natgillin/translations-raw huggingface dataset:
It is important to document your risk assessment, describing the product and all the parameters that you chose while developing it, such as test results, the type(s) of consumers you chose for your injury scenario(s), and the probabilities with the underlying data and assumptions.
Pomembno je, da svojo oceno tveganja dokumentirate ter opišete proizvod in vse parametre, ki ste jih izbrali med ocenjevanjem, kot so rezultati preskusov, vrste potrošnikov, ki ste jih izbrali za scenarije poškodb, ter verjetnosti z osnovnimi podatki in domnevami.
This will enable you to demonstrate unambiguously how you estimated the level of risk, and it will also help you to update your assessment while keeping track of all changes.
Tako boste lahko nedvoumno prikazali, kako ste ocenili stopnjo tveganja, pomagalo pa vam bo tudi pri posodabljanju ocene med spremljanjem vseh sprememb.
Several hazards, several injuries – but only one risk
Več nevarnosti, več poškodb – vendar le eno tveganje
When several hazards, several injury scenarios or differing severities of injuries or probabilities have been identified, each of those should be carried through the entire risk assessment procedure in order to determine the risk for each.
Kadar je ugotovljenih več nevarnosti, več scenarijev poškodb ali različnih resnosti poškodb ali verjetnosti, je treba v zvezi z vsemi opraviti celotni postopek ocene tveganja, da se določi tveganje za vsakega posebej.
As a result, the product may have several risk levels.
Zato ima lahko proizvod več stopenj tveganja.
The overall risk of the product is then the highest risk level identified, because action on the highest risk level is normally the most effective way of risk reduction.
Skupno tveganje, ki ga predstavlja proizvod, je tako najvišja ugotovljena stopnja tveganja, saj je ukrepanje na najvišji stopnji tveganja običajno najučinkovitejši način za njegovo znižanje.
Only in special cases may a less-than-highest risk be considered particularly important, since it may require specific risk management measures.
Tveganje na nižji stopnji je posebej pomembno samo v posebnih primerih, saj lahko zahteva posebne ukrepe za obvladovanje tveganja.
As an example of several risks, a hammer may have a weak head and a weak grip, each of which may break when the hammer is used, and the consumer may be injured.
Primer več tveganj je kladivo, ki ima lahko slabo pritrjeno glavo in slab ročaj, zaradi česar lahko eden ali drugi med uporabo počita in potrošnik se lahko poškoduje.
If the relevant scenarios lead to different risk levels, the highest risk should be reported as ‘the risk’ of the hammer.
Kadar vodijo ustrezni scenariji do različnih stopenj tveganja, je treba navesti najvišje tveganje kot „tveganje“, ki ga predstavlja kladivo.
It could be argued that
Mogoče je trditi, da:
the apparently most significant hazard should be decisive, since it would lead to the most severe injuries.
je očitno najpomembnejša nevarnost odločilna, saj lahko povzroči najresnejše poškodbe.
In the above example of the hammer, this could be the hammer head breaking, since pieces of the broken head could fly into one’s eye, possibly blinding the user.
V navedenem primeru bi bila to glava kladiva, ki bi se zlomila, saj lahko koščki zlomljene glave odletijo v oko uporabnika in ga morebiti oslepijo.
The hammer grip breaking, on the other hand, would never split into small pieces that could do as much damage to the eyes.
Zlomljeni ročaj kladiva pa ne bi nikoli razpadel na majhne koščke, ki bi lahko povzročili takšno škodo očem.
However, this would be a hazard assessment, not a risk assessment.
Zato bi bila to ocena nevarnosti in ne ocena tveganja.
A risk assessment also looks at the probability of an injury actually happening.
Ocena tveganja upošteva tudi verjetnost, da se bo poškodba v resnici zgodila.
Thus, the ‘most significant hazard’ might cause an injury that is much less likely than a lesser hazard, and therefore present a lower risk.
Tako lahko „najpomembnejša nevarnost“ povzroči poškodbo, ki je precej manj verjetna kot pri manjši nevarnosti in zato predstavlja manjše tveganje.
Conversely, a scenario leading to a less severe injury may be much more likely than a scenario resulting in death, and the less severe injury may therefore present a higher risk;
Obratno pa je lahko scenarij, ki vodi do manj resne poškodbe, precej bolj verjeten kot scenarij, katerega izid je smrt, zato lahko manj resna poškodba predstavlja večje tveganje;
the highest probability for an injury scenario to happen should be the decisive factor for ‘the risk’ of the product.
mora biti največja verjetnost, da se bo scenarij poškodbe zgodil, odločilen dejavnik za „tveganje“, ki ga predstavlja proizvod.
In the above example of the hammer, if the hammer grip is very weak, the most likely injury scenario would be from the grip breaking, and that should therefore be decisive.
Če je v navedenem primeru kladiva ročaj kladiva zelo krhek, je najverjetnejši scenarij poškodba zaradi zlomljenega ročaja, zato je ta odločilna.
However, this would not consider the seriousness of eye injuries that the hammer head breaking could cause.
Vendar se ne upošteva resnost poškodb oči, ki jih lahko povzroči zlom glave kladiva.
Looking at probability alone would not therefore give the whole picture.
Zato si zgolj na podlagi same verjetnosti ne moremo ustvariti celotne slike.
In conclusion, risk is a balanced combination of both the hazard and the probability of the injury that the hazard can cause.
Tveganje je torej uravnotežena kombinacija nevarnosti in verjetnosti poškodbe, ki jo nevarnost lahko povzroči.
Risk describes neither the hazard, nor the probability, but both at the same time.
Tveganje ne opisuje niti nevarnosti niti verjetnosti, ampak obe hkrati.
Taking the highest risk as ‘the risk’ of the product will ensure the most effective product safety (apart from specific risks requiring specific risk management, as mentioned above).
Z upoštevanjem največjega tveganja kot „tveganja“, ki ga predstavlja proizvod, se zagotovi najučinkovitejša varnost proizvoda (razen pri posebnih tveganjih, ki zahtevajo posebne ocene tveganja, kot je navedeno zgoraj).
Can risks cumulate?
Ali se lahko tveganja seštevajo?
Several injury scenarios leading to several risks can be developed for virtually every product.
Za skoraj vsak proizvod je mogoče razviti več scenarijev, ki vodijo do resnih tveganj.
For example, an angle grinder may present the risk of an electric shock, because electrical wires may be too exposed, and the risk of fire, because the machine may overheat and ignite during normal use.
Kotni brusilnik lahko na primer predstavlja tveganje električnega šoka, ker so električne žice preveč izpostavljene, in tveganje požara, ker se lahko stroj med normalno uporabo pregreje in vname.
If both risks are considered to be ‘high’, do they add up to the grinder posing an overall ‘serious risk’?
Če štejemo obe tveganji za „veliki“, ali se seštejeta, tako da predstavlja brusilnik „resno tveganje“?
Where several risks are linked to the same product, one of them is obviously more likely to materialise and causes an injury.
Kadar je isti proizvod povezan z več tveganji, obstaja za eno od njih večja verjetnost, da se uresniči in povzroči poškodbo.
The overall likelihood of an injury is therefore greater.
Celotna verjetnost poškodbe je zato večja.
This does not mean that the overall risk is automatically higher, however:
To pa ne pomeni, da je celotno tveganje avtomatično večje:
The overall probability is not calculated by simply adding up probabilities.
Celotna verjetnost se ne izračuna s seštevanjem verjetnosti.
More complex calculations are necessary, and these always result in a probability that is lower than the sum of all probabilities.
Potrebni so zahtevnejši izračuni, katerih rezultat je vedno manjši od vsote vseh verjetnosti.
There is difference of a factor of 10 between two succeeding probability levels (table 4).
Dve zaporedni stopnji verjetnosti se razlikujeta za faktor 10 (preglednica 4).
This means that a lot of different scenarios of the same level would be needed to result in higher overall probability (and possibly risk).
To pomeni, da je za večjo celotno verjetnost (in možno tveganje) potrebno večje število različnih scenarijev za isto stopnjo.
Probability values are estimations which may not be totally accurate, as they often err on the ‘safe’ side in order to ensure a high level of protection.
Vrednosti verjetnosti so ocene, ki morebiti niso povsem točne, saj so zaradi zagotavljanja visoke ravni zaščite pogosto„na varni strani“.
It is therefore more useful to look at a more accurate estimation of the probability of a scenario leading to the highest risk than to add up rough estimations of probabilities of all sorts of scenarios.
Zato je namesto seštevanja grobih ocen verjetnosti iz raznovrstnih scenarijev koristnejše upoštevati bolj točne ocene verjetnosti scenarija, ki vodi do največjega tveganja.
With a little effort hundreds of injury scenarios could be developed.
Z nekaj truda je mogoče razviti na stotine scenarijev poškodb.
If risks were simply added together, the overall risk would depend on the number of injury scenarios generated and could increase ‘endlessly’.
Če bi tveganja preprosto seštevali, bi bilo celotno tveganje odvisno od števila pripravljenih scenarijev poškodb in bi raslo „v neskončnost“.
This does not make sense.
To pa ni smiselno.
Thus, risks are not simply cumulated.
Zato tveganj ne moremo preprosto seštevati.
However, if more than one relevant risk exists, action to manage the risks may need to be taken more rapidly or may need to be more pronounced.
Če obstaja več kot eno ustrezno tveganje, bo morda treba hitreje sprejeti ukrep za njegovo obvladovanje ali pa bo moral biti ukrep bolj izrazit.
For example, with two risks, a product may need to be immediately taken off the market and recalled, whereas, with a single risk, halting sales could be sufficient.
Proizvod z dvema tveganjema bo na primer morda treba takoj umakniti s trga in odpoklicati, medtem ko bi v primeru enega tveganja zadoščalo ustaviti prodajo.
Risk management depends on many factors, not only on the number of risks that a product may present at one and the same time.
Obvladovanje tveganja je odvisno od številnih dejavnikov, ne le od števila tveganj, ki jih lahko proizvod predstavlja naenkrat.
Thus, consideration is given below to the link between risk and risk management (section 4).
Zato je treba usmeriti pozornost na povezavo med tveganjem in obvladovanjem tveganja (oddelek 4).
Compliance with limit values in legislation and standards
Skladnost z mejnimi vrednostmi v zakonodaji in standardih
In market surveillance, consumer products are often tested against limit values or requirements laid down in legislation and in product safety standards.
Pri nadzoru trga se proizvodi za potrošnike pogosto preskušajo glede na mejne vrednosti ali zahteve v zakonodaji in varnostnih standardih za proizvode.
A product that complies with the limit value(s) or requirement(s) [28] is presumed to be safe in terms of the safety characteristics covered by those value(s) or requirement(s).
Proizvod, ki je skladen z mejnimi vrednostmi ali zahtevami [28], se šteje za varnega v smislu lastnosti glede varnosti, ki so zajete v teh vrednostih ali zahtevah.
This assumption can be made because the risks of a product from its intended and reasonably foreseeable use are taken into account when establishing the limit value(s) or requirement(s).
Ta domneva je mogoča na podlagi upoštevanja tveganj, ki jih predstavlja proizvod in ki izhajajo iz njegove nameravane in upravičeno predvidene uporabe ter se upoštevajo pri ugotavljanju mejnih vrednosti ali zahtev.
Manufacturers thus need their products to comply with these values or requirements, because they then only have to look at risks with their products that are not be covered by those limit value(s) or requirement(s).
Proizvajalci zagotavljajo, da so njihovi proizvodi v skladu s temi vrednostmi ali zahtevami, saj morajo tako paziti le še na tveganja v zvezi s proizvodi, ki jih te mejne vrednosti ali zahteve ne zajemajo.
An example of a limit value in
Primer mejne vrednosti v
legislation is the limit of 5 mg/kg benzene in toys which must not be exceeded, as per point 5 of Annex XVII, to the REACH Regulation [29], as amended by Commission Regulation (EC) No 552/2009 [30];a standard is the small parts cylinder: small parts of a toy for children under 36 months must not fit entirely into the cylinder described in the Toys Standard [31].
zakonodaji je meja 5 mg/kg benzena v igračah, ki ne sme biti presežena v skladu s točko 5 Priloge XVII k Uredbi REACH [29], kakor je bila nazadnje spremenjena z Uredbo (ES) št. 552/2009 [30],standardu je valj za majhne dele: majhni deli igrač za otroke, mlajše od 36 mesecev, se ne smejo v celoti prilegati valju, opisanem v standardu za igrače [31].
If they do, they present a risk.
Če se prilegajo, predstavljajo tveganje.
The product is presumed not to be safe where it fails to comply with established limit values.
Šteje se, da proizvod ni varen, kadar ni v skladu z določenimi mejnimi vrednostmi.
For limit values laid down in
Za mejne vrednosti, določene v:
legislation, such as on cosmetics or restrictions on marketing and use, the product must not be made available on the market;
zakonodaji, na primer za kozmetične proizvode ali omejitve glede trženja in uporabe, proizvod ne sme biti na voljo na trgu,
standards, the manufacturer may nevertheless try to provide evidence that his product is as safe as if it were compliant with the standard’s limit value by way of a fully fledged risk assessment on his product.
standardih, proizvajalec lahko kljub vsemu poskuša dokazati, da je njegov proizvod tako varen, kot če bi bil skladen z mejnimi vrednostmi iz standarda, z izvedeno popolno oceno tveganja za svoj proizvod.
However, this may require more effort, and may be impossible in cases such as the small parts cylinder referred to above, than actually manufacturing the product in compliance with the standard’s limit value.
Vendar se lahko zgodi, da je v to treba vložiti več truda kot v izdelavo proizvoda v skladu z mejnimi vrednostmi iz standarda, v nekaterih primerih, kot je navedeni valj za majhne dele, pa je to lahko nemogoče.
Non-compliance with limit values does not automatically mean that the product presents a ‘serious risk’ (which is the highest risk level covered by these guidelines).
Neskladnost z mejnimi vrednostmi ne pomeni samodejno, da proizvod predstavlja „resno tveganje“ (ki je največja stopnja tveganja, ki jo zajemajo te smernice).
Therefore, to ensure appropriate risk reduction measures, a risk assessment will be required for those parts of a product that do not comply with or are not covered by legislation or a standard.
Da se zagotovijo ustrezni ukrepi za zmanjšanje tveganja, je zato treba izvesti oceno tveganja tistih delov proizvoda, ki niso v skladu z zakonodajo ali standardom oziroma jih zakonodaja ali standard ne zajemata.
Furthermore, some products, such as cosmetics, require a risk assessment even when they are compliant with the limit values laid down in legislation.
Poleg tega je treba v zvezi z nekaterimi proizvodi, kot so kozmetični proizvodi, izvesti oceno tveganja tudi, če so v skladu z mejnimi vrednostmi, določenimi v zakonodaji.
This risk assessment should provide evidence of the safety of the whole product [32].In conclusion, compliance with limit values in legislation or in standards provides presumption of safety, but such compliance may not be sufficient.
Ocena tveganja mora navajati dokaze za varnost celega proizvoda [32].Skladnost z mejnimi vrednostmi v zakonodaji ali standardih torej omogoča domnevo varnosti, vendar se lahko zgodi, da takšna skladnost ne zadošča.
Specific risk assessment guidelines in specific cases
Smernice za posebno oceno tveganja v posebnih primerih
For chemicals there are specific instructions on how to prepare a risk assessment [33], and therefore they are not dealt with in detail in these guidelines.
Za kemikalije obstajajo posebna navodila o tem, kako pripraviti oceno tveganja [33], zato v teh smernicah niso obravnavane podrobno.
Nevertheless, they follow the same principles as for ‘normal’ consumer products:
Vendar te smernice sledijo istim načelom kot v primeru „običajnih“ proizvodov za potrošnike:
hazard identification and assessment – this is the same as determining the severity of the injury, as described above;
opredelitev in ocena nevarnosti – enako kot pri določanju resnosti poškodbe, kot je prej opisano,
exposure assessment – in this step, exposure is expressed as the likely dose of the chemical that the consumer may take up via oral, inhalation or dermal routes, separately or jointly, when using the product as anticipated in the injury scenario.
ocena izpostavljenosti – v tem koraku je izpostavljenost izražena kot verjetni odmerek kemikalije, ki ga lahko potrošnik zaužije peroralno, z vdihavanjem ali skozi kožo, ločeno ali skupaj, če uporablja proizvod v skladu s predvidevanji v scenariju poškodb.
This step is the same as determining the probability that the injury will indeed occur;
Ta korak je enak kot določanje verjetnosti, da se bo poškodba v resnici zgodila,
risk characterisation – this step basically consists of comparing the dose of the chemical that the consumer is likely to take up (= exposure) with the derived no-effect level (DNEL) of that chemical.
opredelitev tveganja – ta korak je v osnovi sestavljen iz primerjave odmerka kemikalije, ki ga bo potrošnik verjetno zaužil (= izpostavljenost) in izpeljane ravni brez učinka (DNEL) te kemikalije.
Should the exposure be sufficiently lower than the DNEL, in other words, should the risk characterisation ratio (RCR) be clearly below 1, risk is considered to be adequately controlled.
Če je izpostavljenost ustrezno manjša od DNEL oziroma če je stopnja opredelitve tveganja (RCR) znatno manjša od 1, se šteje, da je nadzor tveganja ustrezen.
This is the same as determining the risk level., Risk management measures may not be needed if the level of risk is sufficiently low.
To je enako določanju stopnje tveganja. Ukrepi za obvladovanje tveganja morda ne bodo potrebni, če bo stopnja tveganja ustrezno majhna.
Since a chemical may possess several hazards, risk is normally determined for the ‘leading health effect’, which is the health effect (or ‘endpoint’ such as acute toxicity, irritation, sensitisation, carcinogenicity, mutagenicity, toxicity for reproduction) considered to be the most important.
Ker lahko kemikalija vključuje več nevarnosti, se tveganje običajno določi za „glavni učinek na zdravje“, ki je učinek na zdravje (ali „končna točka“, kot so akutna toksičnost, draženje, senzibilizacija, rakotvornost, mutagenost, strupenost za razmnoževanje), ki se šteje za najpomembnejšega.
For cosmetics, there is also specific guidance [34], and there may be specific guidance for other products or purposes.It is highly recommended to use such specific guidance, since it is tailored to the specific cases in question.
Za kozmetične proizvode obstajajo posebna navodila [34], lahko pa bi obstajala posebna navodila tudi za druge proizvode in namene.Uporaba posebnih navodil je zelo priporočljiva, saj so prilagojena posebnim obravnavanim primerom.
Nevertheless, where the data required by the specific guidance do not exist or cannot be estimated the present guidelines may be used for a preliminary risk assessment.
Kadar pa podatki, ki jih zahtevajo posebna navodila, ne obstajajo ali jih ni mogoče oceniti, se lahko te smernice uporabijo za izvedbo predhodne ocene tveganja.
This risk assessment will have to be carried out with due care and attention in order to avoid any misinterpretation.
Da bi se izognili napačni razlagi, je treba oceno tveganja izvesti skrbno in pazljivo.
This section describes in detail what points have to be taken into account and what questions have to be asked when preparing a risk assessment.
V tem oddelku je natančno opisano, katere točke je treba upoštevati in katera vprašanja je treba zastaviti pri pripravljanju ocene tveganja.
The product should be identified unambiguously.
Proizvod mora biti nedvoumno prepoznaven.
This includes the product name, the brand, the model name, the type number, a possible production lot number, any certificate that may come with the product, a child-resistant fastening if there is one, the identity of the person who placed it on the market, and the country of origin.
To vključuje ime proizvoda, blagovno znamko, ime modela, številko tipa, morebitno serijsko številko proizvodnje, vsa potrdila, ki so lahko priložena proizvodu, za otroke varno zapiralo, če obstaja, identiteto osebe, ki je dala proizvod na trg in državo porekla.
A picture of the product, the packaging and the marking plate (if appropriate) and a test report(s) identifying the product hazard(s) can also be considered to be part of the product description.
Za del opisa proizvoda se lahko štejejo tudi slika proizvoda, embalaža, označba (če je to ustrezno) in poročila o preskusu za identifikacijo nevarnosti proizvoda.
In particular cases, the hazard may be limited to a distinct part of the product, which can be separate from it and also separately available to consumers.
V posebnih primerih je lahko nevarnost omejena na poseben del proizvoda, ki je lahko ločen od njega in tudi ločeno na voljo potrošnikom.
In such cases, it is sufficient only to assess the distinct part of the product.
V takih primerih zadostuje samo ocena posebnega dela proizvoda.
Rechargeable batteries of notebook computers which may overheat are an example of this.
Primer so baterije za notesnike za ponovno polnjenje, ki se lahko pregrejejo.
The description of the product includes any label that may be relevant for risk assessment, in particular warning labels.
Opis proizvoda vključuje vse oznake, ki so lahko pomembne za oceno tveganja, in zlasti oznake z opozorili.
Instructions for use may also contain relevant information on the risk of the product and how to keep it as low as possible, for example by using personal protective equipment or by excluding children from using the product.
Tudi navodila za uporabo lahko vsebujejo ustrezne informacije glede tveganja, ki ga predstavlja proizvod, in o tem, kako to tveganje vzdrževati na čim manjši ravni, na primer z uporabo osebne varovalne opreme ali z izključitvijo otrok iz uporabe proizvoda.
An example of this is a chain saw.
Takšen primer je verižna žaga.
Products may also need to be self-assembled by consumers before use, such as self-assembled furniture.
Nekatere proizvode morajo potrošniki pred uporabo sami sestaviti, kot na primer pohištvo.
Are the assembly instructions clear enough for the ready-to-use product to meet all the relevant safety requirements?
Ali so navodila za sestavljanje dovolj jasna za proizvod, pripravljen za uporabo, da izpolnjujejo vse ustrezne varnostne zahteve?
Or could consumers make mistakes when putting the product together that could lead to unforeseen risks?
Ali pa lahko potrošniki pri sestavljanju proizvoda delajo napake, ki lahko povzročijo nepredvidena tveganja?
A risk assessment should always consider the entire life time of a product.
Ocena tveganja mora vedno upoštevati celotno življenjsko dobo proizvoda.
This is particularly important when a new product has been developed and its risks are assessed.
To je še posebej pomembno, kadar je bil razvit nov proizvod in se ocenjujejo njegova tveganja.
Will age and usage change the type or the extent of the hazard?
Ali bosta starost in uporaba spremenila vrsto ali obseg nevarnosti?
Will new hazards appear with increasing product age or perhaps through reasonably foreseeable inappropriate use?
Ali se z večjo starostjo proizvoda oziroma morda z razumno predvidljivo neustrezno uporabo pojavijo nove nevarnosti?
How long is the ‘time to product failure’?
Kako dolg je „čas do odpovedi proizvoda“?
What is the product’s lifetime, including shelf life?
Kakšna je življenjska doba proizvoda, vključno z rokom uporabnosti?
How long is the product used in practice by the consumer before it becomes waste?
Kako dolgo potrošnik uporablja proizvod v praksi, preden ta postane odpadek?