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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: Document Number - SOFTWARE CONFIGURATION MANAGEMENT This document contains a set of templates that enable engineers and managers to implement effective, standards-compliant software configuration management (CM).
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: Document Number - SOFTWARE CONFIGURATION MANAGEMENT WORD SEPT This document contains a set of templates that enable engineers and managers to implement effective, standards-compliant software configuration management (CM).
SAE JA1003 - SOFTWARE RELIABILITY PROGRAM IMPLEMENTATION GUIDE Organization: SAE
Date: 2004-01-01
Description: It is these concerns for which this document provides some guidelines - both for management of a software reliability program and conduct of life cycle activities using appropriate software engineering and reliability-specific techniques.
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.
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.
AAMI SW87 - APPLICATION OF QUALITY MANAGEMENT SYSTEM CONCEPTS TO MEDICAL DEVICE DATA SYSTEMS - FDA RECOGNIZED Organization: AAMI
Date: 2012-01-01
Description: Other regulatory jurisdictions might require the use of the international consensus standard developed by the International Organization for Standardization (ISO), ISO 13485:2003, Medical devices─Quality management systems─Requirements for regulatory purposes.
ARMY - DA PAM 710-7 - HAZARDOUS MATERIAL MANAGEMENT PROGRAM Organization: ARMY
Date: 2013-06-25
Description: Not specifically addressed under the HMMP scope are munitions, pesticides, asbestos, radiological, and HM used in the treatment of patients at medical facilities or in medical protocols at medical research facilities. These areas are currently addressed under separate programs.
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.
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).
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.
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.
DSF/ISO/DIS 14641-1 - ELECTRONIC DOCUMENT MANAGEMENT - DESIGN AND OPERATION OF AN INFORMATION SYSTEM FOR THE PRESERVATION OF ELECTRONIC DOCUMENTS - PART 1: SPECIFICATION Organization: DS
Description: . - enterprises providing I.T. services and software publishers seeking to develop systems that ensure the fidelity and integrity of document; - organizations providing third-party document archiving services for their customers.
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.
CLSI GP37 - QUALITY MANAGEMENT SYSTEM: EQUIPMENT; APPROVED GUIDELINE - VOL 31; NO 16 Organization: CLSI
Date: 2011-08-01
Description: Although the requirements for the quality system essential (QSE) Equipment include those for computer system hardware, middleware, and software, guidance for meeting those requirements is provided in other documents8-10 and CLSI documents AUTO08,11 AUTO11,12 and GP19.
CLSI QMS13 - QUALITY MANAGEMENT SYSTEM: EQUIPMENT; APPROVED GUIDELINE - VOL 31; NO 16 Organization: CLSI
Date: 2011-08-01
Description: Although the requirements for the quality system essential (QSE) Equipment include those for computer system hardware, middleware, and software, guidance for meeting those requirements is provided in other documents8-10 and CLSI documents AUTO08,11 AUTO11,12 and GP19.
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: • Enabling automated, intelligent reaction to the environment - e.g. demand-side energy management. The present document defines a smart home system architecture and derives requirements for the Home Gateway
NASA NPR 7123.1 - NASA SYSTEMS ENGINEERING PROCESSES AND REQUIREMENTS W/CHG 1: 3/7/2014 Organization: NASA
Date: 2013-04-18
Description: The description of these disciplines and their relationship to the overall management life cycle are defined in other NASA directives; for example, the safety, reliability, maintainability, and quality assurance requirements are defined in the 8700 series of directives, and health and medical requirements are defined in the 8900 series. To that end, this document contains human systems integration language and requirements.
NBN - EN ISO 16278 - INFORMATIQUE DE SANTÉ - STRUCTURE CATÉGORIELLE DES SYSTÈMES TERMINOLOGIQUES DE L'ANATOMIE HUMAINE (ISO 16278:2016) Organization: NBN
Date: 2016-04-22
Description: The target groups for this International Standard are the following:- designers of specialized standard healthcare terminological categorial structures;- developers of healthcare terminological systems including classifications and coding systems;- producers of services for terminological systems and designers of software including natural language processing;- information modellers, knowledge engineers, and standards developers building models for health information management systems;- developers of information systems that require an explicit representation of healthcare terminological systems;- developers of marked-up standards for representation of healthcare documents.

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