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AAMI TIR45 - GUIDANCE ON THE USE OF AGILE PRACTICES IN THE DEVELOPMENT OF MEDICAL DEVICE SOFTWARE Organization: AAMI
Date: 2012-01-01
Description: The following groups are the intended audience for this TIR: • Medical device manufacturers who are planning to use AGILE techniques • Manufacturers who are currently practicing AGILE and are entering the regulated medical device space • Software development teams, including software test and quality groups • Software definers, including marketing, sales, and other representatives of the customer • Senior management, project managers, quality managers • Quality systems and regulatory affairs personnel • Internal and external auditors • Regulating bodies, agencies, and organizations responsible for overseeing the safety and effectiveness of medical devices Exclusions This TIR is not intended to be used as an educational tool or tutorial for the following: • AGILE development practice • Quality system regulations This TIR should be regarded as a reference and as a guidance intended to provide recommendations for complying with international standards and FDA guidance documents when using AGILE practices in the development of medical device software.
DS/EN 62304/A1 - MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE-CYCLE PROCESSES Organization: DS
Date: 2015-11-05
Description: The set of processes, activities, and tasks described in this standard establishes a common framework for medical device software life cycle processes.Applies to the development and maintenance of medical device software when software is itself a medical device or when software is an embedded or integral part of the final medical device.This standard does not cover validation and final release of the medical device, even when the medical device consists entirely of software.
CEI EN 62304 - MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE-CYCLE PROCESSES Organization: CEI
Date: 2015-08-01
Description: This standard applies to the development and maintenance of MEDICAL DEVICE SOFTWARE when software is itself a MEDICAL DEVICE or when software is an embedded or integral part of the final MEDICAL DEVICE.
CEI - EN 62304/A1 - MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE-CYCLE PROCESSES Organization: CEI
Date: 2016-04-01
Description: * Field of application Replace the entire existing text of this subclause with the following: This standard applies to the development and maintenance of MEDICAL DEVICE SOFTWARE when software is itself a MEDICAL DEVICE or when software is an embedded or integral part of the final MEDICAL DEVICE.
CENELEC - EN 62304 - MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE-CYCLE PROCESSES - INCORPORATING CORRIGENDUM NOVEMBER 2008; INCORPORATES AMENDMENT A1: 2015 Organization: CENELEC
Date: 2006-07-01
Description: Field of application This standard applies to the development and maintenance of MEDICAL DEVICE SOFTWARE when software is itself a MEDICAL DEVICE or when software is an embedded or integral part of the final MEDICAL DEVICE.
AAMI 62304 - MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE CYCLE PROCESSES Organization: AAMI
Date: 2006-01-01
Description: This standard applies to the development and maintenance of MEDICAL DEVICE SOFTWARE when software is itself a MEDICAL DEVICE or when software is an embedded or integral part of the final EDICAL DEVICE.
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.
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 TR does not address: - areas already covered by existing related standards, e.g. the international standards that relate to the four standards used to build this TR (see Bibliography); - FDA guidance documents; or - software development tools. This TR describes the PRM for medical device software development and is limited in scope to the life cycle processes described in IEC 62304:2006.
DSF/IEC 80002-1 - MEDICAL DEVICE SOFTWARE - GUIDANCE ON THE APPLICATION OF ISO 14971 TO MEDICAL DEVICE SOFTWARE Organization: DS
Description: This technical report provides guidance for the application of the requirements contained in ISO 14971:2007, Medical devices- Application of risk management to medical devices to MEDICAL DEVICE SOFTWARE with reference to IEC 62304:2006, Medical device software- Software life cycle processes.
DS/IEC/TR 80002-1 - MEDICAL DEVICE SOFTWARE - PART 1: GUIDANCE ON THE APPLICATION OF ISO 14971 TO MEDICAL DEVICE SOFTWARE Organization: DS
Date: 2009-10-29
Description: This technical report provides guidance for the application of the requirements contained in ISO 14971:2007, Medical devices- Application of risk management to medical devices to MEDICAL DEVICE SOFTWARE with reference to IEC 62304:2006, Medical device software- Software life cycle processes.
AAMI TIR80002-1 - MEDICAL DEVICE SOFTWARE - PART 1: GUIDANCE ON THE APPLICATION OF ISO 14971 TO MEDICAL DEVICE SOFTWARE Organization: AAMI
Date: 2009-01-01
Description: This technical report provides guidance for the application of the requirements contained in ISO 14971:2007, Medical devices— Application of risk management to medical devices to MEDICAL DEVICE SOFTWARE with reference to IEC 62304:2006, Medical device softwareSoftware life cycle processes. It does not add to, or otherwise change, the requirements of ISO 14971:2007 or IEC 62304:2006.
IEC/TR 80002-1 - MEDICAL DEVICE SOFTWARE – PART 1: GUIDANCE ON THE APPLICATION OF ISO 14971 TO MEDICAL DEVICE SOFTWARE - EDITION 1.0 Organization: IEC
Date: 2009-09-01
Description: This technical report provides guidance for the application of the requirements contained in ISO 14971:2007, Medical devices— Application of risk management to medical devices to MEDICAL DEVICE SOFTWARE with reference to IEC 62304:2006, Medical device softwareSoftware life cycle processes. It does not add to, or otherwise change, the requirements of ISO 14971:2007 or IEC 62304:2006.
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 TR does not address: – areas already covered by existing related standards, e.g. the international standards that relate to the four standards used to build this TR (see Bibliography); – FDA guidance documents; or – software development tools. This TR describes the PRM for medical device software development and is limited in scope to the life cycle processes described in IEC 62304:2006.
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.
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: 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.
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.
AAMI HE75 - HUMAN FACTORS ENGINEERING – DESIGN OF MEDICAL DEVICES Organization: AAMI
Date: 2009-01-01
Description: The material emphasizes adoption of a user-centered focus throughout the product design and development process, with the goal of making medical devices easier to use and less prone to use error.
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.
NEMA/MITA CSP 1 - CYBERSECURITY FOR MEDICAL IMAGING Organization: NEMA
Date: 2016-01-01
Description: Introduction Medical imaging devices, like all computer systems, are subject to risks that might harm the software, hardware, or data security of the device. As devices become increasingly connected to networks, security risks move beyond the system to intrusions across digital networks.
DSF/IEC/FDIS 82304-1 - HEALTH SOFTWARE -- PART 1: GENERAL REQUIREMENTS FOR PRODUCT SAFETY Organization: DS
Description: In each referenced standard, the term “medical device” or “medical device software” is to be substituted by the term “HEALTH SOFTWARE” or “HEALTH SOFTWARE PRODUCT”, as appropriate.

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