Specialist Task Force 279:

Review and Revision of Harmonised Standards prepared by ETSI under the R&TTE Directive. 

Team Leader: Kevin Mylan
Team Members: Chris Cant
 Barry Cartman

What we do:

Individual technical bodies will need to identify or generate appropriate work items if it is agreed that an harmonised standard that they are responsible for needs to be updated TC-ERM will need to provide an appropriate work item for the revision of the ETSI Guide (EG 201 399)

Read our Terms of Reference

Why we do it:

The report from RTTE#24 to OCG#23 noted that concern has been expressed by some TCAM Administrations (and by the R&TTE CA to TCAM) that not all of ETSI’s harmonised standards published in the Official Journal follow a common format and in some cases there is a lack of consistency.

The conclusions from TCAM#16 are given below with extracts from some of the original TCAM documents, additionally further information from TCAM is provided in Appendixes A and B to this document. (TCAM is a Member States’ committee chaired by the Commission under the R&TTE Directive)

Extract from - TCAM 16 (04) 2 Rev. 1 - Draft minutes of the fifteenth meeting of the TCAM Committee 23-24 March 2004:

1. Italy introduced the matter, seeking clarity on the status of radio test suites in harmonised standards. They considered that some of these test suites, where not “essential test suites” in the sense of annex III of the Directive.
2. The chairman saw the need to clarify the provisions of the Directive. There are “essential requirements” for which the harmonised standard prescribes that one needs to perform “essential radio test suites”. For other essential requirements, conformity can be proven through other means. Standards thus shouldn’t confuse the reader by suggesting that also for the last group there would be an obligation to use the standardised test suite.
3. Mr. de Brito (ETSI) confirmed that internal guidelines in ETSI seek to avoid these problems, but there may be individual standards, for which this guidance wasn’t followed. He suggested that the ETSI OCG Steering Committee would look into the matter and seek resolution.
4. It then was agreed that ETSI should analyse the matter and report on this issue in TCAM 16 or 17 (Action 11).

Extract from TCAM 15 (05) 104 Rev. 1 - Harmonised Standards, Essential Requirements (Italy) – (Lack of Coherence in Harmonised Standards)
The RTTE Directive offers manufacturers the opportunity to place goods on the market in a simple, straightforward way without delay. In particular, the conformity assessment procedure is facilitated by the ongoing production and maintenance of harmonised standards. From the point of view of manufacturers, the value and object of harmonised standards is the clear definition of how and what to do to ensure compliance with the essential requirements (the so-called “presumption of conformity”).

A harmonised standard is based on a clear and simple proforma. One section is generally headed “Testing for compliance with technical requirements” and this usually includes clauses entitled: “essential radio test suites” and, if needed, “other radio test suites” (or similar).

A precise definition of “essential radio test suites” is not included in the section “Definitions, symbols and abbreviations” but a general reference to the terminology used in the directive is made in the clause “Definitions” with the sentence “For the purposes of the present document, the terms and definitions given in the R&TTE Directive and in EN [number] apply”

Considering the RTTE directive and the terminology usually adopted, the "essential radio test suite" could be considered as the minimum set of tests needed for the presumption of conformity to the relevant essential requirement. However, various ETSI EN 30X XXXs, incorporate an Annex A (normative) setting out “The EN Requirements Table (EN-RT)”. The table identifies the status of the various requirements as mandatory or not. The concern is that there is an unfortunate lack of coherence between the essential radio test suites identified in the clause entitled “essential radio test suite” and the requirements marked as mandatory in Annex A.

In fact, the list in Annex A often includes items described both in the “essential radio test suites” clause and the “other test specifications” clause (or part of it). The confusion caused by this is exaggerated because ETSI grants rights to freely reproduce the proforma table from Annex A of the harmonised standard but not the “essential radio test suites” (which, some might argue, should take precedence by virtue of being in the main body text).

Notwithstanding the provisions of the copyright clause related to the text of the present document, ETSI grants that users of the present document may freely reproduce the EN-RT proforma in this annex so that it can be used for its intended purposes and may further publish the completed EN-RT.
Annex A is often identified as “normative” and includes the statement “These EN-Rs are justified under Article 3.2 of the R&TTE Directive”.

A clear interpretation of the standard is not possible because:

on one hand: if the statement in annex A “These EN-Rs are justified under Article 3.2 of the R&TTE Directive” is considered legally sound, then the clause “essential radio test suites” has no meaning where it is inconsistent with the list in Annex A;

on the other: if the meaning of “essential radio test suites” is to identify the minimum set of tests to be done to assure the conformity to the relevant essential requirement, then the sentence in annex A “These EN-Rs are justified under Article 3.2 of the R&TTE Directive” has no meaning where it is inconsistent with the clause “essential radio test suites”.

This lack of coherence creates many misunderstandings:

• Manufacturers, in the absence of a unique interpretation may ask for an opinion from a Notified Body (although not obligatory) and risk different interpretations from different Notified Bodies.
  
  
• In case of testing for market surveillance there is the real risk that Market Surveillance Authority takes action against a manufacturer for a not well defined non conformance.

A clear and unique interpretation is needed.

Some examples of lack of coherence and different use of Annex A are annexed.

Extract Ends

The examples identified above are included as Appendices A and B to this Document. The text from the Italian administration reflects the concerns expressed by the R&TTE Compliance Association (Notified bodies and test houses) and the discussion at the TCAM Administrative Co-operation Group (ADCO).


Extract from ETSI/OCG23(04)R&TTE - R&TTE Steering Committee Report to OCG#23 also published as TCAM 16 (05) 53

RTTE#24 agreed that ETSI should undertake a number of actions – essentially a review of its harmonised standards and its internal guidelines.

Essentially a review would comprise:

• Re-looking at the ETSI Guide (EG 201 399) and the proforma for harmonised standards (SR 001 470) and revising both documents as necessary.
  
  
• Reviewing the existing ETSI harmonised standards based on any revision of the guidance documents in order to improve the quality and consistency of the ETSI product. This review should initially consider the specific cases that were raised in TCAM.

Other Aspects:

• Member States have requested that all Harmonised Standards should have an Annex with a ‘Requirements Table’. The existing ‘Requirements Table’ in the ETSI guidelines was based on the model of the old TBR - requirements table and is unnecessarily complex. It was agreed that the simplified table identified under 89/336/EEC (EMC Directive) should be used.
• Notified Bodies had recommended that the essential radio test suites should also be referred to in the Harmonised Standard’s ‘Requirements Table’. It was agreed to include this feature in the above revision.
• A common format for the ‘Requirements Table’ should be agreed and then applied across all of ETSI’s harmonised standards irrespective of the source technical body - to provide for a better understanding and product consistency.
• The Harmonised standard proforma SR 001 470, also needs to be updated to include the requirement to translate the titles into the new official languages of the European Union.
• The RTTE Steering committee has also proposed the inclusion of a check-list for harmonised standards be included in the revised documents.
• References to Articles 3.3e & 3.3f - EN 300 220-3 includes a reference to Articles 3.3e and 3.3f in an informative annex. This standard was one of the original harmonised standards prepared by ETSI under the R&TTE Directive.

The reference in the informative annex was included to indicate that the matter had been considered, in the event that these Articles were to be invoked by a Commission Decision. Experience indicates that this informative annex has caused confusion in the market place and that such references should not be included in future harmonised standards where there is no Commission Decision invoking the Article 3.3 provisions, and the references should be deleted from this document.

Other points noted:
In future all harmonised standards will require an individual mandate from the European Commission, it is hoped that these mandates can be presented for a product family to minimise the overhead.
Type Approval Notices issued by bodies such as the RTTE CA, which have no legal basis under the R&TTE Directive, should be replaced by a notification under Article 5 of the Directive where the legal provision exists.
As noted above a review activity is now anticipated as an essential part of ETSI’s quality process. The review will cover the ETSI guidance documents for the preparation of harmonised standards and identify any revision required of existing ETSI harmonised standards, this latter task to be undertaken on the basis of giving priority to specific standards where concerns have been expressed.

The issue of consistency between all of the ETSI technical bodies’ responsible for the preparation of harmonised standards will be discussed in some depth at the next R&TTE Steering Committee meeting to be held first week in October 2004 in Brussels.

A fundamental requirement is that all ETSI harmonised standards use a common ‘Requirements Table’ irrespective of the source technical body.

Extract from TCAM 15 (04) 100 - Superseded Harmonised Standards
At the last ADCO meeting Italy sought clear guidance on the use of harmonised standards after the date on which they are superseded by a new one.

They asked, whether it would be possible to continue to place products complying with superseded standards and if so under what conditions.

After the date on which a harmonised standard is superseded, products complying with that standard are not further presumed to comply with the Directive. Therefore they could only be placed on the market on the basis of conformity assessment procedures that are to be used when a manufacturer doesn’t use harmonised standards.

In a technical file, the manufacturer can demonstrate compliance with the Directive on the basis of a superseded standard. However, in that case he should demonstrate why, despite the fact that the standard has been superseded, that standard is still appropriate as a basis for declaring compliance. For radio transmitting equipment a notified body needs in addition to be consulted.

Normally however, it shouldn’t be necessary for manufacturers to get into such a situation. The period, in which both the old and the new standard give presumption of conformity, is normally chosen sufficiently long so as not to cause problems for manufacturers.

They are normally long enough to ensure that products assessed under the old standard are not further being produced (normally 3 years) by the date that standard is superseded. Where therefore manufacturers use the latest harmonised standard when they first bring a model to the market, they should never get into difficulties.

The Commission Services always recommend manufacturers to use revised standards for all newly produced models. We understand that Member States do the same.

Section 4.5 of the guide to the implementation of Directives based on the New Approach and the global Approach provides further information on the matter.

Conclusion

From the above it follows that (X is the old standard which is superseded on date D by standard Y):

• Each individual apparatus placed on the market before D will enjoy presumption of conformity if they comply either with standard "X" or standard "Y".
• Each individual apparatus placed on the market after D will enjoy presumption of conformity only if they comply with standard "Y".
• Each individual apparatus placed on the market after D and complying with standard “X” can only be placed on the market on the basis of a technical file demonstrating directly compliance with the Directive, including where necessary an opinion from a Notified Body.

Extract ends

Time plan for the work:

February 2005 - Report the R&TTE Steering Committee and all concerned technical bodies on a) the current status of ETSI’s harmonised standards in terms of their compliance with the existing Guide and b) consistency across the range of responsible ETSI technical bodies.

February 2005 - Report to the R&TTE Steering Committee and all concerned technical bodies on an information basis as a set of recommendations for updating the proforma for harmonised standards (SR 001 470).

March 2005 - Report to TC-ERM as a set of recommendations for updating the ETSI Guide (EG 201 399) and all concerned technical bodies on an information basis.

May 2005 - Revision of the ETSI Guide (EG 201 399), for submission to TC-ERM and all concerned technical bodies on an information basis.

May 2005 - Revision of the proforma for harmonised standards (SR 001 470), for submission to the R&TTE Steering Committee document and all concerned technical bodies on an information basis.

June 2005 - Revision of specific harmonised standards, where concerns have been raised in TCAM, and the presentation of drafts to the relevant technical body for consideration.
 

How to contact us:

If you would like more information or to collaborate with the STF, please contact the STF Leader: kevin.mylan@hmgovernment.org.uk
 

Last updated: 2010-02-18 10:21:45