Recognized Consensus Standards: Medical Devices
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311 to 320 of 1497 Results
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Results per Page |
Date of
Entry |
Specialty Task
Group Area |
Recognition
Number |
Extent of
Recognition |
Standards
Developing Organization |
Standard Designation Number and Date |
Standard Title (click for recognition information) |
08/21/2017 | Software/ Informatics |
13-88 | Complete | ISO IEEE | 11073-10417 Third edition 2017-04 | Health informatics - Personal health device communication - Part 10417: Device specialization - Glucose meter |
12/23/2016 | Software/ Informatics |
13-87 | Complete | ISO IEC | 15026-2 First edition 2011-02-15 | Systems and software engineering - Systems and software assurance - Part 2: Assurance case |
12/23/2016 | Software/ Informatics |
13-86 | Complete | ISO IEC | 15026-1 First edition 2013-11-01 | Systems and software engineering - Systems and software assurance - Part 1: Concepts and vocabulary |
12/23/2016 | Software/ Informatics |
13-85 | Complete | CLSI | AUTO11-A2 | Information Technology Security of In Vitro Diagnostic Instruments and Software Systems; Approved Standard - Second Edition |
06/27/2016 | Software/ Informatics |
13-84 | Complete | ISO IEEE | 11073-10103 First edition 2014-03-01 | Health informatics - Point-of-care medical device communication - Part 10103: Nomenclature - Implantable device, cardiac |
06/27/2016 | Software/ Informatics |
13-83 | Complete | AAMI | TIR57:2016 | Principles for medical device security - Risk management. |
06/27/2016 | Software/ Informatics |
13-82 | Complete | ANSI AAMI ISO | TIR 80001-2-6:2014 | Application of risk management for IT networks incorporating medical devices - Part 2-6: Application guidance - Guidance for responsibility agreements |
04/04/2016 | Software/ Informatics |
13-81 | Complete | IEEE | Std 11073-10419:2015 | Health informatics - Personal health device communication - Part 10419: Device Specialization - Insulin Pump |
01/14/2019 | Software/ Informatics |
13-79 | Complete | IEC | 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION | Medical device software - Software life cycle processes |
ANSI AAMI IEC | 62304:2006/A1:2016 | Medical device software - Software life cycle processes [Including Amendment 1 (2016)] | ||||
08/14/2015 | Software/ Informatics |
13-78 | Complete | INCITS ISO IEC | 30111 First edition 2013-11-01 (R2019) | Information technology - Security techniques - Vulnerability handling processes |
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