This Guide provides an approach to writing international standards for medical devices that takes into account the hazards of medical use, the role of standards in managing risk in relation to the medical need for the device and the use of standards in medical device design, manufacture and regulation.
This Guide will also help those who use medical device standards to understand what such standards are intended to accomplish. Among such users are:
— users of medical devices;
— hospital administrators;
— personnel involved in the procurement of medical devices;
— regulatory authorities;
— persons responsible for the design and construction of patient care facilities;
— persons responsible for the installation and maintenance of medical devices;
— manufacturers of medical devices;
— persons who assemble systems of medical devices from more than one manufacturer. This sectoral Guide is intended to be read in conjunction with ISO/IEC Guide 51.
ISO/IEC Guide 63:1999 Referenced Document
ISO 14971-1:1998 Medical devices - Risk management - Part 1: Application of risk analysis