1 of 15 Risk assessment based on EU commission decision (2010/15/EU) Manufacturer: Model name: Description of Product: Applicable to following standard(s) listed in OJ: (Risks covered in standards are not repeated in assessment) Standard: Tested/certified: Yes No Test house / certification body: Ref No: Assessment done by (name + signature) Date: Verified by (name + signature) Date:
2 of 15 Introduction in using this report 1 Describe the product and it s intrinsic hazards (eg sharp edges) 2 Identify consumer (eg children) 3 Describe the injury scenario (eg child drops sharp object on foot) 4 Determine the severity of the injury (eg superficial cut to skin) 5 Determine the probability (eg 00) 6 Look up the risk in the table (eg serious risk)
3 of 15 Step 1: Product and Intrinsic hazards Below are some elements to consider when describing the product: THE PRODUCT Child appealing Y e s N o N /A Remark Child protection Warnings on product Instructions for installation Instructions for use Is any hazards limited to parts of the product (separately available)? Does the product require personal protection? Is the product ready to use? (versus to be assembled/prepared by user) Will age/lack of maintenance effect hazard?
4 of 15 Below are some elements to consider when describing the hazards of the product: INTRINSIC HAZARDS Y e s N o N /A Remark Mechanical hazards Sharp edges Tight openings Kinetic energy (Moving parts etc) Potential energy (Loaded springs, fluid etc) Choking hazards, (small parts, parts getting loose) Suffocation hazard (Drawstrings etc) Electrical hazard (Often covered by safety std) Fire hazard Thermal hazard Chemical hazard Microbiological hazard Noise hazard Explosion/implosion Radiation hazard (EMF, laser etc) Hazard from non-working safety features (as in reflexes, helmets, sunscreen etc)
Step 2: The consumer 5 of 15 Below are some elements to consider when describing the consumer I: Intended user NI: Non-intended user N/A: Not Applicable (will not be using the product) THE CONSUMER I NI Very vulnerable consumers Very young children (0-36 months) Persons with extensive/complex disabilities Vulnerable consumers Young children (3-8 years) Other children (8-14 years) Other: Persons with reduced physical, sensory or mental capabilities (eg partially disabled, elderly) or lack of experience and knowledge Other Consumers (other than vulnerable) N / A Remark Bystanders: Are there bystanders who may be effected by the product Does the product require training for safe use? Will the user recognise dangers of the product? (Like eg for a knife or a chain saw?) Will the consumer act rational in the event of a hazard? May the cultural background of the user effect the risk? Y e s No
6 of 15 Step 3: Injury scenario: steps leading to injury(ies) Most injury scenarios consist of the following three main steps: 1 The product has a defect or can lead to a dangerous situation in its lifetime 2 The dangerous situation leads to an accident 3 The accident results in an injury SCENARIOS Consider from previous pages - the Product - the different intrinsic hazards - the different consumers/use of the product and the combinations of these Examples (to be deleted in final report) - Child is taking the cat-figured lamp into bed causing burn - Child is taking the cat-figured lamp into bed causing a fire - Child is breaking lamp exposing live parts and is electrocuted - Grown-up is breaking lamp exposing live parts and is electrocuted Scenario 1 Xxx Scenario 2 Xxx Scenario 3 Xxx Scenario 4 Xxx Scenario 4 Xxx Scenario 4 Xxx
Step 4: Severity of Injury Local Certification Manual 7 of 15 The injury that a hazard can cause to the consumer can have different degrees of severity The severity of the injury thus reflects the effect the hazard has on the consumer under the condition described in the injury scenario The severity is divided into 4 categories: 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, hospitalization 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 hospitalization 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 Examples of these categories are found in Appendix A
8 of 15 Step 5: Probability of Injury The probability of injury is the probability that injury scenario may indeed materialize during the expected lifetime of the product It is normally generated by multiplying the probability of each step leading up to the overall probability of the scenario described in step 3 Example: handle of cup breaking causing burs from hot liquid - Handle to break of: 00 (example only) - Cup in position to spill: 1/2 (example only) - Fluid hot enough to cause burns: (example only) Probability will then be: 1/1 000 * 1/2 * = 1/20 000 which will be in group 0 000 This guide distinguishes between 8 levels of probability: High risk Low risk > 50 % > > 0 > 1/1 000 > 000 > 0 000 > 1/1 000 000 < 1/1 000 000
9 of 15 Step 6: Determination of risk The risk is defined as a combination between severity and probability and is divided into 4 categories: S H M L Serious risk High risk Medium risk Low risk Severity of injury Probability of damage 1 2 3 4 High risk > 50 % H S S S > M S S S > 0 M S S S > 1/1 000 L H S S > 000 L M H S > 0 000 L L M H > 1/1 000 000 L L L M Low risk < 1/1 000 000 L L L L
Determination of risk 10 of 15 (Example in Appendix B) Injury scenario (include user) Injury type and body part Severity (1-4) Probability of injury Overall possibility Risk (L/M/H/S)
xx/2015 Appendix A 11 of 15 Type of injury Laceration, cut Superficial External (deep) (> 10 cm long on body) (> 5 cm long on face) requiring stitches Tendon or into joint White of eye or cornea abrasion/ contusion, swelling, oedema) Severity of injury 1 2 3 4 Optic nerve Neck artery Trachea Internal organs Superficial 25 cm2 on face 50 cm2 on body Major > 25 cm2 on face > 50 cm2 on body Concussion Very short unconsciousness (minutes) Trachea Internal organs (minor) Heart Brain Lung, with blood or air in chest Prolonged unconsciousness Bronchial tube Esophagus Aorta Spinal cord (low) Deep laceration of internal organs Severed high spinal cord Brain (severe lesion/dysfunction Brain stem Spinal cord causing paralysis Coma Entrapment/ pinching Sprain, strain, musculoskeletal disorder Minor pinching (Use as appropriate the final outcomes of bruising, crushing, fracture, dislocation, amputation, as applicable) Extremities Joints Spine (no dislocation or fracture) Knee ligaments strain Dislocation Extremities (finger, toe, hand, foot) Elbow Jaw Loosening of tooth Fracture Extremities (finger, toe, hand, foot) Wrist Arm Rib Sternum Nose Tooth Jaw Bones around eye Ligament or tendon rupture/tear Muscle tear Whiplash Ankle Wrist Shoulder Hip Knee Spine Ankle Leg (femur and lower leg) Hip Thigh Skull Spine (minor compression fracture) Jaw (severe) Larynx Multiple rib fractures Blood or air in chest (Same outcome as for suffocation/ strangulation) Spinal column Neck Spinal column
xx/2015 12 of 15 Type of injury Severity of injury 1 2 3 4 Crushing Extremities (fingers, toe, hand, foot) Elbow Ankle Wrist Forearm Leg Shoulder Trachea Larynx Pelvis Amputation Finger(s) Toe(s) Hand Foot (Part of) Arm Leg Eye Piercing, puncturing Limited depth, only skin involved Deeper than skin Abdominal wall (no organ involvement) Eye Internal organs Chest wall Ingestion Internal organ injury (Refer also to internal airway obstruction where the ingested object gets stuck high in the oesophagus) Internal airway obstruction Oxygen flow to brain blocked without permanent consequences Spinal cord Mid-low neck Chest (massive crushing) Brain stem Both extremities Aorta Heart Bronchial tube Deep injuries in organs (liver, kidney, bowel, etc) Permanent damage to internal organ Oxygen flow to brain blocked with permanent consequences Suffocation/ Strangulation Oxygen flow to brain blocked without permanent consequences Fatal suffocation/ strangulation Submersion/ Drowning Fatal 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 disorders Triggered epileptic seizure
xx/2015 Type of injury body in eye Hearing injury, foreign body in ear Poisoning from substances (ingestion, inhalation, dermal) Irritation, dermatitis, inflammation or corrosive effect of substances (inhalation, dermal) Allergic reaction or sensitisation Long-term damage from contact with substances or from exposure to radiation Microbiological infection Severity of injury 1 2 3 4 Temporary pain in Temporary loss of Partial loss of sight eye without need sight Permanent loss of for treatment sight (one eye) Temporary pain in ear without need for treatment Diarrhoea, vomiting, local symptoms Local slight irritation Mild or local allergic reaction Diarrhoea, vomiting, local symptoms Temporary impairment of hearing Reversible damage to internal organs, eg liver, kidney, slight haemolytic anaemia Reversible eye damage Reversible systemic effects Inflammatory effects Allergic reaction, widespread allergic contact dermatitis Reversible damage to internal organs, eg liver, kidney, slight haemolytic anaemia Partial loss of hearing Complete loss of hearing (one ear) Irreversible damage to internal organs, eg oesophagus, stomach, liver, kidney, haemolytic anaemia, reversible damage to nerve system Lungs, respiratory insufficiency, chemical pneumonia Irreversible systemic effects Partial loss of sight Corrosive effects Strong sensitisation, provoking allergies to multiple substances Damage to nervous system, eg Organic Psycho Syndrome (OPS; also called Chronic Toxic Encephalopathy, also known as painters disease ) Irreversible damage to internal organs, eg oesophagus, stomach, liver, kidney, haemolytic anaemia, reversible damage to nervous system Permanent loss of sight (both eyes) Complete loss of hearing (both ears) Irreversible damage to nerve system Fatality Lungs, requiring respiratory assistance Asphyxia Anaphylactic reaction, shock Fatality Cancer (leukaemia) Effects on reproduction Effects on offspring CNS depression Reversible damage Irreversible effects Infection requiring prolonged hospitalisation, antibiotics-resistant organisms Fatality 13 of 15
xx/2015 Appendix B 14 of 15 Example of determination of risk (NB: these are examples and the figures used may not be used in actual assessments) Injury scenario (include user) Injury type and body part Severity (1-4) Probability of injury Overall possibility Risk (L/M/H/S) Grownup push lamp from table, breaking lamp and live parts get exposed Picking up lamp with one hand getting exposed to live parts Electrical burn on one hand 2 < 6% of body surface 1 Lamp getting tipped Lamp breaking Live parts exposed Picking up w/o disconnecting 0 1/50 1/500 000 use: >1/1 000 000 L Grownup push lamp from table, breaking lamp and live parts get exposed Picking up lamp with one hand getting exposed to live parts Electrocution 4 Lamp getting tipped Lamp breaking Live parts exposed Picking up w/o disconnecting 0 1/50 1/500 000 use: >1/1 000 M
xx/2015 Child push lamp from table, breaking lamp and live parts get exposed Picking up lamp with one hand getting exposed to live parts Electrical burn on one hand 2 < 6% of body surface 1 Lamp getting tipped Lamp breaking Live parts exposed Picking up w/o disconnecting 1/50 1/50 000 use: >0 000 15 of 15 H Child push lamp from table, breaking lamp and live parts get exposed Picking up lamp with one hand getting exposed to live parts Electrocution 4 Lamp getting tipped Lamp breaking Live parts exposed Picking up w/o disconnecting 1/50 1/5* 1/25 000 use: >0 000 H * A child may be more likely to use two hands rather than one