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 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: ………………………….
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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
1 of 15
.
Risk assessment – based on EU commission decision (2010/15/EU)
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: ………………………….
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
2 of 15
.
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)
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
3 of 15
.
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?
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
4 of 15
.
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.)
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
5 of 15
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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?
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
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
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
7 of 15
.
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
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
8 of 15
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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
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
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 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
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
10 of 15
.
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)
Local Certification Manual
Nemko Norway
Risk assessment report C320 Risk assessment
Issued
xx/2015 Substitutes
(new) Prepared by
G. Horthe Approved by
J.I. Tidemann Page
11 of 15
.
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
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