Risk Assessment ISO Software Standards

Overview This document: - provides risk management elaborations for the processes described in ISO/IEC/IEEE 15288 and ISO/IEC/IEEE 12207, - provides the users of ISO/IEC/IEEE 15288, ISO/IEC/IEEE 12207 and their associated elaboration standards with common...

This document provides the principles, concepts, terms and definitions for health software and health IT systems, key properties of safety, effectiveness and security, across the full life cycle, from concept to decommissioning, as represented in Figure 1. It also identifies the transition...

This document defines the capabilities of issue management tools and is used to select the most appropriate one from many issue management tools. The evaluation and selection of the issue management tools is performed in accordance with ISO/IEC 20741 which defines the general evaluation...

Purpose The measures in this standard were calculated from detecting and counting violations of good architectural and coding practices in the source code that could result in unacceptable operational risks or excessive costs. Establishing standards for these measures at the source code...

Industry and large organisations recognize the value of VSEs, i.e. enterprises, organisations (e.g. government agency, non-profit organization), projects or departments with up to 25 people, in contributing with emerging new technology that bigger organisations cannot use them as easily nor...

This document specifies the requirements for the evaluation of absorbable medical devices during a biological risk assessment based on ISO 10993-1, including a clarification of the terms "absorb", "degrade" and other related terms (see Annex A).

This document provides assistance to the designer/manufacturer of machinery and related components as to how the system of existing type-A, type-B and type-C machinery safety standards should be applied in order to design a machine to achieve a level of tolerable risk by adequate risk...

This document specifies general principles of risk assessment for systems involving structures. The focus is on strategic and operational decision-making related to design, assessment, maintenance and decommissioning of structures. This also includes formulation and calibration...

This document supports and complements the implementation of the risk management process defined in ISO 17666 in situations when the application of a quantitative risk assessment is deemed necessary. This document defines the principles, process, implementation and...

This document presents the assessment of the safety, security, competition, responsibilities, and data protection risks that can originate from the ISO 20078 series. In particular, the following risks are outside the scope of this assessment, because they relate...

This document gives guidance to specifiers and users on the control of eye and face hazards including physical, mechanical, chemical, optical radiation and biological and on the selection, use and maintenance of eye and face protectors. This document applies to - occupational use, - tasks that are...

Fields of application This document defines the process assessment guidelines needed to meet the purpose of defined VSE profiles. It is applicable to all VSE profiles and is compatible with ISO/IEC 33002. The possible uses of this document are as follows. a) Assessment to...

This document is applicable to heart valve substitutes intended for implantation and provides general requirements. Subsequent parts of the ISO 5840 series provide specific requirements. This document is applicable to newly developed and modified heart valve substitutes and to the accessory...

This document addresses how artificial intelligence machine learning can impact the safety of machinery and machinery systems. This document describes how hazards being associated with artificial intelligence (AI) applications machine learning in machinery or machinery systems, and designed to act...

This document is applicable to heart valve substitutes intended for implantation in human hearts, generally requiring cardiopulmonary bypass and generally with direct visualization. See Annex E for examples of surgical heart valve substitutes and their components. This document is applicable to...

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...

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...

Purpose This document is intended to aid project managers in managing to successful conclusion those projects concerned with systems, including software systems. This document specifies the required content of the project management plan (PMP). This document also quotes the extracted purpose...

This document specifies basket heating tests for the characterization of self-heating properties of solid biofuel pellets. This document includes: a) a compilation of basket heating test methods; b) guidance on the applicability and use of basket heating tests for solid biofuel pellets; c)...