Belgrade Serbia November 2010 Jan Coenraads,

Similar documents
THE REGULATORY ENVIRONMENT IN EUROPE

EUROPEAN ACCREDITATION LEGAL FRAMEWORK

New cybersecurity landscape in the EU Sławek Górniak 9. CA-Day, Berlin, 28th November 2017

NIST: Important Considerations for the Certification Body Designating Authority

ITU Asia-Pacific Centres of Excellence Training on Conformity and Interoperability. Session 2: Conformity Assessment Principles

ACCREDITATION: A BRIEFING FOR GOVERNMENTS AND REGULATORS

European Commission Directorate General Enterprise and Industry INSTITUTIONAL FRAMEWORK ON

NIST Designation of CABs: Upcoming Changes for the US and EU Review for Japan

European Standards & Community Specifications

Standardization mandate addressed to CEN, CENELEC and ETSI in the field of Information Society Standardization

Mutual Recognition Agreement/Arrangement: General Introduction, Framework and Benefits

How the European Commission is supporting innovation in mobile health technologies Nordic Mobile Healthcare Technology Congress 2015

European Standards- preparation, approval and role of CEN. Ashok Ganesh Deputy Director - Standards

Standardization and Regulations in the EU/EFTA

Harmonised standards and spectrum regulations

New CEN-CENELEC Technical Committees for Infosec and Data Protection Standardization (TC8) Brussels - 19 September 2017 Alessandro GUARINO Chair,

Mutual Recognition Agreement/Arrangement: General Introduction, Framework and Benefits

Guidelines for Interface Publication Issue 3

Friedrich Smaxwil CEN President. CEN European Committee for Standardization

List of EA Publications. Documents

EC Mandate: Adaptation to climate change use of standards to make key infrastructures more resilient. Ab de Buck/ Caroline van Hoek

Conformity Assessment Schemes and Interoperability Testing (1) Keith Mainwaring ITU Telecommunication Standardization Bureau (TSB) Consultant

Guidelines 4/2018 on the accreditation of certification bodies under Article 43 of the General Data Protection Regulation (2016/679)

CEN and CENELEC Position Paper on the draft regulation ''Cybersecurity Act''

Cybersecurity. Quality. security LED-Modul. basis. Comments by the electrical industry on the EU Cybersecurity Act. manufacturer s declaration

ETSI TCR-TR 006 TECHNICAL COMMITTEE October 1992 REFERENCE TECHNICAL REPORT

Market Surveillance Action Plan

NIST UPDATES TELECOM MRAS

Conformity assessment

THE RADIO EQUIPMENT DIRECTIVE IS COMING IN JUNE 2016 WILL YOU BE READY?

SAS Rules for Accreditation Purposes in the context of Notification - Designation of Conformity Assessment Bodies (CAB)

List of EA Publications. And International. Documents

APLAC Application to Enter the APLAC MRA or to Extend Scope - APLAC MR 003

Market Surveillance Action Plan

ARTICLE 29 DATA PROTECTION WORKING PARTY

Third public workshop of the Amsterdam Group and CODECS European Framework for C-ITS Deployment

Mandate to CEN, CENELEC and ETSI for Standardisation in the field of electric motors

Norme NET 4 Européenne de Télécommunication

INAB Mandatory and Guidance Documents Policy and Index

The Accreditation and Verification Regulation - Verification report

GUIDELINE. of the European Committee for Welding of Railway Vehicles (ECWRV) ( ) PART 1

eias Study on an electronic identification, authentication and signature policy SUPERVISION Presentation on status

Resilience, Deterrence and Defence: Building strong cybersecurity for the EU

Revised November EFESC Handbook

ISO/IEC INTERNATIONAL STANDARD. General requirements for the competence of testing and calibration laboratories

INAB Mandatory and Guidance Documents Policy and Index

Homologation of telecommunication equipment experience in India Vineet Verma Director, Department of Telecom India

Recent developments CEN and CENELEC

ENISA s Position on the NIS Directive

EUROPEAN COMMISSION Enterprise Directorate-General

List of EA Publications. And International. Documents

International Laboratory Accreditation Cooperation. The ILAC Mutual Recognition Arrangement. global trust. Testing Calibration Inspection

Content of mandatory certificates

Solutions that ensure safety, reliability and compliance.

ACCAB. Accreditation Commission For Conformity Assessment Bodies

The emerging EU certification framework: A role for ENISA Dr. Andreas Mitrakas Head of Unit EU Certification Framework Conference Brussels 01/03/18

GUIDELINES ON FEATURES AND TECHNICAL SPECIFICATIONS FOR MOBILE CELLULAR DEVICES IMPORTED INTO AND DISTRIBUTED IN KENYA

IECEE. IEC-ILAC-IAF Tripartite MoU CB-FCS Scheme and Market Control INTERNATIONAL ELECTROTECHNICAL COMMISSION

PEFC Certification System Netherlands - Certification Procedures

EU Code of Conduct on Data Centre Energy Efficiency

The role of Standardization in support of harmonization

MARKET SURVEILLANCE IN SWEDEN

BEST PRACTICE GUIDE for The classification of unforeseen variations

UK-led international standards for BIM

PRESENTATION OVERVIEW

Sources of Test Reports for TUV SUD BABT Product Certification BABT766. TUV SUD BABT is a certification body of. TUV SUD BABT 2015 Issue 7

Minimum Scheme Requirements to Certify Criminal Justice Restraints Described

ACCAB. Accreditation Commission For Conformity Assessment Bodies

USING STANDARDS TO ASSESS THE COMPETENCE OF CONFORMITY

European Standardization

Regulating Cyber: the UK s plans for the NIS Directive

Inspection and Certification for Individual Farms, Smallholder Group Certification S S R A N A S R S C I E N T I S T

Council of the European Union Brussels, 23 November 2016 (OR. en)

OIML-CS PD-08 Edition 1

Committee on the Internal Market and Consumer Protection

Ecodesign compliance, conformity testing and market surveillance Tbilisi, 15 December 2015

Global Specification Protocol for Organisations Certifying to an ISO Standard related to Market, Opinion and Social Research.

Transport Security Standards

Conformity and Interoperability Regime of Telecommunication/ICT equipment in India

International Accreditation Forum, Inc. User Advisory Committee UAC

Guidelines 1/2018 on certification and identifying certification criteria in accordance with Articles 42 and 43 of the Regulation 2016/679

ETSI Introduction. Dr. Carmine Rizzo CISA, CISM, CISSP, ITIL, PRINCE2. ETSI Technical Officer ETSI Standardisation Projects

European Transport Policy: ITS in action ITS Action Plan Directive 2010/40/EU

Cybersecurity Package

ACCREDITATION COMMISSION FOR CONFORMITY ASSESSMENT BODIES. Advisory Document on Tenders For Systems, Processes & Product Certifications

Read Me First for the HP ProCurve Wireless Products - software ver

Technical Report No for the conformity assessment according to the EMC Directive 2004/108/EC

Procedure for the Recognition of Foreign Testing Laboratories

INTERMEDIATE EVALUATION

Third public workshop of the Amsterdam Group and CODECS C-ITS Deployment in Europe: Common Security and Certificate Policy

COMMON REGULATORY OBJECTIVES FOR GSM EQUIPMENT PART 2 SPECIFIC ASPECTS OF GSM EQUIPMENT

ehealth Network ehealth Network Governance model for the ehealth Digital Service Infrastructure during the CEF funding

The European System of Standardization in the Globalized Economy. AFSEC General Assembly Johannesburg, 10 August 2010

COMMERCIAL ELECTRICAL MEDICAL PRODUCTS REGULATORY ACCESS SERVICES. REGULATORY ACCESS SERVICES Safety Brazil.

ETNO Reflection Document on the EC Proposal for a Directive on Network and Information Security (NIS Directive)

COMMISSION IMPLEMENTING DECISION (EU)

Standard Setting and Revision Procedure

European Commission s proposal for a Regulation on Electronic identification and trust services for electronic transactions in the EU internal market

Information technology Security techniques Guidance on the integrated implementation of ISO/IEC and ISO/IEC

Transcription:

EMC Directive 2004/108/EC Standards,, state of the art and laboratory testing Belgrade Serbia November 2010 Jan Coenraads, Secretary ECANB Jan.coenraads@brynyago.com

Relevant Documentation EMC Directive EMCD Guidelines * EMCD Quick Guide * EU Enterprise website (Explanations and Q & A) EU New Approach website (Harmonised Standards) NANDO Notified Bodies information ECANB TGN Technical Guidance Note (on CIRCA) * There may be some mistakes!! * The Guide will be updated after the change of the Directive.

Players at EU level for EMCD Member States Legal/Technical issues ADMINISTRATIVE COOPERATION (ADCO) Market surveillance Authorities ETSI,CEN & CENELEC EMC WORKING PARTY General Policy Issues EU Commission (Chair) NOTIFIED BODIES ECANB Industry associations EC EMC Consultant Mr. Anton Kohling

What is the EMCWP? General Policy Group, chaired by the Commission to discuss any issue related to the EMC Directive, International EMC MRA issues, etc. Meets in general once a year All documents on CIRCA, where all parties concerned (see previous figure) have full access Note: Each NA Directive has a comparable Committee e.g. for the R&TTED it is TCAM.

Can Serbia join the EMCWP? In principle this EMCWP is for the EU Member States but the Commission has indicated that they are willing to consider observer ship for Serbia should they have interest in joining it. Advantage: Important source of information and contact with other authorities and players in the EMCD Field

Players at EU level for EMCD Member States Legal/Technical issues ADMINISTRATIVE COOPERATION (ADCO) Market surveillance Authorities ETSI,CEN & CENELEC EMC WORKING PARTY General Policy Issues EU Commision (Chair) NOTIFIED BODIES ECANB Industry associations EC EMC Consultant Mr. Anton Kohling

EC Contact EMC Directive EC contact point: DG Enterprise & Industry Mr. Pablo Neira Tel. + 32 2 296.70.16 Email contact address for questions: ENTR-RTTE@ec.europa.eu 7

Players at EU level for EMCD Member States Legal/Technical issues ADMINISTRATIVE COOPERATION (ADCO) Market surveillance Authorities ETSI,CEN & CENELEC EMC WORKING PARTY General Policy Issues EU Commission (Chair) NOTIFIED BODIES ECANB Industry associations EC EMC Consultant Mr. Anton Kohling

Items of concern for implementation of the EMC Directive based on previous experience in the Netherlands Note: Already experience with previous EMC Directive Borderline between Directives and relation with borderline between Government Departments What is the Starting point of the national law (what systems are in place and how to create a transitional period for products) Level of (technical) knowledge of inspectors was considered weak and how to improve (budget!). Surveillance shifted more to preventive, requiring inspectors with other capacities and work patterns More need to work together with other MS. No clear guidance from the Commission and the Directive on market surveillance issues. (ADCO was not really active in the beginning)

Items of concern for implementation of the EMC Directive based on previous experience in the Netherlands (2) Testing against HS and essential requirements (Rule: limit can be the guideline but can not be prescribed, especially when no complaints available difficult to handle for inspectors) Real problem was the situation on Fixed Installations (being a typical national regulation). Including borderline between FI s and Large machines. Situation on responsible persons must be legally clear in national legislation otherwise it creates legal uncertainty. Other Directives (e.g. R&TTE) do not have the concept of FI s. Further elements to consider: Do you need Labs and NBs in your country How to use accreditation for NB and how to monitor NB activities How to train inspectors

Items of concern for implementation of the EMC Directive based on previous experience in the Netherlands (2) Further elements to consider: How to organize the border control Which organizations to join and how to get information (EMCWP/CENELEC/ADCO) Which HS to acquire and how to update standards information EMC is basically Radio protection: Are inspectors well aware of that aspect?

Players at EU level for EMCD Member States Legal/Technical issues ADMINISTRATIVE COOPERATION (ADCO) Market surveillance Authorities ETSI, CEN & CENELEC EMC WORKING PARTY General Policy Issues EU Commision (Chair) NOTIFIED BODIES ECANB Industry associations EC EMC Consultant Mr. Anton Kohling

What is ADCO EMC? ADministrative Co-Operation Group Administrative co-operation is an obligation of Member States to ensure together with the EU Commission proper and uniform application of New Approach directives, such as the EMC Directive. Note: Each NA Directive normally has an ADCO

Why do we need such group? Market Surveillance is carried out on a national basis, but there is only one EU Market! Administrative co-operation between national surveillance authorities therefore is necessary and needs to be developed...

Aim of ADCO to increase the efficiency of surveillance; to minimise different surveillance practices; to reduce the overlapping of national surveillance operations; to spread good surveillance practice and techniques across the Community.

Further Background and Activities of ADCO will be covered by presentation of Mr. van Dijk

Can Serbia join ADCO EMC? Advise to contact the Chairman of ADCO EMC to request participation as observer. The Commission will support the participation of Serbia in ADCO if requested. Chairman of ADCO EMC Mr. Gerhard Ludwar (Gerhard( Gerhard.Ludwar@bmwfj.gv.at)

Players at EU level for EMCD Member States Legal/Technical issues ADMINISTRATIVE COOPERATION (ADCO) Market surveillance Authorities ETSI,CEN & CENELEC EMC WORKING PARTY General Policy Issues EU Commision (Chair) NOTIFIED BODIES ECANB Industry associations EC EMC Consultant Mr. Anton Kohling

Harmonised Standards A Technical Specification: 1. Adopted by a Recognised European Standardisation Body 2. Under a mandate from the EU Commission. 3. Accepted in conformity with the procedure of 98/34/EG for the purpose of establishing an European requirement; 4. Reference published in the OJEU.

Latest version of HS list April 2010, Published in OJEU C102 120 HS from 5 HS from (covers only Telecom equipment that is not under the R&TTE Directive) 12 HS from (covers mainly machinery & vehicles)

Participate in Standards work CENELEC is most important organisation. It has 31 Members and 12 Affiliates. One of them being the - Institute for Standardization of Serbia - ISS Most Relevant Technical Committee is CLC TC 210 and its Working Groups. Participation in this TC can give insight information on expected changes to or new Standards that may become HS

Types of Standards Basic Standards contain: Basic test methods & test equipment (no specific limits) Not published in the OJEU Generic Standards: Have generic limits but not specific product operating conditions and can always be applied unless there are: Product or Product Family standards providing specific limits + product test operating conditions (Overrule Generic St)

Incorrect HS MS discovers that a HS does not cover the essential requirements Commission Can also initiate action itself Informs the Standing Committee under 98/34/EC Committee delivers an opinion to the Commission and the EU (mostly after consulting the EMCWP) decides to: a. Not harmonise the Standard; b. Harmonise it with a restriction; c. Contain reference in the OJEU; d. Delete reference in the OJEU.

How does it proceed in reality? MS discovers that existing or proposed HS not covers the essential requirements Informs the Commission. Mostly via the EMCWP The Commission involves CENELEC/CEN/ETSI & Requests update of the Standard A formal legal action is thus avoided and a speedy solution can be achieved.

Players at EU level for EMCD Member States Legal/Technical issues ADMINISTRATIVE COOPERATION (ADCO) Market surveillance Authorities ETSI,CEN & CENELEC EMC WORKING PARTY General Policy Issues EU Commision (Chair) NOTIFIED BODIES ECANB Industry associations EC EMC Consultant Mr. Anton Kohling

What is the ECANB? Note: Most NA Directive have a NB group For EMCD this is the ECANB: European Community Association of EMC Notified Bodies. The ECANB is composed of representatives of the EMC NB, notified under the EMCD, who work with or are involved in conformity assessment procedures. The ECANB has a Technical Secretary and an Administrative Secretariat (CECOFORMA), both funded by the Commission

What is the aim of ECANB? The work of the ECANB must be perfectly transparent: To the EU Commission; This is ensured by means of participation by the EU Commission staff in the meetings of the ECANB and with the help of the records of the meetings; To the Member States; This is ensured by means of the information given by ECANB and/or the EU Commission staff to the working group of government experts under the EMC Directive the EMC Working Party - EMCWP To other groups of NBs; This can be ensured by means of participation of a representative of the ECANB in meetings of other groups of NBs, if appropriate.

Representation in ECANB To play its coordination role the Commission is represented in the ECANB. The Commission shall help the ECANB achieve a better comprehension of the EMCD and to avoid discussions slipping into the legal rather than technical aspects. Representatives of the MS authorities directly responsible for effective implementation of the EMC Directive can be designated to sit in as observers on the ECANB. However, their number should not exceed three (3).

Output of ECANB? Documents drafted (TGN) by the ECANB are submitted for agreement by consensus to EMCWP, after which they will be published on the Public accessible section of CIRCA. Recommendations and associated documents must be understood as giving general guidance to facilitate comprehension and practical implementation of the conformity assessment procedures. They have no legal force.

Current ECANB TGN s TGN 1 Testing of plug-in cards/components in PC s TGN 2 Emission classification of products TGN 8 Inconsistency between levels in basic standards and Generic standards TGN 16 Testing for LAN ports TGN 17 Testing of PLC products TGN 18 QP detector calibration TGN 19 Electric Power Assist Bicycle (EPAC) testing TGN 20 ESD Testing of MP3 Players TGN 21 Lighting Chains TGN 22 Surge testing to EN 61000-4-5 TGN 23 Use of the artificial hand TGN 24 Agricultural/forestry machines/tractors, earth moving & civil engineering machines. TGN 25 Measurement of harmonics TGN 26 Measurement of flicker TGN 27 On site testing of large machines TGN 28 Products modified during testing TGN 29 Railway applications

Players at EU level for EMCD Member States Legal/Technical issues ADMINISTRATIVE COOPERATION (ADCO) Market surveillance Authorities ETSI,CEN & CENELEC EMC WORKING PARTY General Policy Issues EU Commision (Chair) NOTIFIED BODIES ECANB Industry associations EC EMC Consultant Mr. Anton Kohling

EMC Consultant Appointed and funded by CENELEC Supports the Commission in items related to Harmonised Standards, such as checking whether a Standard can be referenced in the OJEU. Example of an action: : Consultant rejected the updated EN 55013 due to the new detector applied not providing adequate/similar protection as the previous used detector.

Link with Radio! The EMC essential requirements are mainly about the protection of radio use. Important to have knowledge about the radio spectrum and its protection. This would involve: R&TTECA ETSI ERO ECC CEPT

R&TTE CA (Compliance Association) AIM: Information exchange Framework for Co-ordination between NB liaise with TCAM, ETSI & RTTE ADCO support for participants in Mutual Recognition Agreements (MRA) co-operation to establish equivalence of interpretation regarding conformity assessment

R&TTE CA (Compliance Association) open to ANY organisation (worldwide) willing to support the aims & objectives and abide by the rules: Notified Bodies, Testing Laboratories, Manufacturers, Administrations, Certification Bodies, Conformity Assessment Bodies, Organisations representing Suppliers or Users Serbian Authority can become member, no restrictions!

CEPT Organisation Important Electronic Communications Committee (ECC) European Radiocommunications Office (ERO)

Information EFIS/ERO Find requirements for use of radio: www.efis.dk Search tables for applications Compare applications between countries www.ero.dk,deliverables, check ECC Recommendations & Decisions Check appendices for implementation

Testing issues For EMCD Testing is not mandatory if other means can also prove compliance, such as: Calculations or design features. Manufacturers can decide to have testing done at: Their own laboratory Accredited 3 rd party Lab Non accredited 3 rd party lab Any other lab (e.g. other manufacturers lab Testing can be done anywhere in the world

No products are excluded from market surveillance operations! Including those subject to: any (voluntary) certification scheme or other voluntary initiatives, an assessment involving a Notified Body.

End of Presentation Thank you for your attention Any QUESTIONS?? 40

Marks Sheets over andere EMC test merken maken