|
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)
|
05/29/2024 |
Software/ Informatics |
13-137 |
Complete |
IEEE |
Std 11073-10101b-2023 |
Health informatics - Point-of-care medical device communication. Part 10101: Nomenclature |
05/29/2024 |
Software/ Informatics |
13-138 |
Complete |
IEEE |
Std 11073-10700-2022 |
Health Informatics - Device Interoperability Part 10700: Point-of-Care Medical Device Communication - Standard for Base Requirements for Participants in a Service-Oriented Device Connectivity (SDC) System |
10/09/2023 |
Software/ Informatics |
13-130 |
Complete |
ANSI AAMI |
2700-2-1:2022 |
Medical devices and medical systems - Essential safety and performance requirements for equipment comprising the patient-centric integrated clinical environment (ICE): Part 2-1: Particular requirements for forensic data logging |
10/09/2023 |
Software/ Informatics |
13-131 |
Complete |
ANSI AAMI |
SW96:2023 |
Standard for medical device security - Security risk management for device manufacturers |
12/19/2022 |
Software/ Informatics |
13-121 |
Complete |
ANSI AAMI UL |
2800-1:2022 |
Standard for Medical Device Interoperability |
12/19/2022 |
Software/ Informatics |
13-122 |
Complete |
IEC |
81001-5-1 Edition 1.0 2021-12 |
Health software and health IT systems safety, effectiveness and security - Part 5-1: Security - Activities in the product life cycle
|
12/19/2022 |
Software/ Informatics |
13-123 |
Complete |
ANSI NEMA |
HN 1-2019 |
American National Standard Manufacturer Disclosure Statement for Medical Device Security |
12/19/2022 |
Software/ Informatics |
13-124 |
Complete |
AAMI |
CR34971:2022 |
Guidance on the Application of ISO 14971 to Artificial Intelligence and Machine Learning |
12/19/2022 |
Software/ Informatics |
13-125 |
Complete |
ANSI AAMI UL |
2800-1-1:2022 |
Standard for Risk Concerns for Interoperable Medical Products |
12/19/2022 |
Software/ Informatics |
13-126 |
Complete |
ANSI AAMI UL |
2800-1-2:2022 |
Standard for Interoperable Item Development Life Cycle |
12/19/2022 |
Software/ Informatics |
13-127 |
Complete |
ANSI AAMI UL |
2800-1-3:2022 |
Standard for Interoperable Item Integration Life Cycle |
12/19/2022 |
Software/ Informatics |
13-128 |
Complete |
IEEE UL |
Std 2621.2-2022 |
Standard for Wireless Diabetes Device Security: Information Security Requirements for Connected Diabetes Solutions |
06/07/2021 |
Software/ Informatics |
13-117 |
Partial |
IEEE |
Std 11073-40101-2020 |
Health informatics - Device interoperability Part 40101: Foundational - Cybersecurity - Processes for vulnerability assessment. |
06/07/2021 |
Software/ Informatics |
13-118 |
Complete |
IEEE |
Std 11073-40102:2020 |
Health informatics - Device interoperability. Part 40102: Foundational - Cybersecurity - Capabilities for mitigation. |
06/07/2021 |
Software/ Informatics |
13-119 |
Complete |
ANSI ISA |
62443-4-1-2018 |
Security for industrial automation and control systems Part 4-1: Product security development life-cycle requirements. |
07/06/2020 |
Software/ Informatics |
13-114 |
Complete |
IEEE |
Std 11073-10101-2019 |
Health informatics - Point-of-care medical device communication. Part 10101: Nomenclature |
07/06/2020 |
Software/ Informatics |
13-115 |
Complete |
ISO IEC IEEE |
29119-1 First edition 2013-09-01 |
Software and systems engineering - Software testing - Part 1: Concepts and definitions |
12/23/2019 |
Software/ Informatics |
13-112 |
Complete |
AAMI |
TIR97:2019 |
Principles for medical device security - Postmarket risk management for device manufacturers |
06/07/2018 |
Software/ Informatics |
13-104 |
Complete |
UL ANSI |
2900-2-1 First Edition 2017 |
Standard for Safety, Software Cybersecurity for Network-Connectable Products, Part 2-1: Particular Requirements for Network Connectable Components of Healthcare and Wellness Systems |
12/04/2017 |
Software/ Informatics |
13-102 |
Complete |
IEC |
TR 80001-2-8 Edition 1.0 2016-05 |
Application of risk management for IT-networks incorporating medical devices - Part 2-8: Application guidance - Guidance on standards for establishing the security capabilities identified in IEC TR 80001-2-2 |
12/04/2017 |
Software/ Informatics |
13-103 |
Complete |
IEC |
TR 80001-2-9 Edition 1.0 2017-01 |
Application of risk management for it-networks incorporating medical devices - Part 2-9: Application guidance - Guidance for use of security assurance cases to demonstrate confidence in IEC TR 80001-2-2 security capabilities |
08/21/2017 |
Software/ Informatics |
13-96 |
Complete |
UL ANSI |
2900-1 First Edition 2017 |
Standard for Safety, Standard for Software Cybersecurity Network-Connectable Products, Part 1: General Requirements |
08/21/2017 |
Software/ Informatics |
13-97 |
Complete |
IEC |
82304-1 Edition 1.0 2016-10 |
Health software - Part 1: General requirements for product safety |
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 |
13-83 |
Complete |
AAMI |
TIR57:2016 |
Principles for medical device security - Risk management. |