New EMC (2014/30/UE) Ursula Zanichelli

Transcription

1 New EMC (2014/30/UE) Ursula Zanichelli Milan, 1 April 2016

2 Summary Scope Structure A look into the chapters Harmonized standards Technical documentation Declaration of Conformity 2

3 Scope Does not apply to custom built evaluation kits destined for professionals to be used solely at research and developement facilities New RED 2014/53/EU has scope changes affecting EMC Directive: Broadcast receivers move from EMC to RED Telecom terminal equipment moves from R&TTE to EMC Transmitters operating <9kHz move from EMC to RED 3

4 Structure Introductory information 6 Chapters, each covering a topic General Provisions Obligations of Economic Operators Same as LVD Conformity of the Equipment Notification of Conformity Assessment Bodies Union Market Surveillance, control of electrical Equipment Entering the Union Market, and Union Safeguard Procedure Same as LVD Committee, Transitional, and Final Provisions Same as LVD Additional 6 informational annexes 4

5 Chapter 1 - New definitions Same new definitions as LVD Others Equipment Apparatus Fixed installation Electromagnetic compatibility Electromagnetic disturbance Immunity Safety purposes Electromagnetic environment 5

6 Chapter 3 - Conformity No substantial changes compared to 2004/108/EC (for manufacturers) Conformity Assessment Procedure: two options Module A Internal production control Module B EU type examination + Module C Conformity of type based on internal production control 6

7 Chapter 3 - Conformity 7

8 Annex II Module A Internal production control EMC assessment and technical documentation (e.g. Harmonized standards) Manufacturing process and monitoring CE marking Declaration of Conformity 8

9 Annex III Module B + Module C EU-type examination (NB) Manufacturer s application (Technical documentation) Technical documentation analisys from NB Internal production control (Manufacturer) Manufacturing process and monitoring CE marking Declaration of Conformity 9

10 Chapter 4 Notification New obligations: renotification required Notified body is a conformity assessment body Manufacturer selects a single Notified Body listed in NANDO database No Notified Body number required for CE marking (no involvement in production control), but name and number required on Declaration of Conformity 10

11 Chapter 4 - Notified Body duties NB monitors conformity Changes to state of art (i.e.harmonized standards) Manufacturer informs NB of product modifications NB asks manufacturer for corrective actions if product becomes non-conforming, otherwise suspends or withdraws certificate NB informs Notifying Authority of: Certificates issued or withdrawn Refusal, restriction, suspension or withdrawal of certificates Changes to their notified scope or status Subcontracting (on request) Request for information by Market Surveillance Authorities NB informs other Notified Bodies of: Refusal, restriction, suspension or withdrawal of a certificate and, on request, positive assessments and additions 11

12 Annexes Annex I - Essential requirements: unchanged Annex II - Internal production control: small changes Annex III -Module B, Module C: similar to old Annex III, but more detailed Annex IV - EU declaration of conformity: changed Annex VI - Correlation Table Correlates between 2004 and 2014 Directives 12

13 Harmonized Standards The EN harmonized standards in the Official Journal don t change as a result of the recast directive, so the technical requirements used previously will remain the same going forward. However, all harmonized standards are regularly updated as they evolve to adapt to new technology. It s the manufacturer s obligation to review the Official Journal on a regular basis and ensure their products remain compliant with the most current revision of the harmonized standards. 13

14 Technical documentation No substantial changes, only risk assessment 14

15 EC declaration - OLD Name and address of the manufacturer or his representative Description of the equipment Reference to harmonized standards Reference to the specifications with which conformity is declared (when necessary) Identification of the signatory (manufacturer or authorized representative) Last two digits of the year of CE marking 15

16 EU declaration - NEW EU DECLARATION OF CONFORMITY (No xxxx *optional*) Model/product type, batch or serial number Name and address of manufacturer or representative «This declaration of conformity is issued under the sole responsibility of the manufacturer» Object of the declaration (i.e. Coloured image) «The object of the declaration described above is in conformity with the relevant Union harmonization legislation» Reference to harmonized standards Where applicable, the notified body s name and number and intervention Additional information: Aigned for and on behalf of: (place and date of issue): (name, function) (signature): 16

17 Grazie! nemko.com/it