Part 2-8 Part 2-8: Safety And Performance Requirements For Medical Electrical Equipment En 60601-2-8:2015
Some companies do not adhere to specific norms and guidelines for a variety reasons. The main reason for this is the constant changing characteristics of the standards. EN 60601-2-8.2015 is one of the most important documents that may affect the medical equipment businesses. It defines the essential requirements for safety and performance for therapeutic Xray equipment. The equipment is connected to alternating-current supply mains with nominal voltages ranging from 10 kV and 1 MV. It addresses the needs to ensure accuracy, reproducibility, performance and radiation quality. This second edition repeals and replaces IEC60601-2-8. This technical revision aligns the standard with IEC 60601-1's third edition and all its collateral standards. If your company is involved in the field of above mentioned equipment, we highly advise you to follow this link. Have a look at the top sist catalog standards sist-tp-etsi-etr-090-e2-2005
Innovation Management - Basics And The Vocabulary. (Iso 56000.2020). EN ISO 56000:2021
Explanatory documents may be required to meet certain standards in technology. For instance, they could be required to provide a rationale for security of information. One notable example is EN ISO 56000: 2021. This document outlines the fundamentals concepts, principles, and concepts for managing innovation as well as its systematic execution. It can be utilized for:A) Companies that have an innovation management system or perform innovation management assessments.b) Organizations that need to increase the efficiency of their innovation management processesc) customers, users and other interested parties (e.g. suppliers, partners, funding organisations university, investors, and public authorities who are seeking confidence in an organization's innovative capabilities.d) companies and other parties seeking to improve communication via a shared knowledge of the terms used in innovation management;e. Providers of training in assessment, training, or consulting to improve innovation management and system-wide innovation managementf) Innovation management experts and related standards1.2 This document is intended to be used by: a) all types of organizations regardless of their type, sector, maturity-level or size;B. All kinds and types of innovation, e.g. Innovations of all kinds that include product, service and model. They could be incremental or radical.c. All kinds of approaches, such as. c) All types of methods, e.g., internal and external innovation, market-, technological and design-driven developments.This document outlines the terms and definitions applicable to all ISO/TC 279.-developed standards for management of innovation and management systems.There are many clarifications in this standard. We suggest that you study them carefully and evaluate them against the technology foundations of your business to ensure that this document will be able to enable you to take your organization to the highest level. See the best cen catalog standards en-14264-2003
Characterization Bulk Materials - Determination Size-Weighted Fine Fractions And Crystalline Silica Content – Part 1 General Information And Selection Of Testing Methods EN 17289-1:2020
The variety of manufacturing materials makes it difficult to regulate both locally as well as globally. International standards have been developed to ease companies and organisations' entry into new markets. One of them is EN 17289-1: 2020.This document outlines the requirements and choices of testing methods to determine the fine fraction of crystalline silica (SWFFCS), and the size-weighted small fraction (SWFF).This document provides guidelines on how to prepare the sample, and then determine crystalline silica using X-ray powder difffractometry (XRD), Fourier Transform Infrared Spectroscopy, (FTIR).EN 17289-2 describes how to calculate the size-weighted portion of fine particles based on a measured size distribution. It assumes that the size distribution of the crystalline quartz particles is exactly the same as the distribution of other particles in the bulk material. EN 1789-3 describes a liquid sedimentation procedure to calculate the size weighted fine portion of crystal silica. Both methods are subject to limits and assumptions. These limitations are outlined in EN 17289-2and EN 17289-3. The procedure in EN 17289-3 can be applied to other constituents than CS, if investigated and confirmed.This document applies to bulk silica that contains crystalline materials that have been thoroughly studied and verified for the determination of the size weighted fine fraction or crystalline silica.Your organization's documentation technology will greatly benefit if your activity comes in contact with the information contained in this section. For more detailed information you can follow the link to our website. Check out the recommended clc catalog standards pren-iec-63248-2021-praa
Software Engineering And Systems. Software Product Quality Requirements Evaluations And Evaluations (Square) For Software Products. Common Industry Format (Cif) To Ensure Usability User Specifications (Iso 25065.2019). EN ISO 25065:2020
The current quality of software is the main advantage for occupying a leading position in the global market. Knowing the rules of these markets is achievable by reference to the international requirements. These standards are included in documents such as EN ISO 25065: 2020.This document provides a consistent structure and language to define the requirements of users. It defines the industry standard format (CIF) which can be used to describe the requirements of users. This is inclusive of the content elements as well as the way to express those specifications.A specification for user requirements is the formal description of the user's requirements. It aids in developing and testing user-friendly interactive systems.This document focuses on the requirements of users. They comprise requirements for interaction between the user and the system (including) the requirements for interactions between the user and the system in order to attain the desired results (including the requirements for system outputs and attributes); and b) quality requirements related to interaction with the system. These quality requirements may be used as a basis for system approval.ISO/IEC 25030 introduces a new concept of quality requirements. One kind of quality requirement is the use-related quality requirement. The elements that constitute a User Requirements Specification can be used to document part of which result from ISO 9241-210 activities or human-centered design processes, such ISO 9241-220.This document is intended to be used by requirements engineers as well as business analysts, product mangers, product owners and others who acquires systems from third party. The CIF series of standards addresses information related to usability (as described in ISO 9241-11 and ISO/IEC TR 25060).They are not only usable however, they also offer other perspectives. ISO 9241-220 introduces human-centred characteristics. Additional quality perspectives are presented in ISO/IEC 25010 and ISO/IEC/TS 25011.This document was created to be used in interactive systems, however it can be used in any field. This document doesn't recommend any kind of process, lifecycle or process. The elements of the User Requirements Specification may be used in iterative Development that is the process of elaboration of and development (e.g. as in agile development).
This international standard can make your work much easier. It will also help to structure the existing system, and create new opportunities for expanding your business's reach and market growth. Check out the best iso catalog standards iso-3297-1998
Health Informatics Interoperability Of Devices Part 20701: Point-Of-Care Medical Device Communications - Service-Oriented Medical Device Exchange Architecture And Protocol Binding (Iso/Ieee 11073-20701:2020) EN ISO 11073-20701:2020
These technologies aren't only used in areas that fall under the umbrella of this category but as well in the medical industry. As the introduction of multiple medical devices is complex and requires the restructuring existing systems, international documents are designed to facilitate these processes.
The scope of this standard is a service-oriented medical device architecture and communication protocol specifications for distributed system of Point-of-Care (PoC) medical devices and medical IT systems that require to exchange data or safely control networked PoC medical devices. It describes the functional components and their interconnections, as well as how they are linked to protocol specifications.This document is particular and has a limited the scope. As such, we recommend that this document be reviewed for more information. If you are unsure you should consult managers who are experts in international document selection. Check out the recommended cen catalog standards en-843-1-2006