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

1 - 20 of 30 results

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.
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.
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.
BSI - BS PD IEC/TR 80002-1 - MEDICAL DEVICE SOFTWARE PART 1: GUIDANCE ON THE APPLICATION OF ISO 14971 TO MEDICAL DEVICE SOFTWARE Organization: BSI
Date: 2010-05-31
GOST R 55544 - RUSSIAN LANGUAGE - MEDICAL DEVICES SOFTWARE. PART 1. GUIDANCE ON THE APPLICATION OF ISO 14971 MEDICAL DEVICES SOFTWARE Organization: GOST
SEPT - MED DEVICE CHECKLIST KIT - SOFTWARE ENGINEERING PROCESS TECHNOLOGY - MEDICAL DEVICE SOFTWARE CHECKLIST KIT - INCLUDES; ISO 13485: 2016, IEC 62304: 2015, UL 1998: 2004, ISO/IEC 90003: 2014, ISO 9001: 2015, FDA SW VAL STD CK/L, FDA OTS SW STD CHK/L, FDA MED DEV SW CK/L - SAVE 40% OVER BUYING INDIVIDUAL DOCUMENTS - REPLACES PRODUCT NUMBER 87: TO PURCHASE CALL 1-800-854-7179 USA/CANADA OR 303-397-7956 WORLDWIDE Organization: SEPT
Date: 2016-03-01
Description: SEPT has packaged 8 documents containing checklists for software standards that medical device firms may need in certifying their medical device products to meet US or EU requirements.
SEPT - MED DEVICE CHECKLIST KIT* - *IN EDITABLE MICROSOFT WORD - SOFTWARE ENGINEERING PROCESS TECHNOLOGY - MEDICAL DEVICE SOFTWARE CHECKLIST KIT - INCLUDES; ISO 13485: 2016, IEC 62304: 2015, UL 1998: 2004, ISO/IEC 90003: 2014, ISO 9001: 2015, FDA SW VAL STD CK/L, FDA OTS SW STD CHK/L, FDA MED DEV SW CK/L - SAVE 40% OVER BUYING INDIVIDUAL DOCUMENTS - REPLACES PRODUCT 87; TO PURCHASE CALL 1-800-854-7179 USA/CANADA OR 303-397-7956 WORLDWIDE Organization: SEPT
Date: 2016-03-01
Description: SEPT has packaged 8 documents containing checklists for software standards that medical device firms may need in certifying their medical device products to meet US or EU requirements.
SEPT - ISO 13485 CHECKLIST - ISO 13485 CHECKLIST - SOFTWARE ENGINEERING PROCESS TECHNOLOGY - EVIDENCE PRODUCT CHECKLIST FOR ANSI/AAMI/ISO STANDARD 13485:2016 "MEDICAL DEVICES QUALITY MANAGEMENT SYSTEMS-REQUIREMENTS FOR REGULATORY PURPOSES" - REPLACES PRODUCT NUMBER 26 Organization: SEPT
Date: 2016-03-03
Description: ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.
SEPT - ISO 13485 CHECKLIST* - ISO 13485 CHECKLIST - SOFTWARE ENGINEERING PROCESS TECHNOLOGY - EVIDENCE PRODUCT CHECKLIST FOR ANSI/AAMI/ISO STANDARD 13485:2016 "MEDICAL DEVICES QUALITY MANAGEMENT SYSTEMS-REQUIREMENTS FOR REGULATORY PURPOSES" **EDITABLE MS WORD VERSION** - REPLACES PRODUCT NUMBER 26; INCLUDES ACCESS TO ADDITIONAL CONTENT Organization: SEPT
Date: 2016-03-03
Description: ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.
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 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 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 processesISO 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.
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.

1 - 20 of 30 results