ISO 14644 : Requirements for Cleanrooms
The ISO 14644 family of standards serves as a comprehensive guide for establishing and maintaining cleanroom environments, especially in the…
ISO 11135: Requirements for sterilisation with ethylene oxide
The ISO 11135 defines the requirements associated to the development, validation and routine control of the process of sterilization with…
IEC 60601-1-11 : Requirements for Medical Equipment to be used at home
In recent years, the number of medical devices designed to be used within a home environment has increased substantially; this…
ISO 17664: Processing Instructions for Medical Devices
In the last years, the reprocessing of medical devices started to play a critical role and additional requirements have been…
IEC 62304:2006 – Medical Device Software
IEC 62304:2006 is an internationally recognised medical device standard which provides a framework for the development, testing and maintenance of…
ISO 10993-1 : Biocompatibility Evaluation for Medical Devices
Biocompatibility evaluation according to ISO 10993-1 and the related biological risk assessment is one of the most important validation activities…
Design History File (DHF): An Overview
Design History File (DHF) for Medical Devices: Introduction This posts wants to provide an overview of the process of preparation…
New ISO 14155:2020 Clinical Investigation for Medical Devices
Very recently, ISO published a new version of ISO 14155:2020 – Clinical investigation of medical devices for human subjects —…
ISO 15223-1:2021 : New Symbols for Medical Devices
ISO 15223-1:2021 new symbols for medical devices In this paragraph, we will talk about the update of ISO 15223-1 that…
ISO 13485 and the FDA : The Future of Quality Management Systems
ISO 13485 and FDA: Harmonization with FDA QSR and insights on next version of ISO 13485 In this paragraph we…