1. RISK ASSESSMENT How to perform the risk assessment
for one product covered by LVD
(in accordance with the Commission Decision 2010/15/EU)

2. Evert van Wilgenburg Senior Product Safety Expert and Policy
new Food and Consumer Product Safety Authority
Netherlands

3. Guidance Guidelines for the ‘RAPEX’ assessment procedure (2010/15/EC)
RAPEX > Rapid exchange procedure
Quick exchange of information
Prevents to supply products with a serious risk
Effectiveness and consistency of market surveillance
Helps to ensure a high uniform level of consumer health
Notification procedure Article 12 and and Article 11 of the GPSD (2001/95/EC)
Article 11 > non-compliant products > notification
Article 12 > products with a serious risk > RAPEX notification
Risk assessment - Rapex

4. Guidance
The Guidelines are addressed to all the authorities of Member States
RAPEX criteria
the product is a consumer product,
the product is subject to measures that prevent, restrict or impose specific conditions on its possible marketing or use (‘preventive and restrictive measures’),
the product poses a serious risk to the health and safety of consumers,
the serious risk has a cross-border effect.
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5. Risk assessment - Rapex

6. Product assessment – Power supply
Isolation separation via a transformer
230 V
SELV terminals
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7. RAG MODEL – IRAG WG
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8. General information
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9. Product hazards
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10. Injury scenarios
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11. Type of injuries
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12. Severity of injuries
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13. Probability factors
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14. Calculated probability
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15. Probability value
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16. Risks
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17. Assumptions
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18. Another scenario/risk
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19. General notes
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20. Information sheets
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21. For example
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22. Product assessment – Power supply
Isolation separation via a transformer
Break down during the high voltage test
230 V
SELV terminals
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23. Risk assessment model – Product hazards
Identify all hazards that may lead to a consumer injury or health
damage. Consider all consumers, including the vulnerable.
Electric shock
Overheating
Fire ……
(see Hazard sheet of model)
(use for every identified hazard a new row)
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24. Risk assessment model – Injury scenarios (1)
The exact hazard or defect in this product and the event that may result; the interaction of a person with the product during the intended and reasonably foreseeable use and the exposure to the hazard; the mechanism of injury.
Connection to the power supply
Phase is connected in most onerous way
Transient (high power peak) on supply side
High percentage of moisture
Transformer isolation break down
A person makes contact to the SELV circuit encompass
The hands are wet
An electric shock follows
An earth leakage protection device shut down the supply
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25. Risk assessment model – Injury scenarios (2)
The exact hazard or defect in this product and the event that may result; the interaction of a person with the product during the intended and reasonably foreseeable use and the exposure to the hazard; the mechanism of injury.
Connection to the power supply
Phase is connected to in most onerous way
Transient (high power peak) on supply side
High percentage of moisture
Transformer isolation break down
A person makes contact to the SELV circuit encompass
The hands are wet
An electric shock follows
An earth leakage protection device shut down the supply
Blue: the shortest possible scenario
Red: the result
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26. Risk assessment model – Injury scenarios (3)
The exact hazard or defect in this product and the event that may result; the interaction of a person with the product during the intended and reasonably foreseeable use and the exposure to the hazard; the mechanism of injury.
Connection to the power supply
Transformer isolation break down
A person makes contact to the SELV circuit engripped
(There are more scenario’s possible)
(use for every scenario a new row)
Blue: the shortest possible scenario
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27. Risk assessment model – Type of injuries
For each hazard identified, describe the injury resulting from the injury scenario. If you select a hazard form the Hazard List, a typical injury(ies) will be filled in here. Make this more specific by describing both the injury and the body part. Click here to consult the Injury Scale.
Electric shock
(See also under burns as electric current can cause burns)
Local effects (temporary cramp or muscle paralysis) -
Electrocution
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28. Risk assessment model – Severity of injuries
Assign from the Injury Scale: 1 to 4. Click into cell below.
1 Electric shock
(See also under burns as electric current can cause burns)
2 Local effects (temporary cramp or muscle paralysis)
3 -
4 Electrocution
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29. Risk assessment model – Probability of factors
For each hazard identified, estimate the probability for each step in the scenario (event, interaction and injury) e.g.: 1/10; 1/100; 1/8
Connection to the power supply 1/1
Transformer isolation break down 1/1000
A person makes contact to the SELV circuit engripped 1/4
For one product during the total life time
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30. Risk assessment model – Calculated probability
Calculated value of probability factors, e.g. 1/10 x 1/100 x 1/8 = 1/8.000
(Connection to the power supply) 1/1 X (Transformer isolation break down) 1/1000 X (A person makes contact to the SELV circuit engripped) 1/4 = 1/4000
For one product during the total life time
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31. Risk assessment model – Probability value
Select the scale value corresponding to the calculated value, e.g. 1/8.000 corresponds to "> 1/10.000"
(Connection to the power supply) 1/1 X (Transformer isolation break down) 1/1000 X (A person makes contact to the SELV circuit engripped) 1/4 = 1/4000 = > 1/10 000
For one product during the total life time
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32. Risk assessment model – Assumptions
Connection to the power supply 1/1
Every product has the construction failure
Transformer isolation break down 1/1000
Transients in the power source OR pollution of the transformer OR ageing of isolation layers, which can lead to bridging of the isolation in the transformer (in time the probability of failure increases); one off ten overall possibilities of a product becoming defect
A person makes contact to the SELV circuit engripped 1/4
The terminals on the outside of the product OR extension leads connected to those terminals Or the connected external peripheral equipment parts under main voltage become directly accessible. If peripheral equipment is metal encased with a common earthing also the encasing can become connected to the main voltage.
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33. Risk assessment model – Risks (1)
Combined result from the risk table: Serious to Low Risk
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34. Risk assessment model – Risks (2)
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35. Risk assessment model – Risks (3)
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36. Actions if necessary
All categories of preventive and restrictive measures ….., including measures:
marking a product with appropriate warnings on the risks it may present;
making the marketing of a product subject to prior conditions;
warning consumers of the risks that could be posed by a product for certain persons;
temporary ban on the supply, offer to supply and display of a product;
ban on the marketing of a product and any accompanying measures;
withdrawal of a product from the market;
recall of a product from consumers;
destruction of a withdrawn or recalled product.
(see par of the guide)
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37. Thank you for your attention
Evert van Wilgenburg
Senior Product Safety Expert and Policy
Chairman LVD-AdCo 2010
Division Primex
new Food and Consumer Product Safety Authority
Westelijke Parallelweg 4 | 3331 EW | Zwijndrecht | TVE
Postbus 3000 | 3330 DC | Zwijndrecht | Netherlands
T 0031 (0)
F 0031 (0)
The AID, PD and VWA are building one new Food and Consumer Product Safety Authority.
Risk assessment - Rapex