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…
Sterilization of Medical Devices: Guidance for Manufacturers and Health Care Providers in Reprocessing
Guidance for Manufacturers For medical devices, sterilization is, unsurprisingly, crucial to patient health. For the best results, sterilization needs to begin with the manufacturers, who…
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…
Outline of Changes to ISO 13485:2016 Compared with the Previous Edition ISO 13485:2003
ISO 13485:2016 incorporates significant changes to quality management systems requirements for medical devices. The most significant changes pertain to added requirements: • document management• management review•…
ISO 9000 and Medical Devices
2015 marks not only an update of ISO 9001 for Quality Management Systems, but also a revision of ISO 9000: Quality Management Systems – Fundamentals…
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….