ISO 14644-3:2019, Cleanrooms & Controlled Environments, Test Methods
Excellence is expected in any industrial activity. Sometimes, this careful assuredness is an excessive welcome; a means to go beyond the bare minimum to instill…
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,…
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….
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…