CE-märkning CE-märkning

CE-märkning

Johan NilssonBiomedicinsk teknik, LTH

CE-märkningVarför?

• Säkerhets och hälsoskäl - etablera en rimlig nivå för produktsäkerhet.

• Kraven ska tolkas som minimi-nivå. • Kvalité - Tillverkaren kan (med hänsyn till kunden) lägga

sig på en högre produktsäkerhetsnivå.

CE-märkning

• CE-märket (Conformité Europeenne):• Visar att produkten uppfyller alla tillämpliga (lag)krav på

produkt- och hälso-säkerhet. • CE-mäkta produkter kan fritt marknadsföras inom EU/EES-

området.

Inte ”China Export”…..

CE-märkningVem är ansvarig?

• Tillverkaren• eller tillverkarens representant inom EU/EES,• eller det företag som marknadsför produkten inom EU/EES. • eller det företag som sätter samman en produkt för intern

användning. • Tänk på: S-märkningen är inte längre obligatorisk. S-

märkningen godkändes av en oberoende tredje part - SEMKO.

The New Approach DirectivesInnehåller fundamentala krav

Low voltage (73/23/EEC)Industrial Trucks (74/150/EEC)Motor Vehicles trailers (70/50/56 EEC)Products labeling directive (83/374 EEC)Simple Pressure Vessels (87/404/EEC)Safety of Toys (87/378/EEC)Construction Products (89/106/EEC)Electromagnetic Compatibility (2004/108/EEC)Machinery Safety (98/37/EC)Personal Protective Equipment (89/686/EEC)Non-automatic Weighing Instruments (90/384/EEC)Active Implantable Medical Devices (90/385/EEC)Gas Appliances (90/396/EEC)

Telecommunications Terminal Equipment (91/263/EEC)Mobile Machinery (91/368 EECHot Water Boilers (92/42/EEC) Medical Devices (93/42/EEC)Lift Machinery (93/44 EEC)Explosive for Civil Uses Directive (93/5/EEC)Satellite Earth Station Equipment (94/9/EEC)Recreational Craft (94/25/EEC)Packaging & packaging waste (94/62EEC)Lift Safety (95/16 EEC)Energy Labeling (97/75 EEC)Pressure Equipment (97/23/EEC)

Harmoniserade Standarder• Direktiven innehåller fundamentala krav på hälso- och

produktsäkerhet.• Detaljerade krav och tekniska lösningar finns i Standarder

(Produktfamiljstandarder eller Generiska standarder). T ex EN 292 Maskinsäkerhet.

• EU-standarder överförs till nationella standarder i varje land. T ex SS-EN 292.

• De standarder som anses uppfylla kraven i direktiven kallas för Harmoniserade Standarder. Dessa standader publiceras i “the EU Official Journal”.

• Dvs, en produkt som designats enligt en Harmoniserad standard kommer att därför att uppfylla kraven i dirketiven.

Standards Organisations

•World standards•IEC - International Electrotechnical Commission•ISO - International organization for Standardization

•European standards•CEN - European Committee for Standardization•CENELEC - European Committe for Electrotechnical Standardization•ETSI - European Telecommunications Standards Institute

•Swedish standards•BST - Byggstandardiseringen•HSS - Hälso- och sjukvårdsstandardiseringen•IKH - Kran- och Hisstandardiseringen•ITS - Informationstekniska standardiseringen•SEK - Svenska Elektriska Kommissionen•SIS - Standardisering I Sverige•SMS - Svensk Material- & Mekanstandard•STG - Allmänna Standardiseringsgruppen•TKS - Tryckkärlsstandardiseringen Ref: www.sp.se

Harmoniserade Standarder• En produkts overenstämmelse med Harmoniserade

standarder visas genom självcertifiering - tillverkaren garanterar att produkten uppfyller kraven.

• I en del fall, t ex medicinteknisk utrustning, krävs kontroll av oberoende organ.

Technical Construction FileTCF

• Must be compiled before the CE mark can be affixed, and the product is sold in the EU. The TCF must be produced in one of the official languages of the European Union and be made available to the responsible authorities in any EU country.

The main parts are:• Declaration of Conformity• A general description of the product• Design and production drawing and diagrams• Detailed technical data for essential aspects of the product• List of standards and/or solutions applied• Report of calculations and tests that have been carried out• Certificate and inspection reports• In the case of series production, the internal conditions that have been observed to

safeguard compliance with the directive• CE user manual

Declaration of Conformity

It should contain the following:• Name and address of the manufacturer or his authorized representative established

within the Community• A description of the product• Reference to the harmonized standards• Where appropriate, reference to the specifications on which conformity is declared• Identification of the signatory who has been empowered to enter into commitments

on behalf of the manufacturer or his authorized representative established within the community

• The last two digits of the year in which the CE marking was affixed (for the first time)

• The declaration of Conformity must be drawn up at least in one of the official languages of the community.  

Declaration of Conformity Example

New Approach Directives

Low voltage (2006/95/EC)Industrial Trucks (74/150/EEC)Motor Vehicles trailers (70/50/56 EEC)Products labeling directive (83/374 EEC)Simple Pressure Vessels (87/404/EEC)Safety of Toys (87/378/EEC)Construction Products (89/106/EEC)Electromagnetic Compatibility (2004/108/EC)Machinery Safety (2006/42/EC)Personal Protective Equipment (89/686/EEC)Non-automatic Weighing Instruments (90/384/EEC)Active Implantable Medical Devices (90/385/EEC)Gas Appliances (90/396/EEC)

Telecommunications Terminal Equipment (91/263/EEC)Mobile Machinery (91/368 EECHot Water Boilers (92/42/EEC)Medical Devices (93/42/EEC)Lift Machinery (93/44 EEC)Explosive for Civil Uses Directive (93/5/EEC)Satellite Earth Station Equipment (94/9/EEC)Recreational Craft (94/25/EEC)Packaging & packaging waste (94/62EEC)Lift Safety (95/16 EEC)Energy Labeling (97/75 EEC)Pressure Equipment (97/23/EEC)

Addressed here:

MaskindirektivetMachinery Safety Directive

2006/42/EG• Contains Fundamental Safety and Health Requirements for

design and construction of machines• Implemented in Swedish legislation through AFS 2008:3

och 2009:5 (Maskindirektivet)

Machinery Safety DirectiveWhat is machinery?

(a)• an assembly of linked parts or components, at least one of which moves,

with the appropriate actuators, control and power circuits, etc., joined together for a specific application, in particular for the processing, treatment, moving or packaging of a material,

• an assembly of machines which, in order to achieve the same end, are arranged and controlled so that they function as an integral whole,

• interchangeable equipment modifying the function of a machine, which is placed on the market for the purpose of being assembled with a machine or a series of different machines or with a tractor by the operator himself in so far as this equipment is not a spare part or a tool;

(b) 'safety components` means a component, provided that it is not interchangeable equipment, which the manufacturer or his authorised representative established in the Community places on the market to fulfil a safety function when in use and the failure or malfunctioning of which endangers the safety or health of exposed persons.

Example of topics covered by the Machinery Safety Directive

• Risk assessment• Emergency stops• Machine control units - single fault tolerant• Safety components - Ex: Logic for Emergency stop• Protective devices• Safety distances and minimum distances• Hydraulics and pneumatics• Ergonomics• Noise• Vibrations• Hot and cold parts• Electrical risks

Machinery Safety DirectiveHow to reach safe machinery?

1.Remove hazards in the machine design step2.Protect hazardous parts from contact3.Warn for the remaining hazards

The producer must consider both normal use and expected abnormal use of the products

Machinery Safety DirectiveExamples

• Transmission parts like axes or gear-wheels may cause jamming or crushing - protection by cover

• If the consequence of a yet very unlikely accident is serious, it is not enough to warn!

Teknisk tidsskrift, 1938

Machine control unitStandard SS-ISO 11 161:1994

• Fault tolerance can be achieved by:

• Partly or full redundance• Use of diversity• Reduced speed or force for risky movements• Supervision of control functions used for safety

purposes• Acceptance systems

Machine control unitStandard SS-ISO 11 161:1994

• The construction of the system must be fault tolerant:

• A single fault must not lead to increased risk• A single fault that is not discovered must not lead

to increased risk if a second fault occures.

Risk assessmentStandard SS-EN 1050:1996

• Risk• Seriousness of the injury• Probability for the injury to occur

• Frequency and durability of exposure• Probability that a risky event will occur• Technical and human possibilities to avoid or

limit injury

Risk assessment process

• Start• Determining the boundaries of the machine• Identifying the sources of risk• Estimation of risk• Evaluation of risk• Is the machine safe?

YesEND

Reduction of risk

No

Risk assessmentSafety strategy

I. Reduce risks through constructionII. Remove working tasks from risk areaIII. Design protective covers for remaining

work tasksIV. Inform about remaining risks,

surveillance, personal protection equipment

V. Warn for still remaining risks

LågspänningsdirektivetLow Voltage Directive

73/23/EEC with amendment 93/68/EEC

• Applicable for electrical equipment with voltage ratings between 50 and 1000 VAC or 75 - 1500 VDC.

Low Voltage DirectiveWhat is electrical equipment?

• Every product that is used for purposes like generation, transformation, transmission, distribution or use of electric energy, e.g. motors, transformers, apparatus, instruments, protective equipment, cables and house-hold equipment. (IEC)

Low Voltage DirectiveWhy safety requirements?

• Accidents involving electricity - Electric shock

• Fire caused by electricity

Low Voltage DirectiveImpedance hand - foot or hand - hand

• Typically in the range of 1kohm - 5 kohm

• Effect on skin from electric current:

< 10 mA/mm2 No harm10 - 20 mA/mm2 Redness20 - 50 mA/mm2 Blisters> 50 mA/mm2 Gets charred (förkolnas)

Low Voltage Directive

• Effect on human body from electric current:

No reaction0.5 mA unlimited time

Notable, no injury 10 mA, 2s / 200 mA, 10 ms Muscles out of control, cramp40 mA, 3s / 500 mA, 10 ms

Risk for auricular fibrillation80 mA, 3s / 1.5 A, 10 ms (flimmer)

50% auricular fibrillation

Low Voltage DirectiveSafety strategy for faults

0 fault Normal function, no hazard

1 fault ? Function, no hazard

>1 fault ? Function, hazard

Low Voltage DirectiveExamples of solutions

• Protective earth (Class I equipment)

• Double isolation - 230 V cables, standard equipment with no protective earth (Class II equipment)

Low Voltage DirectiveExamples of solutions against fire

• Fuses

• ”Shielding” - Reduce supply of air (oxygen) - Transistor in own metal housing

• Thin bond wires in components

EMC Directive2004/108/EG

Essential requirements• The electromagnetic disturbance generated must not exceed a

level not allowing radio and telecommunications equipment and other apparatus to operate as intended (emission)

• The apparatus must have an adequate level of intrinsic immunity to electromagnetic disturbance to enable it to operate as intended (immunity)

EMC StandardsEmissions test

• 150 kHz - 30 MHz: Conducted

• 30 MHz - 1 GHz: Radiated

EMC StandardsEx of immunity tests

• Radiated RF field 80 MHz - 1 GHz• Electrostatic discharge• Electrical fast transients on power and I/O ports• Surge• AC power voltage dips

EMC StandardsEx på emissionskrav

EMC StandardsEx på Immunitetskrav - Hem, kontor

EMC StandardsEx på Immunitetskrav - Industri

Medical Devices Directive93/42/EEC

• Contains all fundamental health and safety requirements relevant for medical devices

• The different aspects of the Machinery, Low Voltage and EMC directives are included in the medical Devices Directive.

• Medical Devices do therefore ”only” need to meet the requirements of MDD

Software

• Currently no requirements on development process except for Medical Devices

• Consequences of software faults must be taken into account

Unused program memory areasWatchdog

IP-klassning

WEEE – Waste Electrical and Electronic Equipment Directive

2002/96/EC

• Manufacturer responsible for disposal of electrical and electronic equipment

• Users (private household) should be able to return waste free of charge

• Products must be marked with

RoHS– Restriction of Hazardous Substances Directive

2002/95/EC

• Restricts the use of six substances:• Lead• Mercury• Cadmium• Hexavalent chromium (Cr6+)• Polybrominated biphenyls (PBB)• Polybrominated diphenyl ether (PBDE)

• Batteries not included• Covered by Battery Directive (2006/66/EC)

Battery Directive

2006/66/EC

• Restricts the use of:• Lead• Mercury• Cadmium

• Recycling

Anmälningsplikt

Elektriska och elektroniska produkter samt batterier

Naturvårdsverkets EE och batteriregister

• Gäller företag som för in eller tillverkar och sätter sådan produkter på den svenska marknaden

• http://eeb.naturvardsverket.se/ProducentansvarforEE/

Quality control of production

The manufacturer must assure that each produced piece of equipment fullfils the requirements

Responsible for implementation of the directives in Sweden

• Machinery Safety Directive - Arbetsmiljöverket (www.av.se)• Low Voltage Directive - Elsäkerhetsverket (www.elsak.se)• EMC Directive - Elsäkerhetsverket• Medical Device Directive - Socialstyrelsen

Responsible for co-ordination of the market control and certification of

third-part test laboratories • SWEDAC - Styrelsen för ackreditering och teknisk

kontroll

Useful links

• www.sp.se - Sveriges provnings och forskningsinstitut• www.swedac.se - SWEDAC• europa.eu.int/comm/enterprise/newapproach/legislation/

guide/legislation.htm - EU hemsida för the New Approach• www.newapproach.org/directiveList.asp• /www.euroinfo.se/ - svensk EU-information

Risk assessmentStandard SS-EN 1050:1996

• Risk• Seriousness of the injury• Probability for the injury to occur

• Frequency and durability of exposure• Probability that a risky event will occur• Technical and human possibilities to avoid or

limit injury

Machine control unitStandard SS-ISO 11 161:1994

• The construction of the system must be fault tolerant:

• A single fault must not lead to increased risk• A single fault that is not discovered must not lead

to increased risk if a second fault occures.

Risk assessment process

• Start• Determining the boundaries of the machine• Identifying the sources of risk• Estimation of risk• Evaluation of risk• Is the machine safe?

YesEND

Reduction of risk

No

Ex: Risk assessment of a deviceMenotreat

Controlunit

PumpDisplay

Power supply

Heater

Tubing Treatment balloon

Keyboard

Pressure sensor

Menotreat

53

Ex: Risk assessment of a deviceMenotreat

• Patient safety!

• LVD - electrical aspects, shock, leakage currents.• MSD - machinery safety aspects, get jammed, (kläm),

heat, • EMC - immunity, emissions• Material, Silicone-other• Software-validation, fault tolerant.

The end