There are several versions of the IEC 62366 standard to be aware of. People working with usability engineering are probably used to it and know the differences, but when you want to buy or download the PDF version of the standard, make sure you purchase the version you need the most. 

Here are some of the versions you should be aware of:  

IEC 62366:2008 
is the first version of the standard.  

EN 62366:2008 
is the European version of the first issue. It is a harmonised standard with the Medical Device Directive (93/42/EEC). 

IEC 62366-1:2015 
In practice, the IEC 62366-1:2015 is the second version of the standard. But since -1 was added to the standard’s number, technically speaking, it is the first version with the new number.  

IEC 62366-1:2015/AMD 1:2020 
is the same as 62366-1 but with an amendment that implements some changes to the IEC 62366-1 standard. Read more about what is new in the IEC 62366-1/AMD1:2020. The amendment is, in some cases referred to as A1. 

EN 62366-1:2015  
is the EU version of the IEC 62366-1:2015. The standard text is the same, but it is the European publication of the same standard. This is now withdrawn. However, there are national versions of the same, for example, SS-EN 62366-1 and BS-EN 62366-1.  

There are several websites where you can buy the IEC 62366-1:2015+A1:2020 standard. And there are substantial price differences.  


Comparing the least expensive version with the most expensive ones will result in a price difference of 1400%.   

It is quite easy to see that the price at the Estonian Centre for standardisation is significantly lower than the others. Many people are surprised when learning that the content of the standard is the same when purchased from Estonia compared to the more expensive sites.  

The website also has a great feature that allows you to acquire a standard for 24 hours for the price of 2 EUR, during which time you can browse it and determine if that particular version is the exact match for you. 


Would you like to learn more about Usability Engineering?

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Michaela Kauer Franz

Michaela Kauer-Franz

Dr. Michaela Kauer-Franz is a highly esteemed trainer, consultant, and entrepreneur in the medical device industry. She has vast hands-on experience, having developed, amongst other things, monitoring devices for ICU and NICUs, diabetes care products, and women’s health products.

Michaela Kauer-Franz has received numerous awards including the Red Dot Winner Interface Design Award and being nominated for the UX Design Award. She is a lecturer for the design of medical and critical user interfaces at the Technische Universität Darmstadt and part of the national standardization committees in Germany for Usability and User Experience.