Regulatory Update – January 2022 Index I have 4 Regulatory updates (US (2), England, Scotland & Wales (1), EU 1)) for you that are full of great information. Below is a mini index so you can jump around the world
Regulatory Updates – January 2022
IEC 60601 Amendments Presentation Now on MDG Premium
Joe Hage graciously invited me to present on July 30 to his MDG premium group on “IEC 60601 Amendments & What’s in the future for Medical Electrical Equipment”. We had a great conversation with about 35 or so people from around the world. They were from Ireland, the Netherlands, India, the US, and elsewhere in the conversation, with questions throughout and at the end too.
IEC 60601-1-2:2020 (Ed. 4.1) Hidden Surprise!
IEC 60601-1-2:2014, 4th edition, references CISPR 11:2010 (a.k.a. EN 55011), had no radiated rf emissions requirements for group 2 devices (intentional radiators) between 150kHz and 30 MHz. This is the basis for all group 2 medical devices on the market today.
IEC 60601-1-2:2020, edition 4.1, got fast tracked by the FDA since it contains new immunity tests (table 11 – RFID requirements based on AIM 735131 standard values) that they want manufacturers to do immediately. In that 2020 standard, 60601-1-2 references CISPR 11:2015 + A1:2016 + A2:2019 version that inherits a new group 2 only RF radiated emissions test with limits that apply for 150kHz – 30 MHz.
FDA Finally Adds to Fall 2020 Recognized Consensus Standards db for Cycle Update
Updated 22 Dec 2020 – In the last couple of years, the FDA has started to post the standards updates on their Recognized Consensus Standards db prior to publishing in the Federal Register (FR). This year, being the year we
Webinar – Standards, Standards, Standards – Makes the Medical Device World go Around
Standards are a key priority for the International Medical Device Regulators Forum (IMDRF). Its forthcoming guidance, “Optimizing Standards for Regulatory Use,” encourages the development of ‘regulatory ready’ standards, including direction to Standards Development Organizations (SDOs) to consider medical device ‘essential