Harmonized standards

New Approach Directive

Conformity assessment procedures Product complies with all applicable NAD (and EN standards), there are no additional requirements in any member state. The product has free access to the internal market of EC.

Standardisation 1(4)

Harmonised EN standards (the reference numbers are published in Official Journal) are essential tool to implement requirements of NAD. Application of harmonised standards is voluntary.

The European Commission gave the mandate for preparation of harmonised EN standards to following institutions:

CEN

(common standards and standards not in the scope of CENELEC and ETSI),

CENELEC

(electrotehnical standards), and standards).

ETSI

(telecommunication

Standardisation 2(4)

Harmonised standards (EN standards) raise the basic technical requirements for products covered by the NAD.

If the product is designed, constructed and manufactured according to the applicable harmonised EN standards there is presumption that the product complies with the corresponding essential requirements of NAD.

Standardisation 3(4)

EN standards can be used for

“presumption of conformity with essential requirements of NAD”

, when they are published in the Official Journal of European Commission.

The basic distinction between European and harmonised European standards is that harmonised European standards have to be implemented on national level without any changes and publicly announced. It is also a duty of member states to withdraw all national standards which are in contrary with harmonised standards.

Standardisation 4(4)

Implementation of requirements of harmonised EN standards to the product is not obligatory on contrary it is voluntary. However implementation of harmonised standards gives manufacturer a very good (the best) basis for the presumption that product fulfils essential requirements of NAD.

Sometimes harmonised standards do not cover all requirements of NAD. In such cases manufacturer can implement requirements of international standards (IEC, ISO, UTI), national standards or other technical specifications.

Harmonized EN standards 1(6)

• Harmonised standards are European standards, which are adopted by European standards organisations, prepared in accordance with the General Guidelines agreed between the Commission and the European standards organisations, and follow a mandate issued by the Commission after consultation with the Member States .

• Harmonised standards in the meaning of the New Approach are deemed to exist when the European standards organisations formally present to the Commission the European standards elaborated or identified in conformity with the mandate .

Harmonized EN standards 2(6)

The basic distinctions between EN standards and harmonized EN standards: • The reference numbers of harmonized standards are published in the Official Journal of EU.

• Harmonized standards shall be transposed into national standards – without any changes.

• Application of harmonized standards give presumption of conformity with essential requirements of New Approach Directives.

Harmonized EN standards 3(6)

Application of harmonized standards is voluntary, and manufacturers are free to choose any technical solution that provides compliance with the essential requirements of New Approach Directives.

However, the application of requirements in harmonized standards give manufacturers presumption that their products comply with the essential requirements.

Use of harmonized standards is the easiest way for the manufacturer to design products which are in compliance with requirements of the New Approach Directives.

Harmonized EN standards 4(6)

Harmonised EN standards (all EN standards) can be bought only at the national standardization bodies which are members of CEN/CENELEC.

There is no EN standard which can be officially purchased – you can purchase BS EN, DIN EN, SIST EN, …

Harmonized EN standards 5(6)

• • • • Important dates in EN standards:

DOR

is the date when the Technical Board confirms that the results of written vote are positive and that the EN/HD is adopted.

DOA

is fixed by the Technical Board, normally six months later than dor. Normally the announcement of the existence of the new CENELEC EN/ENV/HD is made by each CENELEC member in the official national standards journal or in a similar publication at national level.

DOP

is the date limit for identical/harmonized national standards corresponding to the new EN/HD to be available.

DOW

is the latest date for all CENELEC members to withdraw or amend any national standards containing requirements conflicting with those of the new HD or EN, even if the publication of a new national standard on the basis of an HD is not intended.

Harmonized EN standards 6(6)

EN 60335-1:2002

IEC 60335-1:2001 (IEC 60335-1:2001/Corrigendum Jan.

2002)

Modified CLC/TC 61 IEC/TC 61 LVD MD

Household and similar electrical appliances - Safety -- Part 1: General requirements

NOTE: The parts 2 in the EN 60335 series are to be read in conjunction with the edition of EN 60335-1 indicated for the relevant part 2.

dor : 2002-07-02 doa : 2003-01-01 dop : 2003-07-01

+ A11:2004

CLC/TC 61 LVD MD

dor : 2003-09-23 doa : 2004-04-01 dop : 2004-10-01 dow : 2006-10-01

+ A1:2004

IEC 60335-1:2001/A1:2004

CLC/TC 61 IEC/TC 61 LVD MD //

dor : 2004-09-22 doa : 2005-01-01 dop : 2005-07-01 dow : 2007-10-01

EN 60065:2002

IEC 60065:2001 (corrigendum Aug. 2002)

Modified CLC/TC 108 IEC/TC 108 LVD RTTED

Audio, video and similar electronic apparatus Safety requirements

NOTE: Group Safety Publication

dor : 2002-03-01 doa : 2002-09-01 dop : 2003-03-01 dow : 2007-03-01

New Approach Directives and EN standards 1(7)

• • • • • • • • • • • • Standardization procedure under the New Approach: A mandate is drawn up, following consultation with the Member States.

The mandate is transmitted to European standards organisations.

European standards organisations accept the mandate.

European standards organisations elaborate a (joint) programme.

The technical committee elaborates a draft standard.

European standards organisations and national standards bodies organise a public enquiry.

The technical committee considers comments.

National standards bodies vote/European standards organisations ratify.

European standards organisations transmit references to the Commission.

The Commission publishes the references.

National standards bodies transpose the European standard.

National authorities publish references of national standards.

New Approach Directives and EN standards 2(7)

• The easiest way to find relation between NAD and harmonised standards is to visit internet page where we can find the lists of standards which support specific NAD’s.

• Those lists are not always up-to-date – they are published periodically.

New Approach Directives and EN standards 3(7)

http://www.newapproach.org/Directives/DirectiveList.asp

New Approach Directives and EN standards 4(7)

New Approach Directives and EN standards 5(7)

http://www.cenelec.org/Cenelec/Code/Frameset.aspx

New Approach Directives and EN standards 6(7)

To know which harmonised EN standards can be used for presumption of conformity with NADs is very strong connected with experience and knowledge. There are many products for which you have to apply more than one harmonised EN standard or more than one NAD.

One of possible solutions is to contact Notified Bodies. On the internet pages of EU you can find a “tool” called NANDO which helps you to find appropriate Notified for a specific product: http://europa.eu.int/comm/enterprise/nando is/home/index.cfm.

New Approach Directives and EN standards 7(7)

Harmonized EN standards are tool which can be used by: • Manufacturers: in design phase, final inspection, conformity assessment (Module A – self certification); • Notified Bodies: carrying out conformity assessment procedures; • Market surveillance authorities: carrying out market surveillance activities.

Revision of harmonised standards

• The principles concerning the mandate and the adoption of harmonised standards, their availability, and the presumption of conformity to the essential requirements apply also to the revised version of harmonised standards.

• During the transitional period, both the old and the revised standards give presumption of conformity, provided that the conditions for this are met by both standards.

Flow chart of conformity assessment procedures in Machinery directive

Technical construction file (Annex V) EC declaration of conformity with essential requirements MODULE A Not reffered to in Annex IV Safety component do not bear CE marking MANUFACTURER Type of machines and safety components (Annex IV) Reffered to in Annex IV, and complying with standards Reffered to in Annex IV, without meeting or only partly meeting the standards, or if such standards does not exist EC type examination (Annex VI) MODULE B Type of machines and safety components (Annex IV) Technical file (Annex VI) sent to Notified Body EC declaration of conformity covered by the EC type examination MODULE A Technical file (Annex VI) submitted to NB for certification of adequacy for the file EC type examination (Annex VI) MODULE B

EC Declaration of conformity

The content of EC Declaration of conformity is defined in Annex I B in EMC directive. The elements which shall be on DoC are:  description of the apparatus to which it refers,  reference to the specifications under which conformity is declared, and, where appropriate, to the national measures implemented to ensure the conformity of the apparatus with the provisions of the Directive,  identification of the signatory empowered to bind the manufacturer or his authorized representative,  where appropriate, reference to the EC type-examination certificate issued by a notified body.