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…
AORN Guidelines for Perioperative Practice
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, 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 11607 2019 Revisions, Sterilized Medical Device Packaging
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,…
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…
How the Cloud is Transforming the Way Hospitals Store & Use Patient Data
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 for Wheelchairs: How Standards Cut Costs and Help Simulate Human Occupants
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…
ANSI/AAMI/ISO 11737-1:2018 – Determination of a Population of Microrganisms on Products for Sterilization
ANSI/AAMI/ISO 11737-1:2018 – Sterilization of health care products – Microbiological methods – Part 1: Determination of a population of microrganisms on products has been released….
ISO Health Care Product Sterilization Standards Adopted By AAMI
A health care product is not sterile unless it is free of microorganisms. Sterilization is assured with these products and their materials and components through…