Electromagnetic Compatibility

Guidance Notes on UK Regulations May 1995

Contents

This guide is intended to assist manufacturers and suppliers of electronic and electrical equipment to understand the effect of the Regulations. It is not an authoritative interpretation of the Regulations, which is a matter for the Courts.

The guide seeks to explain the requirements of the Regulations in general terms and does not attempt to address detailed issues. You should refer to the Regulations themselves for a full statement of the requirements. These can be obtained from HMSO Publications Centre, details on page 16.

Electromagnetic Compatibility - the law in brief

From 28 October 1992, under the Electromagnetic Compatibility Regulations 1992, manufacturers of electrical and electronic products covered by the Regulations have the choice until 31 December 1995, of either following the European Community regime described below or continuing to comply with existing national legislation in force on 30 June 1992 in the Member State in which the product is marketed. (See Annex D for UK legislation.)

From 1 January 1996:

Most electrical and electronic products made or sold in the United Kingdom, including imports, must:

be so constructed that they do not cause excessive electromagnetic interference and are not unduly affected by electromagnetic interference;

in the case of certain radio-transmitting equipment, be subject to EC type-examination by a notified body; and

carry CE marking.

in some cases a technical construction file must be drawn up and kept available, generally by the manufacturer, or the importer of a product from a non-European Economic Area (EEA) country.

Failure to comply with these requirements:

will mean that those electrical or electronic products may be prohibited from being placed on the EEA market or imported into the United Kingdom, and withdrawn if previously placed on the market;

could result in penalties comprising imprisonment for a term not exceeding 3 months, or a fine not exceeding £5000, or both.

The EC rules apply everywhere in the EEA, so products complying with these requirements and bearing CE marking may be supplied anywhere in the EEA.

The Regulations are not retrospective; products supplied in the EEA before 28 October 1992 are exempt from the Regulations. However, if the same products continue to be sold after 1 January 1996 they will need to comply with requirements of the Regulations.

This booklet describes the Regulations in more detail. You should, however, consult the Regulations themselves for all provisions which may be relevant.

Free movement of goods

The free movement of goods lies at the heart of achieving an open market for business in Europe.

In May 1985, European Community Ministers agreed on a 'New Approach to Technical Harmonisation and Standards' in order to fulfil this objective.

'New Approach' Directives (in other words Community laws) set out the essential requirements (for safety or protection, for example), written in general terms, which must be met before products may be sold in the United Kingdom or elsewhere in the Community.

European standards, which set out the technical details, are the most common means by which business can meet the 'essential requirements'. The Directives also say how manufacturers are to demonstrate that products meet the 'essential requirements'. Products meeting the requirements carry CE marking, which mean they can be sold anywhere in the Community.

The Electromagnetic Compatibility Directive has also been extended by the European Economic Area (EEA) Agreement which came into force on 1 January 1994. Under the Agreement the provisions of the Directive now apply across the fifteen Member States of the European Community and three states of the European Free Trade Association: Norway, Iceland and Liechtenstein.

The Electromagnetic Compatibility Regulations 1992 (SI 1992/2372) transposed into UK law the Electromagnetic Compatibility Directive (89/336/EEC) and the amending Directive (92/31/EEC) which provided a transition period to 31 December 1995.

The CE Marking Directive (93/68/EEC) amended the marking provisions of a number of Directives, including the Electromagnetic Compatibility Directive (89/336/EEC). The CE Marking Directive entered into force on 1 January 1995, with a transitional period to 1 January 1997 when these new CE marking requirements become mandatory.

The main purpose of the Electromagnetic (Amendment) Regulations 1994 (SI 1994/3080) is to bring the 1992 Regulations into line with the CE marking amendments to the Electromagnetic Compatibility Directive.

The Electromagnetic Compatibility Regulations 1992 - (S.I. 1992/2372)

Entry into force: 28 October 1992

Primary legislation: the European Communities Act 1972

Transitional arrangements: until 31 December 1995 Member States must continue to allow to be placed on the market or to be taken into service apparatus which conforms to the national regulations in force in their territory on 30 June 1992.

Coverage: apparatus liable to cause electromagnetic disturbance or the performance of which is liable to be affected by such disturbance.

'Apparatus' is defined, for the purposes of the Regulations, as an electrical or electronic appliance or system consisting of a finished product or products having an intrinsic function which is intended for the end user, and is supplied or intended for supply or taken into service or intended to be taken into service as a single commercial unit.

'Electromagnetic disturbance' is defined as 'any electromagnetic phenomenon which may degrade the performance of a device, unit of equipment or system. An electromagnetic disturbance may be electromagnetic noise, an unwanted signal or a change to the propagation medium itself'. Thus all electromagnetic frequencies are involved and all electromagnetic phenomena as set out in Annex A of this document and Schedule 2 of the Regulations.

A signal or emission which is a necessary function, or a consequence of the operation, of applicable apparatus shall not be taken to be electromagnetic disturbance under the terms of the EMC Regulations if, in relation to that apparatus, that signal or emission is permitted and does not exceed the limits specified by:

the applicable EMC European harmonized standard; or

a technical report or technical certificate issued by a competent body for the purposes of a technical construction file; or

an EC type-examination certificate issued by a notified body (in the case of radiocommunications transmitting equipment); or

a term, provision or limitation of a licence granted under Section 1 of the 1949 Wireless Telegraphy Act, or regulations made under that section of the Act; or

where the applicable apparatus is an item of radiocommunication transmitting equipment, or apparatus other than wireless telegraphy apparatus which operates by emitting electromagnetic radiation in the radio frequency spectrum, the permitted signal or emission does not exceed the limits specified by regulations made under Section 10 of the 1949 Wireless Telegraphy Act concerning radio frequency spectrum planning or implementation of European Community obligations.

For the purposes of the EMC Regulations the performance of apparatus which must comply is taken to be degraded if any of the following types of interference with its function occur:

permanent, temporary or intermittent total loss of function or significant impairment of function; or

where the apparatus is information storage or retrieval equipment, the destruction or corruption of the information stored therein.

Protection requirements is a reference to the essential requirements, being that apparatus shall be so constructed that:

the electromagnetic disturbance it generates does not exceed a level allowing radio and telecommunications equipment and other relevant apparatus to operate as intended; and

it has a level of intrinsic immunity which is adequate to enable it to operate as intended when it is properly installed and maintained, and used for the purpose intended.

However, nothing stated above shall be taken to require apparatus, which is not specifically designed for use at a given location, to be constructed in such a manner as to satisfy the protection requirements in relation to other apparatus which would not reasonably be expected to be present in its usual electromagnetic environment.

Whether the level of intrinsic immunity is adequate is to be considered having regard to all the circumstances of the case, and in particular to:

the level of performance reasonably expected of that apparatus having regard to its intended function;

any specification for an acceptable level of degradation of performance provided by the manufacturer to the end user;

the consequences of degradation of performance;

provided that nothing shall authorise a level of intrinsic immunity which could permit the operation of the apparatus to be dangerous in any reasonable foreseeable circumstances.

The information required to enable use in accordance with the intended purpose of the relevant apparatus must be contained in the manufacturer's instructions accompanying the apparatus.

Note: The illustrative list of the principal protection requirements is set out in Annex C of this document and Schedule 2 of the Regulations.

Modified application: the definition education and training equipment has been amended in the Electromagnetic Compatibility (Amendment Regulations 1994 (SI 1994/3080) allowing a broader modification of the protection requirements. In future equipment in this category will need to satisfy the following:

it must be accompanied by a declaration stating that the use of the apparatus outside the classroom, laboratory, study area or similar, environment invalidates conformity with the EMC Directive and could lead to prosecution; and

when operated, the equipment does not cause electromagnetic disturbance outside its immediate electromagnetic environment.

The modification above also applies to test apparatus which in the Regulations means any apparatus designed or adapted to generate, or be susceptible to electromagnetic disturbance intentionally for the purposes of conducting tests or measurements relating to an item of electrical or electronic apparatus or any other thing, matter or phenomenon.

General exclusions: the Regulations do not apply to:

apparatus for export to a country outside the EEA, where the supplier believes with reasonable cause that the apparatus will not be used either in the United Kingdom or in another Member State;

excluded installations, as defined in the Regulations, comprising two or more combined items of apparatus or system put together at a given place to fulfil a specific objective, but not designed by the manufacturer(s) for supply as a single functional unit;

spare parts, subject to Regulation 14(2) whereby nothing shall be taken to affect the application of the Regulations to relevant apparatus into which a spare part has been incorporated. In the Regulations, 'spare part' means a component or combination of components intended for use in replacing parts of electrical or electronic apparatus;

supply of apparatus by the manufacture to his authorised representative who is responsible for complying with the Regulations;

second-hand apparatus, with the exception of such apparatus which has, since it was last used, been subjected to further manufacture; and second-hand apparatus which is either supplied or taken into service in the EEA for the first time having previously been supplied or used in a country or territory outside the EEA. Second-hand apparatus means that which has previously been used by an end user. Second-hand apparatus may be covered by the General Product Safety Regulations 1994 (SI 1994/2328). (Contact: Mr R Loughlin, Consumer Safety Unit, Department of Trade and Industry, Room 309, 10-18 Victoria Street, London, SWlH ONN);

electromagnetically benign apparatus the inherent qualities of which are such that neither is it liable to cause, nor is its performance liable to be degraded by, electromagnetic disturbances.

Specific exclusions: the Regulations do not apply to:

apparatus for use in a sealed electromagnetic environment so long as it is accompanied by instructions stating that the apparatus is suitable for use only in a sealed electromagnetic environment;

radio amateur apparatus which is not available commercially, i.e. manufactured in the course of a business;

military equipment which is designed for use as arms, munitions and war material within the meaning of Article 223.1(b) of the Treaty establishing the European Economic Community (notwithstanding it is capable of non-military use). Equipment designed for both military and non-military uses is covered by the Regulations.

Apparatus wholly covered by other Directives: the EMC Regulations do not apply to:

active implantable medical devices, within the meaning given by Article 1.2(c) of Council Directive 90/385/EEC;

Medical devices: within the meaning given by Article 1.2(a) of the Electromagnetic Compatibility (Amendment) Regulations 1994 (SI 1994/3080) which increase the options available to manufacturers of medical devices during the transition period of the Medical Devices Directive (93/42/EEC), and ends on 13 June 1998. The options available are:

to comply with the EMC Directive;

to comply with the Medical Devices Directive;

continue to comply with the Wireless Telegraphy Regulations 1963 (SI 1963/1895) (control of interference from electromedical apparatus), if applicable.

Apparatus partly covered by other Directives: the EMC Regulations do not apply to:

electrical energy meters as regards the immunity thereof (the immunity is regulated by Council Directive 76/89/EEC);

spark-ignition engines of vehicles in so far as the electromagnetic disturbance generated thereby is liable to cause radio interference (such interference is regulated by Council Directive 72/245/EEC);

spark-ignition engines of tractors in so far as the electromagnetic disturbance generated thereby is liable to cause radio interference (such interference is regulated by Council Directive 75/322/EEC, as amended by Article 1of Council Directive 82/890/EEC);

non-automatic weighting instruments as regards the immunity thereof (the immunity is regulated by Council Directive 90/384/EEC);

telecommunications terminal equipment (TTE) to the extent that EMC requirements are determined by Council Directive 91/263/EEC;

GENERAL REQUIREMENTS OF THE REGULATIONS

It is an offence for any person to supply relevant apparatus to an end user which does not conform to the following requirements:

the essential 'protection' requirements;

the conformity assessment requirements (see below);

the affixing of CE marking by the manufacturer or his authorised representative, eg importer; and

the issuing of an EC declaration of conformity (see below).

It is an offence for any person to take relevant apparatus into service unless the apparatus conforms with the protection requirements.

HOW TO COMPLY

Manufacturers should first decide whether their products come under the scope of the Directive. If the answer is 'Yes', they should then decide which of the routes to conformity is most applicable to their products.

Step 1 - Conformity Assessment

There are three routes to compliance through the EMC Regulations:

Standards or self certification route. This is perhaps the simplest route for the manufacturer to follow. A manufacturer chooses a relevant European standard from a list published by the European Commission in the Official Journal, and manufactures his product in accordance with that standard. He completes a declaration of conformity and places the CE marking on his product. (Available for apparatus other than radiocommunication transmitting apparatus).

Technical Construction File route. For apparatus other than radiocommunication transmitting apparatus where there is no applicable harmonised European EMC standard , or where a harmonised standard exists but can only be applied in part. This route requires the manufacturer to prepare a technical file on his apparatus and submit it to a Competent Body for assessment. For further information please refer to the DTI's Guidance Document of the Preparation of a Technical Construction File as required by EC Directive 89/336 and Annex B of this document.

EC type-examination route. Under this route a Notified Body is required to issue a certificate of approval in respect of radio transmitting equipment. Only products that are intentional radio transmitters can follow this route, they do not have the option of the first two routes described above.

Step 2 - Declaration of Conformity

For the purposes of the Regulations, an EC declaration of conformity is a declaration which indicates that apparatus conforms with the essential 'protection' requirements of the EMC Directive (however expressed). The declaration shall be regarded as properly issued if the following requirements are complied with:

in the case of the standards route to compliance the declaration, if issued in the United Kingdom, shall:

be in English;

give the name and address of the responsible person and, if not the manufacturer, the details of the manufacturer;

be signed by or on behalf of the manufacturer or his authorised representative and identify that signatory;

bear the date of issue;

give particulars of the apparatus to which it relates sufficiently to identify it;

state the numbers and titles of the applicable EMC standards applied by the manufacturer; and

certify that the apparatus to which the declaration relates conforms with the protection requirements of the EMC Directive.

in the case of the technical construction file route to compliance the declaration, if issued in the United Kingdom, shall:

be in English;

give the name and address of the responsible person and, if not the manufacturer, the details of the manufacturer;

be signed by or on behalf of the manufacturer or his authorised representative and identify that signatory;

bear the date of issue;

give particulars of the apparatus to which it relates sufficiently to identify it;

identify the technical construction file relating to the apparatus, and give the name and address of the competent body which issued the report or technical certificate and the date and any number thereof;

state the numbers and titles of applicable EMC standards, if any, applied by the manufacturer;

certify that the apparatus to which the declaration relates conforms with the protection requirements of the EMC Directive.

in the case of the EC type-examination certificate route to compliance (for radiocommunication transmitting apparatus) the declaration, if in the United Kingdom, shall:

be in English;

give the name and address of the responsible person and, if not the manufacturer, the details of the manufacturer;

be signed by or on behalf of the manufacturer or his authorised representative and identify that signatory;

bear the date of issue;

give particulars of the apparatus to which it relates sufficiently to identify it;

identify the EC type-examination certificate relating thereto, and give the name and address of the notified body which issued it, and the date and any number thereof;

certify that the apparatus to which it relates conforms to the protection requirements of the EMC Directive.

in the case of a declaration issued other than in the United Kingdom, the declaration shall comprise the following:

a description of the apparatus to which it refers;

a reference to the harmonised standards under which conformity is declared as meeting the provisions of the EMC Directive;

identification of the signatory empowered to bind the manufacturer or his authorised representative; and

where appropriate, reference to the EC type- examination certificate issued by a notified body.

all cases where a declaration of conformity is issued it shall be held by a responsible person at the disposal of the Secretary of State for Trade and Industry for ten years beginning with the date on which the last item of apparatus is supplied to the end user.

Technical construction files may be used by a manufacturer to declare and self certify compliance with the protection requirements of the EMC Directive where, for whatever reason, there are no applicable European harmonised standards, or where these do exist he chooses not to apply them or to apply them only in part.

For the purposes of the Regulations a technical construction file:

describes the apparatus to which it relates;

contains information about the design, manufacture and operation thereof;

sets out the procedures used to ensure the conformity of the apparatus with the protection requirements in respect of the applicable electromagnetic characteristics of the apparatus for which the manufacturer has not applied an applicable EMC standard;

and includes a technical report or certificate issued by a competent body.

For the avoidance of doubt a technical construction file may be composed in relation to a single item of equipment, or where a number of items are to be produced, a sample which is representative of the total production, or a number of items of equipment or samples being variants of the same basic design. Further information on the technical construction file route to compliance is given in Annex B.

The technical construction file route to compliance shall not apply in respect of radiocommunication transmission apparatus. Instead refer to the Radiocommunications Agency publications RA 227 EMC Certification of Radio Transmitting Equipment and information sheet RA 200 EMC for Radio.

Note: A list of competent bodies and a guidance document on the preparation of a Technical Construction File is available on request from the DTI contact shown on page 16.

Step 3 - CE Marking

Products meeting the requirements are also to carry CE marking. The marking is as illustrated in diagram 1, below. It may not be smaller than 5mm in its vertical height, and the proportions in diagram 2 below must be maintained whatever its size. The grid does not form part of the marking and is for information only.

Diagram 1 Diagram 2

This mark looks the same as some previous marks, but there are subtle changes, and diagram 2 should be studied closely. It should be noted, for example, that the C and E are not formed by perfect semi-circles, i.e. the top and bottom arms extend one square beyond the semi-circles, and the middle arm of the E stops one square short.

Under whichever route a manufacturer has chosen to follow, he is required to complete a declaration of conformity and place the CE marking on the apparatus. The UK Regulations state that the Marking should be affixed to one of the following:

the apparatus itself; or

the packaging for the apparatus; or

the instructions for use; or

the guarantee certificate.

By affixing the CE Marking to apparatus, a manufacturer is making a statement that his apparatus meets the requirements of all relevant Directives. It is for the manufacturer to decide which other Directives are relevant to his apparatus.

The Amendment Regulations have only made minor changes as far as CE Marking is concerned under the EMC Directive. In future for all electrical and electronic apparatus the CE Marking will consist of the letters 'CE' only (as compared with the previous 'CE' plus the last two digits of the year in which the marking was affixed to the apparatus).

The other main change introduced by the CE Marking Directive is by means of the compliance notice which requires that where the CE Marking has been wrongly affixed (ie. the apparatus may meet the protection requirements but does not, for whatever reason, comply fully with the EMC Directive), the manufacturer or his authorised representative established within the EEA be required bring the apparatus into conformity before further action is taken. The Compliance Notice will only apply to the wrong affixation of the CE Marking (ie. the marking is too small, the marking is illegible etc).

The CE Marking Directive allows a transition period to effect a change from the old CE Mark to the new CE Marking. This comes into effect on 1 January 1995 and applies until 31 December 1996. From 1 January 1997 the use of the new CE Marking will be mandatory.

It is important to note that this transition period is only to make the change from the old CE Mark to the new CE Marking. It is not an extension of the transition period under the EMC Directive. The date for compliance with the EMC Directive is still 1 January 1996, this date will not be extended further.

The Regulations make it an offence to affix CE marking to:

apparatus unless that apparatus complies with the relevant protection requirements and the conformity assessment procedures have been complied with;

electrical apparatus not covered by the Regulations.

Enforcement: the Regulations will be enforced:

in Great Britain, by the trading standards departments of local authorities; and

in Northern Ireland, by the Department of Economic Development.

The above will not apply in respect of radiocommunications transmitting equipment for which the Secretary of State for Trade and Industry may enforce the Regulations. Nor will they apply in respect of wireless telegraphy apparatus

described in Schedule 6 paragraph 2 of the Regulations for which the Civil Aviation Authority (CAA) will be the enforcement authority.

In relation to electricity meters, other than those which are wireless telegraphy apparatus, the Regulations may be enforced:

in Great Britain, by the Director General of Electricity Supply; and

in Northern Ireland, by the Director General of Electricity Supply for Northern Ireland.

1 January 1996 Non-Compliant Stock

From 1 January 1996 Trading Standards Officers can act against non-compliant apparatus that is being supplied or taken into service. Manufacturers, wholesalers or retailers who are likely to have more than the odd item on the shelf or in stock, are advised to speak to their 'Home Authority' Trading Standards Officer as soon as possible and explain the situation. Enforcement Officers will not take kindly to large non-compliant stocks being ordered or manufactured in late 1995, that will mean their continuing supply well into 1996.

Penalties: any person committing an offence under the Regulations is liable, under summary conviction, to imprisonment for a term not exceeding three months or a fine not exceeding £5,000 or both. It is an offence to supply or take into service apparatus which does not comply with the requirements of the Regulations. Apparatus which does not comply with the Regulations, and documents relating thereto, may be seized and the apparatus forfeit. A prohibition or suspension notice may be issued prohibiting the supply or taking into service of any such apparatus, and it is an offence to contravene such a notice.

Free circulation: under European Community rules (as set out in the EMC Directive) Member States are required not to impede the supply or taking into service, for reasons relating to electromagnetic compatibility, apparatus which satisfy the requirements of that Directive, and to presume that apparatus bearing CE marking meet the protection requirements.

Safeguard procedure: Member States are required to take all appropriate measures to withdraw from the market, or to prohibit and restrict the supply of, apparatus bearing CE marking but not complying with the protection requirements. They must then immediately inform the European Commission of its action and give reasons. The Commission must consult the parties concerned as soon as possible and, where it finds the action justified, inform immediately all Member States. The Regulations provide for apparatus to be withdrawn from the market by means of prohibition and suspension notices.

Availability of texts of harmonised standards: these may be obtained from BSI Sales, 389 Chiswick High Road, London W4 4AL. Tel: 0181 996 7000.

Availability of text of the Regulations: the Electromagnetic Compatibility Regulations 1992 (SI 1992/2372) and the Electromagnetic Compatibility (Amendment) Regulations 1994 (SI 1994/3080) are available from HMSO and its agents.

Availability of the text of the EMC Directives: the complete texts of Directives 89/336/EEC, 91/263/EEC and 92/31/EEC have been published in the Official Journal of the European Communities (No. L139 of 23.05.89, pages 19-26, No. L128 of 23.05.91 and No. L126 of 12.05.92 page 11). Copies of these texts are generally available from European Information Centres and European Documentation Centres located throughout the United Kingdom, who may provide them for a modest charge. To locate your nearest Centre, consult the DTI's Business in Europe booklet Contacts, available through the DTI's Business in Europe Hotline on 0117 944 4888.

Please note that the DTI does not supply copies of the Regulations of Standards or of Directives.

For Contacts and useful information see page 179.

ANNEX A

Phenomena and effects which may be regarded as electromagnetic disturbance

Conducted low-frequency phenomena:

slow variations of supply voltages;

harmonics, interharmonics;

signalling voltages;

voltage fluctuations;

voltage unbalance;

power-frequency variations;

induced low-frequency voltages;

DC in AC networks;

DC ground circuits.

Radiated low-frequency phenomena:

magnetic fields (continuous or transient);

electric fields.

Conducted high-frequency phenomena:

induced continuous wave (CW) voltage or currents;

unidirectional transients;

oscillatory transients.

Radiated high-frequency phenomena:

magnetic fields;

electric fields;

electromagnetic fields;

continuous waves;

transients.

Electrostatic discharge phenomena (ESD)

ANNEX B

Technical Construction File route to compliance

BASIC REQUIREMENTS FOR A TCF

Part I: Description of the apparatus:

i) identification of apparatus;

ii) a technical description.

Part II: Procedures used to ensure conformity of the apparatus to the protection requirements:

i) a technical rationale;

ii) details of significant design elements;

iii) test evidence where appropriate.

Part III: A report or certificate from a 'Competent Body'.

SPECIFIC REQUIREMENTS FOR A TCF

The level of detail required in each of the above sections of the TCF will depend on individual circumstances, but might include the following:

Identification of the apparatus:

(a) brand name;

(b) model number;

(c) name and address of manufacturer or agent;

(d) a description of the intended function of the apparatus;

(e) for installations - physical location;

(f) external photographs;

(g) any limitation on the intended operating environment.

Technical description of the apparatus:

(a) a block diagram showing the interrelationship between the different functional areas of the apparatus;

(b) relevant technical drawings, including circuit diagrams, assembly diagrams, parts list, installation diagrams;

(c) description of intended interconnections with other products, devices etc;

(d) descriptions of product variants.

Technical rationale

(a) a brief exposition of the rationale underpinning the inclusion and balance of the evidence

given.

Detail of significant design aspects

(a) design features adopted specifically to address EMC problems;

(b) relevant component specifications, (eg the use of cabling products known to minimise EMC problems);

(c) an exposition of the procedures used to control variants in the design together with an explanation of the procedures used to assess whether a particular change in the design will require the apparatus to be retested;

(d) details and results of any theoretical modelling of performance aspects of the apparatus.

Test data

(a) a list of the EMC tests performed on the product, and test reports relating to them, including details of test methods, etc;

(b) an overview of the logical processes used to decide whether the tests performed on the apparatus were adequate to ensure compliance with the directive;

(c) a list of tests performed on critical sub-assemblies, and test reports or certificates relating to them.

Report or certificate from a competent body

(a) reference to the exact build state of the apparatus assessed, cross referencing with Part I of the basic requirements of a TCF;

(b) comment on the technical rationale;

(c) statement of work done to verify the contents and authenticity of the design information in the TCF, cross-referencing with Part II (ii) of the basic requirements of a TCF;

(d) comment where appropriate on the procedures used to control variants, and on environmental, installation and maintenance factors which may be relevant;

(e) contain an analysis of the tests performed either by the manufacturer, an authorised third party, or the competent body itself, and the results obtained, so as to assess whether those tests indicate that the apparatus should comply with the essential requirements of the Directive, cross-referencing with Part II (iii) of the basic requirements of a TCF.

It is envisaged that Parts I and II of the TCF will be written by the manufacturer in co-operation or consultation with the Competent Body. The report from the Competent Body should therefore not need to repeat much of the information contained in Parts I and II.

At the end of the report a detachable certificate will be supplied. This can be used by the manufacturer as an indicator of compliance where it is felt it would be inappropriate to submit the entire report. It is possible that where Parts I and II of the report prepared by the manufacturer largely 'speak for themselves', the Competent Body might prepare a certificate only.

It should be emphasised that the manufacturer is ultimately responsible for the declaration of conformity of products certified via the TCF route. The role of the Competent Body is to assert that the evidence contained within the TCF is consistent with conformity It is the manufacturer's responsibility to ensure that the information is correct and that subsequent production units are consistent with it.

SUGGESTED TCF CONTENTS IN FIVE POSSIBLE CIRCUMSTANCES

i) For apparatus where there is no applicable harmonised European EMC standard (although the availability of generic standards theoretically means that a standard exists for every product, it is recognised that in practice their use may not be practicable for some products).

There may well be cases where a specific standard for a given product does not exist, and the generic standard is not considered appropriate, but nevertheless it will be in the manufacturer's best interests to assemble test data of some sort as the best method of demonstrating compliance with the protection requirements.

The emphasis will therefore be on drawing up in collaboration with the Competent Body a test programme suitable for the type of product being assessed, and on demonstrating the validity of this programme, rather than on a detailed analysis of the EMC protection methods used in the apparatus. Part II of the TCF (procedures used to ensure conformity) will reflect this, but Part I will still have to contain sufficient detail to identify the product.

ii) For apparatus where harmonised European standards exist but the manufacturer applied that standard in part only (eg where a manufacturer can justify that a particular type of apparatus complies with the protection requirements of the Directive without performing tests to any or all of the phenomena described in the relevant harmonised specifications).

Under the circumstances where European harmonised standards have been applied in part only, it is envisaged that the TCF will seek to demonstrate why tests for certain phenomena were not felt to be necessary.

It is likely that the emphasis of the TCF will be on the construction of the apparatus; in particular to demonstrate what special properties the apparatus demonstrates which render as unnecessary some or all of the tests described in the relevant harmonised standards.

The technical description of the apparatus is therefore likely to be extensive, making easier the theoretical justification for not performing tests in the technical rationale.

iii) For installations where testing to European harmonised standards is not practicable due to the physical properties (eg size, location) of the installations.

It is envisaged that there may be occasions where, because of the physical properties of an installation, it is not practicable to perform tests according to harmonised standards. For instance the installation might be too large, or it might operate in such a way that the tests could not be conducted using established procedures.

Under these circumstances, the role of the TCF is to define a framework within which the creator of the installation can operate and remain confident that the apparatus which makes up the installation complies with the essential requirements of the directive.

The description of the apparatus should therefore include details of the physical location of the installation and also any relevant characteristics of the physical location, eg the composition of the building in which the installation is housed, and any significant local environmental factors such as close proximity to a recognised source of electromagnetic disturbance. Given the difficulty of performing tests on the installation as a whole, Part II will concentrate on tests performed on the apparatus comprising the installation, design steps taken to deal with EMC and adherence to installation and maintenance codes of practice.

iv) For products where the testing of each individual product to European harmonised standards is not practicable due to the large number of similar product variants.

It is envisaged that certain kinds of products and installations will be made available as large numbers of broadly similar product variants, perhaps to meet particular customer specifications. Examples of this might be local area networks in offices or customised variants of commercial vehicles.

The TCF in these cases must concentrate on the design principles which are consistent throughout the whole family of product variants, the steps taken to ensure that variants are consistent with these principles and the specifications of, and tests performed on, critical components and sub-assemblies.

Part I might therefore need to include identification of variants (or broad families of variants where listing every individual variant would be excessive), block diagrams showing typical interrelationship between functional areas and a description of the principal components and sub-assemblies used in the product.

Part II would include design features generally employed to reduce EMC problems, (including the use of components of a particular specification), and tests carried out where appropriate on sub-assemblies and on typical installations.

In the case of system variants such as local area networks, details might also be included of any instructions to installers or users indicating appropriate installation and maintenance codes of practice.

v) For products having existing certification to EMC standards not recognised by the EC, but which are nevertheless regarded as indicating compliance with the protection requirements of the Directive.

It is recognised that compliance with some EMC standards not as yet officially recognised by the European Directive will indicate compliance with the essential requirements of the Directive. Such standards might include military standards, national, civil EMC standards, or standards generated by industry.

In such cases, the TCF could concentrate on the coverage of the standard (ie whether additional verification was needed in regard to phenomena not covered by the standard in question, but addressed in the Directive); the performance levels required by the standard, and the test methods employed.

ANNEX C

Illustrative list of the principal protection requirements

Although all apparatus coming within the scope of the Directive must comply with its provisions, the maximum electromagnetic disturbance generated shall be such as not to hinder the use in particular of the following:

(a) domestic radio and TV receivers;

(b) industrial manufacturing equipment;

(c) mobile radio equipment;

(d) mobile radio and commercial radiotelephone equipment;

(e) medical and scientific apparatus;

(f) information technology equipment;

(g) domestic appliances and household electronic equipment;

(h) aeronautical and marine radio apparatus;

(i) educational electronic equipment;

(j) telecommunications networks and apparatus;

(k) radio and television broadcast transmitters;

(l) lights and fluorescent lamps.

Apparatus, and especially apparatus referred to in (a) to (l), should be constructed in such a way that it has an adequate level of electromagnetic immunity in the usual electromagnetic environment where the apparatus is intended to work so as to allow its unhindered operation taking into account the levels of disturbance generated by apparatus complying with specified European standards or approved national standards.

The information required to enable use in accordance with the intended purpose of the apparatus must be contained in the instructions accompanying the apparatus.

ANNEX D

Existing UK EMC Legislation

(repealed on 1 January 1996)

Statutory Instrument Number

1952 No 2023 The Wireless Telegraphy (Control of as amended Interference from Ignition Apparatus)Regulations 1952

1971 No 1675 The Wireless Telegraphy (Control of Interference from Radio Frequency Heating Apparatus) Regulations 1971

1978 No 1267 The Wireless Telegraphy (Control of as amended Interference from Household Appliances, Portable Tools, etc) Regulations 1978

1978 No 1268 The Wireless Telegraphy (Control of Interference from as amended Fluorescent Lighting Apparatus) Regulations 1978

1982 No 635 The Wireless Telegraphy (Control of as amended Interference from Citizens' Band Radio Apparatus) Regulations 1982


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