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

1 - 20 of 45 results

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.
TSE - TS EN 62304/A1 - MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE-CYCLE PROCESSES Organization: TSE
Date: 2016-03-24
Description: This standard applies to the development and maintenance ofMEDICAL DEVICE SOFTWARE when software is itself a MEDICAL DEVICE orwhen software is an embedded or integral part of the final MEDICALDEVICE.
AAMI 62304 - MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE CYCLE PROCESSES - CONSOLIDATED TEXT A1: 2016 Organization: AAMI
Date: 2006-01-01
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.
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 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.
CRC - EMBEDDED SOFTWARE DEVELOP - EMBEDDED SOFTWARE DEVELOPMENT FOR SAFETY-CRITICAL SYSTEMS Organization: CRC
Date: 2017-09-07
Description: Embedded Software Development for Safety-Critical Systems discusses the development of safety-critical systems under the following standards: IEC 61508; ISO 26262; EN 50128; and IEC 62304.
CRC - KE32677 - EMBEDDED SOFTWARE DEVELOPMENT FOR SAFETY-CRITICAL SYSTEMS Organization: CRC
Date: 2015-10-06
Description: Embedded Software Development for Safety-Critical Systems discusses the development of safety-critical systems under the following standards: IEC 61508; ISO 26262; EN 50128; and IEC 62304.
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.
CRC - PHE1368 - SOFTWARE DEVELOPMENT AND QUALITY ASSURANCE FOR THE HEALTHCARE MANUFACTURING INDUSTRIES, THIRD EDITION Organization: CRC
Date: 2002-07-31
Description: Completely revised and updated, this book is a practical guide for anyone involved in all levels of the development and quality assurance of software programs for healthcare products - particularly in the medical device and equipment manufacturing industries.
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.
CRC - E0312 - MEDICAL DEVICE RELIABILITY AND ASSOCIATED AREAS Organization: CRC
Date: 2000-03-29
Description: With the medical device industry among the fastest growing segments of the US economy, it is vital that the engineering, biomedical, manufacturing, and design communities have up-to-date information on current developments, tools, and techniques. Medical Device Reliability and Associated Areas fills this need with broad yet detailed coverage of the field.

1 - 20 of 45 results