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Part 1-2 Part 1-2 - Medical Electrical Equipment En 60601-1-2:2015
The design of medical equipment is more difficult and requires more detailed knowledge. Every medical system has its own specifications. The document covers basic safety and essential performances of Medical Equipment and ME systems when there are electromagnetic disturbances. The first part of the standard provides an overview of the safety standards in the use of medical equipment. See the most popular sist catalog standards sist-iso-5627-1996-cor-1-2011 review.
Innovation Management - Innovation Management System - Guidance (Iso 56002:2019) En Iso 56002:2021
Nowadays, a modern management system is essential to developing a profitable business. This is why it's crucial to keep an eye on the rules that regulate it. One of them is the international standard EN ISO 56002: 2021.This document provides guidance on the creation, implementation, maintenance, and continual improvement of an innovation management process that can be utilized by every established organization. It is applicable to:a) Companies that wish to achieve sustained growth by proving their capacity and capacity to manage new activities effectively in order to attain the desired results.B. Customers, users or any other interested parties that seek to gain confidence in the organization's innovation capabilities.c. Organizations and interested parties who are interested in improving communication by agreeing on what constitutes an innovative system management systemD) Providers of consulting, training, assessment, and consultation for innovation management and systems.e) The policy makers are aiming to enhance the effectiveness of programs that promote innovation and competitiveness in organizations as well as the development of society.1.2 The guidance contained in this document is general and is designed to be applicable to:an) All types of organizations regardless of type size, size or sector. The focus is on established businesses however, it should be noted that both temporary organizations and startups can benefit from applying these guidelines to all or in part;b) Innovation of all kinds, e.g. The service, product or process could be described as a model or process, product or method. These innovations may range from incremental to radical.c. All approaches, e.g. c) all types of strategies, e.g., internal and external innovation, market- and technology-based innovation as well as design-driven innovation.It doesn't provide detailed descriptions of processes within the company, instead, it provides guidelines at a the general level. It does not prescribe specific guidelines, requirements or techniques for innovation.We suggest consulting with a professional if you are unsure about the suitability of certain changes to this document to your business. Have a look at the top etsi catalog standards etsi-sr-019-510-v1-1-1-2017-05 blog.
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
Regulators face a number of challenges because of the variability in the production materials. International standards have been created to facilitate companies and organizations entering new markets. One of them is EN 17289-1:2020.This document outlines the needs and possibilities for selecting the most appropriate method of testing to determine the size-weighted percentage of crystallized silica as well as the SWFFCS in bulk materials.This document also provides guidance regarding how to prepare the sample and determination of crystalline silica by the X-ray powder diffractometry (XRD) and Fourier Transform Infrared Spectroscopy (FT-IR).EN 17289-2 specifies a method to determine the size-weighted fine percentage of a particle's size distribution and assumes that the particle size distribution of the silica crystals is similar to the other particles present in the bulk material. EN 17289-3 specifies a method using a liquid sedimentation technique to calculate the size-weighted fine portion of silica crystalline. Both methods are subject to limitations and assumptions which are described in EN 17289-2 and EN 17289-3. If properly validated it is possible that the EN 17289-3 methodology can be applied to other constituents.This document applies to crystalline silica containing bulk material that has been thoroughly investigated and confirmed for the analysis of the size-weighted, fine fraction as well as the crystallized silica.The presence of the technology documentation base can help to scale up production in the event that your field of work is in direct contact with the material described in this document. For more detailed information you can follow the link to our site. Have a look at the recommended iso catalog standards iso-11372-2005 information.
Software Engineering And Systems. Software Product Quality Requirements Evaluations And Evaluations (Square) For Software Products. Common Industry Format (Cif), For Usability Specifications For Users (Iso 25065.2019). EN ISO 25065:2020
The quality of software is now the most crucial factor in making sure that your company is in a position of strength on international markets. To comprehend the regulations of these markets, it is essential to know the international standards that have to be followed today. These rules are contained in various documents, such as EN ISO 25065: 2020.This document provides an outline and a consistent language for defining the requirements of users. It defines the common industry format (CIF) that can be used to describe user requirements. This includes the content elements and the manner of expressing the requirements.A user requirements specification is the formal description of an array of user requirementsthat aids in the design and evaluation of usable interactive systems.This document defines user requirements as the following: a. Requirements for interaction between users and systems to attain the intended results (including the requirements and attributes of system outputs and attributes); 2. Quality requirements that are related to usage that define quality requirements that are related to the outcomes of users interacting in the software interactively and may be used in conjunction with system acceptance criteria.ISO/IEC 25030 introduces the notion of quality standards. The requirements for quality related to use in this document are a particular type of quality requirements. The content elements of a user requirements specification are intended to be used as part of documentation resulting from the procedures described in ISO 9241-210, and from human-centered design methods, such as those in ISO 9241-220.This document is designed to serve as a reference for business analysts, requirements engineers and product managers. It can be utilized by product owners who are acquiring systems from third-party suppliers. CIF's standard series covers usability-related data (as specified in ISO 9241-11 and ISO/IEC TR25060).They are not only usable but they can also be used to complement other perspectives. ISO 9241-220 introduces human-centred qualities. Other quality perspectives are presented in ISO/IEC 25010 and ISO/IEC TS 25011.This document was created for interactive systems however it can be used in any area. The document is not a recommendation for any particular method, lifecycle, or method. The content of the user requirements specification can be used to guide iterative development. This can include the formulation changes, development and revisions to requirements. as in agile development).
Use of this international standard can greatly aid your professional activities. It will also organize your existing system and provide the opportunity to expand your business into new markets and grow your business. Have a look at the best iso catalog standards iso-23537-1-2016-amd-1-2018 blog.
Health Informatics - Standard Communication Protocol - Computer-Assisted Electrocardiography EN 1064:2020
Despite the fact that , just a decade ago when technology was being introduced into the medical field was quite slow, in recent years, in the field of the fact that more and more attention is paid to human health, innovations and their advancement are being centered specifically on the medical field. This sector is accountable for protecting human life. Therefore, much attention is paid to security of information. It is governed by international standards like EN 1064:2020.This document describes the requirements for cart-to host and cart-to cart interchange of certain patient data (demographic, recording ...), ECG signals data, ECG measurement, ECG interpretation results). This document describes the contents and format of the data to be transferred between digital ECG Carts and computer ECG Management Systems, as well other computer systems in which ECG data is stored.This standard can be an extremely effective tool for your business's development in today's competitive market. For that reason, we recommend you review its details by clicking the link on our site. See the recommended clc catalog standards en-61557-12-2008 site.
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