After 17 years of designing and launching product developments into a wide range of market sectors including consumer, industrial and medical, I’ve had first hand experience of numerous regulations and associated standards. Seen by many as a burden, I would like to challenge this view.
Each Directive has a relatively simple and laudable aim, such as preventing products sold on the open market from causing death or injury and reducing their impact on the environment. They define which products are within scope, but they do not tell you how to go about achieving the aim.
If you want to, you can design and launch a new product development without ever referring to a standard, but this means that you have to work out for yourself how to meet the relevant Directives. It means that you have to keep on top of best practice and really understand your area, so that if it all goes wrong, and you end up in court, you can convince experts in the field of your design approach.
Conversely, the wide range of standards that are available, represent an incalculable number of hours of experience and best practice that have been written up for others to use. There is also a surprising amount of data which would be hard to measure for yourself, for example IEC 60601-1 (medical electrical equipment) tells you how high an electrical current can be before tissue damage is likely to occur, IEC 60079-11 (ATEX intrinsic safety) tells you how much energy has to be released in a spark in order to ignite a mixture of hydrogen and oxygen. Given the ease of access to this material, it would seem a little rash to ignore it or attempt to reproduce it.
I note however that the aims of the Directives are so very basic, that often they are not written into requirements specifications. For example, no one wants their latest and greatest connected product development to set fire to people, yet this is unlikely to be stated in the requirements, which instead focus of the functionality and cost. However these unwritten specifications are as important as any other and need to be considered in the product development from the very start.
So rather than seeing regulatory standards as a burden, my assertion is that they make life easier, and allow engineers to focus on the real product development challenges rather than keeping up to date on best practices.This can only happen though if the regulations and standards are considered from the very early stages of the project, and the shared best practice is built into the product architecture from the start.