Find the standard you are looking for at Engineering360. Documents are available for purchase from the IHS Standards Store.

1 - 13 of 13 results

DS/IEC/TR 80002-3 - MEDICAL DEVICE SOFTWARE - PART 3: PROCESS REFERENCE MODEL OF MEDICAL DEVICE SOFTWARE LIFE CYCLE PROCESSES Organization: DS
Date: 2014-06-23
Description: This part of IEC 80002, which is a technical report (TR), provides the description of software life cycle processes for medical devices. The medical device software life cycle processes are derived from IEC 62304:2006, with corresponding safety classes.
BSI - BS PD IEC/TR 80002-3 - MEDICAL DEVICE SOFTWARE PART 3: PROCESS REFERENCE MODEL OF MEDICAL DEVICE SOFTWARE LIFE CYCLE PROCESSES Organization: BSI
Date: 2014-07-31
IEC TR 80002-3 - MEDICAL DEVICE SOFTWARE – PART 3: PROCESS REFERENCE MODEL OF MEDICAL DEVICE SOFTWARE LIFE CYCLE PROCESSES (IEC 62304) - EDITION 1.0 Organization: IEC
Date: 2014-06-01
Description: This part of IEC 80002, which is a technical report (TR), provides the description of software life cycle processes for medical devices. The medical device software life cycle processes are derived from IEC 62304:2006, with corresponding safety classes.
DSF/IEC 80002-3 - MEDICAL DEVICE SOFTWARE - PART 3: PROCESS REFERENCE MODEL OF MEDICAL DEVICE SOFTWARE LIFE CYCLE PROCESSES (IEC 62304) Organization: DS
VDI 5702 BLATT 1 - MEDICAL DEVICE SOFTWARE - MEDICAL SPICE - PROCESS ASSESSMENT MODEL Organization: VDI
Date: 2016-05-01
VDI 5702 BLATT 1 - MEDICAL DEVICE SOFTWARE - MEDICAL SPICE - PROCESS ASSESSMENT MODEL Organization: VDI
Date: 2016-05-01
DIN - VDI 5702 BLATT 1 - GERMAN LANGUAGE - MEDICAL DEVICE SOFTWARE MEDICAL SPICE PROCESS ASSESSMENT MODEL Organization: DIN
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.
VDI 5703 - SYSTEMATICAL DEVELOPMENT FOR A MODEL-BASED TESTING OF MEDICAL DEVICES Organization: VDI
Date: 2015-09-01
Description: The scope of this VDI Standard is meant for the development of model-based tests (e.g. on the basis of physical, chemical, biological, or numeric models), which are applied in order to ensure warranty of safety and function, product design and development, certification, reimbursement by public health insurances or product monitoring of medical products, • for materials, components, or complete products, • by manufacturers and users of medical devices, research institutions, test institutes and other authorities.
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.
SAE/TP - 2009-01-3209 - MODEL-BASED DESIGN AND AUTOMATIC PRODUCTION CODE GENERATION FOR SAFETY-CRITICAL SOFTWARE DEVELOPMENT Organization: SAE/TP
Date: 2009-11-10
Description: Model-based software development and automatic production code generation have become increasingly established in recent years.
DIN - VDI 5703 - SYSTEMATICAL DEVELOPMENT FOR A MODEL-BASED TESTING OF MEDICAL DEVICES Organization: DIN
Date: 2015-09-01
Description: Nicht betrachtet werden in dieser Richtlinie: • empirische Untersuchungen am Menschen (klinische Prüfungen) • Software • Kombinationsprodukte in Verbindung mit Pharmaka oder Zellen (ATMPs)
SAE/TP - 2006-01-2043 - SOME ASPECTS OF PELTIER-COOLER OPTIMIZATION APPLIED FOR THE GLOVE BOX AIR TEMPERATURE CONTROL Organization: SAE/TP
Date: 2006-07-17
Description: Besides the optimal power supplies voltage, there is the optimal amount of Peltier elements, if the heat exchangers characteristics are already known (i.e. the Heat Exchangers operational mode, boundary conditions and dimensions are limited with system requirements). The application of own software and software of the Peltier manufacturer is discussed.

1 - 13 of 13 results