EMC Consultancy on ‘Edition 4’
4th edition of medical EMC becomes mandatory
The 4th edition of the medical EM standard IEC 60601-1-2:2014 will become mandatory in the United States and the European Union from December 31st 2018 onwards. This new standard will have a major impact on the medical industry.
- The FDA does not require retesting of legacy products unless changes are made to the product that may affect its compliance.
- In the EU however, all devices including legacy devices sold to the EU, must comply with the new 4th edition standard after this date.
- For other regions it varies with the local regulations of the country.
Get this wrong, and you may no longer be allowed to sell your existing product in the EU.
With requirements becoming up to ten times more stringent, you need to take action to introduce a new way of working for your design teams. Optimization of current processes will simply not suffice.
- Design-in of EMC compliance in the earliest possible phase
- (especially valid with regard to the new EMC standard IEC 60601-1-2:2014)
- Speeding up your time-to-market without compromising EMC compliance
- Lowering cost-of-non-quality on EMC related issues
- Prevent – EMC related – costly and time-consuming field issues
All hands-on, knowledge, skills, state-of-the-art tools etc. for your mechanical and electrical design teams to ‘design-in’ EMC compliance.
- Edition 4 gap analysis
- Advice on the applicable EMC standards (e.g. EMC standard IEC 60601-1-2:2014)
- Composition of EMC specifications
- Electromagnetic risk analysis
- EMC, SI & PI, and wireless coexistence simulations
- Architecture recommendations
- Design reviews
- Pre-compliance measurements
- Wireless performance tests
- Audits, training, toolboxes
- And more
Depending on your requirements we can:
- participate in your design teams;
- provide on-demand expert technical support to them;
- provide consultancy, training and more.
Design for EMC approach (including: electromagnetic emission and immunity, signal and power integrity (SI & PI), electromagnetic risk management, exposure of humans to electromagnetic fields (EMF), and the reliable performance of wireless connections).
“My overall evaluation of the EMC project is pretty positive. We got very good guidance to setup and execute the tests, excellent support to solve technical issues and interpret data. Comprehensive reporting, very fast planning and resource allocation. The communication and interaction was always friendly and productive”
“Thank you for the clear report and the DVDs with data sets. This gives a good basis to start working on our spectrum management database and to learn how to verify and release wireless devices in our medical environments. I liked working with you and the team very much and I am very pleased with the results and the way the project was able to stay on track with planning.”
“Electronics is such a broad field, there’s no way a single person can be an expert in every area, so we were pleased to find Philips Innovation Services had the exact expertise we were looking for.”
Senior Hardware Engineer and Engineering team leader
EMC consultancy in the spotlight
Our challenge was to bring new connected innovations to the market. For us, this means validating electromagnetic compatibility.
Check out our related services
As an innovation team, you are responsible for meeting the ever-increasing market needs by delivering innovations faster. But how can you cut your time-to-market without compromising compliance? How do you drive down the cost of non-quality (CoNQ) end-to-end?