Medical devices utilizing non-viable human materials - Risk management
This document applies to medical devices other than in vitro diagnostic medical devices manufactured utilizing materials of human origin. The materials are non-viable or have been rendered non-viable. The document specifies, in junction with ISO 14971, a procedure to identify the hazards and hazardous situations associated with such devices, to estimate and evaluate the resulting risks, to…
Health informatics - Information security controls in health based on ISO/IEC 27002
ISO 27799:2016 gives guidelines for organizational information security standards and information security management practices including the selection, implementation and management of controls taking into consideration the organization's information security risk environment(s).
It defines guidelines to support the interpretation and implementation in health informatics of ISO/IEC 27002…
