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AAMI TIR32 - MEDICAL DEVICE SOFTWARE RISK MANAGEMENT Organization: AAMI
Date: 2004-01-01
Description: Purpose The goal of this TIR is to be a technical reference on risk management for medical devices. It is intended primarily for software engineers, software quality assurance personnel, and those responsible for medical device risk management.
SEPT - SW CONFIG MGMT TEMPLATE - SOFTWARE ENGINEERING PROCESS TECHNOLOGY - TEMPLATES FOR SOFTWARE CONFIGURATION MANAGEMENT DOCUMENTS VERSION 6.0 - VERSION 6; REPLACES PRODUCT CODE 53 Organization: SEPT
Date: 2012-04-01
Description: The templates conform to software CM requirements specified in standards ANSI/EIA-649-B, Configuration Managements Standard, ISO/IEC 12207:2008, Software life cycle processes, ISO/IEC 15288:2008, System life cycle processes, and IEC 62304, Medical Device Software - Software Life Cycle Processes. In addition to informative and adaptable text, these templates provide many illustrative diagrams that ease the implementation and communication of CM processes.
SEPT - SW CONFIG MGMT TEMPLATE* - * IN EDITABLE MICROSOFT WORD - SOFTWARE ENGINEERING PROCESS TECHNOLOGY - TEMPLATES FOR SOFTWARE CONFIGURATION MANAGEMENT DOCUMENTS VERSION 6.0 - VERSION 6; REPLACES PRODUCT CODE 53; INCLUDES ACCESS TO ADDITIONAL CONTENT Organization: SEPT
Date: 2012-04-01
Description: The templates conform to software CM requirements specified in standards ANSI/EIA-649-B, Configuration Managements Standard, ISO/IEC 12207:2008, Software life cycle processes, ISO/IEC 15288:2008, System life cycle processes, and IEC 62304, Medical Device Software - Software Life Cycle Processes. In addition to informative and adaptable text, these templates provide many illustrative diagrams that ease the implementation and communication of CM processes.
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 software–Software 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.
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).
AAMI SW87 - APPLICATION OF QUALITY MANAGEMENT SYSTEM CONCEPTS TO MEDICAL DEVICE DATA SYSTEMS - FDA RECOGNIZED Organization: AAMI
Date: 2012-01-01
Description: Purpose of this document This document is an introduction to the subject of a quality management system for organizations that develop, provide, and support a medical device data system (MDDS) as defined in 21 CFR 880.6310.
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.
DSF/PRCEN ISO/TS 29321 - HEALTH INFORMATICS - APPLICATION OF CLINICAL RISK MANAGEMENT TO THE MANUFACTURE OF HEALTH SOFTWARE (ISO/TS 29321:2008) Organization: DS
Description: It is acknowledged that, on the boundary, there are health software products that are encompassed by medical device regulations in some countries but not in others.
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: A general software configuration of a microprocessor based programmable component typically includes the operating system or executive software, communication software, micro-controller, input/output hardware, and any generic software libraries, database management or user interface software. The Checklist provides an easy-to-use classification scheme of physical evidence comprised of policies, procedures, plans, records, documents, audits, and reviews.
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: A general software configuration of a microprocessor based programmable component typically includes the operating system or executive software, communication software, micro-controller, input/output hardware, and any generic software libraries, database management or user interface software. The Checklist provides an easy-to-use classification scheme of physical evidence comprised of policies, procedures, plans, records, documents, audits, and reviews.
CLSI EP33 - USE OF DELTA CHECKS IN THE MEDICAL LABORATORY - FIRST EDITION Organization: CLSI
Date: 2016-03-01
Description: This information may also be of interest to hospital or laboratory informatics staff, and software and medical device vendors who need to understand the laboratory’s goals when implementing automated delta checking.
CLSI AUTO11 - INFORMATION TECHNOLOGY SECURITY OF IN VITRO DIAGNOSTIC INSTRUMENTS AND SOFTWARE SYSTEMS; APPROVED STANDARD - SECOND EDITION; VOL 34; NO 17 Organization: CLSI
Date: 2014-10-01
Description: This standard also provides guidance to meet and use existing technical standards for medical device IT security and recommendations for identifying the parties responsible for implementing these requirements.
ETSI - TS 103 424 - PUBLICLY AVAILABLE SPECIFICATION (PAS); SMART MACHINE-TO-MACHINE COMMUNICATIONS (SMARTM2M) HOME GATEWAY INITIATIVE RD036-SMART HOME ARCHITECTURE AND SYSTEM REQUIREMENTS - V1.1.1 Organization: ETSI
Date: 2016-11-01
Description: The rapid increase in the number of smart devices in the home, from entertainment systems to appliances and medical devices and the now near ubiquitous broadband connectivity have created a significant new potential market for service providers.

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