natgillin/translations-raw huggingface dataset:
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.
aste: kuni 100 % kehapinnast
Injury or consequence for which a visit to A&E may be necessary, but in general, hospitalisation is not required.
aste: < 6 % kehapinnast
Functioning may be affected for a limited period, not more than about 6 months, and recovery is more or less complete.
aste: 6–15 % kehapinnast
The ‘Guidelines for the management of the Community Rapid Information System “RAPEX” established under Article 12 and of the notification procedure established under Article 11 of Directive 2001/95/EC (the General Product Safety Directive)’ (the ‘Guidelines’) are adopted by the Commission [1] pursuant to Article 11(1) and Annex II, point 8, of Directive 2001/95/EC [2] of the European Parliament and of the Council of 3 December 2001 on general product safety (the ‘GPSD’), which is assisted by an advisory committee composed of the representatives of Member States and established under Article 15(3) of the GPSD.
Komisjon, [1] keda on abistanud liikmesriikide esindajatest moodustatud ja Euroopa Parlamendi ja nõukogu 3. detsembri 2001. aasta direktiivi 2001/95/EÜ [2] (üldise tooteohutuse kohta) artikli 15 lõike 3 alusel loodud nõuandekomitee, on vastavalt direktiivi 2001/95/EÜ (edaspidi „üldise tooteohutuse direktiiv”) artikli 11 lõikele 1 ja II lisa punktile 8 vastu võtnud üldise tooteohutuse direktiivi artikliga 12 ette nähtud ühenduse kiire teabevahetuse süsteemi RAPEX ja artikliga 11 ette nähtud teavitamise korra haldamise suunised (edaspidi „suunised”).
‘Article 11 notifications’ and reactions to them are prepared and sent to the Commission by the RAPEX Contact Points using the RAPEX application.
RAPEXi kontaktpunkt koostab „artikli 11 kohased teated” ja vastusteate ning saadab need komisjonile, kasutades selleks RAPEXi rakendust.
Chapters 5.1 to 5.3 in Part II of the Guidelines concerning the operation of RAPEX networks (established at EU and national levels) and on practical and technical arrangements (languages, on-line application, and operation outside normal working hours) are relevant to the Article 11 notification procedure.
Artikli 11 kohase teavitamise korra seisukohast on olulised suuniste II osa punktid 5.1–5.3, mis käsitlevad RAPEXi võrgu (ELi ja riiklikul tasandil loodud) tööd ning praktilist ja tehnilist korraldust (keeled, veebirakendus ning süsteemi toimimine väljaspool normaaltööaega).
www.ec.europa.eu/rapex
www.ec.europa.eu/rapex.
Point 8 of Annex II to the GPSD reads as follows: ‘The Commission shall prepare and regularly update, in accordance with the procedure laid down in Article 15(3), guidelines concerning the management of RAPEX by the Commission and Member States’.
Üldise tooteohutuse direktiivi II lisa punktis 8 on sätestatud: „Komisjon koostab artikli 15 lõikes 3 sätestatud korras suunised RAPEXi haldamise kohta liikmesriikides ja komisjonis ning ajakohastab neid korrapäraselt.”
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. 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).
Riskihindamise lõpus tuleks nii üksiku vigastusstsenaariumi kui ka toote üldise riski puhul arvesse võtta riskitaseme usutavust ja hinnangute ebakindlust.
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. The ‘probability of injury’ in this instance is the probability that the injury scenario may actually happen.
See kehtib eelkõige laste kohta, sest lastel ei ole tavaliselt ennetavate meetmete võtmise kogemust (vt ka jagu 3.3 „Kaitsetud tarbijad”);
Within market surveillance, action will often be taken in contact between the authority and the manufacturer, importer or distributor. This can help the authority to determine the most effective and efficient way of managing the risk.
Kui vigastuse raskus ja tõenäosus on kindlaks määratud, võimaluse korral mitme vigastusstsenaariumi puhul, tuleb riskitaset kontrollida tabeli 4 alusel.
National differences may exist, either cultural or caused by different systems of health care and financial arrangements. However, deviating from the proposed classification in the table will affect uniform assessment of risks in the EU; this should be clearly stated and explained in the risk assessment report, and reasons should be given.
või 3. aste: > 35 % kehapinnast
Professional or private e-mail accounts of the officials in charge of the RAPEX Contact Point should not be used as the e-mail account of the Contact Point. The RAPEX Contact Point also has direct phone and fax numbers through which it can be reached during and outside working hours.
RAPEXi kontaktpunkti eest vastutavate ametnike töö- või erameilikontosid ei tohiks kasutada kontaktpunkti meilikontona, RAPEXi kontaktpunktil on samuti telefoni ja faksi otsenumber, mille kaudu saab kontaktpunktiga ühendust tööajal või väljaspool tööaega.
Nevertheless, they follow the same principles as for ‘normal’ consumer products: hazard identification and assessment – this is the same as determining the severity of the injury, as described above;
Siiski järgitakse nende puhul samu põhimõtteid kui tavapäraste tarbekaupade puhul: ohu kindlakstegemine ja hindamine – see on võrdne vigastuse raskuse määramisega, nagu on kirjeldatud eespool;
The probability of this happening is put at 1/10, since the area of upper body exposed to the pieces flying off is considered to be 1/10 of the half-sphere in front of the wall. Of course, if the user were standing very close to the wall, his body would take a larger share of the half-sphere, and the probability would be higher. Step 3:
Selle juhtumi tõenäosuseks on määratud 1/10, sest ülakeha, mida tükid võivad tabada, moodustab seinale projitseeritavast poolsfäärist 1/10.
The piece hits the user on the head. The head is estimated to be about 1/3 of the upper body, and the probability is therefore 1/3.
Kui kasutaja seisaks seinale väga lähedal, hõlmaks tema keha suurema osa poolsfäärist ning juhtumi tõenäosus oleks suurem.
This requires rather a lot of experience, thus suggesting that the assistance of persons experienced in risk assessment should be sought (see above in section ‘Let others check your risk assessment’). As experience is gained with these guidelines estimating probability should become easier, and an increasing number of examples will become available to facilitate this task.
Eespool esitatud etappide tõenäosuste korrutamisel saame stsenaariumi üldiseks tõenäosuseks 1/10 × 1/10 × 1/3 × 1/20 = 1 / 6000.
This applies in particular to children, since children do not normally have the experience to take preventive action, on the contrary (see also ‘Vulnerable consumers’ in section 3.3). 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.
See eeldab palju kogemusi, mis tähendab, et riskihindamisel on soovitatav paluda kogenud isikute abi (vt eespool jagu „Lubage teistel teie riskihindamist kontrollida”).
This may not apply to an injury scenario with a (young) child or other vulnerable user (see table 1) who cannot read. When accidents have been reported that fit into the injury scenario, the probability for that scenario could increase.
Kuna käesolevate suunistega saadakse juurde uusi kogemusi, peaks tõenäosuse hindamine muutuma lihtsamaks ning ülesande lahendamist peaks lihtsustama ka suurem arv näiteid.
When a fairly large number of conditions are needed for the injury to occur, the overall probability of the scenario would normally be lower. When the conditions needed for the injury to occur are easily met, this may increase the probability.
kui toodet kasutab stsenaariumi järgi kaitsetum tarbija, tuleb tõenäosust üldiselt suurendada, sest kaitsetum tarbija võib palju kergemini viga saada.
Probability does not therefore describe the general exposure of the population to the product, calculated, for example, by considering the millions of product items sold on the market and then considering that a few of them might fail. Considerations of this kind do, however, play a role when determining the appropriate risk reduction measures (see section 4).
kui risk on kergesti äratuntav, sealhulgas hoiatussiltide abil, tuleb tõenäosust võib-olla väiksemaks muuta, sest kasutaja kasutab toodet hoolikamalt, et vältida nii palju kui võimalik vigastuse tekkimist.
Also, accident statistics, even if product-specific, have to be considered with care when used for to estimate probability. The circumstances of the accident may not be reported in sufficient detail, the product may have changed over time, or the manufacturer may be different, and so on.
See ei pruugi kehtida vigastusstsenaariumi puhul, kus vaatluse all on väike laps või mõni muu kaitsetu kasutaja (vt tabel 1), kes ei oska lugeda;
In addition, light accidents may not have been reported to those collecting the data for the statistics. None the less, accident statistics can shed light on injury scenarios and their probability. 3.7. Determination of risk
kui on teatatud õnnetusjuhtumitest, mis sobivad vigastusstsenaariumi juurde, võib selle stsenaariumi tõenäosus suureneda.
Once the severity of the injury and the probability have been determined, if possible for several injury scenarios, the risk level then needs to be looked up in table 4. Table 4 combines both the severity of the injury and the probability, and the highest risk is ‘the risk’ of the product.
Juhtudel kui selliseid õnnetusjuhtumeid on üksnes harva registreeritud või neid ei ole üldse teada, võib olla kasulik küsida toote tootjalt, kas ta on teadlik toote tõttu tekkinud õnnetusjuhtumitest või toote kahjulikust mõjust;
Risks requiring specific risk management measures should also be reported, to ensure that all risks are reduced to a minimum. These guidelines distinguish between 4 levels of risk: serious, high, medium and low.
kui vigastuse tekkimiseks on vaja üsna paljude eeltingimuste täitmist, on stsenaariumi üldine tõenäosus tavaliselt madalam;
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. 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.
Vigastuse tõenäosus selles näites on tõenäosus, et vigastusstsenaarium võib ka tegelikult realiseeruda.
This may mean verifying that the risk assessor has used the best information available to make his estimations and assumptions. Feedback from colleagues and other experts can also be helpful.
Tõenäosus ei kirjelda seega elanikkonna üldist kokkupuudet tootega, mis arvutatakse näiteks võttes arvesse miljoneid turul müüdud tooteid ning asjaolu, et mõned neist toodetest ei pruugi toimida nii nagu ette nähtud.
A sensitivity analysis can also be very valuable (see example in section 6.3). How does the risk level change when the severity of injury or probability changes by 1 level up or down?
Sellist liiki kaalutlustel on siiski oluline osa asjakohaste riski vähendamise meetmete kindlaksmääramisel (vt 4. peatükk).
If the risk level does not change at all, it is quite plausible that it has been estimated correctly. If it changes, however, the risk level may be borderline.
Ka õnnetusjuhtumite statistikasse, isegi kui see puudutab konkreetset toodet, tuleb tõenäosuse hindamisel ettevaatlikkusega suhtuda.
From risk to action 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.
Õnnetusjuhtumite statistika võib siiski selgitada õnnetusjuhtumite stsenaariume ja nende tõenäosust.
With a serious risk in a consumer product, measures to reduce the risk may include withdrawal from the market or recall. Lower levels of risk normally lead to less rigorous measures.
Tabelis 4 on ühendatud vigastuse raskus ja tõenäosus ning suurim risk on toote risk.
It may then be sufficient to add warning labels on the product or to improve the instructions to make the product safe. Thus, whatever the level of risk, the authority should consider whether to take action, and if so, what action.
Registreerida tuleks ka riskid, mille puhul on vajalik võtta spetsiaalseid riskijuhtimismeetmeid, et tagada, et kõik riskid on vähendatud miinimumini.
Nevertheless, there is no automatic link from risk to action. 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.
Käesolevates suunistes eristatakse nelja riskitaset: tõsine, suur, keskmine ja väike.
The pattern of risks in the product may indicate a lack of quality control in production. It is also important to take account of exposure of the population as a whole.
Kõrvutiste vigastuse raskusastmete või tõenäosuste vaheline riskitase muutub tavaliselt ühe astme võrra.
Less-than-serious risks may also require action when the product concerned could cause fatal accidents, even though such accidents may be extremely unlikely. 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.
Kui vigastuse raskus suureneb 1. astmelt 2. astmele (tabeli 4 parem pool), suurenevad teatavad riskitasemed kahe astme võrra ehk keskmiselt tõsisele ja väikeselt suurele.
A simple change of design to the lid could eliminate the risk, and no further action might be required. Even a selling-off period may be granted if the risk of a fatal accident were indeed extremely small.
See tuleneb sellest, et käesolevates suunistes on vigastused liigitatud nelja raskusastmesse, samas kui esialgses meetodis (vt sissejuhatus) oli neid viis.
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. These aspects may be especially relevant when the consumers concerned are vulnerable, in particular children.
Siiski peetakse nelja raskusastet tarbekaupade puhul tavaliseks, sest need võimaldavad raskust piisavalt usaldusväärselt hinnata.
It will be up to the national market surveillance authority(ies) to determine what measures are required. 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].
Viie taseme kasutamine oleks liiga keeruline, kuna vigastuse raskust ega ka tõenäosust ei ole võimalik väga täpselt määrata.
In conclusion, there is no automatic link from risk to action. Surveillance authorities will take account of a range of factors such as those indicated above.
Selleks võib olla vajalik kontrollida, kas riskihindaja kasutas oma hinnangute ja eelduste tegemisel parimat kättesaadavat teavet.
The principle of proportionality always has to be considered, and action has to be effective. 5. How to prepare a risk assessment – in brief
Kolleegidelt ja teistelt asjatundjatelt saadav tagasiside võib olla samuti kasulik.
Describe the product and its hazard. Describe the product unambiguously.
Väga väärtuslik võib olla ka tundlikkuse analüüs (vt jagu 6.3).
Does the hazard concern the entire product or only a (separable) part of the product? Is there only one hazard within the product? Are there several hazards? See table 2 for guidance.
Kuidas muutub riskitase, kui vigastuse raskus või tõenäosus muutub ühe astme võrra üles- või allapoole?
Identify the standard(s) or legislation applicable to the product. 2. Identify the type of consumer you want to include in your injury scenario with the hazardous product.
Kui riskitase ei muutu üldse, siis on küllalt usutav, et seda on nõuetekohaselt hinnatud.
Take other consumers (See table 1) and uses for further scenarios. 3. 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.
Sel juhul tuleb vigastusstsenaariumid ning vigastus(t)e raskus ja tõenäosus(ed) uuesti läbi vaadata.
Describe the steps to the injury(ies) clearly and concisely, without exaggerating the details (‘shortest path to injury’, ‘critical path to injury’). If there are several concurrent injuries in your scenario, include them all in that same scenario. 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. See section 3.3 and table 2 for guidance.
Tundlikkuse analüüsi lõpus peaks riskihindaja olema kindel, et riskitase on piisavalt usutav ning et ta saab seda dokumenteerida ning teabe edastada.
Toxicity Toxic solid or fluid
Äge mürgistus kopsudes (aspiratsioonipneumoonia), nakkus
Various injuries Operational inadequacy
Oluline on mõista, et raskusastet tuleks hinnata täiesti objektiivselt.
Various injuries Inadequately fitting parts
Riikide vahel võib esineda erinevusi, mis on tingitud kultuurist või erinevast tervishoiusüsteemist ja rahastamiskorrast.
Injury or consequence that normally requires hospitalisation 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.
aste: 16–35 % kehapinnast või 3. aste: kuni 35 % kehapinnast.
Type of injury Severity of injury 1 2 3 4 Laceration, cut Superficial
Sissehingamisel saadud kahjustus, mille puhul on vaja hingamisabi
External (deep) (> 10 cm long on body) (> 5 cm long on face) requiring stitches
Elektrišokk
Tendon or into joint White of eye or cornea Optic nerve Neck artery Trachea Internal organs Bronchial tube Oesophagus Aorta Spinal cord (low)
(Vt ka tabeli põletuste osa, sest elektrivool võib põhjustada ka põletushaavu).
Deep laceration of internal organs Severed high spinal cord
Lokaalne toime (lühiajaline kramp või lihase halvatus)
≤25 cm2 on face ≤50 cm2 on body Major
Neuroloogilised häired
Spinal cord causing paralysis Concussion —
Ajutine valu silmas, ravi ei ole vaja
Very short unconsciousness (minutes) Prolonged unconsciousness Coma
Ajutine nägemise kaotus
Entrapment/pinching Minor pinching —
Osaline nägemise kaotus
(Same outcome as for suffocation/strangulation.) Sprain, strain, musculoskeletal disorder Extremities Joints
Püsiv nägemise kaotus (mõlemast silmast)
Spine (no dislocation or fracture) Knee ligaments strain
Kuulmiskahjustus, võõrkeha kõrvas
Ligament or tendon rupture/tear Muscle tear Whiplash — Dislocation —
Ajutine valu kõrvas, ravi ei ole vaja
Extremities (finger, toe, hand, foot) Elbow Jaw Loosening of tooth Ankle Wrist Shoulder Hip Knee Spine Spinal column Fracture —
Ajutine kuulmishäire
Extremities (finger, toe, hand, foot) Wrist Arm Rib Sternum Nose Tooth Jaw Bones around eye Ankle Leg (femur and lower leg) Hip Thigh Skull
Osaline kuulmise kaotus
Spine (minor compression fracture) Jaw (severe) Larynx
Täielik kuulmise kaotus (ühest kõrvast)
Multiple rib fractures Blood or air in chest Neck Spinal column Crushing — —
Täielik kuulmise kaotus (mõlemast kõrvast)
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
Ainetest tingitud mürgistus (alla neelates, sisse hingates, naha kaudu)
Piercing, puncturing Limited depth, only skin involved
Kõhulahtisus, oksendamine, lokaalsed sümptomid
Deeper than skin Abdominal wall (no organ involvement) Eye Internal organs Chest wall Aorta Heart
Siseorgani, nt maksa, neeru pöörduv kahjustus, kerge hemolüütiline aneemia
Bronchial tube Deep injuries in organs (liver, kidney, bowel, etc.) Ingestion — —
Siseorgani, nt söögitoru, mao, maksa, neeru pöördumatu kahjustus, hemolüütiline aneemia, närvisüsteemi pöörduv kahjustus
Internal organ injury (Refer also to internal airway obstruction where the ingested object gets stuck high in the oesophagus.)
Närvisüsteemi pöördumatu kahjustus
Permanent damage to internal organ Internal airway obstruction —
Surm
Oxygen flow to brain blocked without permanent consequences Oxygen flow to brain blocked with permanent consequences Suffocation/Strangulation — —
Lokaalne kerge ärritus
Fatal suffocation/strangulation Submersion/Drowning — — —
Pöörduv süsteemne toime
Fatal drowning Burn/Scald (by heat, cold, or chemical substance)
Põletikuline toime
1o, up to 100 % of body surface 2o, < 6 % of body surface
Kopsud, hingamispuudulikkus, keemiline kopsupõletik
2o, 6-15 % of body surface 2o, 16-35 % of body surface, or 3o, up to 35 % of body surface Inhalation burn
Pöördumatu süsteemne toime
or 3o, > 35 % of body surface Inhalation burn requiring respiratory assistance
Osaline nägemise kaotus
Electric shock (See also under burns as electric current can cause burns.)
Söövitav toime
Local effects (temporary cramp or muscle paralysis) —
Kopsud, vaja on hingamisabi
Electrocution Neurological disorders — —
Lämbumine
Triggered epileptic seizure —
Allergiline reaktsioon või ülitundlikkuse põhjustamine
Eye injury, foreign body in eye Temporary pain in eye without need for treatment
Kerge või lokaalne allergiline reaktsioon
Temporary loss of sight Partial loss of sight
Allergiline reaktsioon, levinud allergiline kontaktdermatiit
Permanent loss of sight (one eye) Permanent loss of sight (both eyes)
Tugeva ülitundlikkuse põhjustamine, kutsudes esile allergia mitme aine suhtes
Hearing injury, foreign body in ear Temporary pain in ear without need for treatment
Anafülaktiline reaktsioon, šokk
Complete loss of hearing (one ear) Complete loss of hearing (both ears)
Kõhulahtisus, oksendamine, lokaalsed sümptomid
Diarrhoea, vomiting, local symptoms Reversible damage to internal organs, e.g. liver, kidney, slight haemolytic anaemia
Surm
Irreversible damage to internal organs, e.g. oesophagus, stomach, liver, kidney, haemolytic anaemia, reversible damage to nerve system Irreversible damage to nerve system Fatality
Siseorgani, nt söögitoru, mao, maksa, neeru pöördumatu kahjustus, hemolüütiline aneemia, närvisüsteemi pöörduv kahjustus
Irritation, dermatitis, inflammation or corrosive effect of substances (inhalation, dermal) Local slight irritation
Vähk (leukeemia)
Reversible eye damage Reversible systemic effects Inflammatory effects
Mõju paljunemisvõimele
Lungs, respiratory insufficiency, chemical pneumonia Irreversible systemic effects Partial loss of sight
Mõju järglastele
Corrosive effects Lungs, requiring respiratory assistance Asphyxia
Kesknärvisüsteemi depressioon
Allergic reaction or sensitisation Mild or local allergic reaction
Mikrobioloogiline nakkus
Strong sensitisation, provoking allergies to multiple substances Anaphylactic reaction, shock Fatality
Pöördumatu mõju
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
Tabel 4