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Doctor connecting patient's continuous glucose monitor with a connected diabetes devices, which adheres to IEEE 2621.1-2022, to check his blood sugar level in real time.
ANSI | Medical Devices

IEEE 2621.1-2022: Wireless Diabetes Device Security

ByAlexandra Schirn May 1, 2025May 22, 2025

A growing number of people with diabetes are turning to wireless diabetes devices to monitor and manage their condition in an automated fashion. As diabetes…

Various medical devices in a hospital that have symbols that comply with ISO 15223-1:2021.
ANSI | Health Care | Labels and Symbols

ISO 15223-1:2021—Medical Devices Symbols

ByAlexandra Schirn March 26, 2025June 4, 2025

Symbols on medical devices are crucial for patient safety, regulatory compliance, and effective communication, allowing for clear and concise information across different languages and cultures. ISO…

Female surgeon using monitor in operating room that adheres to health information technology and risk management in AAMI 80001-GS:2011 and IEC 80001-1:2021.
ANSI | Medical Devices

AAMI 80001-GS:2011— Getting Started With IEC 80001

ByAlexandra Schirn April 8, 2024June 4, 2025

Medical errors occur far too frequently: over 7 million American patients are impacted by medical errors each year; there are 7,000 to 9,000 Americans who…

Nurse using medical devices prior to surgery with devices adhering to AAMI TIR12:2020 (R2023) guide for medical device manufacturers (MDMs).
ANSI | Medical Devices

AAMI TIR12:2020 (R2023)— A Guide for Device Manufacturers

ByAlexandra Schirn December 20, 2023June 4, 2025

Medical device manufacturers are required to design and build quality into their products. This means that they must have processes and procedures in place to ensure…

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