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“The Medicines and Healthcare products Regulatory Agency (MHRA) is working to develop a world-leading future regime for medical devices that prioritises patient safety while fostering innovation….”
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.
The international standard for the application of medical device symbols on labels, ISO 15223-1, has been amended and the 4th Edition will replace ISO 15223-1:2016
This amendment is multifaceted and will introduce many new changes to the symbol requirements that medical device organizations around the world will be expected to follow.
The 4th Edition of ISO 15223-1 will include 25 additional symbols in total, newly defined terms and removal of existing terms as well as inclusion of terms from other standards, and expansion of the informative annex containing examples—just to name a few.
DATELINE 27 MAY 2021: Wow! Some companies made it just across the line in time and I’m sure some didn’t. Did you? Not everyone agress with my perspective. Let’s get on with the story.
What does that all mean?
The MDD and AIMDD are dead (Dead on Arrival) and the MDR Date of Application (DoA) has just flown by us, yesterday. So, we are past the transition period, per say, for the MDR and now we’re into a grace (grey zone) for the legacy MDD/AIMDD products that can’t have any significant changes under their existing MDD/AIMDD certificates otherwise they need to go “full up” into MDR-land.
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.