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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….

Visualized bright tooth on blue background with no adhesion problems thanks to ANSI/ADA 111-2019 testing
ANSI | Dentistry

ANSI/ADA 111-2019 Adhesion Test Methods To Tooth Structure

ByBrad Kelechava June 10, 2020May 29, 2025

From the moment your teeth eject in your early life, they are fraught with peril. Covered by plaque and threatened by the semi-daily habit of…

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…

A group of surgeons walking down hallway
ANSI | Health Care

AORN Guidelines for Perioperative Practice

ByBrad Kelechava April 3, 2020June 5, 2025

Perioperative refers to around the time of surgery, encompassing the expanse of time following when the patient goes into the hospital, clinic, or doctor’s office…

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…

ER with ISO 11607-1:2019 Terminally Sterilized Medical Devices Material Packaging
ANSI | Health Care | Sterilization

ISO 11607 2019 Revisions, Sterilized Medical Device Packaging

ByBrad Kelechava February 26, 2019June 5, 2025

Both standards in the international series for the packaging for terminally sterilized medical devices have been revised: ISO 11607-1:2019, which addresses materials, sterile barrier systems,…

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…

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