhat is BS EN 13532 Requirements for in vitro diagnostic medical devices for self testing about? BS EN 13532 is a European standard that discusses in vitro diagnostic medical devices for self testing. BS EN 13532 outlines the general requirements for in vitro diagnostic medical devices (IVD MDs) for self testing to ensure that IVD MDs are safe to use and are suitable for the purposes specified by the manufacturer. Note: BS EN 13532 does not address
combinations of species
BS 15000-1 is withdrawn
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Types of resilience
A medical linear accelerator (LINAC) is the device most used for external beam radiation treatments for patients with cancer
and upkeep and maintenance
Why BS ISO 14046
CENELEC Interpretation Sheet
methodology
Guidance on nominal cover to reinforcement for structural and fire consideration is available in other publications
whether used alone or in combination
resistance to liquids
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