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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).
CEI 62-236 - MEDICAL PLANTAR PRESSURE MEASUREMENT DEVICES (PPMDS): MEASURING PERFORMANCE Organization: CEI
Date: 2015-01-01
Description: NOTE 1 The above technical assessment partly takes into account the appropriateness of the acquisition software associated with the PPMD, since the measured quantities shall be read through it (i.e. data from the PPMD shall be obtained only by means of interfaces delivered by the Manufacturer and Operating Systems declared by the Manufacturer).
SEPT - UL 1998 CHECKLIST - SOFTWARE ENGINEERING PROCESS TECHNOLOGY-EVIDENCE PRODUCT CHECKLIST FOR ANSI/UL 1998-2004 STANDARD FOR SOFTWARE IN PROGRAMMABLE COMPONENTS - REVISION 1 - REVISION 1 Organization: SEPT
Date: 2012-01-10
Description: A general software configuration of a microprocessor based programmable component typically includes the operating system or executive software, communication software, micro-controller, input/output hardware, and any generic software libraries, database management or user interface software. The Checklist provides an easy-to-use classification scheme of physical evidence comprised of policies, procedures, plans, records, documents, audits, and reviews.
SEPT - UL 1998 CHECKLIST* - * IN EDITABLE MICROSOFT WORD - SOFTWARE ENGINEERING PROCESS TECHNOLOGY-EVIDENCE PRODUCT CHECKLIST FOR ANSI/UL 1998-2004 STANDARD FOR SOFTWARE IN PROGRAMMABLE COMPONENTS - REVISION 1 - REVISION 1; INCLUDES ACCESS TO ADDITIONAL CONTENT Organization: SEPT
Date: 2012-01-10
Description: A general software configuration of a microprocessor based programmable component typically includes the operating system or executive software, communication software, micro-controller, input/output hardware, and any generic software libraries, database management or user interface software. The Checklist provides an easy-to-use classification scheme of physical evidence comprised of policies, procedures, plans, records, documents, audits, and reviews.

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