EN ISO 14971-2012 pdf download.Medical devices – Application of risk management to medical devices (ISO 1497 1:2007, Corrected version 2007-10-01). EN ISO 14971 specifies a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls. The requirements of this International Standard are applicable to all stages of the life-cycle of a medical device. This International Standard does not apply to clinical decision making. This International Standard does not specify acceptable risk levels. This International Standard does not require that the manufacturer have a quality management system in place. However, risk management can be an integral part of a quality management system. 2 Terms and definitions For the purposes of this document, the following terms and definitions apply: 2.1 accompanying document document accompanying a medical device and containing information for those accountable for the installation, use and maintenance of the medical device, the operator or the user, particularly regarding safety NOTE Adapted from IEC 60601-1:2005, definition 3.4. 2.2 harm physical injury or damage to the health of people, or damage to property or…

ISO 15223-1:2016 pdf free download.Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1:General requirements Dispositifs médicaux — Syin boles a utiliser avec les étiquettes, l’étiquetage et les informations a fournir relcztifs aux dispositifs médicaux — Partie 1: Exigences générales. Symbols that are registered in ISO 7000 shall comply with the graphical representation in ISO 7000, especially with respect to relative dimensions, including relative line thickness, orientation and the absence or presence of filled or shaded areas. NOTE 1 ISO and IEC jointly maintain an online database of graphical symbols for use on equipment, which contains the complete set of graphical symbols included in ISO 7000 and TEC 60417 available at https://www. isoorg/obp/ul/#search. This online collection shows each graphical symbol and identifies It by a reference number and a title (in English and French). The graphical symbols are available in different formats (e.g. Al, DWG, EPS) and some additional data as applicable is provided. Various search and navigation facilities allow for easy retrieval of graphical symbols. As part of risk management, the manufacturer should determine the appropriate size for the symbol to be legible for its intended function. NOTE 2 This document…