York EMC has unique and proven knowledge in supporting customers in achieving compliance to the EMC standard EN 60601-1-2 and Electrical Safety standard IEC/EN 60601-1-1
Medical Device Compliance
The assessment of medical devices for CE marking requires a more rigorous approach to compliance due to the type of environment they are placed into. Medical devices, by the nature of their operation, can generate potentially high levels of disturbances whilst working in the same environment as sensitive monitoring equipment which, if adversely affected could pose a risk to life.
The medical environment is one where the concept of risk assumes a much greater emphasis and latest standards require the manufacturer to carry out and document a comprehensive risk assessment.
Engineers from our three accredited test laboratories will work with you to identify the appropriate standards for your medical products on which the testing will be based for CE marking.
Please refer to our UKAS schedule for full details of specific standards we are accredited to and contact us for a full list of standards we can test to.
The Fourth Edition of EN 60601-1-2 changes the basic EMC compliance philosophy by defining tests and limits according to risk and intended use instead of a device type.
Tests are defined based on where the equipment will be used
- In a healthcare facility
- At home
- Special environment such as military, heavy industrial
- Medical treatment area with high-powered medical equipment
We have been offering accredited EMC testing for medical devices to IEC / EN 60601-1-2 for many years, including the 2014 version with the increased radiated immunity requirements for CE marking.
We offer accredited Electrical Safety testing for in vitro diagnostic (IVD) medical equipment compliance with the IEC / EN 61010-2-101 standard and will have accreditation to IEC / EN 60601-1-1 during Q2 of 2017.
We can work with you to identify the appropriate CE marking directives and standards if you are planning to incorporate a wireless interface into a medical device.
We offer radio testing for equipment with embedded wireless technology; whether it be to check pre-tested modules incorporated into your product or full compliance testing.
We can advise manufacturers on managing their regulatory risk to ensure that they get their product to market quickly and efficiently, whilst protecting their brand reputation. In particular, we can provide guidance on
- Procurement strategies
- Families of similar products
- Risk assessments
- Technical documentation preparation
- Design consultancy
- On-going compliance
York EMC Services offers training at various levels, from one-day Essentials courses through to five-day Fundamentals helping manufacturers and their supply chains to achieve on-going compliance to a number of CE Marking Directives including the EMC, Low Voltage and Radio Equipment Directives.