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 – Sterilization of health care products – Microbiological methods – Part 1: Determination of a population of microrganisms on products has been released….
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…
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…
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…
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…
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 ED. 2.0 B:2011 – Medical electrical equipment – Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs addresses a…
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•…