IEC 60601-1 Amendment 2 (IEC 60601-1:2005 +A1:2012 + A2:2020) has been in the making since 2015 (officially) along with the other published Amendments (IEC 60601-1-6, 60601-1-8, 60601-1-9, 60601-1-10, 60601-1-11, & 60601-1-12). It was published on 20 August 2020 on the IEC website and you can obtain it either as a separate Amendment (A2) or as a consolidated edition (CSV). Unfortunately, you can’t obtain a red-line of the document showing from the previous edition. I was hoping for that myself as so much easier to see the changes. Also, I don’t recommend purchasing it from the IEC website as the standards there are usually too expensive to purchase. I usually go to the Estonian Standards website but since the standard won’t be Harmonized for many years that won’t help. So, I suggest going to your local standards distributor site such as IHS, SAI Global, or TechStreet are some of the more common ones.
So are you ready for all the changes of Amendment 2 of IEC 60601-1 and all the Amendments?
Join us for a live free webinar on an Insider’s look at IEC60601 Amendments: detailed guidance from a committee member responsible for changes – Aug 27, 10 AM PT/ 1 PM ET
With several hundred changes written into the 60601-1 Amendment alone, suffice it to say that the full scope of changes to the IEC60601 series is massive, creating a swell of confusion around understanding the updates & how to transition for compliance.
Greenlight Guru has teamed up with Leonard Eisner, the “IEC 60601 Guy”, of Eisner Safety Consultants to share his expertise on the topic, notably his contributions to The Amendments Project.
This in-depth webinar will cover clarifying details around the massive changes of the Amendments Project, provide guidance on updated standards already published, insider knowledge into updated standards not yet published & what to expect, & how to prepare accordingly for the impact it will have on your firm and product lines.
SOME OF THE CHANGES WE WILL COVER INCLUDE:
- Updates to IEC 60601-1 (Medical Electrical Equipment)
- Updates to IEC 60601-1-2 (EMC)
- Updates to IEC 60601-1-8 (Alarms)
- Impacts of standard changes on:
- Design
- Regulatory approvals (i.e. FDA vs EU Notified Body – current vs new standards)
- Safety certifications
- Labeling / markings / packaging
- Tests/ retesting
- Essential Performance
- Risk Management File
- Usability Engineering File
- Software Life Cycle Process
- Q&A session
WHO SHOULD ATTEND?
- R&D Engineers and Management
- Regulatory Affairs Professionals and Management
- Quality Professionals and Management
- Medical Device Executives
- Clinical Affairs Professionals and Management
