Risk Assessment by the Market Surveillance Authorities Content • risk/safety definitions and aspects • risk assessment methodology • risk calculation Dr. Jörg Windberg, Dortmund (Germany) joerg.windberg@gmx.de
What means risk?
temporal and/or local temporal and/or local separation: Safety overlapping: Risk/Danger/Hazard Principles of hazard, risk and danger
Safety Danger Highest Risk not higher risk higher than reasonable than highest highest risk reasonable risk reasonable risk residual risk risk without safety measures minimum risk reduction actual risk reduction risk low high Risikoansatz zur Beurteilung der technischen Sicherheit (nach Hosemann)
Akzeptanzschwelle Toleranzschwelle Safety Action Danger State of the art Further design- Common action understanding that no further action recommended risk is not needed acceptable Width depending on technical and cultural powers in every single area steigendes Risiko
Risk assessment Risk Safety meaasures by the designer Step 1: inherent safety Step 2: safeguarding resi Step 3: information for use dua risk put into user service by feedback the designer safety measures by the user (not to be dealt in this ISO standard) ISO 12100 acceptable risk
IEC- Guide 51
Foreseeable (mis)use GPSD Article 2(a): “product” shall mean any product • which is intended for consumers or • under reasonably foreseeable conditions, to be used by consumers even if not intended for them
Tendencies for reasonably foreseeable (mis)use: Situations which are reasonable by common sense and are in accordance with common life experience. (eg.: touching of hot oven doors by young children) A misuse cannot be recognized by the user. (eg.: combining of multiple power sockets risk of fire) The misuse will be recognized by the user but the risk will be underestimated. (eg.: fork lifts – driving too fast / driving with lifted load risk of tilting) The misuse is broadly common and will no more recognized by the user. (eg.: removing a plug by pulling the wire) A misuse can be expected because it is more comfortable for the user. (eg.: incomplete winding up of a cable roller) non rational behaviour in case of malfunction during use of a product. (eg.: removing of a blockage inside the opening of a garden shredder)
Example: Child appealing luminary – Product description notified as RAPEX No. 0051/06 No transformer (reducing high voltage to low voltage) was provided with the child-appealing portable luminary. Thermal heating during normal operation: During the thermal test the highest measured temperature of the accessible parts (including the lamp) was 175,2°C.
The 3 Steps of Risk Assessment (based on RAPEX-Guidelines) 1 2 3
Example: Child appealing luminary – scenario and questions Scenario Questions Experts have concluded that the following scenario may How do you estimate the likelihood occur (among others): of each step, and of the total scenario? 1. Child takes lamp to play. What is your conclusion about the 2. During playing life parts risk? become touchable. Which is the severity class of that 3. Child touches live parts injury? 4. Child gets electric shock; 5. Child is electrocuted;
Elements of the risk assessment method (Table 1: Vulnerable consumers) Table 2: Hazards, typical injury scenario and typical injury Table 3: Severity of injury Table 4: Probability of injury Table 5: Risk level from the combination of the severity of injury and the probability Dr. Jörg Windberg, Dortmund (Germany) joerg.windberg@gmx.de
Example: Child appealing luminary – Risk Assessment Injury scenario: Child takes lamp to play. During playing life parts become touchable. Child touches life parts and gets electric shock; child is electrocuted;
Table 2. Hazards and their typical injury scenario and typical injury Hazard group Hazard (product Typical injury scenario Typical injury property) Size, shape and Product is obstacle Person trips over product and falls; or person Bruising; fracture, concussion surface bumps into product Product is impermeable to Product covers mouth and/or nose of a person Suffocation air (typically a child), or covers internal airway Product is or contains small Person (child) swallows small part; the part gets Choking, internal airway obstruction part stuck in larynx and blocks airways Possible to bite off small part Person (child) swallows small part; the part gets Digestive tract obstruction from product stuck in the digestive tract Sharp corner or point Person bumps into sharp corner or is hit by Puncture; blinding, foreign body in moving sharp object; this causes a puncture or eye; hearing, foreign body in ear penetration injury Sharp edge Person touches sharp edge; this lacerates the skin Laceration, cut; amputation or cuts through tissues Slippery surface Person walks on surface, slips and falls Bruising; fracture, concussion Rough surface Person slides along rough surface; this causes Abrasion friction and/or abrasion Gap or opening between Person puts a limb or body in opening and finger, Crushing, fracture, amputation, parts arm, neck, head, body or clothing is trapped; strangulation injury occurs due to gravity or movement Potential Low mechanical stability Product tips; person on top of product falls from Bruising; dislocation; sprain; energy height, or person near product is hit by the fracture, concussion; crushing; product; electrical product tips, breaks and gives electric shock; burns access to live parts, or continues to work heating nearby surfaces Low mechanical strength Product collapses by overloading; person on top of Bruising; dislocation; fracture, product falls from height, or person near product concussion; crushing; electric is hit by the product; electrical product tips, shock; burns breaks and gives access to live parts, or continues to work heating nearby surfaces High position of user Person at high position on the product loses Bruising; dislocation; fracture, balance, has no support to hold on to and falls concussion; crushing from height Elastic element or spring Elastic element or spring under tension is suddenly Bruising; dislocation; fracture, released; person in the line of movement is hit by concussion; crushing the product Pressurised liquid or gas, or Liquid or gas under pressure is suddenly released; Dislocation; fracture, concussion; vacuum person in the vicinity is hit; or implosion of the crushing; cuts (see also under fire product produces flying objects and explosion) Kinetic energy Moving product Person in the line of movement of the product is Bruising; sprain; fracture, hit by the product or run over concussion; crushing Parts moving against one Person puts a body part between the moving parts Bruising; dislocation; fracture; another while they move together; the body part gets crushing trapped and put under pressure (crushed) Parts moving past one Person puts a body part between the moving parts Laceration, cut; amputation another while they move close by (scissor movement); the body part gets trapped between the moving parts and put under pressure (shearing) Rotating parts A body part, hair or clothing of a person is Bruising; fracture; laceration (skin entangled by the rotating part; this causes a of the head); strangulation pulling force Dr. Jörg Windberg, Dortmund (Germany) joerg.windberg@gmx.de
Table 2 - Hazards, typical injury scenario and typical injury Hazard group Hazard (product property) Typical injury scenario Typical injury Electrical High/low voltage Shock, Electrocution electric shock - burns 2nd degree on energy hand electric shock - electrocution Dr. Jörg Windberg, Dortmund (Germany) joerg.windberg@gmx.de
Table 3 - Severity of injury Type of injury Severity of injury 1 2 3 4 Electric (see also under burns Local effects (temporary - Electrocution shock as electric current can cramp or muscle paralysis) cause burns) Burn/Scald 1º, up to 100% of body 2º, 6-15% of body surface 2º, 16-35% of body 2º or 3º, >35% of body surface surface surface, or 3º, up to 35% Inhalation burn requiring 2º, <6% of body surface of body surface respiratory assistance Inhalation burn Injury or consequence 1. Basic treatment, First Aid 2. Emergency room, no hospitalisation 3. hospitalisation 4. Fatal outcome (possible)
Example: Child appealing luminary – Risk Assessment Table 2: Injury scenario Table 2: Hazard, typical injury Child takes lamp to play. During playing life parts Hazard Group: Electrical Energy become touchable. Child touches life parts and Hazard: shock, electrocution gets electric shock; child is electrocuted; Typical injury: electric shock electrocution - death Table 3: Severity of injury electrocution 4
Table 4 - Probability of injury Dr. Jörg Windberg, Dortmund (Germany) joerg.windberg@gmx.de
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