EMC Regulatory Requirements: What you need to know for the EU, EAEU & Australia. Dr Alex Martin

Transcription

1 EMC Regulatory Requirements: What you need to know for the EU, EAEU & Australia Dr Alex Martin C&R Webinar, 29 May 2018

2 Agenda What is EMC? Why has EMC legislation been introduced? The 2014 EU EMC Directive. The 2011 EAEU EMC Technical Regulation. The 2017 Australian Radiocommunications Labelling (EMC) Notice. Conclusion.

3 RINA Overview Originally established in 1861, RINA is an Italian-owned business active across testing, inspection and certification as well as in engineering consultancy. In recent years it has grown through acquisitions, including Edif ERA (ERA Technology Ltd) in As of 2018, RINA has a global network of 3,700 professionals across 65 countries. At Leatherhead in the UK, RINA s Industry service includes consultancy on technical and environmental regulation affecting electrical and electronic equipment.

4 Product Regulatory Compliance Support with product-related requirements, including: Chemicals Circular Economy Responsible Sourcing Global Market Access

5 What is EMC and why are there laws related to it?

6 IEC Definition of EMC the ability of equipment or a system to function satisfactorily in its electromagnetic environment without introducing intolerable electromagnetic disturbance to anything in that environment

7 IEC Definition of the EME the totality of EM phenomena existing at a given location Any electrical or electronic device creates an electromagnetic environment as electrons are moved around to make the device work. Natural phenomena may also occur in the same location, e.g. lightning. In addition, electrostatic discharge can take place even when a device or system is not in its normal functioning mode.

8 Additional Terms Emission: the generation and release into the environment of electromagnetic energy by a specified source, whether deliberate or accidental. Susceptibility: the tendency of electrical equipment ( the victim ) to malfunction or break down in the presence of unwanted emissions electromagnetic interference. Immunity: the opposite of susceptibility, meaning the ability of electrical equipment to function correctly in the presence of electromagnetic interference (it is hardened to it). Coupling: the means (pathways) by which emitted interference reaches the victim.

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15 Key Points EMC is the control of electromagnetic interference so that unwanted effects are prevented. Different legislatures around the world have adopted EMC laws in light of recognising the risks posed by electromagnetic interference; the intent of the legislation is to reduce the risks such that they are tolerable (it is unlikely the risks will ever be completely eliminated). The laws vary, but generally entail characterising the threat before specifying requirements regarding emissions and susceptibility/immunity. For equipment manufacturers, regulatory compliance is likely to entail one or more of: quietening noise; inhibiting coupling paths; and hardening potential victims (e.g. via use of grounding/shielding).

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17 The EU EMC Directive (2014/30/EU)

18 Scope and Definitions The Directive applies to equipment meaning apparatus and fixed installations. The law applies when equipment is both placed on the market and put into service. There are exclusions, including for radio equipment, aeronautical products, inherently benign equipment, and custom built evaluation kits. As a law aligned with the New Legislative Framework, the Directive specifies obligations for various economic operators : Manufacturers; Authorised Representatives; Importers; Distributers.

19 Essential Requirements There are general and specific essential requirements. The general requirements are that equipment is to be designed and manufactured so that: The electromagnetic disturbance generated does not exceed the level above which radio and telecommunications equipment or other equipment cannot operate as intended; and It has a level of immunity to the electromagnetic disturbance to be expected in its intended use which allows it to operate without unacceptable degradation of its intended use. More specifically, fixed installations are to be installed applying good engineering practices and respecting the information on the intended use of its components, with a view to meeting the [general] essential requirements.

20 The Presumption of Conformity The Directive offers a presumption of conformity meaning that if in-scope equipment adheres to relevant harmonised standards (EN standards) then the equipment will be considered in compliance with essential requirements. There are a large number of harmonised standards, the listing of which is found on the European Commission s EMC webpages (DG GROW, Single Market). The listing pertains to product groups, e.g. EN Electrical equipment for measurement, control and laboratory use EMC requirements Part 1: General requirements; EN Electrical equipment for measurement, control and laboratory use EMC requirements Part 2-1: Particular requirements Test configurations, operational conditions and performance criteria for sensitive test and measurement equipment for EMC unprotected applications.

21 Manufacturer Obligations Carry out relevant conformity assessment procedure. Draw up technical documentation: (a) general description, (b) conceptual design and manufacturing drawings, (c) relevant descriptions and explanations, (d) list of harmonised standards applied, (e) results of design calculations, and (f) test reports. Plus an adequate analysis and assessment of the risk(s). Draw up a Declaration of Conformity. Affix the CE marking. Provide for traceability. Keep a register of non-conforming equipment and product recalls. Be prepared to take corrective actions.

22 European Commission Guide to the EMC Directive Section Scope Essential requirements Economic operator obligations Apparatus conformity assessment procedure Fixed installations Market surveillance Guidance divided between three subsections: general, defining the scope of apparatus, and defining the scope of fixed installations. Presents an overview of mandatory requirements. Not present. Gives information including the usual steps of an EMC assessment, information and documentation requirements. Guidance spans relevant requirements and documentation. Comment also made on the use of apparatus in fixed installations. Gives information on the duties of authorities; specific comment regarding the use of apparatus at trade fairs. New guidance related to placing on the market/putting into service, equipment and products. Jammers case study is also new. Also presents an overview of mandatory requirements. Newly introduced in light of the Directive now referring to such obligations. Largely the same content, although new guidance is introduced pertaining to risk analyses and assessment. Similarly, information on identification is new. No change from Very similar to 2010, although the use of apparatus at trade fairs comment is removed.

23 The EAEU EMC Technical Regulation (TR CU 020/2011)

24 Scope and Definitions The Regulation applies to technical means that can cause electromagnetic interference, and/or quality of operation which depends on the influence of external electromagnetic interference. The application pertains to making technical means available for circulation. Technical means is any electrical, electronic and radio-electronic product, as well as any products containing electrical and/or electronic components, which can be categorized as a component unit and installation. Like the EU EMC Directive, there are exclusions, e.g. for technical means passive with respect to electromagnetic compatibility. Annex 1 gives a list. Obligations fall upon manufacturers, authorised representatives and importers. No obligations fall upon distributors, however.

25 EMC Requirements The law requires that technical means should be designed and manufactured in such a way that: Any electromagnetic interference generated does not affect communications and other equipment; Equipment has a level of immunity to electromagnetic interference (noise) such that it can operate in the electromagnetic environment as intended. Annex 2 of the Regulation lists types of electromagnetic interference spanning the likes of low-frequency conductive electromagnetic interference (e.g. power supply voltage fluctuation) through to electrostatic discharges. The EMC requirements are to be met either directly or through use of standards, which is voluntary. Relevant standards are listed in the Regulation; they are mainly GOST R versions of CISPR/IEC standards.

26 Manufacturer Obligations - 1 Carry out relevant conformity assessment procedure. This is not a matter of self-certification but entails working with an EAEU accredited test house and obtaining either an EAC Declaration or Certificate of Conformity. Obtaining a Certificate is mandatory in the case of household appliances, personal computers and peripherals, electric tools and electronic musical instruments. The process is likely to entail submission of internal audit reports and test reports while copies of the required operational documents will be expected. Third party factory audit and sample testing of equipment may be expected too. Applicants for either an EAC Declaration or Certificate of Conformity must be a legal entity registered in an EAEU Member State (RU, AM, BY, KZ, KGZ).

27 Manufacturer Obligations - 2 Affix the EAC marking to the equipment, maybe also on packaging and in instructions. Label the equipment with a name and/or designation (e.g. type, brand, model); its main features and characteristics; the name of the manufacturer; and the name of the country of manufacture. This information is also to go in accompanying operational documents. Label the equipment packaging with the manufacturer s name and/or trademark as well as the equipment name and/or designation (type, brand, model, etc.). Provide accompanying operational documents that, in addition to equipment designation/manufacturer information, give information on: installation; safe use and any usage restrictions; relevant storage, delivery, marketing and disposal requirements; location, month and year of manufacture; how to determine the year of manufacture. Operational documents must be hard (paper) copies and in Russian and other, relevant EAEU Member State languages.

28 The Australian Radiocommunications Labelling (EMC) Notice 2017

29 Scope and Definitions The Notice applies to devices [undefined] that pose a risk of causing an interference impact on other devices that use the radiofrequency spectrum. Devices are of high, medium or low risk. High-risk refers to Group 2 ISM equipment that entails the intentional use of electromagnetic radiation for the treatment of material, e.g. a microwave oven. Medium-risk may have an interference impact if operated in contravention of an applicable standard, e.g. DECT device. Low-risk, as medium-risk but the interference impact is low, e.g. a garage door control. Requirements apply when devices are supplied. Supply is broadly defined and can include the lending of a device to another person. Obligations fall upon suppliers, meaning Australian based device importers and/or manufacturers (or their authorised representatives, agents ).

30 Supplier Requirements (medium- to high-risk devices) Register with the regulatory authority, ACMA. Prepare compliance records. These span the following: A method of uniquely identifying the device (brochure, manual, etc.); A signed Australian Supplier s Declaration of Conformity; A complete copy of an EMC test report to the relevant standard, in English; A technical construction file [defined in the Notice]. Affix the Regulatory Compliance Mark (RCM) to the device. Significantly, EMC standards are mandatory although ACMA does not specify which of these standards must be used for any given device it is up to the supplier to choose, likely in tandem with a test house (the supplier should be able to justify their choice).

31 In Conclusion

32 Same Risk, Different Regulatory Requirements Countries may work together on international standards regarding EMC, but regional/national regulatory regimes can and do differ: Standards are normally voluntary but can be mandatory while some may additionally confer a presumption of conformity when used; Conformity assessment may be via self-certification or necessitate using a suitably accredited certification body (test house); Business registration may be a necessity; Different compliance markings arise, etc. etc. It is important to research and understand the EMC (plus product safety and environmental) legislation that applies in all the countries that you distribute and sell in. If not technically, then administratively requirements differ. Do not assume that, for example, an EU Declaration of Conformity and supporting technical documentation will be accepted elsewhere in the world.

33 Sources & Further Information RINA Product Regulatory Compliance Team. Compliance & Risks C2P. European Commission (DG GROW). Eurasian Economic Commission (Technical Regulation & Accreditation Department). Australian Communications and Media Authority.

34 --- Electrical & Electronic Equipment and the Environment - Meeting the technical and regulatory compliance challenges Dr Alex Martin Product Regulatory Compliance +44 (0) alex.martin@rina.org November 2018, Heathrow