Search results
Results from the WOW.Com Content Network
ISO 14971 Medical devices — Application of risk management to medical devices is a voluntary consensus standard, [1] published by International Organization for Standardization (ISO) for the first time in 1998, and specifies terminology, principles, and a process for risk management of medical devices.
Download as PDF; Printable version; ... Risk management is the identification, ... The requirements of EN 14971:2012 are nearly identical to ISO 14971:2007. The ...
Medical Device Risk Management - ISO 14971 – ISO standard; Occupational safety and health – Field concerned with the safety, health and welfare of people at work; Reliability engineering – Sub-discipline of systems engineering that emphasizes dependability
ISO 31000 is a set of international standards for risk management.It was developed in November 2009 by International Organization for Standardization. [1] The goal of these standards is to provide a consistent vocabulary and methodology for assessing and managing risk, resolving the historic ambiguities and differences in the ways risk are described.
The IEC 62304 standard calls out certain cautions on using software, particularly SOUP (software of unknown pedigree or provenance).The standard spells out a risk-based decision model on when the use of SOUP is acceptable, and defines testing requirements for SOUP to support a rationale on why such software should be used.
ISO 14971:2007 Medical devices – Application of risk management to medical devices; ISO 14972:1998 Sterile obturators for single use with over-needle peripheral intravascular catheters; ISO 14975:2000 Surface chemical analysis – Information formats; ISO 14976:1998 Surface chemical analysis – Data transfer format
Get AOL Mail for FREE! Manage your email like never before with travel, photo & document views. Personalize your inbox with themes & tabs. You've Got Mail!
In this context, risk is the combination of the frequency (likelihood) and the consequence of a specified hazardous event. Several factors are likely to be considered when deciding whether or not a risk has been reduced as far as reasonably practicable: [2] [3] Health and safety guidelines and codes of practice