Early Steps to Designing Product Safety Requirements Into Your Product
To be able to meet a portion of the requirements of the electrical medical standards (IEC60601-1 or other 60601-1 based national standards) the first step you should do as you are designing a medical device is to generate an isolation diagram of the product. The term isolation or insulation diagram is used interchangeably. An isolation diagram is a GREAT tool to communicate spacings and dielectric requirements of the standards to the designers of the product. You may also be able to identify alternative ways to meet the requirements and therefore design the product at a lower cost or make it easier to manufacture which could also save money and time. If you get to the Safety Agency evaluation of the product and you have not conducted this step you may be out of luck and need to re-design the product which is very costly in time and money and you could lose your market advantage.
An isolation diagram indicates how the patient is isolated from the mains and secondary circuits of the product. There are quite a few additional areas of concern for a product in terms of meeting insulation requirements, other than patient and circuit isolation but patient isolation is critical to a design. The isolation diagram proves that you have two levels of protection available so if a single fault occurs the user or patient will be safe from an electrical shock hazard or another type of hazard.
A good reason for an isolation diagram is that it is a good block diagram that can show some general information about the product without extensive schematics that many non-technical people can understand more readily. Therefore, you can use this tool to meet many needs instead of just to meet the Safety Agency Requirements.
To find out more about isolation diagrams and the product safety requirements for your products please contact us at Leo at EisnerSafety dot com