In vitro diagnostic medical Devices. Information supplied by the manufacturer (labelling) - In vitro diagnostic reagents for self-testing algolia-ignore This part of ISO 15859

This part of ISO 15859 specifies the limit values for the composition of oxygen and establishes the sampling and test requirements applicable for the verification of the oxygen composition

and counteract adverse effects on human subjects’ health due to repeated mechanical vibration and shock

It does not permit the use of a cylindrical test piece

The standard does not include devices or systems to prevent the occurrence of explosive atmospheres

In vitro diagnostic medical Devices. Information supplied by the manufacturer (labelling) - In vitro diagnostic reagents for self-testing algolia-ignore This part of ISO 158591 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