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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.
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.
AAMI HE74 - HUMAN FACTORS DESIGN PROCESS FOR MEDICAL DEVICES Organization: AAMI
Date: 2001-01-01
Description: ., 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. This document is not intended as a sole source for HFE guidance or as a substitute for human factors expertise.
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.
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: This standard is used by the fuel cell and medical device business community. The ANSI/UL 1998 standard is focused toward application-specific, non-networked software in a programmable component embedded in a product for which a failure may result in injury to persons.
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: This standard is used by the fuel cell and medical device business community. The ANSI/UL 1998 standard is focused toward application-specific, non-networked software in a programmable component embedded in a product for which a failure may result in injury to persons.
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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