DIN EN ISO 13485:2016 abbreviations

It doesn’t matter if you first mention the DIN EN ISO or the year at the end, or if you don’t – all people involved talk about this norm as a matter of course. This is why I want to briefly explain at this point what these abbreviations and the letters in this norm mean.

 

DIN EN ISO

The letter combination in front of the norm number contains 3 parts. Consequently, they need to be treated separately.

 

DIN

The abbreviation DIN doesn’t mean “Deutsche Industrienorm” (= German industry norm) as often assumed, but Deutsches Institut für Normung (German Institute for Standardization).

This means that the norm is a binding and accepted norm in Germany due to the Deutsches Institut für Normung.

 

EN

The abbreviation EN means, in this case, European norm. This means that the norm has been ratified by the European Committee for Standardization (CEN) and is now binding.

 

ISO

The abbreviation ISO means International Organization for Standardization.

 

13485

The norms are numbered consecutively, starting with the ISO 1 (Geometrical product specification, GPS). Please don’t ask me why it starts with this norm and why Medical devices – Quality management systems – Requirements for regulatory purposes has the number 13485.

 

2016

The 2016 after the norm number means the year in which the norm has been revised for the last time and from which year the current number is. DIN norms for example are checked for relevance at least every five years and are revised if necessary. The version previous to DIN EN ISO 13485:2016 was from 2012.

 

The abbreviations explained above resp. the knowledge of them might rather be extra knowledge. But maybe someone is pleased to know the answers to these questions.