Most recent
ONORM EN ISO 14155:2021
Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)
This document sets out the good clinical practice for the design, implementation, recording and reporting of clinical trials of medical devices to human exam participants in order to evaluate clinical performance or efficacy and security. For clinical investigations after the placing on the market, the principles set out in this document should be followed, taking into account the type of clinical trial, as far as relevant. This document specifies general requirements to achieve the following: - the protection of rights, security and well-being of the participating examiners; - ensuring the scientifically correct implementation of the clinical trial and credibility of the results of the clinical trial; - determining the responsibilities of the sponsor and main auditor; - the support of the work of sponsors, examiners, ethics commissions, regulators and other institutions involved in the conformity assessment procedures for medical devices. This document does not apply to medical devices for in vitro diagnostics. However, there may be situations in depending on the product and national or regional requirements, where users could consider this document whether certain sections and / or requirements of this document may be applicable.
Austrian Standards Institute [on]