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AAMI TIR32 - MEDICAL DEVICE SOFTWARE RISK MANAGEMENT Organization: AAMI
Date: 2004-01-01
Description: The report attempts to clarify process relationships outlined in ANSI/AAMI SW68:2001, Medical device softwareSoftware life cycle processes, and ANSI/AAMI/ISO 14971:2000, Medical devices—Application of risk management to medical devices, in the context of software system safety, keeping in mind the varied interests of the audience.
IEC TR 62366-2 - MEDICAL DEVICES – PART 2: GUIDANCE ON THE APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES - EDITION 1.0 Organization: IEC
Date: 2016-04-01
Description: This technical report discusses the business benefits of USABILITY ENGINEERING, the basics of applicable analysis and design techniques, MEDICAL DEVICE USABILITY EVALUATION approaches, efficient ways to address USABILITY ENGINEERING project implementation issues (e.g. integration into a quality management system) and provides a list of useful USABILITY ENGINEERING resources.
AAMI HE74 - HUMAN FACTORS DESIGN PROCESS FOR MEDICAL DEVICES Organization: AAMI
Date: 2001-01-01
Description: By providing a structured approach to user interface design, this document can help manufacturers develop safe and usable medical devices. This document includes an overview of the human factors engineering (HFE) discipline, a discussion of the benefits of HFE, a review of the HFE process and associated analysis and design techniques, and a discussion of implementation issues and relevant national and international standards and regulations (see annex B).
SEPT - IEC 62304 CHECKLIST - SOFTWARE ENGINEERING PROCESS TECHNOLOGY - EVIDENCE PRODUCT CHECKLIST FOR STANDARD IEC 62304:2015 “MEDICAL DEVICE SOFTWARESOFTWARE LIFE CYCLE PROCESSES” - REPLACES PRODUCT 40 Organization: SEPT
Date: 2015-10-20
Description: Clarification of requirements and updates for Software Safety Classification to include a risk-based approach, focus on overall medical device risk analysis.
WILEY - DESIGN AND DEVELOP - DESIGN AND DEVELOPMENT OF MEDICAL ELECTRONIC INSTRUMENTATION: A PRACTICAL PERSPECTIVE OF THE DESIGN CONSTRUCTION AND TEST OF MEDICAL DEVICES Organization: WILEY
Date: 2005-01-01
Description: Master the building blocks of medical devices with this hands-on guide This book provides a uniquely practical approach that enables readers to learn the design of medical electronic devices through the analysis of specific projects. Walking you through the building blocks of implementing medical devices, Design and Development of Medical Electronic Instrumentation addresses the practical aspects of amplifying, processing, simulating, and evoking biopotentials.
SEPT - IEC 62304 CHECKLIST* - * IN EDITABLE MICROSOFT WORD - SOFTWARE ENGINEERING PROCESS TECHNOLOGY - EVIDENCE PRODUCT CHECKLIST FOR STANDARD IEC 62304:2015 “MEDICAL DEVICE SOFTWARESOFTWARE LIFE CYCLE PROCESSES” - REPLACES PRODUCT 40; INCLUDES ACCESS TO ADDITIONAL CONTENT Organization: SEPT
Date: 2015-10-20
Description: Clarification of requirements and updates for Software Safety Classification to include a risk-based approach, focus on overall medical device risk analysis.
CRC - TELEMEDICINE AND ELECTRON - TELEMEDICINE AND ELECTRONIC MEDICINE Organization: CRC
Date: 2015-11-24
Description: This handbook also intends to bridge the gap between scientists, engineers, and medical professionals by creating synergy in the related elds of biomedical engineering, information and communication technologies, network operations, business opportunities, and dynamically evolving modern medical and healthcare practices.
CRC - TELEHEALTH AND MOBILE HEA - TELEHEALTH AND MOBILE HEALTH Organization: CRC
Date: 2015-12-02
Description: This handbook also intends to bridge the gap between scientists, engineers, and medical professionals by creating synergy in the related fields of biomedical engineering, information and communication technologies, network operations, business opportunities, and dynamically evolving modern medical and healthcare practices.

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