Understanding the Standards’ references

This article’s objective is to clarify the Standards’ references. As you will have noticed from your research: the names of the standards are difficult to grasp and the explanations are not easy to find. This article gives the definitions of the main terms, using information from ISO where available.

The different categories of abbreviations used in Standards’ references

Four main groups of information are deduced from the title of a standard, they usually appear in this order:

• The document type;
• The geographic area covered by the document;
• The organisation behind the drafting; and
• The current stage in the drafting cycle.

Information on standards bodies

Here is a list of the standardisation bodies most active:

We note that combinations are possible in the title of standards, for example with IEEE 11073: this standard was drafted by the IEEE then adopted by the ISO and its members: ISO/IEEE 11073 and finally by the CEN: CEN ISO/IEEE 11073.

Standard validation information

Information is presented in chronological order of stages in drafting an international standard:

Some documents complement or substitute for others:

• ISO/PAS instead of a CD;
• ISO/TS or ISO/TR (for a non-normative document) in addition to a DIS.

Information on the “area of applicability” of the standard

Having a geographical indication does not mean that the standard becomes mandatory, it has simply been adopted in the area described. It may also mean that the standard is country specific.

This information can also cumulate, let’s take the NF EN ISO 14971 standard on Application of risk management to medical devices :

1. It is an international standard: ISO.
2. The European Commission has added it to the list of harmonised standards: Software Item.
3. The AFNOR (French Standardization Association) has published a French version: NF.

Note that the requirements of ISO, EN ISO and NF EN ISO standards are strictly the same

Only the Z annexes distinguish the different prints, for example the Z annex of ISO 13485:2016.

Regarding harmonised standards: they are harmonised with respect to the requirements of a European Directive, in the case of medical devices they are harmonised to the Directive 93/42/EEC.

The case of NF standards (France)

No official source define the codification of NF (French) standards, but one can note the use of the following codes:

Other document types

Not all documents are standards, there are also guides and other good practices:

Other considerations

Other rules are applied to construct the title of a standard, here are the most common: