natgillin/translations-raw huggingface dataset:
When the risk is readily recognisable, including through warning labels, the probability may have to be lowered because the user will use the product more carefully in order to avoid injury as far as possible.
Kako se spremeni stopnja tveganja, kadar se resnost poškodbe ali verjetnost spremeni za eno stopnjo navzgor ali navzdol?
This may not apply to an injury scenario with a (young) child or other vulnerable user (see Table 1) who cannot read.
Če pa se spremeni, je lahko stopnja tveganja na mejni vrednosti.
When accidents have been reported that fit into the injury scenario, the probability for that scenario could increase.
OD TVEGANJA DO UKREPANJA
In cases where accidents have only rarely been reported, or are not known at all, it may be useful to ask the manufacturer of the product whether he is aware of any accident or adverse effect caused by the product.
Ko je ocena tveganja dokončana, se običajno uporabi za odločanje o ukrepu za zmanjšanje tveganja in s tem preprečevanje škode za zdravje potrošnika.
When a fairly large number of conditions are needed for the injury to occur, the overall probability of the scenario would normally be lower.
Čeprav je ukrep ločen od ocene tveganja, je tukaj navedenih nekaj točk za ponazoritev možnih nadaljnjih ukrepov v zvezi z ugotovljenimi tveganji.
When the conditions needed for the injury to occur are easily met, this may increase the probability.
Pri nadzoru trga se ukrepi pogosto izvajajo s stiki med organom in proizvajalcem, uvoznikom ali distributerjem.
When the test results of the product fail by a large margin to come within the limit values required (by the relevant standard or legislation), the probability of the injury (scenario) occurring may be higher than if the product performed close to the limit values.
Tako lahko organ določi najučinkovitejši način obvladovanja tveganja.
The ‘probability of injury’ in this instance is the probability that the injury scenario may actually happen.
Kadar vključuje proizvod za potrošnike resno tveganje, sta med ukrepi za zmanjšanje tveganja lahko umik s trga ali odpoklic.
Also, accident statistics, even if product-specific, have to be considered with care when used for to estimate probability.
Ne glede na stopnjo tveganja pa mora organ razmisliti o sprejemu ukrepov, in če se odloči za ukrepe, kakšni naj bi ti bili.
Nonetheless, accident statistics can shed light on injury scenarios and their probability.
Vzorec tveganj v zvezi s proizvodom lahko kaže na pomanjkanje nadzora kakovosti med izdelavo.
The risk level between neighbouring severities of injury or probability normally changes by 1 level.
Preprosta sprememba v zasnovi pokrovčka bi lahko odpravila to tveganje in nadaljnje ukrepanje ne bi bilo potrebno.
This is consistent with the general experience that risk does not increase incrementally when input factors change gradually.
Če bi bilo tveganje za nesrečo s smrtnim izidom v resnici izredno majhno, bi se lahko odobrilo obdobje odprodaje proizvoda.
However, where the severity of injury increases from level 1 to level 2 (on the right-hand side of Table 4), some risk levels increase by 2 levels, namely from medium to serious and from low to high.
Drugi vidiki, povezani s tveganjem, so javno dojemanje tveganja in možnih posledic tveganja, kulturna in politična občutljivost ter prikaz tveganja v medijih.
This is due to the fact that these guidelines include 4 graduations of severity of injury, whereas the original method (see Introduction) included 5.
Ti vidiki so še posebej pomembni, kadar so zadevni potrošniki ranljivi, zlasti otroci.
Nevertheless, 4 graduations are considered normal for consumer products, since they make for a sufficiently robust estimation of severity; 5 levels would be too sophisticated since neither the severity of the injury nor the probability can be determined with very high precision.
O potrebnih ukrepih odločajo nacionalni organi za nadzor trga.
At the end of the risk assessment, be it for an individual injury scenario or for the overall risk of the product, the plausibility of the risk level and uncertainties in the estimates should be considered.
Ukrepanje z namenom preprečevanja tveganja je lahko odvisno tudi od samega proizvoda in od „minimalnega tveganja, primernega uporabi proizvoda, ki je sprejemljivo in v skladu z visoko ravnjo zagotavljanja varnosti“ [35].
This may mean verifying that the risk assessor has used the best information available to make his estimations and assumptions.
To minimalno tveganje bo verjetno precej manjše pri igračah, pri katerih so udeleženi otroci, kot pri verižni žagi, ki je poznana po tako veliki stopnji tveganja, da se zahteva močna varovalna oprema za ohranjanje tveganja na obvladljivi ravni.
Feedback from colleagues and other experts can also be helpful.
Tudi če tveganja ni, je lahko potrebno ukrepanje, na primer, kadar proizvod ni v skladu z veljavnimi predpisi (npr. nepopolne označbe).
A sensitivity analysis can also be very valuable (see example in Section 6.3).
Samodejna povezava med tveganjem in ukrepanjem ne obstaja.
How does the risk level change when the severity of injury or probability changes by 1 level up or down?
Nadzorni organi bodo upoštevali vrsto dejavnikov, kot so tisti, ki so bili prej navedeni.
If the risk level does not change at all, it is quite plausible that it has been estimated correctly.
Vedno je treba upoštevati načelo sorazmernosti, ukrep pa mora biti učinkovit.
If it changes, however, the risk level may be borderline.
KAKO PRIPRAVITI OCENO TVEGANJA – NA KRATKO
It is then necessary to reconsider the injury scenarios and the assigned severity of injury(ies) and probability(ies).
Opišite proizvod in nevarnost.
At the end of the sensitivity analysis the risk assessor should be confident that the risk level is sufficiently plausible and that he can document it and pass the information on.
Proizvod opišite nedvoumno.
FROM RISK TO ACTION
Ali se nevarnost nanaša na celoten proizvod ali samo na (ločljivi) del proizvoda?
Once the risk assessment is complete it will normally be used to decide whether action needs to be taken to reduce the risk and thus prevent harm to a consumer's health.
Ali proizvod vključuje samo eno nevarnost?
Although action is separate from risk assessment, some points are raised here to illustrate the possible follow-up of identified risks.
Ali obstaja več nevarnosti?
Within market surveillance, action will often be taken in contact between the authority and the manufacturer, importer or distributor.
Za vodilo glej preglednico 2.
This can help the authority to determine the most effective and efficient way of managing the risk.
Ugotovite, kateri standardi ali predpisi veljajo za proizvod.
With a serious risk in a consumer product, measures to reduce the risk may include withdrawal from the market or recall.
Opredelite vrsto potrošnika, ki ga želite vključiti v scenarij poškodb z nevarnim proizvodom.
Lower levels of risk normally lead to less rigorous measures.
Pri prvem scenariju poškodbe začnite z osebo, ki ji je proizvod namenjen.
It may then be sufficient to add warning labels on the product or to improve the instructions to make the product safe.
Za naslednje scenarije uporabite druge potrošnike (glej preglednico 1) in uporabe.
Thus, whatever the level of risk, the authority should consider whether to take action, and if so, what action.
Opišite scenarij poškodbe, v katerem nevarnosti proizvoda, ki ste jih izbrali, povzročijo poškodbe ali škodljive učinke za izbranega potrošnika.
Nevertheless, there is no automatic link from risk to action.
Jasno in zgoščeno opišite korake do poškodb, brez nepotrebnih podrobnosti („najkrajša pot do poškodbe“, „kritična pot do poškodbe“).
When a product shows several less-than-serious risks, and its overall risk is thus not serious, urgent action may be necessary since any of the risks may materialise quite quickly.
Če vaš scenarij vključuje več sočasnih poškodb, vključite vse te poškodbe v isti scenarij.
The pattern of risks in the product may indicate a lack of quality control in production.
Kadar opisujete scenarij poškodbe, upoštevajte pogostost in trajanje uporabe, potrošnikovo prepoznavanje nevarnosti, ali je potrošnik ranljiv (zlasti otroci), varovalno opremo, potrošnikovo vedenje v primeru nesreče, potrošnikovo kulturno ozadje in druge dejavnike, ki se vam zdijo pomembni za oceno tveganja.
It is also important to take account of exposure of the population as a whole.
Za vodilo glej oddelek 3.3 in preglednico 2.
Where there are a large number of products on the market and the product is therefore used by a large number of consumers, even a single less-than-serious risk may require quick action to avoid adverse effects to the health of consumers.
Določite resnost poškodbe.
Less-than-serious risks may also require action when the product concerned could cause fatal accidents, even though such accidents may be extremely unlikely.
Določite stopnjo resnosti (1 do 4) poškodbe potrošnika.
This could be the case with a fastening on a beverage container, which could come loose and be swallowed by a child, causing the child to choke to death.
Če v vašem scenariju potrošnik utrpi več poškodb, ocenite resnost vseh poškodb skupaj.
A simple change of design to the lid could eliminate the risk, and no further action might be required.
Za vodilo glej preglednico 3.
Even a selling-off period may be granted if the risk of a fatal accident were indeed extremely small.
Določite verjetnost scenarija poškodbe.
Other risk-related aspects may be the public perception of risk and its likely consequences, cultural and political sensitivities and how it is portrayed in the media.
Vsakemu koraku v vašem scenariju poškodbe določite verjetnost.
These aspects may be especially relevant when the consumers concerned are vulnerable, in particular children.
Pomnožite verjetnosti in izračunajte celotno verjetnost scenarija poškodbe.
It will be up to the national market surveillance authority(ies) to determine what measures are required.
Za vodilo glej levo stran preglednice 4.
Taking action to counteract a risk may also depend on the product itself and the ‘minimum risks compatible with the product's use, considered to be acceptable and consistent with a high level of protection’ [35].
Določite stopnjo tveganja.
This minimum risk will probably be much lower for toys, where children are involved, than for a chain-saw, which is known to be so high-risk that solid protective equipment is required to keep the risk at a manageable level.
Združite resnost poškodbe in celotno verjetnost scenarija poškodbe ter preverite stopnjo tveganja v preglednici 4.
Finally, even if there is no risk, action may be necessary, for example, when a product is non-compliant with the applicable regulation/legislation (e.g. incomplete markings).
Preverite verjetnost stopnje tveganja.
In conclusion, there is no automatic link from risk to action.
Če se stopnja tveganja ne zdi verjetna ali ste negotovi glede resnosti poškodb oziroma verjetnosti, jih pomaknite za eno stopnjo navzgor in navzdol ter ponovno izračunajte tveganje.
Surveillance authorities will take account of a range of factors such as those indicated above.
Ta „analiza občutljivosti“ bo pokazala, ali se tveganje spremeni s spremembo vnosa.
The principle of proportionality always has to be considered, and action has to be effective.
Če ostane stopnja tveganja enaka, ste lahko dokaj prepričani v svojo oceno tveganja.
HOW TO PREPARE A RISK ASSESSMENT — IN BRIEF
Če se zlahka spremeni, se boste morda odločili za varnejši pristop in kot „tveganje“, ki ga predstavlja proizvod za potrošnike, upoštevali večjo stopnjo tveganja.
Describe the product and its hazard.
O verjetnosti stopnje tveganja se lahko posvetujete tudi z izkušenimi sodelavci.
Describe the product unambiguously.
Izdelajte več scenarijev poškodbe za opredelitev največje stopnje tveganja, ki jo predstavlja proizvod.
Does the hazard concern the entire product or only a (separable) part of the product?
Če vaš prvi scenarij poškodbe opredeljuje stopnjo tveganja, ki je manjša od največje stopnje tveganja iz teh smernic, in če lahko po vašem mnenju proizvod predstavlja večje tveganje od ugotovljenega:
Is there only one hazard within the product?
izberite druge potrošnike (vključno z ranljivimi potrošniki, zlasti otroki),
Are there several hazards?
opredelite druge uporabe (vključno z razumno predvidljivimi uporabami),
See Table 2 for guidance.
da določite, kateri scenarij poškodb predstavlja največje tveganje, povezano s proizvodom.
Identify the standard(s) or legislation applicable to the product.
Največje tveganje je običajno „tveganje“, ki ga predstavlja proizvod, ki omogoča najučinkovitejše ukrepe za obvladovanje tveganja.
Identify the type of consumer you want to include in your injury scenario with the hazardous product.
V posebnih primerih lahko določena nevarnost vodi do tveganja, ki je manjše od največjega, in zahteva posebne ukrepe za obvladovanje tveganja.
Start with the intended user and the intended use of the product for your first injury scenario.
To je treba ustrezno upoštevati.
Take other consumers (See Table 1) and uses for further scenarios.
Praviloma lahko scenariji poškodbe vodijo do največje stopnje tveganja iz teh smernic, kadar:
Describe an injury scenario in which the product hazard(s) you have selected causes an injury(ies) or adverse health effect(s) to the consumer you selected.
so obravnavane poškodbe vsaj na 3. ali 4. stopnji;
Describe the steps to the injury(ies) clearly and concisely, without exaggerating the details (‘shortest path to injury’, ‘critical path to injury’).
je celotna verjetnost scenarija poškodbe vsaj > 1/100.
If there are several concurrent injuries in your scenario, include them all in that same scenario.
Za vodilo glej preglednico 4.
When you describe the injury scenario, consider the frequency and duration of use, hazard recognition by the consumer, whether the consumer is vulnerable (in particular children), protective equipment, the consumer's behaviour in the case of an accident, the consumer's cultural background, and other factors that you consider important for the risk assessment.
Dokumentirajte in posredujte oceno tveganja.
See Section 3.3 and Table 2 for guidance.
Bodite jasni in predstavite tudi vse negotovosti, s katerimi ste se srečali med izvajanjem ocene tveganja.
Determine the severity of the injury.
Primeri poročanja o oceni tveganja so navedeni v oddelku 6 teh smernic.
Determine the level of severity (1 to 4) of the injury to the consumer.
Shematski prikaz ocene tveganja
If the consumer suffers from several injuries in your injury scenario, estimate the severity of all those injuries together.
Ugotovljeno največje tveganje? 3.
See Table 3 for guidance.
Opišite scenarij poškodbe v več korakih: „Najkrajša pot do poškodbe“
Determine the probability of the injury scenario.
Določite verjetnost
Assign a probability to each step of your injury scenario.
Določite verjetnost za vsak korak.
Multiply the probabilities to calculate the overall probability of your injury scenario.
Pomnožite, da dobite celotno verjetnost.
See left-hand side of Table 4 for guidance.
Preverite tveganje v preglednici 4
Determine the risk level.
prepoznavanje nevarnosti / zaščitno vedenje
Combine the severity of the injury and the overall probability of the injury scenario and check the risk level in Table 4.
vedenje potrošnikov ob nezgodi
Check whether the risk level is plausible.
kulturno ozadje potrošnika
If the risk level does not seem plausible, or if you are uncertain about the severity of injury(ies) or about the probability(ies), move them one level up and down and recalculate the risk.
Določite resnost poškodbe
This ‘sensitivity analysis’ will show you whether the risk changes when your input changes.
Nedvoumno opišite proizvod in njegove nevarnosti
If the risk level remains the same, you can be quite confident of your risk assessment.
Opredelite potrošnike
If it changes easily, you may want to err on the safe side and take the higher risk level as ‘the risk’ of the consumer product.
Zložljivi stol ima mehanizem za zlaganje, ki je oblikovan tako, da se prsti uporabnika lahko ujamejo med sedež in mehanizem.
You could also discuss the plausibility of the risk level with experienced colleagues.
To lahko povzroči zlome ali celo izgubo enega ali več prstov.
Develop several injury scenarios to identify the highest risk of the product.
Določitev tveganja(tveganj)
If your first injury scenario identifies a risk level below the highest risk level set out in these guidelines, and if you think that the product may pose a higher risk than the one identified,
Scenarij poškodbe
select other consumers (including vulnerable consumers, in particular children),
Vrsta in mesto poškodbe
identify other uses (including reasonably foreseeable uses),
Celotna verjetnost
in order to determine which injury scenario puts the product at its highest risk.
Tveganje
As a rule of thumb, injury scenarios may lead to the highest risk level set out in these guidelines where:
> 1/1000
Determine the probability
Zlom prsta
Assign a probability to each step.
> 1/10000
Multiply to get the overall probability.
Veliko tveganje
Yes
Prst je med oporo za hrbet in sedalom
Pass on the risk assessment.
Prst se ujame
Highest risk identified?
Izguba prsta (ali dela prsta)
Look up the Risk in Table 4.
Sedenje na stolu
See table 4: Probability levels from high (> 50 %) to low (< 1/1 000 000) See table 3: Severity of injury — Laceration, cut — Bruising — Concussion — Entrapment/pinching — Sprain, strain, musculoskelelt a disorder — Dislocation — Fracture — Crushing — Amputation — etc.
Ta primer obravnava varovala za vtičnice.
See table 2: Hazards … — Size, shape and surface
To so naprave, ki jih uporabniki (starši) vstavijo v odprtine električnih vtičnic, da preprečijo majhnim otrokom dostop do delov pod napetostjo z vtikanjem dolgega kovinskega predmeta v eno izmed odprtin vtičnice in utrpijo (smrtni) električni udar.
Potential energy — Kinetic energy
Odprtine v teh varovalih (v katere se vtakne vtikač) so tako ozke, da se lahko vtikač zatakne.
Electrical energy — Extreme temperatures
To pomeni, da uporabnik lahko izvleče varovalo iz vtičnice, ko bo izvlekel vtikač.
Radiation — Fire and explosion — etc.
Uporabnik morda ne bo opazil, da se je to zgodilo.
See table 1: Consumer types, incl. vulnerable consumers (in particular children) — Intended/non-intended user
Varovalo je odstranjeno iz vtičnice, ki ni več zavarovana.
Intended and reasonably foreseeable use — Frequency and duration of use
Otrok se igra s tankim prevodnim predmetom, ki ga je mogoče vtakniti v vtičnico, pride v stik z električno napetostjo in umre zaradi električnega udara.
Hazard recognition/protective behaviour …
smrt zaradi električnega udara.
Consumer's cultural background
Prezrta odstranitev varovala
Determine the severity of the injury 3.
Otrok se igra s tankim prevodnim predmetom
Describe the Injury scenario in several steps: ‘Shortest path to injury’
Otrok je med igro brez varstva
Describe the product unambiguously, and its hazard(s)
Otrok vtakne predmet v vtičnico
Identify consumer(s)
Dostop do električne napetosti
This can lead to fractures or even loss of one or more fingers.
Otrok se igra s tankim prevodnim predmetom, ki ga je mogoče vtakniti v vtičnico, pride v stik z električno napetostjo in utrpi električni udar.
Injury type and location
Nezavarovana vtičnica.
Overall probability
> 1/100000
Risk
Celotno tveganje varovala za vtičnice je torej „resno“.
Low risk
Zato je treba upoštevati stopnjo negotovosti obeh dejavnikov in izvesti analizo občutljivosti.
Gripping the seat at back corner while unfolding
Namen te analize je določiti spremembo stopnje tveganja glede na spremembo ocenjenih dejavnikov.
Minor pinching
Praktični način izvedbe analize občutljivosti je ponovitev ocene tveganja za določen scenarij, vendar z uporabo drugačne verjetnosti za enega ali več korakov v scenariju.
Person unfolds the chair, grips seat at the side by mistake (Person inattentive/distracted), finger gets caught between seat and link
Na primer, sveča, ki vsebuje semena, lahko povzroči požar, ker se semena vnamejo in gorijo z visokim plamenom.
Gripping the seat at the side while unfolding
Pohištvo ali zavese se lahko vnamejo in osebe, ki niso v sobi, vdihavajo strupen dim ter se zastrupijo in umrejo:
Person unfolds the chair, chair is clamped, person tries to push down the seat and grips seat close to the corner by mistake (Person inattentive/distracted), finger gets caught between seat and backrest
Verjetnost
Chair clamps
Osebe niso v sobi, vendar vdihavajo strupen dim.
Gripping the seat at corners while unfolding
Zastrupitev s smrtnim izidom
Person unfolds the chair, chair is clamped, person tries to push down the seat and grips seat at the side by mistake (Person inattentive/distracted), finger gets caught between seat and link
Semena ali zrna se vnamejo: 90 % (0,9).
Person is sitting on chair, wants to move the chair and tries to lift it by gripping the chair at the rear part of the seat, finger gets caught between seat and backrest
Osebe, ki jih nekaj časa ni bilo v sobi: 30 % (0,3).
Loss of digit
Pohištvo ali zavese se vnamejo: 50 % (0,5) (odvisno od površine, na kateri je sveča)
Sitting on chair
Osebe vdihavajo strupen dim: 5 % (0,05).
> 1/10000
Resno
High risk
Stopnje verjetnosti za korake iz scenarija so bile ocenjene, kot je prikazano v preglednici.
Moves the chair while sitting
Celotna verjetnost je 0,00675, kar ustreza > 1/1000 v preglednici 4.
Grips chair at rear part while moving
Iz tega izhaja, da gre za „resno tveganje“.
Chair partially folds, creating a gap between the backrest and seat
Upoštevati je treba, da je natančna verjetnost bližje 1/100 kot 1/1000, kar že daje določeno mero zaupanja v stopnjo tveganja, saj je globlje v območju resnega tveganja v preglednici 4 kot predvideva vrstica > 1/1000.
Finger is between backrest and seat
Domnevajmo, da nismo gotovi glede 5 % verjetnosti, da osebe vdihavajo strupeni dim.
Loss of (part of) finger
Verjetnost lahko močno zmanjšamo na 0,1 % (0,001 = 1 na tisoč).
Person is sitting on chair, wants to move the chair and tries to lift it by gripping the chair at the rear part of the seat, finger gets caught between seat and link
Če naredimo ponoven izračun s to domnevo, je celotna verjetnost 0,000135, kar pomeni > 1/10000.
The overall risk of the folding chair is thus ‘high risk’.
Kljub temu pa je tveganje še vedno resno.
This case deals with socket protectors.
Tudi če bi bila verjetnost iz katerega koli razloga za faktor 10 manjša, bi bilo tveganje še vedno veliko.
These are devices that users (parents) put into the electrical socket outlets to stop small children from accessing live parts by putting a long metal object into one of the holes in the outlet and getting a (fatal) electric shock.
Zato kljub temu, da se lahko verjetnost spremeni od 10- do 100-kratno, tveganje še vedno ostane resno ali veliko (slednje je precej blizu „resnega“).
The holes in this particular protector (where the pins of the plug go through) are so narrow that the pins can get stuck.
Z analizo občutljivosti lahko tveganje z gotovostjo ocenimo kot resno.
This means that the user may pull the protector off the outlet when the plug is pulled out.
Na splošno pa bi morala ocena tveganja temeljiti na „utemeljeno najhujših primerih“: ne preveč črnogledih glede vsakega dejavnika, zagotovo pa ne preveč optimističnih.
The user may not notice this happening.
Preglednica 1
Protector is removed from the socket, which becomes unprotected.
Potrošniki
Child is playing with thin conductible object, which can be inserted into the socket, accessing high voltage and is electrocuted.
Opis
Electrocution
Zelo ranljivi potrošniki
Removal of protector
Zelo majhni otroci: 0 do 36 mesecev
Not noticing the removal of protector
Ostali: osebe z obsežnimi in zahtevnimi posebnimi potrebami
Child is playing with thin conductible object
Ranljivi potrošniki
Child is unattended when playing
Majhni otroci: otroci, starejši od 36 mesecev in mlajši od 8 let
Child inserts the object into the socket
Starejši otroci: otroci od 8 do 14 let