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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.
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.
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.
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.
SEPT - FDA MED DEV SW CK/L - SOFTWARE ENGINEERING PROCESS TECHNOLOGY - EVIDENCE PRODUCT CHECKLIST FOR FDA GUIDANCE FOR THE CONTENT OF PREMARKET SUBMISSIONS FOR SOFTWARE CONTAINED IN MEDICAL DEVICES - 2005 REVISION Organization: SEPT
Date: 2011-11-29
Description: General Principles of the checklist "FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" This checklist was prepared by analyzing each clause of this guidelines for the keywords that signify a: Procedure Plan Records Document (Including Lists, Manuals, Reports, Scripts and Specification) Audit Review This checklist specifies evidence that is unique.
SEPT - FDA MED DEV SW CK/L* - * IN EDITABLE MICROSOFT WORD - SOFTWARE ENGINEERING PROCESS TECHNOLOGY - EVIDENCE PRODUCT CHECKLIST FOR FDA GUIDANCE FOR THE CONTENT OF PREMARKET SUBMISSIONS FOR SOFTWARE CONTAINED IN MEDICAL DEVICES - 2005 REVISION; INCLUDES ACCESS TO ADDITIONAL CONTENT Organization: SEPT
Date: 2011-11-29
Description: General Principles of the checklist "FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" This checklist was prepared by analyzing each clause of this guidelines for the keywords that signify a: Procedure Plan Records Document (Including Lists, Manuals, Reports, Scripts and Specification) Audit Review This checklist specifies evidence that is unique.
AAMI HE74 - HUMAN FACTORS DESIGN PROCESS FOR MEDICAL DEVICES Organization: AAMI
Date: 2001-01-01
Description: By providing a structured approach to user interface design, this document can help manufacturers develop safe and usable medical devices. This document includes an overview of the human factors engineering (HFE) discipline, a discussion of the benefits of HFE, a review of the HFE process and associated analysis and design techniques, and a discussion of implementation issues and relevant national and international standards and regulations (see annex B).
SEPT - FDA OTS SW STD CK/L* - * IN EDITABLE MICROSOFT WORD - SOFTWARE ENGINEERING PROCESS TECHNOLOGY - EVIDENCE PRODUCT CHECKLIST FOR THE FDA DOCUMENT: “GUIDANCE FOR INDUSTRY, FDA REVIEWERS AND COMPLIANCE ON OFF-THE-SHELF SOFTWARE USE IN MEDICAL DEVICES” - INCLUDES ACCESS TO ADDITIONAL CONTENT Organization: SEPT
Date: 2012-01-04
Description: Documnet Number - FDA INDUSTRY GUIDANCE WORD SEPT Software Engineering Process Technology - Evidence Product Checklist for the FDA Document: "Guidance For Industry, FDA Reviewers and Compliance On Off-The-Shelf Software Use In Medical Devices" As Amended By: "Guidance for Industry, FDA Reviewers and Compliance On Cybersecurity for Networked Medical Devices Containing Off-The Shelf (OTS) Software" The experts at SEPT have updated Guidance for Industry, FDA Reviewers and Compliance on Off-the-Shelf Software Use in Medical Devices to reflect the suggested compliance with the document Compliance on Cyersecurity for Networked Medical Devices Containing Off-the Shelf (OTS) Software dated January 14, 2005.
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.
AAMI TIR36 - VALIDATION OF SOFTWARE FOR REGULATED PROCESSES Organization: AAMI
Date: 2007-01-01
Description: It does not apply to • software used as a component, part, or accessory of a medical device, or • software that is itself a medical device. This TIR may provide useful information and recommendations to • people responsible for determining the appropriate content and size of a validation effort; • people responsible for performing the analyses and evaluations that drive the content or size determination; • people responsible for planning and executing the validation activities; • people responsible for reviewing and approving the adequacy of the validation effort; and • people responsible for auditing, inspecting, and evaluating the validation for compliance to regulation.
SEPT - UL 1998 CHECKLIST - SOFTWARE ENGINEERING PROCESS TECHNOLOGY-EVIDENCE PRODUCT CHECKLIST FOR ANSI/UL 1998-2004 STANDARD FOR SOFTWARE IN PROGRAMMABLE COMPONENTS - REVISION 1 - REVISION 1 Organization: SEPT
Date: 2012-01-10
Description: The experts at SEPT have revised this checklist to reflect revision 1 to this major software engineering document: ANSI/UL 1998 Standard for Software in Programmable Components. This standard is used by the fuel cell and medical device business community. The ANSI/UL 1998 standard is focused toward application-specific, non-networked software in a programmable component embedded in a product for which a failure may result in injury to persons.
SEPT - UL 1998 CHECKLIST* - * IN EDITABLE MICROSOFT WORD - SOFTWARE ENGINEERING PROCESS TECHNOLOGY-EVIDENCE PRODUCT CHECKLIST FOR ANSI/UL 1998-2004 STANDARD FOR SOFTWARE IN PROGRAMMABLE COMPONENTS - REVISION 1 - REVISION 1; INCLUDES ACCESS TO ADDITIONAL CONTENT Organization: SEPT
Date: 2012-01-10
Description: The experts at SEPT have revised this checklist to reflect revision 1 to this major software engineering document: ANSI/UL 1998 Standard for Software in Programmable Components. This standard is used by the fuel cell and medical device business community. The ANSI/UL 1998 standard is focused toward application-specific, non-networked software in a programmable component embedded in a product for which a failure may result in injury to persons.
SEPT - FDA OTS SW STD CK/L - SOFTWARE ENGINEERING PROCESS TECHNOLOGY-EVIDENCE PRODUCT CHECKLIST FOR THE FDA DOCUMENT: “FDA 21 CFR PART 11 ELECTRONIC RECORDS; ELECTRONIC SIGNATURES; FINAL RULE” Organization: SEPT
Date: 2012-01-10
Description: Document Number - SEPT FDA INDUSTRY GUIDANCE Software Engineering Process Technology - Evidence Product Checklist for the FDA Document: "Guidance For Industry, FDA Reviewers and Compliance On Off-The-Shelf Software Use In Medical Devices" As Amended By: "Guidance for Industry, FDA Reviewers and Compliance On Cybersecurity for Networked Medical Devices Containing Off-The Shelf (OTS) Software" The experts at SEPT have updated Guidance for Industry, FDA Reviewers and Compliance on Off-the-Shelf Software Use in Medical Devices to reflect the suggested compliance with the document Compliance on Cyersecurity for Networked Medical Devices Containing Off-the Shelf (OTS) Software dated January 14, 2005.

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