Risk assessment based on EU commission decision (2010/15/EU) · 2017-10-17 · Risk assessment report C320 Risk assessment Issued 08/2015 Substitutes (new) Prepared by G. Horthe Approved

Local Certification Manual

Nemko Norway

Risk assessment report C320 Risk assessment

Issued

08/2015 Substitutes

(new) Prepared by

G. Horthe Approved by

J.I. Tidemann Page

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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: ………………………….


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Introduction in using this report

1. Describe the product and it’s intrinsic hazards. (e.g. sharp edges) 2. Identify consumer (e.g. children) 3. Describe the injury scenario. (e.g. child drops sharp object on foot) 4. Determine the severity of the injury. (e.g. superficial cut to skin) 5. Determine the probability. (e.g. 1/1000) 6. Look up the risk in the table. (e.g. “serious risk)


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Step 1: Product and Intrinsic hazards Below are some elements to consider when describing the product:

THE PRODUCT

Yes

No

N/A

Remark

Child appealing

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?


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Below are some elements to consider when describing the hazards of the product:

INTRINSIC HAZARDS

Yes

No

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.)


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Step 2: The consumer 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 N/A

Remark

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 (e.g. partially disabled, elderly) or lack of experience and knowledge

Other Consumers (other than vulnerable)

Yes

No

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 e.g. 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?


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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


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Step 4: Severity of Injury 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


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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: 1/1000 (example only) - Cup in position to spill: 1/2 (example only) - Fluid hot enough to cause burns: 1/10 (example only) Probability will then be: 1/1 000 * 1/2 * 1/10 = 1/20 000 which will be in group 1/100 000 This guide distinguishes between 8 levels of probability:

High risk

Low risk

> 50 %

> 1/10

> 1/100

> 1/1 000

> 1/10 000

> 1/100 000

> 1/1 000 000

< 1/1 000 000


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Step 6: Determination of risk The risk is defined as a combination between severity and probability and is divided into 4

categories:

S Serious risk

H High risk

M Medium risk

L Low risk

Probability of damage

Severity of injury

1 2 3 4

High risk

Low risk

> 50 % H S S S

> 1/10 M S S S

> 1/100 M S S S

> 1/1 000 L H S S

> 1/10 000 L M H S

> 1/100 000 L L M H

> 1/1 000 000 L L L M

< 1/1 000 000 L L L L


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Determination of risk.

(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)


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Appendix A

Type of injury Severity of injury

1 2 3 4

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

Optic nerve Neck artery Trachea Internal organs

Bronchial tube Esophagus Aorta Spinal cord (low) Deep laceration of internal organs Severed high spinal cord Brain (severe lesion/dysfunction

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

Concussion — Very short unconsciousness (minutes)

Prolonged unconsciousness

Coma

Entrapment/ pinching

Minor 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


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1 2 3 4

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, puncturing Limited 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 obstruction

— — Oxygen flow to brain blocked without permanent consequences

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

—


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1 2 3 4

body in eye Temporary pain in eye without need for treatment

Temporary loss of sight

Partial loss of sight Permanent loss of sight (one eye)

Permanent loss of sight (both eyes)

Hearing injury, foreign body in ear

Temporary pain in ear without need for treatment

Temporary 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 symptoms

Reversible damage to internal organs, e.g. liver, kidney, slight haemolytic anaemia

Irreversible 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 sensitisation

Mild or local allergic reaction

Allergic reaction, widespread allergic contact dermatitis

Strong sensitisation, provoking allergies to multiple substances

Anaphylactic reaction, shock Fatality

Long-term damage from contact with substances or from exposure to radiation

Diarrhoea, vomiting, local symptoms

Reversible damage to internal organs, e.g. liver, kidney, slight haemolytic anaemia

Damage 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 infection

Reversible damage Irreversible effects Infection requiring prolonged hospitalisation, antibiotics-resistant organisms Fatality


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Appendix B

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

1/100

1/10

1/10

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

1/100

1/10

1/10

1/50

1/500 000

use:

>1/1 000

M


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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

1/10

1/10

1/10

1/50 000

use:

>1/100

000

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

1/10

1/10

1/5*

1/25 000

use:

>1/100

000

H

* A child may be more likely to use two hands rather than one

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Risk assessment based on EU commission decision (2010/15/EU) · 2017-10-17 · Risk assessment report C320 Risk assessment Issued 08/2015 Substitutes (new) Prepared by G. Horthe Approved