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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.
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.
DS/EN 15521 - HEALTH INFORMATICS - CATEGORIAL STRUCTURE FOR TERMINOLOGIES OF HUMAN ANATOMY Organization: DS
Date: 2007-11-30
Description: The target groups for this European standard are: - designers of specialised 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 represent
NBN - EN 15521 - HEALTH INFORMATICS - CATEGORIAL STRUCTURE FOR TERMINOLOGIES OF HUMAN ANATOMY Organization: NBN
Date: 2008-01-29
Description: The target groups for this European standard are:- designers of specialised 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 represent
NBN - EN 15521 - INFORMATIQUE DE SANTÉ - STRUCTURE CATÉGORIELLE DES TERMINOLOGIES D'ANATOMIE HUMAINE Organization: NBN
Date: 2008-01-29
Description: The target groups for this European standard are:- designers of specialised 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 represent
NBN - EN 15521 - HEALTH INFORMATICS - CATEGORIAL STRUCTURE FOR TERMINOLOGIES OF HUMAN ANATOMY Organization: NBN
Date: 2008-01-29
Description: The target groups for this European standard are:- designers of specialised 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 represent
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.
NBN - EN ISO 16278 - HEALTH INFORMATICS - CATEGORIAL STRUCTURE FOR TERMINOLOGICAL SYSTEMS OF HUMAN ANATOMY (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.
NBN - EN ISO 16278 - HEALTH INFORMATICS - CATEGORIAL STRUCTURE FOR TERMINOLOGICAL SYSTEMS OF HUMAN ANATOMY (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.
ISO 16278 - HEALTH INFORMATICS - CATEGORIAL STRUCTURE FOR TERMINOLOGIES SYSTEMS OF HUMAN ANATOMY - FIRST EDITION Organization: ISO
Date: 2016-03-01
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.
CEN - EN ISO 16278 - HEALTH INFORMATICS - CATEGORIAL STRUCTURE FOR TERMINOLOGICAL SYSTEMS OF HUMAN ANATOMY Organization: CEN
Date: 2016-03-01
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.
DIN EN ISO 16278 - HEALTH INFORMATICS - CATEGORIAL STRUCTURE FOR TERMINOLOGICAL SYSTEMS OF HUMAN ANATOMY (ISO 16278:2016) Organization: DIN
Date: 2016-08-01
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.
CRC - ELEC HLTH REC: SYS ANALY MEDS DOMN - ELECTRONIC HEALTH RECORD: A SYSTEMS ANALYSIS OF THE MEDICATIONS DOMAIN Organization: CRC
Date: 2012-03-22
Description: Even when an organization does have the systems analysis related to EHRs it has developed or implemented, this reference is considered an intellectual property to be guarded accordingly, as a secret possession. Unfortunately, a software blueprint kept in a vault cannot be improved, lessons learned by others cannot be applied to or derived from it, and the professionals involved in the development or implementation of EHRs may find themselves "reinventing the wheel" solving problems others have already solved or worse-making the same mistakes others did before them.
CRC - CIRCADIAN PHYSIOLOGY - CIRCADIAN PHYSIOLOGY - SECOND EDITION Organization: CRC
Date: 2005-10-21
Description: A CD-ROM included in the book provides a suite of computer programs designed to offer practical experience in a variety of topics. Instructions for software installation are given in a separate section before the first chapter, and programs for data analysis - as well as tutorials and simulation programs - are introduced at the appropriate points in the various chapters.

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