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3d printing jaw
ANSI | Medical Devices

3D Printing: Revolutionizing Medical Care With Personalized Precision

ByGuest Contributor June 25, 2024May 21, 2025

The field of medicine is undergoing a significant transformation thanks to advancements in 3D printing technology. This innovative process, which creates three-dimensional objects from digital…

Appointment schedule planner and date calendar on hybrid laptop, adhering to ISO 21802:2019 assistive product requirements, helping an individual with cognitive limitations manage her time.
ANSI | Medical Devices

ISO 21802:2019— Assistive Products

ByAlexandra Schirn June 17, 2024May 21, 2025

A study found that individuals with cognitive disability experienced lower scores in general self-efficacy and time management skills than with individuals without cognitive disability. Luckily,…

Safe and stable wheelchair that went through ANSI/RESNA WC-1:2019 testing requirements with test dummies.
ANSI | Medical Devices

ANSI/RESNA WC-1:2019—Wheelchairs and Scooters

ByAlexandra Schirn June 10, 2024May 21, 2025

An estimated 5.5 million Americans use a wheelchair, as do 65 million people worldwide. Wheelchairs are thereby commonly used assistive devices that help people with…

X-ray machine that adheres to medical light source equipment specifications in IEC 60601-2-57 Ed. 2.0 b:2023.
ANSI | Medical Devices

IEC 60601-2-57 Ed. 2.0 b:2023— Medical Electrical Equipment

ByAlexandra Schirn May 2, 2024June 4, 2025

Patients in hospitals can be exposed to electromagnetic fields and optical radiation. This exposure may be associated with risks and hazards. IEC 60601-2-57 Ed. 2.0…

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…

Medical instruments inserted into the autoclave for ethylene oxide (EO) sterilization process that adheres to AAMI TIR16:2023.
ANSI | Medical Devices | Sterilization

AAMI TIR16:2023—Ethylene Oxide Sterilization

ByAlexandra Schirn March 12, 2024June 4, 2025

Ethylene oxide (EO or EtO) gas is one of the most common ways to sterilize medical devices, as approximately 50% of sterile medical devices are treated…

Nurse preparing medication for bloodstream infection in a hospital with an intravascular catheter, which adheres to ISO 10555-1:2023.
ANSI | Medical Devices

ISO 10555-1:2023— Intravascular Catheters

ByAlexandra Schirn January 22, 2024June 4, 2025

Intravascular catheters are an indispensable tool in modern-day medical practice, both for patients with acute injuries and for those with chronic illnesses. Approximately 90% of patients…

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…

xpert toxicologist identifying the substances of potential significance present at medical laboratory adhering to the toxicological risk assessment process in ISO 10993-17:2023.
ANSI | Medical Devices

ISO 10993-17:2023— Toxicological Risk Assessment

ByAlexandra Schirn October 9, 2023June 10, 2025

Risk assessment is a multi-step process which produces estimates of risk of an adverse health effect occurring as a consequence of ingesting, inhaling, and/or absorbing…

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