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A dentist who has read ISO/TS 22911 is suited up and prepared for evaluating dental implant systems on animals.
ANSI | Health Care

Evaluating Functional Stress Due to Dental Implants

BySonali Desai June 20, 2017May 29, 2025

With the trust patients have in their doctor, whether ophthalmologist, gynecologist, pediatrician, or dentist, it is expected that the doctor has completed thorough risk analysis…

Checking the boxes on a clipboard to evaluate, via ANSI/IESNA RP-29-20, the effects illuminating health care spaces can have on health.
ANSI | Health Care | Lighting

ANSI/IES RP-29-22: Lighting Hospitals & Healthcare Facilities

ByNancy Jiang June 14, 2017May 29, 2025

Workplace lighting is a very nuanced subject, especially when the psychological and physiological effects that poor lighting can have on people are taken into account….

Cat receiving ultrasound to see her babies on screen with IEC 62304 technology
ANSI | Health Care | Medical Devices

Amendment to ANSI/AAMI/IEC 62304:2006 – Medical Device Software – Software Life Cycle Processes

ByBrad Kelechava May 18, 2017May 29, 2025

ANSI/AAMI/IEC 62304:2006/A1:2016 – Medical device software – Software life cycle processes – Amendment has been released. This document is an amendment to the existing ANSI/AAMI/IEC…

Stethoscope hanging on white sterilized medical ventilator
ANSI | Health Care | Sterilization

Sterilization of Medical Devices: Guidance for Manufacturers and Health Care Providers in Reprocessing

ByBrad Kelechava April 4, 2017May 29, 2025

Guidance for Manufacturers For medical devices, sterilization is, unsurprisingly, crucial to patient health. For the best results, sterilization needs to begin with the manufacturers, who…

Doctor inserting used medical instruments into machine to conduct ethylene oxide sterilization.
ANSI | Health Care | Sterilization

AAMI TIR14:2016 – Contract Sterilization Using Ethylene Oxide

ByBrad Kelechava October 14, 2016May 30, 2025

Contract sterilization is rapidly growing within the medical device industry, as contracting the sterilization of manufactured health care products to an external organization simplifies the…

Bright colorful stainless steel needle tubing following ISO 9626:2016.
ANSI | Medical Devices

ISO 9626:2016 – Stainless Steel Needle Tubing for Medical Devices

ByBrad Kelechava September 8, 2016May 27, 2025

In our last post, we discussed the changes made to ISO 7864:2016, the standard for sterile hypodermic needles for single use. However, ISO 7864 was…

A plain white ISO 7846:2016 hypodermic needle, kept sterile and ready for use.
ANSI | Medical Devices

Changes to ISO 7864:2016 – Sterile Hypodermic Needles for Single Use

ByBrad Kelechava September 7, 2016May 30, 2025

ISO 7864:2016 – Sterile hypodermic needles for single use – Requirements and test methods is the latest version of the standard that specifies guidelines for…

Gold nugget on white background that could be used in titanium-gold alloy
ANSI | Health Care

New Titanium-Gold Alloy Could Improve Medical Implants

ByBrad Kelechava July 27, 2016May 30, 2025

In mid-July 2016, a team at Rice University, led by Professor Emilia Morosan, created a super-hard metal made from titanium and gold. The research team…

An IEC 60601-2-25 electrocardiograph (ECG or EKG) showing colorful lines of vital results
ANSI | Medical Devices

IEC 60601-2-25, Safety and Performance of Electrocardiographs

ByBrad Kelechava June 22, 2016May 27, 2025

IEC 60601-2-25 ED. 2.0 B:2011 – Medical electrical equipment – Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs addresses a…

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