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…
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…
AAMI TIR59: Integrating Human Factors into Medical Devices
Human factors, or ergonomics, strives to understand the interactions among humans and the other elements of a system. Integrating human factors engineering, otherwise known as…
Amendment to ANSI/AAMI/IEC 62304:2006 – Medical Device Software – Software Life Cycle Processes
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…
ISO 9626:2016 – Stainless Steel Needle Tubing for Medical Devices
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…
Changes to ISO 7864:2016 – Sterile Hypodermic Needles for Single Use
ISO 7864:2016 – Sterile hypodermic needles for single use – Requirements and test methods is the latest version of the standard that specifies guidelines for…