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General requirements for in vitro diagnostic medical devices for self-testing

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General requirements for in vitro diagnostic medical devices for self-testingBS EN 13532: 2002 specifies general requirements for in vitro diagnostic medical devices (IVD MDs) for self testing in order to ensure that IVD MDs for self testing are safe and suitable for the purposes as specified by the manufacturer. This European standard does not address medical aspects of IVD MDs for self testing.

Provide an appropriate level of protection (as specified by this PAS) upon implementation/installation either through the use of default settings or configuration in accordance with user documentation

or just below

A format for presentation of functional performance values is given in Annex A

Programmable wedge fields (PWF)

regardless of type

BS EN 12522-2

you can facilitate the exploitation and the administration of the document modifications

Edge camber

Who is BS EN 12094-1 – Electrical automatic control and delay devices for

Protective coating options

This will be influenced by parent metal

This European Standard specifies requirements

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