Laboratoriemedicin

This document addresses good clinical practice for the design, conduct, recording and reporting of pre-market clinical investigations carried out in human subjects to assess the clinical performance or effectiveness and safety of medical devices.

The principles set forth in this document also apply to post-market clinical investigations and should be followed as far as relevant, considering the nature of the clinical investigation and the requirements of national regulations (see Annex I).

This document specifies general requirements intended to

— protect the rights, safety and well-being of human subjects,

— ensure the scientific conduct of the clinical investigation and the credibility of the clinical investigation results,

— define the responsibilities of the sponsor and principal investigator, and

— assist sponsors, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of medical devices.

NOTE 1 This standard can be used for regulatory purposes.

NOTE 2 Users of this International Standard will need to consider whether other standards and/or requirements also apply to the investigational device(s) under consideration.

NOTE 3 For Software as a Medical Device (SaMD), justifications for exemptions of this standard can consider the uniqueness of indirect contact between subjects and the SaMD. However it is required to demonstrate the analytical validity (the SaMD’s output is accurate for a given input), and where appropriate, the scientific validity (the SaMD’s output is associated to the intended clinical condition/physiological state), and clinical performance (the SaMD’s output yields a clinically meaningful association to the target use) of the SaMD (see Reference [5]).

This document does not apply to in vitro diagnostic medical devices.

This part of ISO 20776 describes one reference method, broth micro-dilution, for determination of MICs. The MIC may be a guide for the clinician, and reflects the activity of the drug under the described test conditions, by taking into account other factors, such as drug pharmacology, pharmacokinetics, or bacterial resistance mechanisms. This allows categorisation of bacteria as “susceptible” (S), “intermediate” (I), or “resistant” (R). In addition, MIC distributions can be used to define wild type or non-wild type bacterial populations. Although clinical interpretation of the MIC value is beyond the scope of this part of ISO 20776, modifications of the basic method are required for certain antimicrobial agent - bacteria combinations to facilitate clinical interpretation. These modifications are included in a separate Annex of this document. It is necessary to compare other susceptibility testing methods (e.g. disc diffusion or diagnostic test devices) with this reference method for validation, in order to ensure comparable and reliable results.