natgillin/translations-raw huggingface dataset:
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.
Ali se z večjo starostjo proizvoda oziroma morda z razumno predvidljivo neustrezno uporabo pojavijo nove nevarnosti?
This risk assessment will have to be carried out with due care and attention in order to avoid any misinterpretation.
Kako dolg je „čas do odpovedi proizvoda“?
BUILDING A RISK ASSESSMENT STEP BY STEP
Kakšna je življenjska doba proizvoda, vključno z rokom uporabnosti?
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.
Kako dolgo potrošnik uporablja proizvod v praksi, preden ta postane odpadek?
The product should be identified unambiguously.
Podobna vprašanja si je treba zastaviti, ko postane proizvod po določenem obdobju neuporaben, tudi če ni bil nikoli v uporabi.
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.
Primer so električne odeje ali grelne blazine.
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.
Električni kabli v proizvodih so običajno tanki in postanejo po desetih letih krhki, tudi če izdelek ni bil nikoli uporabljen.
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.
Grelni kabli lahko pridejo v medsebojni stik, sprožijo kratek stik in vnamejo posteljnino.
In such cases, it is sufficient only to assess the distinct part of the product.
Poleg tega je treba v vsako oceno tveganja vključiti tudi embalažo proizvoda.
Rechargeable batteries of notebook computers which may overheat are an example of this.
Nevarnost je bistvena lastnost proizvoda, ki lahko povzroči poškodbo potrošnika, ki uporablja proizvod.
The description of the product includes any label that may be relevant for risk assessment, in particular warning labels.
Pojavi se lahko v različnih oblikah:
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.
mehanska nevarnost, kot so ostri robovi, na katerih si lahko porežemo prste, ali ozke odprtine, v katerih se lahko prsti zagozdijo,
An example of this is a chain saw.
nevarnost zadavljenja, na primer z majhnimi delci, ki odpadejo z igrače ter jih lahko otrok pogoltne in se z njimi zadavi,
Products may also need to be self-assembled by consumers before use, such as self-assembled furniture.
nevarnost zadušitve, na primer z vrvico kapuce anoraka, ki lahko privede do zadušitve,
Are the assembly instructions clear enough for the ready-to-use product to meet all the relevant safety requirements?
nevarnost električnega udara, na primer deli pod napetostjo, ki lahko povzročijo električni udar,
Or could consumers make mistakes when putting the product together that could lead to unforeseen risks?
nevarnost visokih temperatur ali ognja, na primer grelni ventilator, ki se pregreje, zaneti ogenj in povzroči opekline,
A risk assessment should always consider the entire life time of a product.
toplotna nevarnost, na primer vroča zunanjost pečice, ki lahko povzroči opeklino,
This is particularly important when a new product has been developed and its risks are assessed.
kemična nevarnost, na primer strupene snovi, ki lahko zastrupijo potrošnika takoj po zaužitju, ali rakotvorne snovi, ki lahko dolgoročno povzročijo raka.
Will age and usage change the type or the extent of the hazard?
Nekatere kemikalije lahko potrošniku škodujejo šele po večkratni izpostavljenosti,
Will new hazards appear with increasing product age or perhaps through reasonably foreseeable inappropriate use?
mikrobiološka nevarnost, na primer bakteriološko onesnaženje kozmetičnih proizvodov, ki lahko povzroči vnetje kože,
How long is the ‘time to product failure’?
nevarnost zaradi hrupa, na primer zvonjenje mobilnih telefonov – igrač, ki so veliko preglasni in lahko poškodujejo sluh otroka,
What is the product's lifetime, including shelf life?
ostale nevarnosti, na primer eksplozija, implozija, zvočni ali nadzvočni tlak, tlak v tekočini ali sevanje iz laserskih virov.
How long is the product used in practice by the consumer before it becomes waste?
V teh smernicah so bile nevarnosti združene v skupine glede na velikost, obliko in površino proizvoda, potencialno, kinetično ali električno energijo, ekstremne temperature in druge lastnosti, kot je prikazano v preglednici 2.
Additional considerations may need to be taken into account when a product becomes unusable after a certain time period, even though it has never been used.
Preglednica je samo vodilo in vsak ocenjevalec tveganja mora scenarij prilagoditi obravnavanemu proizvodu.
Examples are electric blankets or heating pads.
Seveda se vsaka vrsta nevarnosti ne nanaša na vsak proizvod.
The electric cords in the products are usually thin and become fragile after ten years, even if the product has never been used.
Kljub temu pa bo preglednica 2 pomagala ocenjevalcem tveganja pri iskanju in ugotavljanju vseh možnih nevarnosti v proizvodih za potrošnike, ki se ocenjujejo.
The heating cords can come into contact with each other, can cause a short-circuit and set the bedclothes on fire.
Kadar ima proizvod več nevarnosti, se vsaka nevarnost obravnava ločeno, s svojo oceno tveganja in največjim tveganjem, ki se ga določi kot „tveganje“, ki ga predstavlja proizvod.
Finally, the packaging of the product should also be included in any risk assessment.
Seveda je treba poročati tudi o tveganjih, ki zahtevajo posebne ukrepe za obvladovanje tveganja, da se zagotovi zmanjšanje vseh tveganj.
Hazard is the intrinsic property of the product that may cause an injury to the consumer who uses the product.
Upoštevati je treba, da lahko ena nevarnost v istem scenariju povzroči več poškodb.
It can appear in different forms:
Na primer, okvarjene zavore na motornem kolesu lahko povzročijo nesrečo, katere posledica je lahko poškodba voznikove glave, rok in nog, lahko pa povzročijo tudi opekline, če se ob nesreči vname bencin.
mechanical hazard, such as sharp edges that can cut fingers, or tight openings in which someone can trap their fingers,
V tem primeru spadajo vse poškodbe v isti scenarij poškodb in bi bilo treba oceniti resnost vseh poškodb skupaj.
choking hazard, such as from small parts that come loose from a toy, which may be swallowed by a child and make the child choke,
Seveda so vse te poškodbe skupaj zelo resne.
suffocation hazard, such as from the drawstrings of an anorak hood which may lead to strangulation,
Vendar ne gre dodajati več poškodb iz različnih scenarijev.
electrical hazard, such as from live electrical parts that can cause an electric shock,
V vsakodnevni praksi nadzora trga bi zadostovala ocena tveganja, ki izhaja iz ene same nesreče.
heat or fire hazard, such as a heater fan that overheats, catches fire and causes burns,
Če zahteva tveganje, ki izhaja iz te nevarnosti, ukrepe za obvladovanje tveganja, je treba ukrepe izvesti brez obotavljanja.
thermal hazard, such as the hot outer surface of an oven that can cause a burn,
Vendar mora biti ocenjevalec tveganja prepričan, da je ugotovljeno tveganje največje ali eno od največjih tveganj, da zagotovi ustrezno učinkovitost ukrepa za obvladovanje tveganja.
chemical hazard, such as a toxic substance that can poison a consumer immediately upon ingestion, or a carcinogenic substance that can cause cancer in the long term.
To velja v vsakem primeru resnega tveganja, saj je to največja možna stopnja tveganja, predlagana v teh smernicah.
Some chemicals may damage the consumer only after repeated exposure,
V primerih tveganja, ki je manjše od resnega tveganja, bo morda treba izvesti nadaljnje ocene tveganja, pozneje pa tudi posebno oceno tveganja.
microbiological hazard, such as a bacteriological contamination of cosmetics which may cause a skin infection,
Izkušnje v zvezi z oceno tveganja v praksi nadzora trga bodo kar najbolj omejile število zahtevanih ocen tveganja.
noise hazard, such as ring tones from toy mobile phones that are much too loud and can damage children's hearing capacity,
Ugotavljanje nevarnosti s preskusi in standardi
other hazards, such as explosion, implosion, sonic and ultrasonic pressure, fluid pressure, or radiation from laser sources.
Nevarnosti se pogosto ugotovijo in količinsko opredelijo s preskusi.
For the purpose of these guidelines, hazards have been grouped, linked to the size, shape and surface of a product, to potential, kinetic or electric energy, to extreme temperatures, and others, as shown in Table 2.
Preskusi in njihova izvedba so lahko opisani v evropskih in mednarodnih standardih za proizvode.
The table is for guidance only, and any risk assessor should adapt the scenario to the product under consideration.
Skladnost proizvoda z „usklajenim“ evropskim standardom („EN …“), katerega sklicevanja so bila objavljena v Uradnem listu, omogoča domnevo o varnosti (čeprav samo za lastnosti glede varnosti, ki so zajete v vrednostih ali standardih).
Of course not every type of hazard applies to every product.
V teh primerih se lahko domneva, da predstavlja proizvod minimalno tveganje in visoko raven zaščite glede na preskušeno nevarnost.
Nevertheless, Table 2 should help risk assessors to look for and identify all possible hazards in consumer products that are being assessed.
Kljub temu pa so možni primeri, ko domneva o varnosti ne velja in je treba pripraviti izčrpno dokumentirano oceno tveganja, vključno z zahtevo po spremembi usklajenega standarda.
Where a product has several hazards, each hazard should be taken separately with its own risk assessment and the highest risk identified as ‘the risk’ of the product.
Če pa proizvod ne opravi preskusa, se običajno domneva, da obstaja tveganje, razen če lahko proizvajalec dokaže, da je proizvod varen.
Of course, risks requiring specific risk management measures should also be reported, to ensure that all risks can be reduced.
Proizvodi lahko predstavljajo tveganje tudi, če ne povzročajo poškodb
Note that a single hazard may lead to several injuries in the same scenario.
Proizvodi, ki niso nevarni, lahko kljub temu povzročijo tveganje, ker ne ustrezajo nameravani uporabi.
For example, malfunctioning brakes on a motor cycle could cause an accident and result in damage to the driver's head, hands and legs, and could even cause burns if the petrol bursts into flames in the accident.
Primere tega je mogoče opaziti na področju osebne varovalne opreme ali reševalne opreme, kot so odsevni jopiči, ki si jih nadenejo vozniki avtomobilov po nesreči.
In this case, all injuries would belong to the same injury scenario, and the severity of all injuries together would have to be estimated.
Namen teh jopičev je pritegniti pozornost voznikov in udeležencev v prometu, da jih opozorijo o nesreči, zlasti ponoči.
Of course, these injuries together are very serious — several injuries in different scenarios should, however, not be added.
Vendar če so odsevni pasovi premajhni ali ne odsevajo dovolj, jih morda ne bo mogoče videti in zato uporabnikom ne zagotavljajo ustrezne zaščite.
In the daily practice of market surveillance, it may be sufficient to assess the risk from even a single hazard.
Ti jopiči zato predstavljajo tveganje, čeprav sami po sebi niso nevarni.
If the risk from that hazard provides for risk management action, that action can be taken without further ado.
Naslednji primer je proizvod za zaščito pred soncem z oznako „visoka zaščita“ (zaščitni faktor 30), ki pa zagotavlja le „nizko zaščito“ (faktor 6).
Nevertheless, the risk assessor should be sure that the risk identified is (one of) the highest risk(s), to ensure that the risk management action is sufficiently effective.
Posledica so lahko hude opekline.
This is always the case when the risk is serious, since this is the highest possible risk level proposed in these guidelines.
Zmožnosti in vedenje potrošnika, ki uporablja proizvod, lahko pomembno vplivajo na stopnjo tveganja.
In cases of less than serious risk, however, further risk assessments might be necessary and possibly specific risk management at a later stage.
Zato je v scenariju poškodbe najpomembnejša jasna predstava o vrsti potrošnika.
In conclusion, experience with risk assessment in market surveillance practice will limit the number of required risk assessments to a minimum.
Da bi lahko določili največje tveganje in s tem „tveganje“, ki ga predstavlja proizvod, bo morda treba izdelati scenarije poškodb z različnimi vrstami potrošnikov.
Hazard identification by tests and standards
Ni dovolj, če se na primer upoštevajo samo najranljivejši potrošniki, saj je lahko verjetnost, da bodo utrpeli škodljive učinke, v scenariju tako majhna, da je tveganje manjše kot v scenariju poškodb s potrošnikom, ki ni ranljiv.
Hazards are often identified and quantified by tests.
Treba je upoštevati tudi ljudi, ki proizvoda dejansko ne uporabljajo, vendar so lahko v bližini uporabnika.
These tests and how to carry them out may be laid down in European or international product standards.
Verižna žaga lahko na primer povzroča okruške, ki letijo naokrog in zadenejo v oko osebo v bližini.
Compliance of a product with a ‘harmonised’ European standard (‘EN …’), of which the references have been published in the Official Journal, provides presumption of safety (albeit only for the safety characteristics covered by the value(s) or standard(s)).
Čeprav lahko uporabnik sam učinkovito obvladuje tveganje, ki ga povzroča verižna žaga, s tem, da nosi varovalno opremo in izpolnjuje druge ukrepe za obvladovanje tveganja, ki jih določi proizvajalec, je lahko oseba, ki je v bližini, resno ogrožena.
It can be presumed in such cases that the product presents only a minimum risk and a high level of protection with regard to the specific hazard tested.
Zato je treba zagotoviti opozorila o tveganjih za osebe, ki so v bližini, na primer v navodilih za uporabo verižne žage, in navesti, kako je mogoče ta tveganja zmanjšati.
Nevertheless, there may be instances where presumption of safety is not the case, and in such cases a particularly well-documented risk assessment will have to be prepared, including a call for amendment to the harmonised standard.
Pri razvoju scenarija poškodbe je treba upoštevati naslednje vidike v zvezi z vrsto potrošnika in njegovo uporabo proizvoda.
On the other hand, if a product fails the test, a risk can normally be assumed, unless the manufacturer can provide evidence that the product is safe.
Ta seznam ni popoln, vendar bi moral spodbuditi ocenjevalce tveganj k dovolj natančnemu opisu scenarijev poškodb.
Products may still present a risk even though they do not cause injuries
Treba je opozoriti, da „uporabnik“ pomeni tudi ljudi, ki proizvoda dejansko ne uporabljajo, vendar so lahko prizadeti, ker so v bližini:
Products may not be hazardous but can nevertheless cause a risk, due to not being fit for their intended use.
oseba, ki ji je proizvod namenjen / ki ji proizvod ni namenjen: oseba, ki ji je proizvod namenjen, lahko proizvod uporablja brez težav, saj sledi navodilom ali pozna to vrsto proizvodov, vključno z njegovimi očitnimi in neočitnimi nevarnostmi.
Examples of this can be observed in the area of personal protective equipment or life-saving equipment, such as reflective jackets that car drivers put on after an accident.
Nevarnost proizvoda se ne uresniči in tveganje je lahko manjše.
These jackets are meant to get the attention of oncoming drivers and traffic participants to warn them of the accident, in particular at night.
Oseba, ki ji proizvod ni namenjen, proizvoda ne pozna in ne prepozna njegovih nevarnosti.
However, they might not be seen if the reflector stripes are too small or do not reflect sufficiently, and do not therefore protect users as they should.
Zato je izpostavljena tveganju za poškodbo in tveganje za potrošnika je večje.
These jackets therefore pose a risk even though they are not hazardous in themselves.
Tveganji za osebo, ki ji je proizvod namenjen, in osebo, ki ji proizvod ni namenjen, se razlikujeta glede na proizvod in način uporabe;
Another example is a sunscreen product which displays ‘high protection’ (sun protection factor of 30) on the label but provides only ‘low protection’ (factor of 6).
ranljivi potrošniki: razlikujemo več kategorij ranljivih in zelo ranljivih potrošnikov: otroci (0 do 36 mesecev, > 36 mesecev do < 8 let, 8 do 14 let) in ostali, na primer starejši (glej preglednico 1).
This can lead to severe sunburn.
Vsi ti imajo manjšo sposobnost prepoznavanja nevarnosti, na primer otroci, ki se dotaknejo vroče površine, občutijo vročino šele po 8 sekundah (in takrat so že opečeni), medtem ko jo odrasli občutijo takoj.
The abilities and behaviour of the consumer using the product may greatly influence the level of risk.
Ranljivi potrošniki imajo lahko težave z upoštevanjem oznak z opozorili, ali pa imajo težave z uporabo proizvoda, ki ga še niso uporabljali.
It is therefore of prime importance to have a clear idea of the type of consumer pictured in the injury scenario.
S svojimi dejanji lahko prav tako pripomorejo k večji izpostavljenosti, na primer majhni otroci se plazijo in dajejo stvari v usta.
It may be necessary to generate injury scenarios with different types of consumers in order to identify the highest risk and thus ‘the risk’ of the product.
Otroke lahko privlači tudi videz proizvodov, ki v njihovih rokah predstavljajo veliko tveganje.
It is not enough, for example, to consider only the most vulnerable consumers, because the probability of their suffering adverse effects in the scenario may be so low that the risk is lower than in an injury scenario with a non-vulnerable consumer.
Po drugi strani pa bi morali starši ali druge odrasle osebe z nadzorom običajno preprečiti, da otroci zaidejo v težave.
Consideration should also be given to people who are not actually using the product, but who may be in the vicinity of the user.
Poleg tega lahko potrošniki, ki običajno niso ranljivi, v posebnih okoliščinah postanejo ranljivi, na primer, kadar so opozorila na proizvodu v tujem jeziku, ki ga potrošnik ne razume.
For example, a chain saw may cause splinters to fly around and hit a bystander in the eye.
In nenazadnje, v primeru kemikalij so lahko otroci bolj dovzetni za strupenost kemikalij kot povprečna odrasla oseba.
Thus, although the risk from the chain saw may be effectively managed by the user him- or herself wearing protective equipment and complying with any other risk management measures specified by the manufacturer, bystanders may be under serious threat.
Zato se otrok ne sme obravnavati kot „majhnih odraslih“.
Consequently, warnings should be given, for example in the chain saw instructions for use, about the risks to bystanders and how to minimise such risks.
Proizvod, ki je za povprečnega odraslega človeka običajno varen, pa morda ni varen za ranljive potrošnike.
Thus, when developing an injury scenario, the following aspects should be taken into account regarding the type of consumer and how they use the product.
To je treba upoštevati pri določanju resnosti in verjetnosti poškodbe (glej spodaj) ter s tem tveganja.
This is not a complete list, but it should encourage risk assessors to describe their injury scenarios with the necessary level of detail.
nameravana in razumno predvidena uporaba: potrošniki lahko uporabljajo proizvod za druge namene kot so tisti, za katere je namenjen, čeprav so navodila popolnoma razumljiva, vključno z opozorili.
It should be noted that ‘consumer’ also means people who are not actually using the product, but who may be affected by virtue of being nearby:
Ker opozorila morda ne bodo dovolj učinkovita, je treba pri oceni tveganja upoštevati tudi druge uporabe.
Intended/non-intended user: The intended user of a product may use the product with ease because he goes by the instructions or because he is familiar with this kind of product, including its apparent and non-apparent hazard(s).
Ta vidik je zlasti pomemben za proizvajalca proizvoda, saj mora zagotoviti, da je proizvod varen pod vsakimi razumno predvidenimi pogoji uporabe.
The hazard of the product may not then materialise, and the product risk could be minor.
Razumno predvidena uporaba lahko temelji na izkušnjah, saj v uradnih statistični podatkih ali drugih virih informacij morda ni razpoložljivih informacij.
The non-intended user may not be familiar with the product and may not recognise the hazard(s).
V takšnem primeru je težko potegniti črto med „razumno predvidljivim“ in „popolnoma nepričakovanim“ scenarijem.
He therefore runs the risk of injury, and the consumer risk is thus higher.
Kljub temu pa se lahko v skladu s temi smernicami upoštevajo tudi „popolnoma nepričakovani“ scenariji, celo kadar vodijo do zelo resnih poškodb, saj bo verjetnost takšnih scenarijev vedno majhna.
Thus, the risk may be different for an intended and a non-intended user, depending on the product and the way it is used.
To naj bi bila zaščita pred prevelikim vplivom takšnih scenarijev pri določanju celotnega tveganja, ki ga predstavlja proizvod;
Vulnerable consumers: Several categories of vulnerable and very vulnerable consumers can be distinguished: children (0 to 36 months, > 36 months to < 8 years, 8 to 14 years) and others such as the elderly (see Table 1).
pogostost in trajanje uporabe: različni uporabniki uporabljajo proizvod različno pogosto za krajši ali daljši čas.
They all have less capacity to recognise a hazard, for example children who, when touching a hot surface, notice the heat only after some 8 seconds (and then are already burnt), whereas adults notice heat immediately.
To je odvisno od privlačnosti proizvoda in enostavnosti uporabe.
Vulnerable consumers may also have problems taking account of warning labels, or may have particular problems using a product they have never used before.
Ob vsakodnevni ali dolgotrajni uporabi se lahko potrošnik v celoti seznani s proizvodom in njegovimi lastnostmi, vključno z nevarnostjo, navodili in oznakami z opozorili, ter s tem zmanjša tveganje.
They may also act in a way that makes them more exposed, for example young children crawling and mouthing.
Po drugi strani pa se lahko potrošnik zaradi vsakodnevne ali dolgotrajne uporabe preveč navadi na proizvod, kar povzroča utrujenost uporabnika, ki nepremišljeno prezre navodila in opozorila ter s tem poveča tveganje.
Children may also be attracted to products because of their appeal, which makes them a high risk in the hands of children.
Vsakodnevna ali dolgotrajna uporaba pa lahko tudi pospešita staranje proizvoda in deli, ki ne prenesejo tako pogoste rabe, lahko hitro odpovejo in povzročijo nevarnost, lahko pa tudi poškodbo, kar prav tako poveča tveganje;
On the other hand, supervision by parents or other adults should normally prevent children from running straight into trouble.
prepoznavanje nevarnosti ter zaščitno vedenje in oprema: nevarnosti nekaterih proizvodov so znane, kot na primer škarij, nožev, vrtalnih strojev za domačo uporabo, verižnih žag, krožnih rezil, koles, motornih koles in avtomobilov.
Furthermore, consumers who are not usually vulnerable may become vulnerable in specific situations, for example when the instructions or warnings on a product are in a foreign language that the consumer does not understand.
V vseh teh primerih je nevarnost proizvoda znana ali lahko prepoznavna, ali pa je opisana v navodilih, ki vključujejo ukrepe za obvladovanje tveganja.
Finally, in the particular case of chemicals, children may be more susceptible to the toxicity of chemicals than the average adult.
Potrošnik je lahko tako pri delu previden ali uporablja osebno varovalno opremo, kot so rokavice, čelade ali varnostni pasovi, in s tem uporablja proizvod na način, ki zmanjša tveganje.