Electro medical device mainly consists of electro medical equipment and system. The equipment performs the functions or takes input for a function and the system display the output. The IEC 60601-1 addresses risks associated with electronic medical devices –this standard has become a de facto requirement for most companies manufacturing electro medical equipments. The standard does not cover the in vitro devices and medical gas pipelines. The objective of the standard is to measure the essential performance and safety of the devices.
First and foremost whenever a device is received for testing purpose it is visually inspected. Visual inspection has many parameters. The visual inspection starts with checking the devices for general transport related damages, then the devices is checked for markings and other applicable sign and safety symbols.. Every Device when tested for the general standards is then tested as the applicable particular 60601 standards for additional required.
This standard has many changes since its first edition was published and recently 4th edition of the IEC60601 standard is out which is , slated for adoption in 2018. The fourth edition emphasize on” design consideration” while manufacturing the next generation medical equipment.
EN 60601 standards cite three classifications for medical equipments namely: class CF, BF, and B based on safety & performance level as per EN60601-1-2 of medical device applied parts. Out of all three CF, or Cardiac Floating, is the most demanding performance level. Applied parts falling under this rating have direct connection with patient’s heat during the operation. Examples include ventricular assist device (VAD’s or dialysis machine).Applied parts which have long-term conductive contact with a patient comes under Type BF or Body Floating is less stringent than CF .Example of BF types includes incubators, patient heating and cooling equipment, ultrasound monitoring, cardiac monitoring, long term diagnostic equipment and blood pressure monitoring.
The least stringent safety requirement is for the type B, or Body, classification where the body parts are non- conductive and can be immediately taken off the patient body. Examples of B type includes, LED lighting, medical lasers, medical imaging, hospital beds and photo-therapy equipment. Another major difference between the 3 which can be notated is that type B is connected to earth ground where as both type BF & CF are not grounded that is why also they are known as floating.
Now testing as per IEC 60601 is mandatory for all electro-medical devices aimed for obtaining CE mark. While 60601 is not a single standard and it has a services of standards involved within specially aimed at different devices. It is mandatory to understand the requirements of your device as per IEC 60601. SO before going for the testing is is necessary to opt for a pretesting consultancy so that you can understand the in-depth the requirements needed for performing your product testing so that once the testing stats it does not get hold due to the requirement which needs to be fulfilled earlier. We have the technical experts who can pay visit to specially examine your product and pre-define the requirements and standards applicable on your product.
We also have a NABL accredited lab based at Mohali (Punjab) . We offer medical testing for compliance with this standard. We can also issue the CE mark after successful product testing against applicable standards. We can also provide test reports for your technical files for European and U.S. Food and Drug Administration (FDA) approval submissions.