Recognized Consensus Standards: Medical Devices
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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) |
12/19/2022 | Software/ Informatics |
13-125 | Complete | ANSI AAMI UL | 2800-1-1:2022 | Standard for Risk Concerns for Interoperable Medical Products |
08/21/2017 | Software/ Informatics |
13-90 | Complete | IEEE | Std 11073-10417-2015 | Health Informatics - Personal Health Device Communication, Part 10417: Device Specialization - Glucose Meter |
12/19/2022 | Software/ Informatics |
13-123 | Complete | ANSI NEMA | HN 1-2019 | American National Standard Manufacturer Disclosure Statement for Medical Device Security |
10/19/2020 | Software/ Informatics |
13-116 | Complete | FIRST | CVSS v3.0 | Common Vulnerability Scoring System version 3.0 |
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 |
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 |
09/09/2008 | Software/ Informatics |
13-19 | Complete | CLSI | LIS04-A | Standard Guide for Documentation of Clinical Laboratory Computer Systems |
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 |
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 |
06/07/2021 | Software/ Informatics |
13-118 | Complete | IEEE | Std 11073-40102:2020 | Health informatics - Device interoperability. Part 40102: Foundational - Cybersecurity - Capabilities for mitigation. |