Electronics
Electronics designed to reduce the risk of failing safety and electromagnetic testing. Insulation, leakage and emissions are set against IEC 60601-1 at schematic stage, not after a failed test report.
When electronics design is the right step
For any device with a battery, a mains supply or a sensor. The architecture should set the insulation before the first schematic, because the layout follows from it.
Turn a breadboard into a medical board
A working breadboard or development-kit prototype that must become a board that can pass IEC 60601-1.
Build a sensing front end
Analog front ends for signals such as ECG, temperature or pressure, where noise and patient isolation shape the circuit.
Fix a safety or EMC problem
A board that failed, or is likely to fail, electrical safety or EMC testing and needs a redesign.
What you bring, and what you get back
You bring
- What the device measures, powers or controls
- How it is powered: mains, battery or both
- Where it is used: hospital, home or in transit
- Your prototype or reference design, if any
- Limits on board size and shape
You get back
- Schematics and PCB layout
- Bill of materials
- Insulation diagram
- Bring-up records
- Pre-compliance results for safety and EMC
Set the insulation before the first layout
IEC 60601-1 asks for means of protection between hazardous voltages and the people who touch the device. Protection for patients (MOPP) needs larger creepage and clearance distances, and higher test voltages, than protection for operators (MOOP). These distances decide board size, part choice and the isolation parts. Set them in the architecture and the layout follows. Find them at the lab and the board is redesigned.
How electronics design works
Questions clients ask
Why pre-test before the accredited lab?
A pre-compliance check finds the likely failures while the fix is still a small change. Lab time is booked and paid for, and a failed test means a redesign and a second booking.
What does IEC 60601-1-2 cover?
Electromagnetic disturbances: what the device emits, and how well it keeps working when exposed to them. The test levels depend on where the device is used, such as a hospital or a home.
Does a battery-powered device still need isolation?
Often, yes. A charger, a data cable or a connected accessory can bring mains voltage close to the patient. The insulation diagram shows each path and how it is protected.
Which battery standard applies?
For lithium cells and packs, IEC 62133-2 covers battery safety. Shipping lithium batteries also has its own transport rules.
Pre-tested before the lab
Boards are brought up in our labs in Navi Mumbai, and safety and EMC are checked in-house before the accredited lab. Electronics sits in one team with embedded, mechanical and verification.
Devices we have worked on
We name the type of device, not the client. Client work stays confidential. See every device type.
- Pulsed lavage irrigation system for orthopaedic surgery
- Battery-powered bone drill with its docking station
- Bipolar coagulation instrument for neurosurgery
- Blood and fluid warmer, in two flow ranges
- Whole-body patient warming pad system
- Membrane oxygenator for cardiopulmonary bypass
Run under an ISO 13485:2016 quality system certified by TÜV SÜD, certificate 99 400 00046. What it covers.
Not quite you?
Standards this work is done against
- IEC 60601-1Basic safety and essential performance
- IEC 60601-1-2Electromagnetic disturbances
- IEC 60601-1-11Home healthcare use, where it applies
- IEC 62133-2Safety of lithium batteries
The list for a given device, and the edition of each, is set in its regulatory plan.
Where this sits
Also in Co-Design & Develop
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