Regulatory Open Forum

Hi community,

I am seeking for some expertise related to harmonized standards in EU. I am wondering why there is an EN version for ISO 8536-4 (EN ISO 8536-4:2020) but when I look into the standard content, there is no Annex Z correlating clauses of the standard with any specific EU regulation. In addition, this standard is not even listed in the MDD standards harmonized list or the MDR standards harmonized list. What are the implications of an EN adopted standard that is not harmonized and does not correlate to any EU regulation?

Thanks,

Luis

Hello Luis,

There are many standards which are released in the national systems which are originally released as ISO, i.e. CSA, AAMI, EN, BSI, DS, EVS, etc.  Most of these are released "as is" meaning there are no changes between the national version and the ISO version.  If there are Annex 'Z' for the European Norm (EN) version, this usually means there is clarification or additional requirements which are related to the regulations.  Harmonised standards for the EU MDD and EU MDR ... no comment on that except it is not working and would not rely on that - there are plenty of other discussions in the forum regarding this topic of harmonised list in the EU framework.

Hi community,

I am seeking for some expertise related to harmonized standards in EU. I am wondering why there is an EN version for ISO 8536-4 (EN ISO 8536-4:2020) but when I look into the standard content, there is no Annex Z correlating clauses of the standard with any specific EU regulation. In addition, this standard is not even listed in the MDD standards harmonized list or the MDR standards harmonized list. What are the implications of an EN adopted standard that is not harmonized and does not correlate to any EU regulation?

Thanks,

Luis

Hi community,

I am seeking for some expertise related to harmonized standards in EU. I am wondering why there is an EN version for ISO 8536-4 (EN ISO 8536-4:2020) but when I look into the standard content, there is no Annex Z correlating clauses of the standard with any specific EU regulation. In addition, this standard is not even listed in the MDD standards harmonized list or the MDR standards harmonized list. What are the implications of an EN adopted standard that is not harmonized and does not correlate to any EU regulation?

Thanks,

Luis

In the EU, there is multi-step process around standards.

The EU has three major standards bodies (CEN, CENELEC, and ETSI) which either write standards or adopt them from international standards bodies. Consider CEN as an example, CENELEC is a little different.

In the case of the standard you mention, there is an international standard, ISO 8536-4:2019. CEN has adopted it as an EU standard and designated it EN ISO 8536-4:2020. CEN is made up of the standards bodies in the Member States, each of which will adopt the CEN standards. For example, the Estonian standard is EVS-EN ISO 8536-4:2020.

The other path is that CEN could write a standard instead of adopting an international standard. Consider, for example, EN 13485:2023 which is a standard about thermometers. Notice that the prefix doesn't include ISO, which says that this standard is not from an international standard.

Harmonization is a different process. It starts with a request from the Commission to the standards bodies to write a harmonized version of an EN standard. The request specifies the regulation or directive for harmonization.

If the standards body accepts the request, it will start by determining how the clauses of the standard support the Annex I requirements in the regulation or directive. After some rounds of review the standards body will publish the standard with the Z annexes and, at some point, the Commission will add it to the list of Harmonized Standards.

The EU has many standards that are not harmonized, primarily because they don't have specific application to a directive or regulation. Consider EN 13485:2023.

In the case of EN ISO 8536-4:2020, the Commission has, probably, not made the harmonization request, but determining the reason is not easy.

Hi community,

I am seeking for some expertise related to harmonized standards in EU. I am wondering why there is an EN version for ISO 8536-4 (EN ISO 8536-4:2020) but when I look into the standard content, there is no Annex Z correlating clauses of the standard with any specific EU regulation. In addition, this standard is not even listed in the MDD standards harmonized list or the MDR standards harmonized list. What are the implications of an EN adopted standard that is not harmonized and does not correlate to any EU regulation?

Thanks,

Luis

In the EU, there is multi-step process around standards.

The EU has three major standards bodies (CEN, CENELEC, and ETSI) which either write standards or adopt them from international standards bodies. Consider CEN as an example, CENELEC is a little different.

In the case of the standard you mention, there is an international standard, ISO 8536-4:2019. CEN has adopted it as an EU standard and designated it EN ISO 8536-4:2020. CEN is made up of the standards bodies in the Member States, each of which will adopt the CEN standards. For example, the Estonian standard is EVS-EN ISO 8536-4:2020.

The other path is that CEN could write a standard instead of adopting an international standard. Consider, for example, EN 13485:2023 which is a standard about thermometers. Notice that the prefix doesn't include ISO, which says that this standard is not from an international standard.

Harmonization is a different process. It starts with a request from the Commission to the standards bodies to write a harmonized version of an EN standard. The request specifies the regulation or directive for harmonization.

If the standards body accepts the request, it will start by determining how the clauses of the standard support the Annex I requirements in the regulation or directive. After some rounds of review the standards body will publish the standard with the Z annexes and, at some point, the Commission will add it to the list of Harmonized Standards.

The EU has many standards that are not harmonized, primarily because they don't have specific application to a directive or regulation. Consider EN 13485:2023.

In the case of EN ISO 8536-4:2020, the Commission has, probably, not made the harmonization request, but determining the reason is not easy.

Hi community,

I am seeking for some expertise related to harmonized standards in EU. I am wondering why there is an EN version for ISO 8536-4 (EN ISO 8536-4:2020) but when I look into the standard content, there is no Annex Z correlating clauses of the standard with any specific EU regulation. In addition, this standard is not even listed in the MDD standards harmonized list or the MDR standards harmonized list. What are the implications of an EN adopted standard that is not harmonized and does not correlate to any EU regulation?

Thanks,

Luis

Dan,

Thanks for this thorough and detailed response. The matter is clear to me now. I was mixing "adoption" with "harmonization" and thought that adopting a standard was made solely for harmonization purposes, but it looks like this is not the case.

Dan, let me ask you one more thing. In cases like this where we identify an adopted standard with no changes from the original version, does it really make a difference to call out the EN version in EU documents (let's say a verification report, an ERC or a GSPR checklist)? In other words, do NBs really look to see EN standards even when they are the same as the original standard?

Thanks!

In the EU, there is multi-step process around standards.

The EU has three major standards bodies (CEN, CENELEC, and ETSI) which either write standards or adopt them from international standards bodies. Consider CEN as an example, CENELEC is a little different.

In the case of the standard you mention, there is an international standard, ISO 8536-4:2019. CEN has adopted it as an EU standard and designated it EN ISO 8536-4:2020. CEN is made up of the standards bodies in the Member States, each of which will adopt the CEN standards. For example, the Estonian standard is EVS-EN ISO 8536-4:2020.

The other path is that CEN could write a standard instead of adopting an international standard. Consider, for example, EN 13485:2023 which is a standard about thermometers. Notice that the prefix doesn't include ISO, which says that this standard is not from an international standard.

Harmonization is a different process. It starts with a request from the Commission to the standards bodies to write a harmonized version of an EN standard. The request specifies the regulation or directive for harmonization.

If the standards body accepts the request, it will start by determining how the clauses of the standard support the Annex I requirements in the regulation or directive. After some rounds of review the standards body will publish the standard with the Z annexes and, at some point, the Commission will add it to the list of Harmonized Standards.

The EU has many standards that are not harmonized, primarily because they don't have specific application to a directive or regulation. Consider EN 13485:2023.

In the case of EN ISO 8536-4:2020, the Commission has, probably, not made the harmonization request, but determining the reason is not easy.

Hi community,

I am seeking for some expertise related to harmonized standards in EU. I am wondering why there is an EN version for ISO 8536-4 (EN ISO 8536-4:2020) but when I look into the standard content, there is no Annex Z correlating clauses of the standard with any specific EU regulation. In addition, this standard is not even listed in the MDD standards harmonized list or the MDR standards harmonized list. What are the implications of an EN adopted standard that is not harmonized and does not correlate to any EU regulation?

Thanks,

Luis

Hi community,

I am seeking for some expertise related to harmonized standards in EU. I am wondering why there is an EN version for ISO 8536-4 (EN ISO 8536-4:2020) but when I look into the standard content, there is no Annex Z correlating clauses of the standard with any specific EU regulation. In addition, this standard is not even listed in the MDD standards harmonized list or the MDR standards harmonized list. What are the implications of an EN adopted standard that is not harmonized and does not correlate to any EU regulation?

Thanks,

Luis

Hi community,

I am seeking for some expertise related to harmonized standards in EU. I am wondering why there is an EN version for ISO 8536-4 (EN ISO 8536-4:2020) but when I look into the standard content, there is no Annex Z correlating clauses of the standard with any specific EU regulation. In addition, this standard is not even listed in the MDD standards harmonized list or the MDR standards harmonized list. What are the implications of an EN adopted standard that is not harmonized and does not correlate to any EU regulation?

Thanks,

Luis