New EMC directive (2014/30/UE)
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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”
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Medical Devices Postmarket Surveillance in Europe updated
Medical Device Postmarket Surveillance and Clinical Follow-up under the proposed European Medical Device Regulation updated according to the latest amendments.
Clinical evaluations and impact of the new Regulations y R. Higgins MHRA ( Qs...
Clinical evaluations and impact of the new Regulations y R. Higgins MHRA ( Qs...qserveconference2013
The document discusses proposed regulations for clinical evaluations and investigations of medical devices in the EU. It notes concerns about how notified bodies have assessed clinical data and challenges manufacturers to provide sufficient clinical evidence. New rules would require clinical investigations for implantable devices and class III devices, with equivalence not sufficient justification to avoid investigations. Notified bodies would be expected to thoroughly review clinical data and ensure studies are completed before certification. Clinical investigations in the EU would involve a single application process and oversight by member states.Economic operators and post market surveillance under the proposed EU medicin...
The document discusses new post-market surveillance and vigilance obligations for economic operators in the medical device supply chain under revisions to the Medical Device Directive. It defines roles for manufacturers, authorized representatives, importers, and distributors, assigning responsibilities to ensure device quality and safety at each stage. These include oversight of conformity assessments, labeling, reporting issues and recalls. Concerns are raised about overlapping responsibilities adding burden without benefit. Clear definition and allocation of roles is important to avoid catastrophic effects on the supply chain.
Postmarket Surveillance Medical Devices
Author:Susan Gardner, PhD
Director, Office of Surveillance and Biometrics, CDRH
FDLI Annual Meeting 4/08/05
Materiovigilance programme of india by akhilesh sachan
The Materiovigilance Programme of India (MvPI) was launched in 2015 to study incidents related to medical devices and ensure patient safety. It allows dangerous devices to be removed from the market and defects to be addressed. The MvPI collects reports of device malfunctions, defects, or other issues directly from healthcare professionals and the public. It is coordinated by the Indian Pharmacopoeia Commission and Sree Chitra Tirunal Institute of Medical Sciences and Technology, with support from the National Health Systems Resource Centre. The program has established guidelines, forms, and monitoring centers to facilitate medical device safety surveillance in India.
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Post Market Clinical Surveillance, Experience of the Industry by S. Menzl - ...
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The document provides an overview of CE marking and EMC regulatory requirements in the EU. It discusses the key directives, conformity assessment procedures, and steps to affixing the CE marking. The CE marking symbolizes a product's compliance with EU directives and allows for free circulation of goods within the EU market. Manufacturers must verify product requirements, test for conformity, document technical files, and affix the marking before placing a product on the EU market. Notified bodies can assist with conformity assessment but are not always required.
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The web page for the European Commission (Enterprise and Industry) states:
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CE marking is a declaration by the manufacturer that a product meets the requirements of the applicable European directives. It allows for free movement of goods within the EU and some non-EU countries. The CE marking must be in the correct format and no smaller than 3mm for small products. While consumers may see CE marking as an indicator of quality, it actually only signifies that a product meets essential safety and regulatory requirements. Technical files must be compiled and maintained by manufacturers to demonstrate a product's compliance through documentation such as standards applied, test reports, and declarations of conformity.
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In this webinar on Certification we are going to explain the various sources of certified data available to Assessors.
Most of these resources have been available since the introduction of BER certification in 2007. While some more experienced Assessors may feel some of the topics should be well known at this point, the purpose of the presentation is to accommodate Assessors of all levels of experience and knowledge.
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9th March 2011: the European Parliament and the European Union Board adopt the Regulation (UE) N.305/2011, published on 4th April 2011 on the European Union Official Gazette and effective 20 days later.
The regulation of building products – the so-called CPR, acronym for Construction Products Regulation – is currently completing its transition period. As from 1st July 2013 it will be fully operating.
Among the innovations comparing to the Directive, we have the definition and use of the declaration of performance (replacing the compliance declaration). The change is not just about the terms, yet it involves a greater completeness and clarity of information matching the product.
Before entering the matter, it’s better to clarify that European EN Standards remains those already operating and issued for CPD Directive purposes.
The Commission will instruct CEN through a task for their revision and adjustment according to the basic requirements, as reported within enclosure no. I of CPR.
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This document summarizes the objectives and contents of an upcoming presentation on ANSI standards for electricity meter testing. The presentation will:
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2) Discuss planned 2015 revisions to C12.20 and 2014 revisions to C12.1.
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The theme of the WSB14 was: "Sustainability. Are we moving as quickly as we should? It is up to us!"
Session 111 (out of 144 sessions) had to answer the question: "Are we moving in the same direction?"
This presentation by CEN-CENELEC standardisation gave an overview of EU's rules, regulations and policies and the role of EN standards with regard to this.
This presentation was one out of the 5 from this session 111. After a questioning, answering and discussion with the audience the session concluded: "No, we are not moving in the same direction!"
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Eu approval of host devices with integrated wireless modules v5
Technological advances and the increased allocation of electromagnetic spectrum for advanced communications have produced a wave of new electronic and digital devices
that communicate wirelessly. As a result, product manufacturers are increasingly abandoning wired communications interfaces in favor of wireless technologies that offer greater user mobility without compromising transmission speed and accuracy. But obtaining worldwide regulatory approval for products with integrated wireless modules is a complex process.
In the European Union (EU), compliance with the essential requirements of the EU’s directive on Radio & Telecommunications Terminal Equipment (also known as the R&TTE Directive) is required for all wireless transmitters, including wireless modules integrated into end host devices. Ensuring compliance with the Directive’s essential requirements is the legal obligation of any party that seeks to import or sell such devices in the EU. However, unlike regulations in the United States that require manufacturers to obtain approval either from the FCC or an FCC-approved telecommunications certification body (TCB), the EU approval process for wireless modules offer manufacturers some flexibility in their chosen method for demonstrating compliance, including the ability to self-declare compliance with the applicable harmonized standards.
This white paper from UL is discusses the key regulatory compliance and approval issues facing manufacturers and importers of host devices with integrated wireless modules. This paper provides information on the regulations regarding the sale of host devices with integrated wireless modules in the EU and guidance on how to efficiently navigate the Union’s regulatory approval process.
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Understand the Relationship of C12.20 to C12.1.
Understand ANSI C12.20 Changes Planned for 2015. Edition and ANSI C12.1 changes planned for 2014.
Understand new ANSI C12.29 for Field Testing and potential time frame.
Discuss – Will this affect how we test in the field?
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Whether the focus is on design/specification, installation or operation/maintenance of building automation and controls, having a strong basis in terms of standardisation is of equal added value.
Further emphasis is given when keeping in mind the overarching role and deep impact of building automation and controls on actual building performance (e.g. energy, environment, indoor environment quality).
This webinar aims to provide a solid foundation for building automation and controls standards and to showcase EN ISO 16484 and EN 15232, relevant for all building professionals.
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Nemko vi offre la possibilità di eseguire i test EMC sui vostri prodotti presso la vostra sede. Avete apparecchiature di grandi dimensioni e/o macchinari industriali oppure con particolari esigenze di funzionamento non trasferibili presso laboratori? Chiedete a Nemko di eseguire i test di cui avete bisogno dove voi volete!
Contattaci per un preventivo: https://www.nemko.com/it/contact
Esempio Dichiarazione Conformità CE
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Direttiva RED - 2014/53/UE
La Direttiva RED 2014/53/UE
Ambito di applicazione
Requisiti essenziali
Operatori economici
Immissione nel mercato
Compiti del Fabbricante
Valutazione della conformità
Documentazione tecnica
Analisi dei rischi
Nemko Direct for Telecom + CB
Nemko offre un programma di grande successo per l'accesso ai mercati di tutto il mondo - Nemko Direct per Telecom. Il servizio è concepito per ottenere l'accesso al mercato mondiale per i vostri prodotti di telecomunicazione wireless.
Questo programma si basa su una rete di rapporti con le autorità di regolamentazione di tutto il mondo. La nostra rete comprende paesi situati nelle Americhe, in Estremo Oriente, Medio Oriente, Africa, Asia, Europa, Europa Orientale e Oceania.
RED vs FCC
Anche per il mercato USA Nord-Americano e Canadese è necessario verificare la compatibilità elettromagnetica (EMC) dei dispositivi di telecomunicazione radio. Le prove e le certificazioni FCC e ISED deve essere condotta presso un Telecommunications Certification Body (TCB).
Come nel mercato Europeo, anche in USA e Canada l’utilizzo dei dispositivi che operano come trasmettitori intenzionali e non, viene regolamentato al fine di evitare interferenze con altre apparecchiature elettroniche o con telecomunicazioni radio. Nemko è in grado di seguirti in tutti gli step del tuo progetto FCC (Federal Communications Commission) e ISED (Innovation, Science and Economic Developmen , nuovo IC – Industry Canada); dalla prima fase prototipale alla certificazione completa.
Radio International
Nemko offre servizi completi adatti a coprire le vostre esigenze specifiche nel settore wireless e delle telecomunicazioni.
Il settore wireless e telecomunicazione è uno dei settori in più rapida crescita delle industrie del nostro tempo. Lo sviluppo delle tecnologie innovative wireless ha portato internet a prodotti che mai prima avevano avuto la connessione wireless. Questo significa che i produttori devono immettere velocemente sul mercato prodotti wireless per tenersi al passo con il cambiamento tecnologico.
I nostri servizi includono:
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Coinvolgere Nemko all’inizio dello sviluppo e progettazione del prodotto, permetterebbe alle aziende di risparmiare tempo e soldi. Il servizio di pre-compliance include: ◦Informazioni su requisiti nazionali e internazionali
◦Interpretazione delle norme
◦Analisi della documentazione e della progettazione del prodotto
◦Test preliminari per facilitare le prove complete sul prodotto e la certificazione
◦Dalla progettazione del prodotto, tutti i processi fino ai requisiti normativi
•Prove su prodotto ◦I laboratori Nemko e la rete di partner mondiale riescono a soddisfare tutti i requisiti di prove sui prodotti elettrici. Il personale Nemko, le attrezzature di prova e gli accreditamenti forniscono un’ampia gamma di servizi di prova.
◦Le prove eseguite da terza parte indipendente implicano la valutazione di conformità da parte di un ente che sia indipendente rispetto al fornitore e anche al cliente.
•Certificazione di prodotto e di sistema ◦Nemko offre un’ampia varietà di certificazioni che dimostrano che una terza parte indipendente riconosciuta a livello internazionale ha verificato la conformità dei prodotti alle norme applicabili.
◦Nemko è membro di numerosi schemi di certificazione nazionali ed internazionali.
◦Oltre alla certificazione di prodotto, Nemko vanta più di 20 anni di esperienza nella certificazione di sistema.
◦Ogni mercato ed ogni settore industriale ha specifiche esigenze e requisiti. I servizi di certificazione Nemko possono soddisfare tali requisiti in accordo alle esigenze del cliente.
•Certificazione Internazionale ◦Nemko vanta una combinazione esclusiva di presenza locale, rete internazionale ed accordi bilaterali. Possiamo garantire che i vostri prodotti accedano ai mercati velocemente.
◦Grazie alla nostra conoscenza in merito alle norme e procedure in più di 150 paesi, possiamo aiutarvi ad ottenere tutta la documentazione necessaria per accedere ad ogni mercato e a tutti i mercati.
RED
Nemko S.p.A. è Organismo Notificato numero 2051 per le seguenti direttive:
DIRETTIVA 2014/53/UE (RED) DEL PARLAMENTO EUROPEO E DEL CONSIGLIO del 9 marzo 1999 Direttiva 1999/5/CE, riguardante le apparecchiature radio e le apparecchiature terminali di telecomunicazione e il reciproco riconoscimento della loro conformità
Radio International
Nemko offre servizi completi adatti a coprire le vostre esigenze specifiche nel settore wireless e delle telecomunicazioni.
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I nostri servizi includono:
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◦Le prove eseguite da terza parte indipendente implicano la valutazione di conformità da parte di un ente che sia indipendente rispetto al fornitore e anche al cliente.
•Certificazione di prodotto e di sistema ◦Nemko offre un’ampia varietà di certificazioni che dimostrano che una terza parte indipendente riconosciuta a livello internazionale ha verificato la conformità dei prodotti alle norme applicabili.
◦Nemko è membro di numerosi schemi di certificazione nazionali ed internazionali.
◦Oltre alla certificazione di prodotto, Nemko vanta più di 20 anni di esperienza nella certificazione di sistema.
◦Ogni mercato ed ogni settore industriale ha specifiche esigenze e requisiti. I servizi di certificazione Nemko possono soddisfare tali requisiti in accordo alle esigenze del cliente.
•Certificazione Internazionale ◦Nemko vanta una combinazione esclusiva di presenza locale, rete internazionale ed accordi bilaterali. Possiamo garantire che i vostri prodotti accedano ai mercati velocemente.
◦Grazie alla nostra conoscenza in merito alle norme e procedure in più di 150 paesi, possiamo aiutarvi ad ottenere tutta la documentazione necessaria per accedere ad ogni mercato e a tutti i mercati.
FCC certification
The document compares the regulatory frameworks for radio equipment in the US (FCC) and EU (RED). It discusses the different legal sources and hierarchy of laws in each system, as well as the equipment authorization procedures of verification, declaration of conformity, and certification. It provides details on the requirements for intentional radiators, mobile and portable devices, and the application process for FCC certification through a TCB. In summary, the document outlines the key similarities and differences between the FCC and RED regulations for radio equipment.
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Questo programma si basa su una rete di rapporti con le autorità di regolamentazione di tutto il mondo. La nostra rete comprende paesi situati nelle Americhe, in Estremo Oriente, Medio Oriente, Africa, Asia, Europa, Europa Orientale e Oceania.
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Ogni martedì pubblichiamo una scheda presentazione su di uno specifico paese: oggi è il turno dell'Arabia Saudita.
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Ogni martedì pubblichiamo una scheda presentazione su di uno specifico paese: oggi è il turno del Sudafrica.
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Ogni martedì pubblichiamo una scheda presentazione su di uno specifico paese: oggi è il turno dell'Ucraina.
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Canada requires certification by the Standard Council of Canada which includes factory inspection and use of the SCC certification logo with no expiration. Certification can be obtained using a CB test report but no in-country testing is needed and the process takes 2-3 weeks.
Canada - ISED
Nemko Italy e il Gruppo Nemko offrono il servizio Nemko Direct for Telecom (ND4T), un programma concepito per ottenere l'accesso al mercato mondiale per tutti i prodotti integranti interfacce di telecomunicazione radio come Wireless, Bluetooth, SRD, RFID. Ad oggi, con il servizio ND4T siamo in grado di accompagnare il cliente nel processo di certificazione di oltre 160 paesi.
Ogni martedì pubblichiamo una scheda presentazione su di uno specifico paese: oggi è il turno del Canada.
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Ogni martedì pubblichiamo una scheda presentazione su di uno specifico paese: oggi è il turno di Israele.
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Ogni martedì pubblichiamo una scheda presentazione su di uno specifico paese: oggi è il turno di Taiwan.
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Nemko Italy e il Gruppo Nemko offrono il servizio Nemko Direct for Telecom (ND4T), un programma concepito per ottenere l'accesso al mercato mondiale per tutti i prodotti integranti interfacce di telecomunicazione radio come Wireless, Bluetooth, SRD, RFID. Ad oggi, con il servizio ND4T siamo in grado di accompagnare il cliente nel processo di certificazione di oltre 160 paesi.
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referred to as the "New Great Game." This research centres on the power struggle, considering
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in Central Asia. This study adheres to the empirical epistemological method and has taken care of
objectivity. This study analyze primary and secondary research documents critically to elaborate role of
china’s geo economic outreach in central Asian countries and its future prospect. China is thriving in trade,
pipeline politics, and winning states, according to this study, thanks to important instruments like the
Shanghai Cooperation Organisation and the Belt and Road Economic Initiative. According to this study,
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governments. This success may be attributed to the effective utilisation of key tools such as the Shanghai
Cooperation Organisation and the Belt and Road Economic Initiative.
A review on techniques and modelling methodologies used for checking electrom...
The proper function of the integrated circuit (IC) in an inhibiting electromagnetic environment has always been a serious concern throughout the decades of revolution in the world of electronics, from disjunct devices to today’s integrated circuit technology, where billions of transistors are combined on a single chip. The automotive industry and smart vehicles in particular, are confronting design issues such as being prone to electromagnetic interference (EMI). Electronic control devices calculate incorrect outputs because of EMI and sensors give misleading values which can prove fatal in case of automotives. In this paper, the authors have non exhaustively tried to review research work concerned with the investigation of EMI in ICs and prediction of this EMI using various modelling methodologies and measurement setups.
Iron and Steel Technology Roadmap - Towards more sustainable steelmaking.pdf
Iron and Steel Technology towards Sustainable Steelmaking
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Harnessing WebAssembly for Real-time Stateless Streaming Pipelines
Traditionally, dealing with real-time data pipelines has involved significant overhead, even for straightforward tasks like data transformation or masking. However, in this talk, we’ll venture into the dynamic realm of WebAssembly (WASM) and discover how it can revolutionize the creation of stateless streaming pipelines within a Kafka (Redpanda) broker. These pipelines are adept at managing low-latency, high-data-volume scenarios.
TIME DIVISION MULTIPLEXING TECHNIQUE FOR COMMUNICATION SYSTEM
Time Division Multiplexing (TDM) is a method of transmitting multiple signals over a single communication channel by dividing the signal into many segments, each having a very short duration of time. These time slots are then allocated to different data streams, allowing multiple signals to share the same transmission medium efficiently. TDM is widely used in telecommunications and data communication systems.
### How TDM Works
1. **Time Slots Allocation**: The core principle of TDM is to assign distinct time slots to each signal. During each time slot, the respective signal is transmitted, and then the process repeats cyclically. For example, if there are four signals to be transmitted, the TDM cycle will divide time into four slots, each assigned to one signal.
2. **Synchronization**: Synchronization is crucial in TDM systems to ensure that the signals are correctly aligned with their respective time slots. Both the transmitter and receiver must be synchronized to avoid any overlap or loss of data. This synchronization is typically maintained by a clock signal that ensures time slots are accurately aligned.
3. **Frame Structure**: TDM data is organized into frames, where each frame consists of a set of time slots. Each frame is repeated at regular intervals, ensuring continuous transmission of data streams. The frame structure helps in managing the data streams and maintaining the synchronization between the transmitter and receiver.
4. **Multiplexer and Demultiplexer**: At the transmitting end, a multiplexer combines multiple input signals into a single composite signal by assigning each signal to a specific time slot. At the receiving end, a demultiplexer separates the composite signal back into individual signals based on their respective time slots.
### Types of TDM
1. **Synchronous TDM**: In synchronous TDM, time slots are pre-assigned to each signal, regardless of whether the signal has data to transmit or not. This can lead to inefficiencies if some time slots remain empty due to the absence of data.
2. **Asynchronous TDM (or Statistical TDM)**: Asynchronous TDM addresses the inefficiencies of synchronous TDM by allocating time slots dynamically based on the presence of data. Time slots are assigned only when there is data to transmit, which optimizes the use of the communication channel.
### Applications of TDM
- **Telecommunications**: TDM is extensively used in telecommunication systems, such as in T1 and E1 lines, where multiple telephone calls are transmitted over a single line by assigning each call to a specific time slot.
- **Digital Audio and Video Broadcasting**: TDM is used in broadcasting systems to transmit multiple audio or video streams over a single channel, ensuring efficient use of bandwidth.
- **Computer Networks**: TDM is used in network protocols and systems to manage the transmission of data from multiple sources over a single network medium.
### Advantages of TDM
- **Efficient Use of Bandwidth**: TDM all
5214-1693458878915-Unit 6 2023 to 2024 academic year assignment (AutoRecovere...
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The smart irrigation system represents an innovative approach to optimize water usage in agricultural and landscaping practices. The integration of cutting-edge technologies, including sensors, actuators, and data analysis, empowers this system to provide accurate monitoring and control of irrigation processes by leveraging real-time environmental conditions. The main objective of a smart irrigation system is to optimize water efficiency, minimize expenses, and foster the adoption of sustainable water management methods. This paper conducts a systematic risk assessment by exploring the key components/assets and their functionalities in the smart irrigation system. The crucial role of sensors in gathering data on soil moisture, weather patterns, and plant well-being is emphasized in this system. These sensors enable intelligent decision-making in irrigation scheduling and water distribution, leading to enhanced water efficiency and sustainable water management practices. Actuators enable automated control of irrigation devices, ensuring precise and targeted water delivery to plants. Additionally, the paper addresses the potential threat and vulnerabilities associated with smart irrigation systems. It discusses limitations of the system, such as power constraints and computational capabilities, and calculates the potential security risks. The paper suggests possible risk treatment methods for effective secure system operation. In conclusion, the paper emphasizes the significant benefits of implementing smart irrigation systems, including improved water conservation, increased crop yield, and reduced environmental impact. Additionally, based on the security analysis conducted, the paper recommends the implementation of countermeasures and security approaches to address vulnerabilities and ensure the integrity and reliability of the system. By incorporating these measures, smart irrigation technology can revolutionize water management practices in agriculture, promoting sustainability, resource efficiency, and safeguarding against potential security threats.
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this notes have been created
by Eric36 at nyamata ttc
after readings
pe book for y2sme .
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New EMC directive (2014/30/UE)
- 1. New EMC (2014/30/UE) Ursula Zanichelli Milan, 1 April 2016
- 2. 01.04.2016 NEW EMC DIRECTIVE2 • Scope • Structure • A look into the chapters • Harmonized standards • Technical documentation • Declaration of Conformity Summary
- 3. 01.04.2016 NEW EMC DIRECTIVE3 • 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 Scope
- 4. 01.04.2016 NEW EMC DIRECTIVE4 • 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 Structure
- 5. 01.04.2016 NEW EMC DIRECTIVE5 • Same new definitions as LVD • Others Equipment Apparatus Fixed installation Electromagnetic compatibility Electromagnetic disturbance Immunity Safety purposes Electromagnetic environment Chapter 1 - New definitions
- 6. 01.04.2016 NEW EMC DIRECTIVE6 • 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” Chapter 3 - Conformity
- 7. 01.04.2016 NEW EMC DIRECTIVE7 Chapter 3 - Conformity
- 8. 01.04.2016 NEW EMC DIRECTIVE8 • EMC assessment and technical documentation (e.g. Harmonized standards) • Manufacturing process and monitoring • CE marking • Declaration of Conformity Annex II Module A – Internal production control
- 9. 01.04.2016 NEW EMC DIRECTIVE9 EU-type examination (NB) Manufacturer’s application (Technical documentation) Technical documentation analisys from NB Annex III Module B + Module C Internal production control (Manufacturer) Manufacturing process and monitoring CE marking Declaration of Conformity
- 10. 01.04.2016 NEW EMC DIRECTIVE10 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
- 11. 01.04.2016 NEW EMC DIRECTIVE11 • 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 Chapter 4 - Notified Body duties
- 12. 01.04.2016 NEW EMC DIRECTIVE12 • 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 Annexes
- 13. 01.04.2016 NEW EMC DIRECTIVE13 • 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. Harmonized Standards
- 14. 01.04.2016 NEW EMC DIRECTIVE14 • No substantial changes, only risk assessment Technical documentation
- 15. 01.04.2016 NEW EMC DIRECTIVE15 • 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 EC declaration - OLD
- 16. 01.04.2016 NEW EMC DIRECTIVE16 • 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): EU declaration - NEW