1 Scope
This document specifies requirements for information supplied by the manufacturer
of in vitro diagnostic (IVD) instruments intended for self-testing.
This document is also applicable to apparatus and equipment intended to be used with
IVD instruments for self-testing.
This document can also be applicable to accessories.
This document does not apply to:
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a) instructions for instrument servicing or repair;
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b) IVD reagents, including calibrators and control materials for use in control of the
reagent;
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c) IVD instruments for professional use.