IEC and CENELEC Standard Naming Conventions: 60601-1-2 4th Edition vs. EN 60601-1-2:2015 vs IEC 60601-1-2:2014-02

The International Electrotechnical Commission (IEC) is the leading global organization that prepares and publishes International Standards for all electrical, electronic and related technologies. Both Safety and Electromagnetic compliance standards are produced by the IEC.

Virtually all countries in the world rely on and adopt the IEC standards, in part to simplify creating their own standards, and in part to harmonize their country standards with the world. However most countries choose to not directly use the IEC standards, but instead create derivative standards directly based on the IEC standards. In this way it is possible to add minor changes to the adopted standards on an as needed basis.

CENELEC is the European agency which typically controls the EN standards. Most of the EN electro-technical standards produced by CENELEC are directly derived from IEC standards, and typically the major numeric part of standard name is identical. Differences in the standard number however may occur in the suffix which will typically indicate year of publication as 4 digits. CENELEC and standards published by various countries typically will lag the publication of the IEC standard by one or more years.

Additionally, whereas Edition levels are used for many of the IEC standards to clarify to the user a major change to the standard, this is not practiced in the CENELEC naming convention of EN standards.

The IEC recommends a 5 year allowance for manufacturers to modify their products before the derived national standards, become mandatory, and any conflicting national standards are withdrawn. Therefore when countries adopt a new version/edition of an IEC standard, two key dates are typically specified in the new derived standard:

• DOP, Date of Publication
• DOW, Date of Withdrawal

These two key dates are typically shown within the first 5 pages of an EN specification, and the CENELEC requirements for DOW mostly follow the IEC recommendations.

As an example, let us consider the medical EMC control document IEC 60601-1-2-2014, 4th edition.

The full numeric descriptor of the standard is IEC 60601-1-2:2014-02. The year and month of publication follow the colon which is attached to the primary specification number. Although the 4th edition does not appear in the number, reviewing the Title page of the standard shows it prominently displayed. After this IEC edition was published, subsequently in January 2015, the CENELEC Standard EN 60601-1-2:2015 was ratified. Note, only the year is shown as part of the standard name, the month is not included.

The DOP for the EN 60601-1-2:2015 is 2016-03-18, the DOW is 2018-12-31. After 2018-12-31 all products sold in the EU are required to meet the requirements in this medical EMC standard.

REF: https://www.cenelec.eu/dyn/www/f?p=104:110:974359894211801::::FSP_ORG_ID,FSP_PROJECT,FSP_LANG_ID:1257161,44445,25

GlobTek products compliant with IEC 60601-1-2 4th edition: