1 Scope
This part of ISO 18113 specifies requirements for information supplied by the manufacturer of IVD reagents for self-testing.
This part of ISO 18113 also applies to information supplied by the manufacturer with calibrators and control materials intended for use with IVD medical devices for self-testing.
This part of ISO 18113 can also be applied to accessories.
This part of ISO 18113 applies to the labels for outer and immediate containers and to the instructions for use.
This part of ISO 18113 does not apply to:
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a) IVD instruments or equipment,
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b) IVD reagents for professional use.