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SAE JA1003 - SOFTWARE RELIABILITY PROGRAM IMPLEMENTATION GUIDE Organization: SAE
Date: 2004-01-01
Description: It is these concerns for which this document provides some guidelines - both for management of a software reliability program and conduct of life cycle activities using appropriate software engineering and reliability-specific techniques.
AAMI HE74 - HUMAN FACTORS DESIGN PROCESS FOR MEDICAL DEVICES Organization: AAMI
Date: 2001-01-01
Description: This document addresses the needs of a diverse group of professionals who handle the planning, funding, management, and performance of research, design, and testing activities related to the safety and usability of medical devices, including: a) Company, department, project, and product managers; b) Design and engineering professionals (e.g., human factors engineers, industrial designers, technical writers, information designers, software developers, mechanical engineers, electrical engineers, packaging engineers); c) Medical researchers and other interested clinicians; and d) Marketers and other business professionals in the medical device industry.
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 also can be useful for other healthcare products (e.g. drug packaging and drug LABELLING, drug-MEDICAL DEVICE combination products and health IT software). Purpose The intent of this technical report is to provide guidance related to: • the essential elements of a USABILITY ENGINEERING PROCESS as required by IEC 62366-1:2015, including: – USER research techniques, – analysis techniques, – design techniques, and – MEDICAL DEVICE USABILITY EVALUATION approaches (e.g.
CLSI EP33 - USE OF DELTA CHECKS IN THE MEDICAL LABORATORY - FIRST EDITION Organization: CLSI
Date: 2016-03-01
Description: This information may also be of interest to hospital or laboratory informatics staff, and software and medical device vendors who need to understand the laboratory’s goals when implementing automated delta checking.
NAVY - OPNAV 2710.1 - (N65) DEPARTMENT OF THE NAVY STANDARDS FOR COMMERCIAL (NON-TACTICAL) LANS ON NAVY SHIPS Organization: NAVY
Date: 1993-04-30
Description: In general, shipboard office automation and tactical support functions include, but are not limited to, the following: (1) Wordprocessing (2) Spreadsheets (3) Database (4) Business Graphics (5) Engineering Graphics (6) Forms (7) E-mail (8) Accounting (9) Message Handling (10) Ships Maintenance (11) Aviation Maintenance (12) Administration (13) Personnel Management (14) Medical and Dental Record Management (15) Technical Library Storage and Retrieval Systems (16) Logistics, Inventory Management and Configuration Management (17) Training Scenario Generation (18) Training Performance Data Collection (19) Computer based Training and Instruction (20) Work Flow Processing c.
IEEE - ANSI N42.45 - AMERICAN NATIONAL STANDARD FOR EVALUATING THE IMAGE QUALITY OF X-RAY COMPUTED TOMOGRAPHY (CT) SECURITY-SCREENING SYSTEMS Organization: IEEE
Date: 2011-01-01
Description: The software used at all locations in the field must perform the same as the software did at the time of evaluation by the regulator. Configuration management of such software is a well known and straightforward art.
NAVY - SECNAV 4200.31C - (NAVCOMPT: NCB-6) ACQUIRING AND MANAGING CONSULTING SERVICES Organization: NAVY
Date: 1993-06-22
Description: For example: installation, operation, or maintenance of systems; monitoring day-to-day hardware (or software) performance; and support services required to accomplish these particular actions.
CRC - BYOD FOR HEALTHCARE - BYOD FOR HEALTHCARE Organization: CRC
Date: 2014-04-23
Description: Thus, we will spend some time in addressing the topics such as content and data management, risk assessment, performance measurement and management, and even configuration management.

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