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…
IEC 60601-2-25, Safety and Performance of Electrocardiographs
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…
Blood Collection Standard Practices
Blood collection standard practices can guarantee efficiency and ensure the safety of all people involved with the drawing and testing of blood. Our blood is…
Assistive Device Standards for Wheelchairs
Do you know RESNA, Rehabilitation Engineering & Assistive Technology Society of North America? RESNA members promote the exchange of ideas and information for the advancement…
Sterilization of Medical Devices
Sterilization of medical devices, pharmaceuticals and other medical products is critical to patient safety. Methods of sterilization involve steam, bleach, ethylene oxide, radiation among others….
Rice University Engineering Students Collaborate on Design of Cervical Collar
Rice University biomedical engineering and mechanical engineering students designed and prototyped the HeadCase cervical collar. They studied existing cervical collars and their results showed that existing cervical collars can push the head…