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Description of ASTM-F2761 2013ASTM F2761-09-Reapproved2013Withdrawn Standard: Medical Devices and Medical Systems - Essential safety requirements for equipment comprising the patient-centric integrated clinical environment (ICE) - Part 1: General requirements and conceptual modelASTM F2761Scope This standard specifies general requirements, a model and framework for integrating equipment to create a INTEGRATED CLINICAL ENVIRONMENT (ICE), as defined in 3.6. This standard specifies the characteristics necessary for the safe integration of MEDICAL DEVICES and other equipment, via an electronic interface, from different MANUFACTURERS into a single medical system for the care of a single high acuity PATIENT. This standard establishes requirements for a medical system that is intended to have greater error resistance and improved PATIENT safety, treatment efficacy and workflow efficiency than can be achieved with independently used MEDICAL DEVICES. This series of standards establishes requirements for design, verification, and validation processes of a modelbased integration system for an INTEGRATED CLINICAL ENVIRONMENT. This series of standards is intended to define the requirements essential for safety and thereby facilitate regulatory acceptance. NOTE These requirements were derived to support the clinical scenarios or clinical concepts of operations described in Annex B. Keywords ICS Code ICS Number Code 35.240.80 (IT applications in health care technology) DOI: 10.1520/F2761-09R13 This book also exists in the following packages...Subscription InformationMADCAD.com ASTM Standards subscriptions are annual and access is unlimited concurrency based (number of people that can access the subscription at any given time) from single office location. For pricing on multiple office location ASTM Standards Subscriptions, please contact us at info@madcad.com or +1 800.798.9296.
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About ASTMASTM International, formerly known as the American Society for Testing and Materials (ASTM), is a globally recognized leader in the development and delivery of international voluntary consensus standards. Today, some 12,000 ASTM standards are used around the world to improve product quality, enhance safety, facilitate market access and trade, and build consumer confidence. ASTM’s leadership in international standards development is driven by the contributions of its members: more than 30,000 of the world’s top technical experts and business professionals representing 150 countries. Working in an open and transparent process and using ASTM’s advanced electronic infrastructure, ASTM members deliver the test methods, specifications, guides, and practices that support industries and governments worldwide. |
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