Technical Fille TF

8/3/2019 Technical Fille TF

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Zahtevi niskonaponske direktive (LVD).

y procena rizika. Prema EN 14121-1 and EN 954-1 / EN ISO 13849-1 / EN 62061.y reference o osnovnim zahtevima zatite.y reference o harmonizovanim EN standardima.y Izrada fajle sa tehnikim podacima.y Izjava o usklaenosti proizvoday Ispitne metode i postupci.

Sakupljanje LVD tehnikih podataka.Obavezno je oznaavanje CE znakom proizvoda koji spadaju u

delokrug ove Direktive i to mora biti podrano sa ispravnomdokumentacijm (Technical File-TF).

Direktivom je odreeno ta ovaj fajl mora da sadri:

y opti opis elektrine opremey Projektantski I proizvodni crtei, plus crtei-skice komponenti, podsklopova, ema povezivanjay opise i objanjenja potrebna za razumevanje pomenutih crtea i dijagrama, plus elektrinu emu

povezivanja sa objanjenjem .

y Listu standarda koji su , u potpunosti ili delimino primenjeni i opis reenja konstruktora ifabrike kontrole da se zadovolje aspekti bezbednosti ove direktive ako nisu primenjeni svi

standardi .

y Rezultate prorauna i izvrenih provera, itdy testiranje bezbednosti proizvoda (Izvetaji)

Pretpostavku o usklaenosti sa LVD moemo izjaviti-tvrditi samo pod uslovom da su korieni Harmonizovanistandardi . Ukoliko to nije sluaj moemo koristiti tumaenje rezultata i zahteva od drugih meunarodnih

bezbednosnih ema.Takoe, treba da se oformi : Izjava o usklaenosti (DOC) , Technical file (TF) i mora se uvati I na zahtev datina uvid nacionalnim vlastima (HSE, Standardi Trgovina itd) u toku najmanje 10 godina od poslednjeg datuma

proizvodnje proizvoda.Treba imati na umu da netano CE Obeleavanje proizvoda povlai za sobom stroge kazne i za kompaniju iza pojedinca koji je odgovoran za potpisivanje DOC.


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Sertifikacija Elektrinih ureaja- CE oznaka je data u okviru LVD ili EMC direktiva.LVD ili direktiva niskog napona se primenjuje na sve elektrine proizvode koji rade u opsegu napona od 50 do1000 V AC i 75-1500 V DC jednosmerne struje.EMC ili direktiva elektromagnetske kompatibilnosti govori o usaglaenosti za elektromagnetnu emisiju iimunost odreenog ureaja ..CE oznaka-Sertifikacija pod LVD / EMC direktivom obuhvata: -

-Procena rizika i kontrola

-Izrada tehnike datoteke koja sadri sva dokumenta kojima se dokazuje usaglaenost proizvoda sa

vaeim standardima i pravilima.

-Pozivanje na vaee EN standarde.

-Uputstva za bezbedan rad proizvoda .

-Ispitni metodi i postupci .

-Deklaracija o usklaenosti .

-Analiza osnovnih zahteva sigurnosti,

-Ispitni izvetaji za EMC / LVD usaglaenost po relevantnim standardima.- Revizorski izvetaj za LVD / EMC usaglaenost

EMC testing for Lighting (Luminaires)

EMC for electrical/electronic items intended for lighting purposes is covered by the standards EN55015 (EMCemissions) and EN61547 (EMC Immunity).These standards are applicable to lighting equipment such as lamps, lighting auxiliaries (e.g. power supplies &dimmer switches) and luminaires that are connected to the mains or that are battery powered; and have a

primary function of illumination.These standards specify various emissions and immunity test to be carried out on the product either throughradiated means or by conduction along the signal or power supply cables. In particular, EN55015 calls for

magnetic field emissions and insertion loss measurements on certain types of devices.


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magnetic field and electric field emissions, radiated immunity, conducted RF and transient type immunity testson power and signal cables as well as ESD (Electrostatic Discharge).Examples of equipment that fall into the requirements of EN55015 & EN61547 are:

y Energy Saving Bulbsy Lighting Ballastsy Lighting Convertersy Fluorescent Tube Starting Devicesy Dimmer switchesy Light Fittings with active components (such as fluorescent fittings)

Lighting technology is advancing at impressive rate with control being enhanced by the use of radio controltechnology being employed in the host product. However, with the inclusion of radio technology, requires theessential requirements of the RTTE directive to be satisfied in addition to the intrinsic product compliancerequirements. Many radio technologies are being used as a control transport includingBluetooth and ZigBee.TRaC has a comprehensive range of services and can offer Qualification Testing forBluetooth and CertificationTesting for ZigBee as well as all of the appropriate regulatory requirements for these and traditional radiotechnologies.

Technical Construction File (TCF).

In order to prove compliance to the essential requirements of the LVD one has to make up a

Technical Construction File. This includes all safety related topics, such as precautions,instructions, test reports and everything necessary to identify the apparatus, such as circuitdiagrams, mechanical drawings and detailed part lists.The LVD is not just limited to electrical shock and insulation only.Once an apparatus falls into the scope of it, many other aspects of safety like fire hazards,mechanical hazards, radiation and chemical hazards are part of the approval procedure.Future developments will bring more and more apparatuses within the scope of safetydirectives.

Basic Safety Concepts

Protection against electrical shockElectrical safety is implemented using the concept of double safety layers:

y Isolation + Groundingy Insulation + Extra Insulation (double or re-enforced insulation)

Any part at hazardous voltage should be separated from the operator by 2 layers of safety likespecified under 1. or 2.In addition to this the failure of one layer may not affect the sessentialsafety of the equipment. Full safety must be achieved with one layer only. The testing of onelayer of safety failure is called SINGLE FAULT TESTING; evulated are the effects of(among others) :

y loose wire,y defective component,y loss of ground connection.

Misuse (foreseeable abuse) of an equipment is considered as a single fault.The LVD approvalprocedure is based on the utilization of safe and approved parts in all applicable circuits (mostimportant in the mains circuit). This implies that all parts having a safety function need anexamination to their specifications and (if applicable) need a ce-declaration of conformityavailable, before they are allowed in the construction of an apparatus.Componentmanufacturers in generally are not very cooperative in producing accurate declarations, as ace-declaration of conformity involves direct liability of the manufacturer for the safety of it'scomponents . A UL, CSA or VDE declaration -although very valuable- is a testimonialdeclaration and not a manufacturers declaration: less liability for the manufacturer is involved.Most US originated equipment lack sufficient component safety due to the difference in mainsvoltage. Although manufacturers may specify a product as being suitable for 250 Vac, thisdoes not imply that the same component is safe at 250 Vac. In order of relevance we requiresafety certificates from (for your applied components with a safety function)

y Any recognized European test house with certificate (KEMA, NEMKO,VDEetc),

y CE marked component with Declaration of Conformity,


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y UL or CSA marked components with proof of approval for 250 Vac,y Not certified or manufacturer certified components.

(applying this category may lead to extra test costs)Safety Function

What components do have a essential safety function ?In general, all components carryingmains voltage and all components carrying a hazardous voltage to the operator have a safetyfunction. Eevne more general, all components carrying any hazard in them may qualify assuch.Other requirements

Many more requirements exist considering hazards associated with heat, fire propagation,radiation, mechanical hazards (sharp edges), short circuits, leakage current (touch current) andmore.The electrical safety test procedures are not to be underestimated !

Harmonized standards

This list of standards is an ever increasing subset of world-wide existing standards, that due totheir way of defining test-methods, limits and susceptibility criteria, are very well suited fortesting by the manufacturer himself, or by any test house using the right equipmentThis list ofstandards is published approximately once a year.

Routine testingThe Declaration of Conformity is most often based on a one sample of a "type tested product"

that ideally should be identically reproduced in series.In order to maintain safety in real lifeproduction, some quality control is imperative. The LVD specifies the requirement of such a

scheme. Therefore each and every produced apparatus must be numbered and verified for alist of essential parameters -composed by your test house- such as functionality, dielectricstrength , the grounding qualities and potential pitfalls created by foreseeable mistakes in

production.This focuses the attention on those faults that are easily made without beingdetected in functionality tests, and that may create a potential hazard to the operator.Examples are grounding clips, insulation barriers, warning labels, insulation (rubber) rings

below ring core transformers etc.In general, safety measures should be applied exclusively forthe safety purpose, and should not share any task with functionality , unless the safetymeasure is very obvious. Safety features must be visible and easy distinguishable fromfnctional features.Safety measures should not be compromised during normal operation and

service.Routine test must be logged, therefore serial numbering your equipment isrequired.Standards exist for setting up these so-called routine tests::

y House hold appliances EN 50106y Hand held motor operated tools EN 50144-1y Luminaries ENEC 303y ITE equipment EN 50116

Your test house will be helpful in selecting a routine type test protocol.

Most popular failures....

y Insufficient insulation distances in connectors and printed circuit boards.Although exceptions exist, the insulation between metal (accessible) parts and hazardousvoltages (mains) must be no less of 4 mm and up to 8 mm in medical equipment.

y Unknown safety status of safety critical componentsNot only equipment but also components must be tested for safety. Most components complyto international IEC or EN standards. Equipment brought to Europe often uses UL or CSAapproved components.This is not necessarily sufficient for safe operation at 230 Vac.IYou definitely have to make sure that your components are suitable for European voltagesand make sure they are sold to you with written proof of compliance. Just a catalogue pageshowing the ce mark in the corner won't do ! If it's writing "designed for (to) comply with.[standard].. ' or"tested for [standard]...." , then you can be sure the part is not compliant.Look for the phrase: "Compliant with [standard] " and then don't forget to check it's thecorrect standard and not an obsolete one.........!Correct part number and applied standard are

best be mentioned on a signed document.y Undefined parts


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You must have seen that in your product's Bill of Materials: many parts have no specified typeor manufacturers name behind them. How can you be sure that this part performs the requiredfunction, and how can you declare liability for the safety of those parts ?Make sure you know who's manufacturing the building blocks of your equipment, and onwhich components the safety of your equipment and reputation of your brand relies.Did youmake a grounding diagram ?

y Incomplete manualsAll equipment should ideally be accompanied by the following documents:

y Compliance declarationStatement of originSafety manualInstallationManualOperators manual

y Service manualOf all these parts the safety part MUST be translated in the language of the country you areselling to. Many countries require other parts to be translated too. Several parts may becontained in one volume however, but we recommend a separate sheet for those safety aspectsthat require immediate attention when opening the box... should we mention why ??Let us quote you for your product and get all this and more taken care of....

All CE marking directives require the manufacturer of the product to create a technical file which

should contain the information required to show that the product properly complies with the

requirements of the directives which apply to it.

The directives contain clauses which give some general details of the kind of information which will berequired in the technical file, but this is couched in the most general of terms. As a general guide, the followingitems should be included:

y Description of the apparatus, usually accompanied by block diagramy Wiring and circuit diagramsy General Arrangement drawingy List of standards appliedy Records of riskassessments and assessments to standardsy Description of control philosophy/logicy Datasheets for critical sub-assembliesy Part listy Copies of any markings and labelsy Copy of instructions (user, maintenance, installation)y Test reportsy Quality control & commissioning proceduresy Declaration of Conformity

There is nothing to stop the file containing a great deal more information than is listed here - for instance copiesof the engineering drawings for any bespoke parts could also be included. However, these should not be used to

pack the file at the expense of the more relevant information on how the equipment operates and how it meetsthe safety objectives of the Directives.Of course, for simple products (e.g. household domestic appliances) the control philosophy may be so simple asto be self evident, in which case it is unnecessary for the file to include this information. Often, this sort of

product will be the subject of a notified body report confirming compliance to a harmonised standard and acopy of the report should be included in the file. The importance of including a basic general description of the

appliance cannot be overstated. Furthermore, the action of providing a properly documented description of thecontrol system will often allow the designer to spot potential flaws in the logic of the operation.Checklists for the content of technical files under various directives can be purchased form our online shop.

Access to the Technical FileIt is important to understand that only the authorities given power to enforce the directives have a right to seethe technical file. It does not need to be published or given to customers. With the exception of the MedicalDevices Directive, there is no clear requirement that the file should be kept on EU soil. However, for amanufacturer based outside of the EU, any approach made by the authorities will initially come to theauthorised agent or the importer of the goods, so they must have access to the file to be able to fulfil their legalobligations. Access to technical information may also be a condition of contract laid down by some customers.


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as the contact point for their technical documents. More details of this requirement can be found on ourDOC-EUPOINT pages.

When should the file be created?Different directives treat the creation of the file with different priorities. The LVD strictly requires themanufacturer to have the file in place before the CE mark is applied, whereas the Machinery Directive says thatthe file does not have to be in constant existence and thereby provides for a period of grace in which it can becompiled. In practice, it usually makes sense to ensure the file is created early in the life of a product and is thenkept up to date.For some directives the creation of the file and its assessment by aNotified Body are a pre-requisite for propercompliance with the Directives. This is the case for the higher classes ofmedical device,personal protectiveequipment and forequipment for explosive atmospheres. Assessment of the technical file is also a requirementfor Type Approval under the Machinery Directive.There are also other reasons why it makes sense to compile the file at the time the product is originally designedrather than waiting until a request is received from an enforcement body. Firstly, there is the problem that muchof the information required for the file (particularly component data and supplier information) may no longer beavailable several years after the product design has been completed. Secondly, the file can for a usefulrepository for information on changes to the design or manufacturing processes used to make the product.Finally, if used correctly, the file can itself become a useful way to manage the process of properly completingthe CE marking process: if a list of the contents required for the file is drawn up at an early stage then this listcan be used to identify whether all of the necessary steps have been completed by identifying the relevant

information in the file for each stage in the process.

Delivery of the fileThe purpose of the Technical File is to provide evidence for an enforcement authority that the product hascorrectly completed the assessment and attestation procedures of the relevant directive(s).The enforcement authorities have the right to demand a copy of the file for up to 10 years after the last date onwhich the product(s) described in the file were made. This is by no means a trivial requirement - changes in

personnel, company facilities, IT systems and file formats all represent major challenges to guaranteeing theavailability of the required information and need to be considered carefully.The file must be delivered 'in material form' which may be taken to mean as a paper copy. In practice, however,the enforcement bodies are likely to be satisfied with an electronic version, and in fact may only demandspecific sections of the file if their concerns relate to specific aspects of the product's compliance with the

directives.The file has to be drawn up in a European language, and will normally be requested by the relevantenforcement body for the country and region in which the manufacturer of the product is located (the "HomeAuthority Principle"). The manufacturer is not obliged to translate the file before delivery to an enforcementauthority from outside their home country.

COUNCIL DIRECTIVE 89/336/EEC of 3 May 1989

This directive has been amended by the following Council Directives:1. 92/59/eec of 29 June 1992 (General Product Safety) ;2. 93/68/eec of 22 July 1993 (CE Marking directive);

3. 99/5/ec: Directive of Radio Equipment & Telecommunications Terminal Equipment (R&TTE).Your Ad Here

Other Related CE Publications:

1. 73/23/eec: Directive ofLow Voltage Electrical Equipment (LVD)2. Guidelines to Low Voltage Directive (LVD) 73/23/eec3. 2000&2001 Frameworkof implementation of (LVD) Directive 73/23/eec4. Guidelines to Electromagnetic Compatibility (EMC) Directive 89/336/eec5. Technical-Aspects relating EMC Directive 89/336/eec6. 2000 Framework of implementation of EMC Directive 89/336/EEC7. List of Harmonised (European) Standards

8.L

ist of Notified Bodies


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1 Background

1.1 The EMC Directive (89/336/EEC) is primarily concerned with removing trade barriers in the area ofelectromagnetic compatibility and, being a total harmonization directive, it replaces national provisionswhere they previously existed.It is a new approach directive, which means that it lays down mandatory essential requirements anddescribes the methods by which conformity with these requirements can be demonstrated.

1.2 The directive relies on the availability of harmonised standards which provide test methods and limits, andsignificant work has been done to provide such methods and limits for the major industrial sectors.

2 Scope

2.1 The following represents a necessarily brief overview of the subject. The text of the directive is at all timesthe definitive guide to its requirements. Under its terms apparatus shall be constructed so that;

a) the electromagnetic disturbance it generates does not exceed a level allowing radio andtelecommunication equipment and other apparatus to operate as intended, and that

b) the apparatus has an adequate level of intrinsic immunity to electromagnetic disturbance to enable it tooperate as intended.

2.2 There have been difficulties in establishing exactly what equipment comes within the scope of the directive,and in October 1993 the Commission published "Guidelines on the Application of the Council Directive89/336/EEC"

2.3 The directive applies to 'all electrical and electronic appliances' together with equipment and installationscontaining electrical and/or electronic components liable to cause electromagnetic disturbance, and the

performance of which is liable to be affected by such disturbance.

2.4 In order to clarify this point, the guideline document defines a 'non-restrictive' but comprehensive range ofequipment which must be considered as being covered by the directive, as follows :-

a) Emission and Immunity aspects

I. Telecommunications terminal equipment (in so far as theprotection requirements are not peculiar to this equipment) (see13th recital of Directive 91/263/EEC).; [Note: "recital" is areference to the numerous clauses commencing with the word"whereas", with which Directives begin.]

II. Electrical household appliances, portable tools and similar

equipment (last recital of the EMC Directive and Annex III(g));

III. Radio equipment used by radio amateurs if it is availablecommercially (Article 2(3) and Annex III (c) and (d));

IV. Radio and television receivers (Annex III (a));

V. Aeronautical and marine radio apparatus (Annex III (h));

VI. Radio and television broadcast transmission (Annex III (k));

VII. Fluorescent lighting luminaries fitted with starters (last recitalof the relevant Directive);

VIII. Lights and Fluorescent lamps (Annex III (I));

IX. Industrial equipment (Annex III (b));

X. Telecommunications apparatus (Annex III (j));

XI. Information technology equipment (Annex III (f));

XII. Educational electronic equipment (Annex III (i));

b) Emission aspect only

I. Non-automatic weighing instruments (immunity aspect is coveredby Annex I, paragraph 8(2), Directive 90/384/EEC).

c) Immunity aspect only

I. Agricultural and forestry tractors (the emission aspect is covered


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by Directive 75/322/EEC).

2.5 The following is a non-restrictive list of apparatus specifically excluded from the scope of the directive.

a) Emission and immunity aspects

I. Radio equipment used by radio amateurs unless the apparatus iscommercially available (Article 2 (3)).

II. Motor vehicles (covered by Directive 72/245/EEC).

III. Active implantable medical devices (covered by SpecificDirective 90/385/EEC).

IV. Medical devices (covered by Directive 93/42/EEC).

b) Emission aspects only

I. Agricultural or forestry tractors (covered by Directive75/332/EEC).

c) Immunity aspects only

I.Non-automatic weighing instruments (covered by Annex 1, para 8(90/384/EEC).

3 Definitions

3.1 Some important definitions are listed below

a) ManufacturerThe person who accepts responsibility for the design and manufacture of a product covered by thedirective with a view to placing it on the Community market on his own behalf. As part of thisresponsibility he takes on the obligation.

y to design and manufacture the product in line with the essential requirements of the directive.y to follow the relevant conformity assessment procedures as detailed in the directive.

b) Authorized representativeThis is the person who is expressly appointed by the manufacturer and who acts on his behalf in respectof certain obligations laid down under the directive.

c) ImporterThis is the person who places on the Community Market products covered by the directive and

imported and a third country. The importer must keep the manufacturer's declaration of conformity andtechnical file at the disposal of the authorities, where neither the manufacturer nor his authorizedrepresentative is established within the Community. (Article 10(1) 3rd paragraph and Article 10(2), 3rd

paragraph).

d) ComponentsThe directive does not apply to components, which are defined as any item which is used in thecomposition of an apparatus and which is not itself an apparatus with an intrinsic function intended forthe final consumer.

e) ApparatusThe directive applies to all apparatus as defined in the directive : that is, a finished product with anintrinsic function intended for the final user and intended to be placed on the market as a singlecommercial unit. The term equipment is synonymous with an apparatus.

f) SystemsThe directive applies to systems, which are several items of apparatus combined to fulfill a specificobjective and intended to be placed on the market as a single functional unit.

g) InstallationsThe directive does not apply to installations, which are defined as several combined items of apparatusor systems put together at a given place to fulfill a specific objective but not intended to be placed onthe market as a single functional unit. Apparatus and systems which make up the installation arehowever subject to the provisions of the Directive.

h) Placing a product on the marketThis means the first making available against payment, or free of charge, of a product covered by thedirective in the Community Market for the purpose of distribution and/or use on the Community

territory.


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i) Putting into serviceThis means the first use on the Community territory, by its final user, of a product referred to in thedirective.

4 Conformity Assessment

4.1 Conformity assessment is the means of demonstrating that the apparatus complies with the essentialrequirements of the directive. These means are described in Article 10 of the Directive. Article 10 describesthe procedure by which the manufacturer applies harmonised standards. This is a self-certificationapproach, whereby having satisfied himself that this equipment compiles with the relevant harmonisedstandards, the manufacturer makes a declaration of conformity as defined in Annex I(I) and applies the CEMarking. (This follows Module A of the Council Directive 93/465/EEC on page 5 of this document).

4.2 Article 10(2) describes the procedure where the manufacturer has not applied the standards or has appliedthem only in part, or in the absence of relevant standards. Under these circumstances, the manufacturercompiles a technical construction file containing all the relevant technical data required to assess the

product.The file must include a certificate or technical report form a Competent Body, confirming compliance withthe relevant standards.

4.3 Having satisfied himself that the equipment complies with the directive's requirements, the manufacturerdraws up the declaration of conformity ( Annex I(I) ) and applies the CE Marking. This also followsModule Aa of Directive 93/465/EEC. (Page 5).

4.4 Under each approach the manufacturer must take all measures necessary to ensure that products within the

scope of the directive comply with the protection requirements described in the declaration of conformity inthe former case, and the technical construction file and the applicable requirements of relevant standards inthe latter.

5 Article 10 (5)

5.1 This article concerns equipment designed for transmission of radio communications.The manufacturer must obtain an EC Type-Examination certificate from a Notified Body, and declare thathis series - manufactured products conform to the type as described in the certificate, and ensure that theysatisfy the protection requirement of the directive.He then declares conformity with directive (Annex I(I) ) and applies the CE Marking.

6 Bodies defined under the EMCDirective

6.1 Competent Authorities

These are the administrations of the Member States which are responsible for Market Control.

6.2 Competent BodiesThe EMC Directive defines a body as competent if it fulfills the Annex II of the Directive criteria. They are

presumed competent if they can prove their conformity with the appropriate harmonised standard of the EN45000 series.The Competent body issues the technical reports or certificates referred to in Article 10 (2) of the Directive.The "guideline document" lists the known Competent Bodies.

6.3 Notified BodiesA notified body must fulfill the requirements as set out an Annex II of the directive. It must be able tofurnish proof that it conforms to the appropriate harmonised standards in the EN 45001.

7 Implementation

7.1 The provisions of this directive have applied since 1st January 1992. However due to its wide scope, it wasnecessary to introduce a transitional period in order to ensure that a smooth changeover from purelynational systems to an exclusively community-wide system took place. On 28th April 1992, the Counciladopted Directive 92/31/EEC to allow a transitional period until 31st December 1995. During thistransitional period, national systems may continue to be used, alongside the system given in the directive.Since 1st January 1996, the EMC Directive has become mandatory.

The LV-Directive (73/23/EEC)

As all ce-related directives this is a new-approach directive, which means that only mainrequirements (essential requirements) are required. The LV-directive shows the way of

showing compliance to the main requirements.


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Using a list of harmonized standards a manufacturer may assess the safety of its productor apparatus.Manufacturers declaration

y The manufacturers declaration consists mainly of a liability statement from themanufacturer or importing agent in which he accepts the legal consequences(liability) for conformity of its equipment to the LVD-essential requirements. Themanufacturer is granted permission to do the testing himself, or let the testing beexecuted by any test-house. Using this route the manufacturer is strongly suggestedto use the so-called Harmonized Standards for type testing, although in absence ofthese any other safety standard or no standard at all may be applied.Harmonized standards, especially created for this purpose and modified existingstandards are published in the official newspaper of the EC (OJEC), and in theofficial journals of all EC-members.

Purchase a model ce declaration of conformityTechnical Construction File (TCF).

In order to prove compliance to the essential requirements of the LVD one has to make up aTechnical Construction File. This includes all safety related topics, such as precautions,instructions, test reports and everything necessary to identify the apparatus, such as circuitdiagrams, mechanical drawings and detailed part lists.The LVD is not about electrical safety only.Once an apparatus falls into the scope of it, many other aspects of safety like fire hazards,mechanical hazards, radiation and chemical hazards are part of the approval procedure.

Future developments will bring more and more apparatuses within the scope of safetydirectives.

Basic Safety Concepts

Protection against electrical shock

Electrical safety is implemented using the concept of double safety layers:1. Isolation + Grounding2. Insulation + Extra Insulation (double or re-enforced insulation)

Any part at hazardous voltage should be separated from the operator by 2 layers of safetylike specified under 1. or 2.In addition to this both layers are not to be affected in their efficacy in the CASE OF ANYSINGLE FAULT (loose wire, defective component, loss of earth etc.)Misuse (foreseeable abuse) of an equipment is considered as a single fault.

The LVD approval procedure is based on the utilization of approved parts in all applicablecircuits (most important in the mains circuit).This implies that all parts having a safety function need an examination to theirspecifications and (if applicable) need a ce-declaration of conformity available, before theyare allowed in the construction of an apparatus.Component manufacturers in generally are not very cooperative in producing accuratedeclarations, as a ce-declaration of conformity involves direct liability of the manufacturerfor the safety of its components . A UL, CSA or VDE declaration -although veryvaluable- is a testimonial declaration and not a manufacturers declaration: less liability forthe manufacturer is involved. Most US originated equipment lacks sufficient componentsafety due to the difference in mains voltage. Although manufacturers may specify a productas being suitable for 250 Vac, this does not imply that the same component is safe at 250Vac.Many more requirements exist considering hazards associated with heat, fire propagation,radiation, mechanical hazards (sharp edges), short circuits, leakage current (touch current)and more.The electrical safety test procedures are not to be underestimated !

Harmonized standards

This list of standards is an ever increasing subset of world-wide existing standards, that dueto their way of defining test-methods, limits and susceptibility criteria, are very well suitedfor testing by the manufacturer himself, or by any test house using the right equipmentThis list of standards is published approximately once a year.


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Routine testingThe Declaration of Conformity is most often based on a one sample of a "type tested

product" that ideally should be identically reproduced in series. In order to maintain safetyin real life production, some quality control is imperative. The LVD specifies therequirement of such a scheme. Therefore each and every produced apparatus must benumbered and verified for a list of essential parameters -composed by your test house- suchas functionality, dielectric strength , the grounding qualities and potential pitfalls created byforeseeable mistakes in production.This focuses the attention on those faults that are easily made without being detected infunctionality tests, and that may create a potential hazard to the operator. Examples aregrounding clips, insulation barriers, warning labels, insulation (rubber) rings below ring coretransformers etc.In general, safety measures should be exclusively for the safety purpose, and should notshare functionality , unless the safety measure is very obvious. Safety features must bevisible and easy distinguishable .Routine test must be logged, therefore serial numbering your equipment is required.Standards exist for setting up these so-called routine tests::

y House hold appliances EN 50106y Hand held motor operated tools EN 50144-1y Luminaries ENEC 303y ITE equipment EN 50116

Your test house will be helpful in selecting a routine type test protocol.

Most popular failures....

Insufficient insulation distances in connectors and printed circuit boards.Although exceptions exist, the insulation between metal parts and hazardous voltages(mains) must be no less of 4 mm and up to 8 mm in medical equipment.Unknown safety status of safety critical components

Not only equipment but also components must be tested for safety. Most componentscomply to international IEC or EN standards. Equipment brought to Europe often uses ULor CSA approved components.This is not necessarily sufficient for safe operation at 230 Vac.In many cases approval by UL is for 115 Volts only instead of 230 Vac for Europe. Oftenno safety indication is available but a small sign on the back saying UL or CSA.

You definitely have to make sure that your components are suitable for European voltagesand make sure they are sold to you with written proof of compliance. Just a catalogue pageshowing the ce mark in the corner wont do ! If its writing "designed for (to) complywith .[standard].. or"tested for [standard]...." , then you can be sure the part is notcompliant. Look for the phrase:"Compliant with [standard] "

and then dont forget to check its the correct standard and not an obsolete one.........!Correct part number and applied standard are best be mentioned on a signed document.Undefined partsYou must have seen that in your products Bill of Materials: many parts have no specifiedtype or manufacturers name behind them. How can you be sure that this part performs therequired function, and how can you declare liability for the safety of those parts ?

Make sure you know whos manufacturing the building blocks of your equipment, and onwhich components the safety of your equipment and reputation of your brand relies.Did you make a grounding diagram ?Incomplete manuals

All equipment should ideally be accompanied by the following documents:y Compliance declarationy Statement of originy Safety manualy Installation Manualy Operators manualy Service manual

Documents

Technical Fille TF