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Patient undergoes red light of PET scan and CAT scan technology refurbished to IEC 63077 medical imaging requirements.
ANSI | Health Care | Medical Devices

Good Refurbishment Practices for Medical Imaging Equipment

ByBrad Kelechava January 6, 2021June 10, 2025

The medical industry follows a pattern of continuous advancement to meet patient needs, with innovations in medical technology plentiful at almost any point in time….

ANSI/AAMI ST79:2017 Steam Sterilization Guide Standard Medical Devices Health Care
ANSI | Medical Devices

ANSI/AAMI ST79: Guide to Steam Sterilization

ByBrad Kelechava April 13, 2020May 29, 2025

A consolidation of several previous standards, ANSI/AAMI ST79:2017 offers a Comprehensive Guide To Steam Sterilization And Sterility Assurance In Health Care Facilities. How Steam Sterilization…

Woman in an operating room with personal protective equipment on that is specified in ANSI/AAMI PB70:2012
ANSI | Medical Devices

ANSI/AAMI PB70 – Protective Apparel Liquid Barrier Requirements in Health Care

ByBrad Kelechava April 9, 2020May 29, 2025

Patient care is a hands-on process, but this contact places unique stresses on healthcare professionals. Infection control practices, such as protective apparel, help protect patients…

Blue medical device in hallway biologically evaluated to ISO 10993 risk management.
ANSI | Medical Devices

ISO 10993 Biocompatibility and Risk Management

ByBrad Kelechava April 7, 2020June 5, 2025

Burgeoning alongside advancements in the medical industry itself, innovations in medical devices have blossomed over the past few centuries. Even before a rolled up notebook…

ISO 14117:2019 electromagnetic compatibility (EMC) test protocols active implantable medical devices Pacemaker
ANSI | Medical Devices

ISO 14117:2019, EMC Tests for Implantable Medical Devices

ByBrad Kelechava October 25, 2019June 5, 2025

An international standard, ISO 14117:2019, outlines electromagnetic compatibility (EMC) test protocols for various active implantable medical devices. The heart typically pumps at 60-100 beats per…

Nurse in blue gloves preparing ISO 15747:2018 plastic containers for intravenous injections.
ANSI | Medical Devices

ISO 15747:2018 – Plastic Containers for Intravenous Injections

ByBrad Kelechava November 9, 2018May 30, 2025

The standard for plastic containers for parenterals, ISO 15747:2018 – Plastic Containers For Intravenous Injections, has been revised. Intravenous (IV) medications are often optimal due…

The Cloud IoT Changing Hospital Data
ANSI | Computer Science | Health Care | Medical Devices

How the Cloud is Transforming the Way Hospitals Store & Use Patient Data

ByGuest Contributor September 6, 2018May 30, 2025

The massive cloud migration of recent years has spread across a myriad of industries, with healthcare being one of the latest to adopt its systems…

Test Dummies Wheelchair Standards ISO RESNA ANSI
ANSI | Medical Devices

Test Dummies for Wheelchairs: How Standards Cut Costs and Help Simulate Human Occupants

ByBrad Kelechava August 14, 2018May 30, 2025

Don’t let the name fool you. Test dummies, as anthropomorphic testing devices, are designed to suffer blunt force trauma, but they do so to acquire…

AAMI TIR59: Integrating Human Factors into Medical Devices
ANSI | Health Care | Medical Devices | Sterilization

AAMI TIR59: Integrating Human Factors into Medical Devices

ByBrad Kelechava August 31, 2017May 29, 2025

Human factors, or ergonomics, strives to understand the interactions among humans and the other elements of a system. Integrating human factors engineering, otherwise known as…

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