🔥 Find me at MedicalDevicesGroup.net 🔥
< 1 min reading time
As originally asked by Luke Barratt.
need HELP. I’m an ME doing some consulting for a small ophthalmic start-up. In making an accessory for a Slit Lamp functional across multiple brands we’re really struggling to understand 60601’s application.
We hired a local expert on 60601 and found that we didn’t actually get straight answer on keeping our designs compliant. The project EE is doing his best with the circuity, but not able to help me know if my machined AL components should be grounded, or left isolated.
Any thoughts / help most welcome!
You may already have your answers, or have found someone to help, but I just thought I would clarify something you asked about earlier. The IEC 60601-1 classification (Class I and Class II) relate to grounding (see definition below), and is completely unrelated to the FDA regulatory Classifications I, II and III, which relate to risk, and which determine the regulatory process with FDA.
Also, make sure you use the 3rd edition of IEC 60601-1. There are a number of requirements (in addition to the electrical shock shock) that should be considered early in the design process.
All the best.
Yuri Sokolov, MSc, PhD, MBA
If you want to sell in jurisdictions beyond the US, then there may be variations of requirements and marks, such as CE-Mark. All requirements should be defined at an early stage of development to avoid any surprises at the testing stage. Such surprises may be quite costly.
In my experience, the best course of action is to consult the Lab where you plan to have your device tested.
The process of interaction with UL is outlined at:
Some find it easier to work with Intertek:
Having said all this, your starting point for a medical device should always be an isolation diagram. You then might need the help of an electrical or electronics engineer and one that knows how to apply 601-1.
Campo Elias Pena Laiton
Yep, you nailed it – we know we need to know and if even the Mechanical guy is looking for answers we much be desperate! I’ll take this off line and would be interested to get you in touch with the Chief Engineer / Partner for whom I “consult”.
Your issue deals with isolation/insulation requirements. It is essential that you identify how you are going to isolate accessible parts and patient applied parts from “live” parts. There are many ways to achieve the isolation required (i.e. BI, DI, RI). You need to speak with someone who knows the standard inside and out (like myself). However, I don’t generally help Consultants. A person claiming to be a “Consultant” should know what they are talking about (no offense).
Daniel, I believe I understand what you’re saying – need to meet the spec, but you can meet the spec without necessarily applying an isolation transformer (hence 1 slit lamp that’s grounded while another brand isn’t).
The Slit Lamps are Class II according to FDA guidance from 1998. I can’t find 510k’s from the equipment we’re talking about, but the designs could well be grandfathered.
Thank you again gentleman!
Regarding your issue, is the device with with infinite resistance from chassis to gnd Class II?
Marked as spam