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Commission Decision of 16 December 2009 laying down guidelines for the management of the Community Rapid Information System ‘RAPEX’ established under Article 12 and of the notification procedure established under Article 11 of Directive 2001/95/EC (the General Product Safety Directive) (notified under document C(2009) 9843) (2010/15/EU) (repealed)

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6.Examples

6.1.Folding chair

A folding chair has a folding mechanism constructed in such a way that the user’s fingers can get trapped between the seat and the folding mechanism. This can lead to fractures or even loss of one or more fingers.

Determination of risk(s)

Injury scenarioInjury type and locationSeverity of injuryProbability of injuryOverall probabilityRisk
Person unfolds the chair, grips seat close to the back corner by mistake (Person inattentive/distracted), finger gets caught between seat and backrestMinor pinching of finger1Unfolding the chair11/500Low risk
Gripping the seat at back corner while unfolding1/50
Finger gets caught1/10> 1/1 000
Minor pinching1
Person unfolds the chair, grips seat at the side by mistake (Person inattentive/distracted), finger gets caught between seat and linkMinor pinching of finger1Unfolding the chair11/500Low risk
Gripping the seat at the side while unfolding1/50
Finger gets caught1/10> 1/1 000
Minor pinching1
Person unfolds the chair, chair is clamped, person tries to push down the seat and grips seat close to the corner by mistake (Person inattentive/distracted), finger gets caught between seat and backrestFracture of finger2Unfolding the chair11/500 000Low risk
Chair clamps1/1 000
Gripping the seat at corners while unfolding1/50
Finger gets caught1/10> 1/1 000 000
Fracture of finger1
Person unfolds the chair, chair is clamped, person tries to push down the seat and grips seat at the side by mistake (Person inattentive/distracted), finger gets caught between seat and linkFracture of finger2Unfolding the chair11/500 000Low risk
Chair clamps1/1 000
Gripping the seat at the side while unfolding1/50
Finger gets caught1/10> 1/1 000 000
Fracture of finger1
Person is sitting on chair, wants to move the chair and tries to lift it by gripping the chair at the rear part of the seat, finger gets caught between seat and backrestLoss of digit3Sitting on chair11/6 000High risk
Moves the chair while sitting1/2
Grips chair at rear part while moving1/2
Chair partially folds, creating a gap between the backrest and seat1/3> 1/10 000
Finger is between backrest and seat1/5
Finger gets caught1/10
Loss of (part of) finger1/10
Person is sitting on chair, wants to move the chair and tries to lift it by gripping the chair at the rear part of the seat, finger gets caught between seat and linkLoss of digit3Sitting on chair11/6 000High risk
Moves the chair while sitting1/2
Grips chair at rear part while moving1/2
Chair partially folds, creating a gap between the backrest and seat1/3> 1/10 000
Finger is between backrest and seat1/5
Finger gets caught1/10
Loss of (part of) finger1/10

The overall risk of the folding chair is thus ‘high risk’.

6.2.Socket protectors

This case deals with socket protectors. These are devices that users (parents) put into the electrical socket outlets to stop small children from accessing live parts by putting a long metal object into one of the holes in the outlet and getting a (fatal) electric shock.

The holes in this particular protector (where the pins of the plug go through) are so narrow that the pins can get stuck. This means that the user may pull the protector off the outlet when the plug is pulled out. The user may not notice this happening.

Determination of risk(s)

Injury scenarioInjury type and locationSeverity of injuryProbability of injuryOverall probabilityRisk
Protector is removed from the socket, which becomes unprotected. Child is playing with thin conductible object, which can be inserted into the socket, accessing high voltage and is electrocuted.Electrocution4Removal of protector9/1027/160 000Serious risk
Not noticing the removal of protector1/10
Child is playing with thin conductible object1/10
Child is unattended when playing1/2> 1/10 000
Child inserts the object into the socket3/10
Access to voltage1/2
Electrocution due to voltage (without circuit interrupter)1/4
Protector is removed from the socket, which becomes unprotected. Child is playing with thin conductible object, which can be inserted into the socket, accessing high voltage and sustains shock.Burns 2nd degree1Removal of protector9/1081/160 000Low risk
Not noticing the removal of protector1/10
Child is playing with thin conductible object1/10
Child inserts the object into the socket3/10
Access to voltage1/2> 1/10 000
Child is unattended when playing1/2
Burn due to electric current (without circuit interrupter)3/4
Socket unprotected. Child is playing with thin conductible object, which can be inserted into the socket, accessing high voltage and is electrocuted.Electrocution4Child is playing with thin conductible object1/103/80 000High risk
Child is unattended when playing1/100
Child inserts the object into the socket3/10
Access to voltage1/2> 1/100 000
Electrocution due to voltage (without circuit interrupter)1/4

The overall risk of the socket protectors is thus ‘serious’.

6.3.Sensitivity analysis

The factors used to calculate the risk of an injury scenario, namely the severity of the injury and the probability, often have to be estimated. This creates uncertainty. Probability in particular can be difficult to estimate, since the behaviour of consumers, for example, can be difficult to predict. Does a person perform a certain action often or only occasionally?

It is therefore important to consider the level of uncertainty of the two factors and to make a sensitivity analysis. The purpose of this analysis is to establish how much the risk level varies when the estimated factors vary. The example below only shows the variation of probability, since the severity of the injury is usually predicted with more certainty.

A practical way of performing the sensitivity analysis is to repeat the risk assessment for a certain scenario, but to use a different probability for one or more steps in the scenario. For example, a candle containing seeds could cause a fire, because the seeds can catch fire and generate high flames. Furniture or curtains can catch fire and persons not in the room could inhale toxic fumes and suffer fatal poisoning:

Injury scenarioInjury type and locationSeverity of injuryProbability of injuryResulting proba-bilityRisk
Seeds or beans catch fire generating high flames. Furniture or curtains catch fire. Persons are not in room, but inhale toxic fumes.Fatal poisoning4
  • Seeds or beans catch fire: 90 % (0,9)

  • People not in the room for some time: 30 % (0,3)

  • Furniture or curtains catch fire: 50 % (0,5) (depends on surface on which candle is placed)

  • Persons inhale toxic fumes: 5 % (0,05)

0,00675

> 1/1 000

Serious

The probability levels for the steps in the scenario were estimated as shown in the table.

The overall probability is 0,00675, which corresponds to > 1/1 000 in table 4. This leads to the conclusion of ‘serious risk’. Note that the exact probability is closer to 1/100 than to 1/1 000, which already gives some confidence in the risk level because it is a little deeper in the serious risk area of table 4 than the > 1/1 000 row suggests.

Suppose we are uncertain about the 5 % probability that persons inhale the toxic fumes. We could put it at a much lower 0,1 % (0,001 = 1 in a thousand). If we recalculate with that assumption, the overall probability is 0,000135, which translates into > 1/10 000. Nevertheless, the risk is still serious. Even if for some reason the probability were to be a factor of 10 lower, the risk would still be high. Therefore, although the probability may vary 10- or 100-fold, we still find a serious or high risk (the latter being quite close to ‘serious’). Thus, this sensitivity analysis lets us confidently assess the risk as serious.

In general, however, risk assessment should be based on ‘reasonable worst cases’: not too pessimistic on every factor, but certainly not too optimistic.

Table 1

Consumers

ConsumersDescription
Very vulnerable consumers

Very young children: 0 to 36 months

Others: Persons with extensive and complex disabilities

Vulnerable consumers

Young children: Children older than 36 months and younger than 8 years

Older children: Children 8 to 14 years

Others: Persons with reduced physical, sensory or mental capabilities (e.g. partially disabled, elderly, including those over 65, with some reduction in their physical and mental capabilities), or lack of experience and knowledge

Other consumersConsumers other than very vulnerable or vulnerable consumers
Table 2

Hazards, Typical Injury Scenarios And Typical Injuries

NB: This table is for guidance only; the typical injury scenarios should be adapted when preparing a risk assessment. There is specific risk assessment guidance for chemicals, cosmetics and possibly others. It is highly recommended to use this specific guidance when assessing such products. See section 3.2.

Hazard groupHazard (product property)Typical injury scenarioTypical injury
Size, shape and surfaceProduct is obstaclePerson trips over product and falls; or person bumps into productBruising; fracture, concussion
Product is impermeable to airProduct covers mouth and/or nose of a person (typically a child), or covers internal airwaySuffocation
Product is or contains small partPerson (child) swallows small part; the part gets stuck in larynx and blocks airwaysChoking, internal airway obstruction
Possible to bite off small part from productPerson (child) swallows small part; the part gets stuck in the digestive tractDigestive tract obstruction
Sharp corner or pointPerson bumps into sharp corner or is hit by moving sharp object; this causes a puncture or penetration injuryPuncture; blinding, foreign body in eye; hearing, foreign body in ear
Sharp edgePerson touches sharp edge; this lacerates the skin or cuts through tissuesLaceration, cut; amputation
Slippery surfacePerson walks on surface, slips and fallsBruising; fracture, concussion
Rough surfacePerson slides along rough surface; this causes friction and/or abrasionAbrasion
Gap or opening between partsPerson puts a limb or body in opening and finger, arm, neck, head, body or clothing is trapped; injury occurs due to gravity or movementCrushing, fracture, amputation, strangulation
Potential energyLow mechanical stabilityProduct tips; person on top of product falls from height, or person near product is hit by the product; electrical product tips, breaks and gives access to live parts, or continues to work heating nearby surfacesBruising; dislocation; sprain; fracture, concussion; crushing; electric shock; burns
Low mechanical strengthProduct collapses by overloading; person on top of product falls from height, or person near product is hit by the product; electrical product tips, breaks and gives access to live parts, or continues to work heating nearby surfacesBruising; dislocation; fracture, concussion; crushing; electric shock; burns
High position of userPerson at high position on the product loses balance, has no support to hold on to and falls from heightBruising; dislocation; fracture, concussion; crushing
Elastic element or springElastic element or spring under tension is suddenly released; person in the line of movement is hit by the productBruising; dislocation; fracture, concussion; crushing
Pressurised liquid or gas, or vacuumLiquid or gas under pressure is suddenly released; person in the vicinity is hit; or implosion of the product produces flying objectsDislocation; fracture, concussion; crushing; cuts (see also under fire and explosion)
Kinetic energyMoving productPerson in the line of movement of the product is hit by the product or run overBruising; sprain; fracture, concussion; crushing
Parts moving against one anotherPerson puts a body part between the moving parts while they move together; the body part gets trapped and put under pressure (crushed)Bruising; dislocation; fracture; crushing
Parts moving past one anotherPerson puts a body part between the moving parts while they move close by (scissor movement); the body part gets trapped between the moving parts and put under pressure (shearing)Laceration, cut; amputation
Rotating partsA body part, hair or clothing of a person is entangled by the rotating part; this causes a pulling forceBruising; fracture; laceration (skin of the head); strangulation
Rotating parts close to one anotherA body part, hair or clothing of a person is drawn in by the rotating parts; this causes a pulling force and pressure on the body partCrushing, fracture, amputation, strangulation
AccelerationPerson on the accelerating product loses balance, has no support to hold on to and falls with some speedDislocation; fracture, concussion; crushing
Flying objectsPerson is hit by the flying object and depending on the energy sustains injuriesBruising; dislocation; fracture, concussion; crushing
VibrationPerson holding the product loses balance and falls; or prolonged contact with vibrating product causes neurological disorders, osteo-articular disorder, trauma of the spine, vascular disorderBruising; dislocation; fracture; crushing
NoisePerson is exposed to noise from the product. Tinnitus and hearing loss may occur depending on sound level and distanceHearing injury
Electrical energyHigh/low voltagePerson touches part of the product that is at high voltage; the person receives an electric shock and may be electrocutedElectric shock
Heat productionProduct becomes hot; a person touching it may sustain burns; or the product may emit molten particles, steam, etc., that hits a personBurn, scald
Live parts too closeElectric arc or sparks occur between the live parts. This may cause a fire and intense radiationEye injury; burn, scald
Extreme temperaturesOpen flamesA person near the flames may sustain burns, possibly after clothing catches fireBurn, scald
Hot surfacesPerson does not recognise the hot surface and touches it; the person sustains burnsBurn
Hot liquidsPerson handling a container of liquid spills some of it; the liquid falls on the skin and causes scaldsScald
Hot gasesPerson breathes in the hot gases emitted from a product; this causes lung burn; or prolonged exposure to hot air causes dehydrationBurn
Cold surfacesPerson does not recognise the cold surface and touches it; the person sustains frostbiteBurn
RadiationUltraviolet radiation, laserSkin or eyes of a person are exposed to radiation emitted by the productBurn, scald; neurological disorders; eye injury; skin cancer, mutation
High intensity electromagnetic field (EMF) source; low frequency or high frequency (microwave)Person is close to the electromagnetic field (EMF) source, body (central nervous system) is exposedNeurological (brain) damage, leukaemia (children)
Fire and explosionFlammable substancesPerson is near the flammable substance; an ignition source sets the substance on fire; this causes injuries to the personBurn
Explosive mixturesPerson is near the explosive mixture; an ignition source causes an explosion; the person is hit by the shock wave, burning material and/or flamesBurn, scald; eye injury, foreign body in eye; hearing injury, foreign body in ear
Ignition sourcesThe ignition source causes a fire; a person is injured by flames, or intoxicated by gases from the house fireBurn; poisoning
OverheatingProduct overheats; fire, explosionBurn, scald; eye injury, foreign body in eye; hearing injury, foreign body in ear
ToxicityToxic solid or fluidPerson ingests substance from product, e.g. by putting it in mouth, and/or substance gets on skinAcute poisoning; irritation, dermatitis
Person breathes in solid or fluid, for example vomited material (pulmonary aspiration)Acute poisoning in lungs (aspiration pneumonia); infection
Toxic gas, vapour or dustPerson inhales substance from product; and/or substance gets on skinAcute poisoning in lungs; irritation, dermatitis
Sensitising substancePerson ingests substance from product, e.g. by putting it in mouth; and/or substance gets on skin; and/or person inhales gas, vapour or dustSensitisation; allergic reaction
Irritating or corrosive solid or fluidPerson ingests substance from product, e.g. by putting it in mouth, and/or substance gets on skin or in eyesIrritation, dermatitis; skin burn; eye injury, foreign body in eye
Irritating or corrosive gas or vapourPerson inhales substance from product, and/or substance gets on skin or in eyesIrritation, dermatitis; skin burn; acute poisoning or corrosive effect in lungs or in eyes
CMR substancePerson ingests substance from product, e.g. by putting it in mouth, and/or substance gets onto skin; and/or person inhales substance as gas, vapour or dustCancer, mutation, reproductive toxicity
Microbiological contaminationMicrobiological contaminationPerson gets into contact with contaminated product by ingestion, inhalation or skin contactInfection, local or systemic
Product operating hazardsUnhealthy postureDesign causes unhealthy posture of person when operating the productStrain; musculoskeletal disorder
OverexertionDesign requires use of considerable force when operating the productSprain or strain; musculoskeletal disorder
Anatomical unsuitabilityDesign is not adapted to human anatomy, which makes it difficult or impossible to operateSprain or strain
Ignoring personal protectionDesign makes it difficult for a person wearing protection to handle or operate the productVarious injuries
Inadvertent (de)activationPerson can easily (de)activate product, which leads to unwanted operationVarious injuries
Operational inadequacyDesign provokes faulty operation by a person; or product with a protective function does not provide expected protectionVarious injuries
Failure to stopPerson wants to stop the product, but it continues to operate in situation where this is unwantedVarious injuries
Unexpected startProduct shuts down during a power failure, but resumes operation in a hazardous wayVarious injuries
Inability to stopIn an emergency situation, person is not able to stop operation of the productVarious injuries
Inadequately fitting partsPerson tries to fit a part, needs too much force to fit, product breaks; or part is too loosely fitted and becomes loose during useSprain or strain; laceration, cut; bruising; entrapment
Missing or incorrectly fitted protectionHazardous parts are reachable for a personVarious injuries
Insufficient warning instructions, signs and symbolsUser does not notice warning instructions signs and/or does not understand symbolsVarious injuries
Insufficient warning signalsUser does not see or hear warning signal (optical or audio), causing dangerous operationVarious injuries
Table 3

Severity of injury

Introduction

These risk assessment guidelines distinguish between four levels of injury severity. It is important to realise that severity should be assessed completely objectively. The aim is to compare the severity of different scenarios and to set priorities, not to judge the acceptability of a single injury at this stage. Any injury that could easily have been avoided will be difficult to accept for a consumer. However, authorities can justifiably invest more effort into avoiding irreversible consequences than into preventing temporary discomfort.

In order to assess the severity of the consequences (acute injury or other damage to health), objective criteria can be found, on the one hand, in the level of medical intervention, and, on the other hand, in the consequences to the further functioning of the victim. Both could be expressed as cost, but the costs of consequences of health damage may be difficult to quantify.

Combining these criteria, the four levels may be defined as follows:

1.

Injury or consequence that after basic treatment (first aid, normally not by a doctor) does not substantially hamper functioning or cause excessive pain; usually the consequences are completely reversible.

2.

Injury or consequence for which a visit to A&E may be necessary, but in general, hospitalisation is not required. Functioning may be affected for a limited period, not more than about 6 months, and recovery is more or less complete.

3.

Injury or consequence that normally requires hospitalisation and will affect functioning for more than 6 months or lead to a permanent loss of function.

4.

Injury or consequence that is or could be fatal, including brain death; consequences that affect reproduction or offspring; severe loss of limbs and/or function, leading to more than approximately 10 % of disability.

The following table, which should be considered as a guide rather than prescriptive or complete, provides examples of injuries at all four levels. National differences may exist, either cultural or caused by different systems of health care and financial arrangements. However, deviating from the proposed classification in the table will affect uniform assessment of risks in the EU; this should be clearly stated and explained in the risk assessment report, and reasons should be given.

Type of injurySeverity of injury
1234
Laceration, cutSuperficial

External (deep) (> 10 cm long on body)

(> 5 cm long on face) requiring stitches

Tendon or into joint

White of eye or cornea

Optic nerve

Neck artery

Trachea

Internal organs

Bronchial tube

Oesophagus

Aorta

Spinal cord (low)

Deep laceration of internal organs

Severed high spinal cord

Brain (severe lesion/dysfunction)

Bruising (abrasion/contusion, swelling, oedema)

Superficial

≤25 cm2 on face

≤50 cm2 on body

Major

> 25 cm2 on face

> 50 cm2 on body

Trachea

Internal organs (minor)

Heart

Brain

Lung, with blood or air in chest

Brain stem

Spinal cord causing paralysis

ConcussionVery short unconsciousness (minutes)Prolonged unconsciousnessComa
Entrapment/pinchingMinor pinching(Use as appropriate the final outcomes of bruising, crushing, fracture, dislocation, amputation, as applicable.)(Same outcome as for suffocation/strangulation.)
Sprain, strain, musculoskeletal disorder

Extremities

Joints

Spine (no dislocation or fracture)

Knee ligaments strain

Ligament or tendon rupture/tear

Muscle tear

Whiplash

Dislocation

Extremities (finger, toe, hand, foot)

Elbow

Jaw

Loosening of tooth

Ankle

Wrist

Shoulder

Hip

Knee

Spine

Spinal column
Fracture

Extremities (finger, toe, hand, foot)

Wrist

Arm

Rib

Sternum

Nose

Tooth

Jaw

Bones around eye

Ankle

Leg (femur and lower leg)

Hip

Thigh

Skull

Spine (minor compression fracture)

Jaw (severe)

Larynx

Multiple rib fractures

Blood or air in chest

Neck

Spinal column

Crushing

Extremities (fingers, toe, hand, foot)

Elbow

Ankle

Wrist

Forearm

Leg

Shoulder

Trachea

Larynx

Pelvis

Spinal cord

Mid-low neck

Chest (massive crushing)

Brain stem

Amputation

Finger(s)

Toe(s)

Hand

Foot

(Part of) Arm

Leg

Eye

Both extremities
Piercing, puncturingLimited depth, only skin involved

Deeper than skin

Abdominal wall (no organ involvement)

Eye

Internal organs

Chest wall

Aorta

Heart

Bronchial tube

Deep injuries in organs (liver, kidney, bowel, etc.)

Ingestion

Internal organ injury

(Refer also to internal airway obstruction where the ingested object gets stuck high in the oesophagus.)

Permanent damage to internal organ
Internal airway obstructionOxygen flow to brain blocked without permanent consequencesOxygen flow to brain blocked with permanent consequences
Suffocation/StrangulationOxygen flow to brain blocked without permanent consequencesFatal suffocation/strangulation
Submersion/DrowningFatal drowning
Burn/Scald (by heat, cold, or chemical substance)

1o, up to 100 % of body surface

2o, < 6 % of body surface

2o, 6-15 % of body surface

2o, 16-35 % of body surface, or 3o, up to 35 % of body surface

Inhalation burn

2o or 3o, > 35 % of body surface

Inhalation burn requiring respiratory assistance

Electric shock(See also under burns as electric current can cause burns.)Local effects (temporary cramp or muscle paralysis)Electrocution
Neurological disordersTriggered epileptic seizure
Eye injury, foreign body in eyeTemporary pain in eye without need for treatmentTemporary loss of sight

Partial loss of sight

Permanent loss of sight (one eye)

Permanent loss of sight (both eyes)
Hearing injury, foreign body in earTemporary pain in ear without need for treatmentTemporary impairment of hearing

Partial loss of hearing

Complete loss of hearing (one ear)

Complete loss of hearing (both ears)
Poisoning from substances (ingestion, inhalation, dermal)Diarrhoea, vomiting, local symptomsReversible damage to internal organs, e.g. liver, kidney, slight haemolytic anaemiaIrreversible damage to internal organs, e.g. oesophagus, stomach, liver, kidney, haemolytic anaemia, reversible damage to nerve system

Irreversible damage to nerve system

Fatality

Irritation, dermatitis, inflammation or corrosive effect of substances (inhalation, dermal)Local slight irritation

Reversible eye damage

Reversible systemic effects

Inflammatory effects

Lungs, respiratory insufficiency, chemical pneumonia

Irreversible systemic effects

Partial loss of sight

Corrosive effects

Lungs, requiring respiratory assistance

Asphyxia

Allergic reaction or sensitisationMild or local allergic reactionAllergic reaction, widespread allergic contact dermatitisStrong sensitisation, provoking allergies to multiple substances

Anaphylactic reaction, shock

Fatality

Long-term damage from contact with substances or from exposure to radiationDiarrhoea, vomiting, local symptomsReversible damage to internal organs, e.g. liver, kidney, slight haemolytic anaemiaDamage to nervous system, e.g. Organic Psycho Syndrome (OPS; also called Chronic Toxic Encephalopathy, also known as ‘painters' disease’). Irreversible damage to internal organs, e.g. oesophagus, stomach, liver, kidney, haemolytic anaemia, reversible damage to nervous system

Cancer (leukaemia)

Effects on reproduction

Effects on offspring

CNS depression

Microbiological infectionReversible damageIrreversible effects

Infection requiring prolonged hospitalisation, antibiotics-resistant organisms

Fatality

Table 4

Risk level from the combination of the severity of injury and probability

Probability of damage during the foreseeable lifetime of the productSeverity of injury
1234
High> 50 %HSSS
> 1/10MSSS
> 1/100MSSS
> 1/1 000LHSS
> 1/10 000LMHS
> 1/100 000LLMH
> 1/1 000 000LLLM
Low< 1/1 000 000LLLL
S — Serious Risk
H — High risk
M — Medium risk
L — Low risk

Glossary of terms

Hazard: Source of danger involving the chance of being injured or harmed. A means of quantifying the hazard in a risk assessment is the severity of the possible injury or harm.

Product hazard: Hazard created by the properties of a product.

Risk: Balanced combination of a hazard and the probability that damage will occur. Risk describes neither the hazard, nor the probability, but both at the same time.

Risk assessment: Procedure for identifying and assessing hazards, consisting of three steps:

  • identification of the seriousness of a hazard;

  • determination of the probability that a consumer will be injured by that hazard;

  • combination of the hazard with the probability.

Risk level: Degree of risk, which may be ‘serious’, ‘high’, ‘medium’ and ‘low’. When the (highest) level of risk has been identified, the risk assessment is complete.

Risk management: Follow-up action, which is separate from risk assessment and aims to reduce or eliminate a risk.

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