How Is A Harmonised Standard Made?

Historically speaking, the majority of European standards focused on product safety, machinery and EMC compliance originate from German standards. As overall, a big part of the harmonised system is based on thousands of German standards (e.g. VDE, DIN, VBG).

The process of producing a harmonised standard consists of several phases: drafting, enquiry, voting, numbering, and publication. A proper interpretation of the whole process is presented in the figure below.

Figure 1. Production of a Harmonised Standard

Source (Tricker, 2004)

The first phase of the process is the drafting of the harmonised standard. There are many ways to start making a harmonised standard, some of which are:

• In the majority of cases, an initial document is sent by the International Electro-Technical Commission;
• The first draft of a document with European origin comes from one of CEN/ CENELEC/ETSI’s co-operating partners;
• A European document arises in one of CEN/CENELEC/ETSI’s technical bodies;
• The National Committees themselves initiate it.

Once an international standard or another document is selected, CEN/CENELEC/ETSI start working on it to develop it into a draft of a European standard. Meanwhile, all work on a national level concerning the same subject is stopped immediately. This interruption is called ‘STANDSTILL’.

The second part of the process is called ‘enquiry’, during which the draft is submitted to the National Committees for enquiry. Usually, this procedure lasts around half a year. Afterwards, the National Committees sent comments on the draft to the technical body. Then the notified body needs to study and incorporate them into the document before sending out the final draft for voting. 

Voting is the third stage of the process of producing a harmonised standard, and it normally takes three months. Here, all Member States give their vote. The bigger countries, such as Germany and France, have ten weighted votes each. Smaller countries, such as Bulgaria, have one or two weighted votes.

The ratification of a standard happens only when the following two requirements are met:

• The majority of National Committees is in favour of the document;
• At least 71 per cent of all weighted votes is positive.

After the voting is completed with success, the standard needs to be numbered. Using a number is the shortest way possible to refer to a European standard. Each European standard consists of the capital letters ‘EN’ and a number in Arabic numerals (e.g. EN 62311:2008, EN 61010-1:2010). The letters and the numbers are separated with space.

Let’s take EN 61010-1:2010. This standard refers to ‘Safety requirements for electrical equipment for measurement, control, and laboratory use’. The last four digits indicated by a colon show the year of availability of this particular harmonised standard. If the standard consists of more than 1 part, the part number is separated by a hyphen as it is in the exemplary. Furthermore, the first two numerals show the standard’s origin. In our example (EN61010-1:2010), the first two numerals are 61, which refer to the CENELEC implementation of IEC documents.

Usually, standards with publication numbers from 1 to 59,999 are for the ISO, and those from 60,000 above are for the IEC.

Once the new standard has passed all formal acceptance procedures and has been assigned a number, a list of references needs to be published in OJEC. With this, the process of producing a harmonised standard ends.

Reference:

1. Tricker, Ray. ‘CE Conformity Marking and New Approach Directives’. (2004)