ISO 14971:2019 pdf download

ISO 14971:2019 pdf download

ISO 14971:2019 pdf download.Medical devices — Application of risk management to medical devices
1 Scope
This document specifies terminology, principles and a process for risk management of medical devices, including software as a medical device and in vitro diagnostic medical devices. The process described in this document intends to assist manufacturers of medical devices to identify the hazards associated with the medical device, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls. The requirements of this document are applicable to all phases of the life cycle of a medical device. The process described in this document applies to risks associated with a medical device, such as risks related to biocompatibility, data and systems security, electricity, moving parts, radiation, and usability. The process described in this document can also be applied to products that are not necessarily medical devices in some jurisdictions and can also be used by others involved in the medical device life cycle. This document does not apply to: — decisions on the use of a medical device in the context of any particular clinical procedure; or — business risk management. This document requires manufacturers to establish objective criteria for risk acceptability but does not specify acceptable risk levels. Risk management can be an integral part of a quality management system. However, this document does not require the manufacturer to have a quality management system in place. NOTE Guidance on the application of this document can be found in ISO/TR 24971 [9] .
2 Normative references
There are no normative references in this document.
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
3.1 accompanying documentation
materials accompanying a medical device (3.10) and containing information for the user or those accountable for the installation, use, maintenance, decommissioning and disposal of the medical device (3.10), particularly regarding safe use
Note 1 to entry: The accompanying documentation can consist of the instructions for use, technical description,installation manual, quick reference guide, etc.
3.9 manufacturer
natural or legal person with responsibility for the design and/or manufacture of a medical device (3.10) with the intention of making the medical device (3.10) available for use, under his name, whether or not such a medical device (3.10) is designed and/or manufactured by that person himself or on his behalf by another person(s) Note 1 to entry: The natural or legal person has ultimate legal responsibility for ensuring compliance with all applicable regulatory requirements for the medical device in the countries or jurisdictions where it is intended to be made available or sold, unless this responsibility is specifically imposed on another person by the Regulatory Authority (RA) within that jurisdiction.