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Overview ISO 18113-5:2022 - part of the ISO 18113 series - specifies requirements for information supplied by the manufacturer (labelling) for in vitro diagnostic (IVD) instruments intended for self-…
1 Scope This part of ISO 18113 specifies requirements for information supplied by the manufacturer of IVD instruments for self-testing. This part of ISO 18113 also applies to apparatus and equipment…