ISO 10993-17:2023— Toxicological Risk Assessment
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 […]
Medical Tools and Devices
Standard for Medical Face Masks, ASTM F2100-23
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 […]
ASA/ANSI S3.6-2018 (R2023): Specification For Audiometers
According to the National Institute of Health (NIH), approximately 15% of American adults (37.5 million) aged 18 and over report some trouble hearing, about one […]
ASTM F2077-22: Intervertebral Body Fusion Devices
You are taller in the morning and in outer space. The lack of gravity from lying down to sleep or being in outer space causes […]
Symbols for Medical Device Labels
A voluntary consensus standard can result in the summation of the best existing practices and techniques in an industry that were in use prior to […]
ANSI/AAMI ST79: Guide to Steam Sterilization
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 […]
ANSI/AAMI PB70 – Protective Apparel Liquid Barrier Requirements in Health Care
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 […]
ISO 10993 Biocompatibility and Risk Management
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, EMC Tests for Implantable Medical Devices
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 […]
ISO 15747:2018 – Plastic Containers for Intravenous Injections
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 […]