|
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)
|
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)] |
08/21/2017 |
Software/ Informatics |
13-94 |
Complete |
ISO IEEE |
11073-10424 First edition 2016-06-15 |
Health informatics - Personal health device communication - Part 10424: Device specialization - Sleep Apnoea Breathing Therapy Equipment (SABTE) [Including TECHNICAL CORRIGENDUM 1 (2018)] |
08/06/2013 |
Software/ Informatics |
13-49 |
Complete |
ISO IEEE |
11073-20101 First edition 2004-12-15 |
Health informatics - Point-of-care medical device communication - Part 20101: Application Profiles - Base Standard |
07/09/2014 |
Software/ Informatics |
13-69 |
Complete |
ISO IEEE |
11073-10472 First edition 2012-11-01 |
Health informatics - Personal health device communication -- Part 10472: Device specialization - Medication monitor |
08/06/2013 |
Software/ Informatics |
13-40 |
Complete |
ANSI AAMI IEC |
TIR 80001-2-1 2012 |
Application of risk management for IT-networks incorporating medical devices - Part 2-1: Step-by-step risk management of medical IT-networks; Practical applications and examples |
IEC |
TR 80001-2-1 Edition 1.0 2012-07 |
Application of risk management for IT- networks incorporating medical devices - Part 2-1: Step-by-step risk management of medical IT-networks - Practical applications and examples |
08/06/2013 |
Software/ Informatics |
13-44 |
Complete |
ANSI AAMI IEC |
TIR 80001-2-3:2012 |
Application of risk management for IT Networks incorporating medical devices - Part 2-3: Guidance for wireless networks |
IEC |
TR 80001-2-3 Edition 1.0 2012-07 |
Application of risk management for IT Networks incorporating medical devices - Part 2-3: Guidance for wireless networks |
07/06/2020 |
Software/ Informatics |
13-113 |
Complete |
IEEE |
Std 11073-20601-2019 |
Health informatics - Personal health device communication - Part 20601: Application profile - Optimized exchange protocol. |
07/06/2020 |
Software/ Informatics |
13-114 |
Complete |
IEEE |
Std 11073-10101-2019 |
Health informatics - Point-of-care medical device communication. Part 10101: Nomenclature |
07/15/2019 |
Software/ Informatics |
13-108 |
Complete |
IEEE |
Std 11073-20701-2018 |
Health informatics - Point-of-care medical device communication - Part 20701: Service-Oriented Medical Device Exchange Architecture and Protocol Binding |
01/14/2019 |
Software/ Informatics |
13-106 |
Complete |
IEEE |
Std 11073-10207-2017 |
Health informatics - Point-of-care medical device communication Part 10207: Domain Information and Service Model for Service-Oriented Point-of-Care Medical Device Communication |