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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.
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 provides guidance for those new to the concepts of software system safety in the medical device industry and as an aide-memoire for medical device and software designers more familiar with the topic.
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.
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.
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.
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.
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.
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 TIR45 - GUIDANCE ON THE USE OF AGILE PRACTICES IN THE DEVELOPMENT OF MEDICAL DEVICE SOFTWARE Organization: AAMI
Date: 2012-01-01
Description: It relates them to the following existing standards, regulations, and guidance: • ISO 13485:2003, Quality management systems─Requirements for regulatory purposes • IEC 62304, Medical device softwareSoftware lifecycle processes • ISO 14971:2007, Medical devices─Application of risk management to medical devices • FDA Code of Federal Regulations (CFR), Title 21, Part 820.30, Quality System Regulation: Design Controls– • FDA Guidance for the content of premarket submissions for software contained in medical devices • FDA General principles of software validation; Final guidance for industry and FDA staff Although this TIR does not provide a particular perspective for IEC TR 80002-1 (Guidance on the application of ISO 14971 for medical device software), the pertinent aspects of software risk management for medical devices were integrated throughout this TIR.
DSF/IEC/FDIS 82304-1 - HEALTH SOFTWARE -- PART 1: GENERAL REQUIREMENTS FOR PRODUCT SAFETY Organization: DS
Description: 1.1 Purpose This Part of 82304 applies to the SAFETY and SECURITY of HEALTH SOFTWARE PRODUCTS designed to operate on general computing platforms and intended to be placed on the market without dedicated hardware, and its primary focus is on the requirements for MANUFACTURERS. 1.2 Field of application This document covers the entire lifecycle including design, development, VALIDATION, installation, maintenance, and disposal of HEALTH SOFTWARE PRODUCTS. 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.
DS/IEC 82304-1 - HEALTH SOFTWARE – PART 1: GENERAL REQUIREMENTS FOR PRODUCT SAFETY Organization: DS
Date: 2016-11-10
Description: 1.1 Purpose This Part of 82304 applies to the SAFETY and SECURITY of HEALTH SOFTWARE PRODUCTS designed to operate on general computing platforms and intended to be placed on the market without dedicated hardware, and its primary focus is on the requirements for MANUFACTURERS. 1.2 Field of application This document covers the entire lifecycle including design, development, VALIDATION, installation, maintenance, and disposal of HEALTH SOFTWARE PRODUCTS. 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.
DS/ISO/TS 25238 - HEALTH INFORMATICS - CLASSIFICATION OF SAFETY RISKS FROM HEALTH SOFTWARE Organization: DS
Date: 2007-06-29
Description: This Technical Specification does not apply to any software which is necessary for the proper application or functioning of a medical device.NOTE: This Technical Specification is intended for the assignment of health software to broad risk classes, so as to aid decisions such as what controls should be applied to ensure safety.
ISO/IEC DIS 82304-1 - HEALTH SOFTWARE - PART 1: GENERAL REQUIREMENTS FOR PRODUCT SAFETY Organization: ISO
Date: 2015-07-31
Description: Specifically, IEC 82304-1 does not apply to: a) medical electrical equipment or systems covered by the IEC 60601/IEC 80601 series; b) in vitro diagnostic equipment covered by the IEC 61010 series; c) implantable devices covered by the ISO 14708 series NOTE This standard also applies to HEALTH SOFTWARE PRODUCTS (e.g., medical apps, health apps) intended to be used in combination with mobile computing platforms.
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.
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.

1 - 20 of 31 results