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ANNEXU.K.

RISK ASSESSMENT GUIDELINES FOR CONSUMER PRODUCTS (1) U.K.

6. Examples U.K.

6.3. Sensitivity analysis U.K.
Table 3 Severity of injury U.K.
IntroductionU.K.

These risk assessment guidelines distinguish between four levels of injury harm 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 harm 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.

Harm 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.

Harm 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.

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

4.

Harm 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 air way 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)

1°, up to 100 % of body surface

2°, < 6 % of body surface

2°, 6-15 % of body surface

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

Inhalation burn

2° or 3°, > 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

(1)

If you need more information on the Risk Assessment method for harmonised products (both consumer and professional products) in relation to broader categories of public risks protected under EU harmonisation legislation, please refer to Part I, Chapter 5.3.