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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…

Dental equipment on blue background.
ANSI | Dentistry

Understanding American National Standards for Dental Practices

ByGuest Contributor August 18, 2023June 4, 2025

American National Standards developed by the American Dental Association allow patients across the nation to receive standardized care of the highest quality. ANSI/ADA 35-2019, for…

Medical drugs in a pharmacy adhering to ANSI/PDA Standard 001-2020 and FDA requirements.
ANSI | Medicine and Pharmaceuticals

ANSI/PDA Standard 001-2020: Medical Purchasing Controls

ByAlexandra Schirn August 10, 2023June 4, 2025

Concerns related to the efficacy and safety of medical drugs have caused most governments to develop regulatory agencies to oversee development and marketing of drug products and…

Semiconductor chip in electronic device adhering to IEC 62779-1:2016.
ANSI | Medical Devices

IEC 62779-1 Ed. 1.0 b:2016— Semiconductors for Human Body

ByAlexandra Schirn July 26, 2023May 21, 2025

What if we could use the human body itself to transfer and collect information? This area of research is known as human body communication (HBC,…

Selection of essential oils in the perfume and pharmaceuticals industry that adhere to liquid chromatography specifications in ISO 8432:1987.
ANSI | Medicine and Pharmaceuticals

ISO 8432:1987— Liquid Chromatography For Essential Oils

ByAlexandra Schirn May 10, 2023June 4, 2025

Essential oils are concentrated plant extracts that retain the natural smell and flavor of their source. Since most of their components are volatile (i.e., a…

Sensory assessor performing sensory analysis of sea fish sample in a test tube that adheres to ISO 8586:2023.
ANSI | Food Safety | Medicine and Pharmaceuticals

ISO 8586:2023—Selection And Training Of Sensory Assessors

ByAlexandra Schirn May 5, 2023June 10, 2025

In the early 1950s, a milestone for sensory evaluation occurred when the Quartermaster Food and Container Institute developed the nine-point hedonic scale: a category scaling…

Surgeon in health care facility picking up medical devices that adhere to risk management requirements in ISO 14971:2019.
ANSI | Health Care

ISO 14971:2019–Risk Management To Medical Devices

ByAlexandra Schirn April 18, 2023June 4, 2025

Flint knives, saws, and drills were used for surgery, amputation, and trepanation during the Upper Paleolithic and Mesolithic times in 6000 BCE. These were the…

Medical devices in health care facility adhering to security risk management in ANSI/AAMI SW96:2023 and ISO 14971:2019.
ANSI | Health Care

ANSI/AAMI SW96:2023—Medical Device Security

ByAlexandra Schirn April 17, 2023June 4, 2025

The steps that involve manufacturing, regulation, planning, assessment, acquisition, and management of medical devices are complex but essential to guarantee their quality, safety, and compatibility…

Young female doctor wearing medical face mask adhering to ASTM F2100-23 before surgery.
ANSI | Clothing and Textiles | Medical Devices

Standard for Medical Face Masks, ASTM F2100-23

ByBrad Kelechava April 13, 2023June 4, 2025

Some 16 million people work in the healthcare sector, doing the work that keeps the rest of us alive. Personal protective equipment (PPE), such as…

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