Historical

BS EN ISO 14155-2:2009

Clinical investigation of medical devices for human subjects. Clinical investigation plans (British Standard)

1 Scope

This part of EN ISO 14155 provides requirements for the preparation of a Clinical Investigation Plan (CIP) for the clinical investigation of medical devices. The compilation of a CIP in accordance with the requirements of this standard and adherence to it will help in optimising the scientific validity and reproducibility of the results of a clinical investigation.

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

CONTENT PROVIDER
British Standards Institution [bsi]

Others Also Bought
Clinical investigation of medical devices for human subjects. General requirements (British Standard)
Sterilization of health care products. Biological indicators. Biological indicators for ethylene oxide sterilization ...
Medical devices - Application of risk management to medical devices
Included in Packages
This standard is not included in any packages.
Document History
Amendments & Corrections
We have no amendments or corrections for this standard.